Pharmacological Action
Acryth® suspension is highly effective against most strains of the following microorganisms, both in vitro and in clinical infections:

Gram-positive microorganisms: Streptococcus pneumoniae, Streptococcus pyogenes, Staphylococcus aureus, Corynebacterium diphtheriae, Corynebacterium minutissimum and Listeria monocytogenes.
Gram-negative microorganisms: Haemophilus influenzae, Bordetella pertusis, Legionella pneumophilia, Campylobacter jejuni and Neisseria gonorrhoeae.
Other microorganisms: Mycoplasma pneumoniae, Chlamydia trachomatis, Entamoeba histolytica, Treponema pallidum and Ureaplasma urealyticum.

Mechanism of Action
Acryth® suspension inhibits protein synthesis by binding to the 23S rRNA molecule (in the 50S subunit) of the bacterial ribosome blocking the exit of the growing peptide chain of sensitive microorganisms.

Therapeutic Indications:
Acryth® suspension is the drug of choice in the following indications-
Alternative to a penicillin in penicillin-sensitive patients-

• Penicillin-resistant staphylococcal infections
• Alternative to a tetracycline in mycoplasma pneumonia
• Pertussis, diphtheria- especially in treatment of the carrier state
• Rheumatic fever prophylaxis
• Chronic bronchitis
  
• Otitis media
• Chronic prostatitis.
  

Adults:
The usual dose is 250mg 6 hourly. This may be increased up to 4gm per day according to the severity of the infections.

Children
The usual regimen is 30-50mg/kg/day. In severe cases this dosage may be doubled.

Contraindications
Acryth® suspension is contraindicated in patients hypersensitive to Erythromycin.

Use in patients with impaired hepatic function
Acryth® suspension should be given with care in patients with impaired hepatic function.

Ergotamine: Concurrent use of Erythromycin & Ergotamine has been associated in some patients with acute ergot toxicity characterized by severe peripheral vasospasm and dysesthesia.

Warfarin: Acryth® suspension may decrease the clearance of warfarin and thus potentiate the hypoprothrombinic effect of warfarin.

Theophylline: Acryth® suspension use in patients who are receiving high doses of Theophylline may be associated with an increase in serum Theophylline levels and potential Theophylline toxicity.

Use in Pregnancy & Lactation
Acryth® suspension is a pregnancy category B drug and considered compatible with breast feeding by the American Academy of Paediatrics.

Acryth® suspension is one of the safer antibiotics, gastrointestinal disturbances and allergy being the commonest (0.5-5%) adverse effects.

PHARMACEUTICAL INFORMATION
Storage & Conditions
Store in a cool (below 30ºC) and dry place, away from light. Keep out of reach of children.
Presentation & Packaging
Acryth® suspension: Each amber glass bottle contains dry powder for preparation of 100ml suspension.

Pharmacological Action
Algerd® works by forming a raft (thick layer) on top of the stomach contents soon after it has made contact with the stomach acid. The raft acts as a strong physical barrier and helps keep all the components of the stomach contents in the stomach where they work, not letting them seep back up into the esophagus where they hurt.

Therapeutic Indications:
Treatment of symptoms of gastro-esophageal reflux, such as acid regurgitation, heartburn and indigestion (related to reflux), for example, following meals or during pregnancy or in patients with symptoms related to reflux esophagitis.

Daily 4 times, after meals & before bedtime.
Adult and child over 12 years: 5-10 ml.
Child 2-12 years: 2.5-5 ml.
Algerd® is not recommended for children under 2 years of age.

Sodium Alginate and Potassium Bicarbonate is contraindicated in patients with known hypersensitivity to these.

Concomitant use of other drug treatments should be done under physician's instructions in order to prevent hazards or inefficacy arising from drug interactions.

Algerd® should be prescribed with caution in patients with renal impairment and congestive cardiac failure.

Overdosage with this formulation is a rare case. In case of overdose please consult with a registered physician.

In addition to the desired effect of the drug, some side effects may appear such as: nausea, constipation, diarrhoea or headache. In these cases consult a physician. In case excess dosage has been taken, there might appear a sensation of swelling. In this case it is advisable to consult a physician.

Algerd® can be given in pregnant and lactating women.

Storage & Conditions:
Store in a cool place (in room temperature, below 30 °C).
Presentation & Packaging:
Algerd® Suspension: Bottle containing 200 ml of suspension.

Pharmacological Action
Ketotifen has anti-allergic properties and has been used similarly, to sodium chromoglicate in the prophylactic treatment of asthma. It also has the properties of an antihistamine. Ketotifen (Allerkit®) possesses marked anti-anaphylactic properties and is effective in preventing asthamatic attack. Ketotifen (Allerkit®) exerts as sustained inhibitory effect on histamine reactions, which can be clearly dissociated from its anti-anaphylactic properties experimental investigations in asmatic subject have shown that Ketotifen is as effective orally as a selective mast cell stabilizer administered by inhalation. Antihistamine were ineffective in those tests, the effectiveness of Ketotifen has been studied in long term clinical trials. Asthma attacks were reduced in number, severity and duration and in some cases, the patients were completly freed from attacks. Progressive reduction of corticosteroids and/or bronchodilators was also possible the prophylactic activity of Ketotifen may take several weeks to become fully established. Ketotifen will not abort established attacks of asthma.

Therapeutic Indications:
Prophylactic treatment of bronchial asthma.
Symptomatic treatment of allergic conditions including rhinitis and conjuctivitis.

Children above 3 years: 1mg (5ml of syrup) twice daily.
Children 6 months -3 years: 0.5 mg (2.5ml of syrup) twice daily.

Hypersensitivity to Ketotifen or any other components of the formulation.

A reversible fall in the thrombocyte count in patients receiving Ketotifen concomitantly with oral anti-diabetic agents has been observed in rare case. So it has been suggested that this combination should therefore be avoided. Ketotifen may potentiate the effects of sedatives, hypnotics, anti-histamins and alcohol.

Pregnancy: Its safety in human pregnancy has not been established. Ketotifen should therefore be given to pregnant women only in compelling circumstances.
Lactation: Ketotifen is excreted in breast milk. Therefore mothers receiving Ketotifen should not breast-feed.

It is important to continue the previous treatment for a minimum of two weeks after starting Ketotifen to avoid the possibility of exacerbation of asthma. This applies specially to systemic corticosteroids and ACTH because of the possible existence of adrenocortical insufficiency in steroid depended patient if inter current infection occurs, ketotifen treatment must be supplemented by specific antimicrobial therapy. During the first day of treatment with Kitotifen, reaction may be impaired and patient should be warned not to take charge of vehicle or machinery until the effect of Kitotifen treatment on the individual is known. Patient should be advised to avoid alcoholic drinks. Kitotifen may potentiate the effects of sedatives, hypnoties, antihistamines and alcohol.

The reported features of overdose include confusion, drowsiness , headache, bradycardia, respiratory depression etc. should be watched for elimination of the drug with gastric lavage or emesis is recommended. Otherwise general supportive treatment is all that is required shall be instituted.

Drowsiness and in isolated cases, dry mouth and slight dizziness may occur at the beginning of treatment but usually disappear spontaneously after a few days.

Storage & Conditions:
Store in a cool and dry place, protected from light, keep out of the reach of children.
Presentation & Packaging:
Allerkit® Syrup: Each amber pet bottle contains 100ml syrup.

Pharmacological Action:
Ketotifen is a relatively selective, non-competitive histamine antagonist (H1-receptor) and mast cell stabilizer. Ketotifen inhibits the release of mediators (e.g. histamine, leukotrienes, prostaglandin etc.) from cells involved in hypersensitivity reactions (mast cell, eosinophils, basophils and neutrophils). Ketotifen also reduces the chemotaxis, activation and degranulation of eosinophils.The antihistaminic effect of Ketotifen eye drops is significantly more effective than placebo in preventing ocular itching associated with allergic conjunctivitis. The actions of Ketotifen occur rapidly within minutes after administration and persist for 8-12 hours.

Therapeutic Indications:
Allerkit-E® Sterile Eye Drops is indicated for the treatment of signs & symptoms (itchy, watery, red & swollen eyes and/or eyelids) of allergic conjunctivitis including vernal keratoconjunctivitis, vernal keratitis, blepharitis, blepharoconjunctivitis, and giant papillary conjunctivitis.

Adults and children over 3 years of age: 1 drop Allerkit-E® Sterile Eye Drops into the conjunctival sac of the affected eye(s) twice a day or as directed by the physician.
Children below 3 years of age: Not recommended.

Allerkit-E® Sterile Eye Drops is contraindicated in patients with known hypersensitivity to ketotifen or to any of the excipients of the preparation.

Pregnancy:There are no adequate and well-controlled studies about the use of Ketotifen eye drops in pregnant women. Systemic levels after ocular administration are much lower than oral use. Caution should be exercised when prescribing to pregnant women.

Lactation:Topical administration to humans is unlikely to produce detectable quantities in breast milk. Allerkit-E® Sterile Eye Drops can be used during lactation.

If Allerkit-E® Sterile Eye Drops is used concomitantly with other eye medications there must be an interval of at least 5 minutes between the two medications.

Storage Conditions:
Close the bottle immediately after use. Do not use more than 1 month after opening the bottle. Keep in a cool and dry place, protect from light. Keep all the medicines out of reach of children.

Allerkit-E® Sterile Eye Drops: Each plastic dropper bottle contains 5 ml eye drops.

Pharmacological Action
Ancliz® is a combination of Meclizine HCl and Pyridoxine HCl. Meclizine HCl is a piperazine-derivative antihistamine that is used as an antiemetic. It has antiemetic, anticholinergic and antihistaminic properties. It exhibits its action by an effect on CNS, possibly by its ability to block muscarinic receptors in the brain.

It has marked effects in blocking the vasodepressor response to histamine, but only a slight blocking action against acetylcholine. It reduces the sensitivity of the labyrinthine apparatus. The site and mechanism of action of Meclizine HCl in controlling vertigo from various conditions have not been clearly defined. Pyridoxine HCl (vit-B6), either alone or combination has been used to prevent nausea and vomiting due to its antiemetic properties.

Therapeutic Indications: For prophylaxis and symptomatic relief of nausea, vomiting, dizziness, motion sickness, radiation sickness and vertigo associated with diseases of vestibular system (e.g. Meniere's syndrome, labyrinthitis and other vestibular disturbances) and morning sickness during pregnancy.

The fixed-dose combination (FDC) is recommended for oral administration.
Nausea & vomiting (including morning sickness in pregnancy): One tablet 1-2 times daily or as directed by physician.
Motion sickness: The initial dose is one or two tablets daily; it should be taken one hour prior to journey for protection against motion sickness. Therefore, the dose may be repeated every 24 hours as indicated for the duration of journey.
Vertigo: One tablet two times daily or as directed by physician.
Labyrinthine and vestibular disturbances: The optimal dose of Meclizine HCl is usually 25 to 100mg daily in divided doses, depending on the clinical response.
Radiation sickness: 50mg (Meclizine HCl) administered 2 to 12 hours prior to radiation treatment. Pyridoxine (vitamin B6) has been shown to be safe and effective in dosages of 50 to 200mg per day.

The fixed-dose combination is contra-indicated in individuals who have shown a previous hypersensitivity to these ingredients.

There may be increased CNS depression when Meclizine HCl and Pyridoxine HCl is administered concurrently with other CNS depressants, including benzodiazepines, barbiturates, tricyclic antidepressants, opiate agonists, skeletal muscle relaxants, antihistamines, alcohol, tranquilizers. Meclizine HCl can increase the absorption of digoxin by decreasing gastrointestinal motility. MAO inhibitors may prolong and intensify the anticholinergic effects of meclizine HCl.

Drowsiness, dry mouth, urinary retention or rare occasions, blurred vision have been reported.

Due to its potential anticholinergic action, patient with asthma, bronchitis, emphysema, enlarged prostate, glaucoma or urinary tract blockade should take meclizine HCl (like other antiemetics) with caution. Although meclizine HCl may excrete into the milk, it causes no harm in nursing babies.
Meclizine HCl: Pregnancy category B. Large-scale human studies have not demonstrated adverse fetal effects. It has been suggested that, based on available data, meclizine HCl presents the lowest risk of teratogenicity and is the drug of first choice in treating nausea and vomiting during pregnancy.
Pyridoxine HCl: Pregnancy category A. Pyridoxine HCl itself is considered safe during pregnancy and has been used in pregnant women without any evidence of fetal harm.

Symptoms: Extreme excitability, seizure, drowsiness, temporary nerve damage, hallucination.
Treatment: Appropriate supportive and symptomatic treatment.

Storage & Conditions:
Store in a cool, dry place, away from light. Keep out of reach of children.
Presentation & Packaging:
Ancliz ® tablet: Each commercial box contains 5x10's, tablets in blister pack.

Pharmacological Action:
Cytochrome C is involved in the oxidative phosphorylation for synthesizing ATP from ADP. Anhydrous Sodium Succinate (intermediate substance) promotes the production of ATP. Adenosine plays essential role in producing energy required for the vital function of the life lens e.g. the biosynthesis of glutathione, intermembrane active transport of ions and amino acid, the synthesis of DNA, RNA and nucleic acids. Nicotinamide is said to be involved in the process of creating ATP. NADPH plays a major role in protecting cell against oxidizing agents and from free radicals by maintaining glutathione in its reduced form.

Therapeutic Indications:
Ancys® Sterile Eye Drops is used for the treatment of lens opacification.

One drop into the affected eye twice daily.

Ancys® Sterile Eye Drops is contraindicated in patients with known hypersensitivity to any ingredient of the product.

In pregnancy and lactation, it is recommended to take advice from doctor before using Ancys® Sterile Eye Drops.

No specific drug interaction has been demonstrated.

Storage Conditions:
Close the bottle immediately after use. Do not use more than 1 month after opening the bottle. Keep in a cool and dry place, protect from light. Keep all the medicines out of reach of children.

Ancys® Sterile Eye Drops: Each plastic dropper bottle contains 5 ml eye drops.

Pharmacological Action:
Iron sucrose is dissociated into iron and sucrose by the reticuloendothelial system . Iron is trensferred from the blood to a pool of iron in the liver and bone marrow. The Ferritin (Iron Storage protein) binds and sequesters Iron into a nontoxic Iron. The Iron binds to plasma transferrin, which carries Iron within the plasma and the extracellular fluid to supply to the tissues.

Anofer® (Iron Sucrose) is indicated for the treatment of iron deficiency in the following conditions:

• Where there is a clinical need for a rapid iron supply in patients who cannot tolerate oral iron therapy or who are non-compliant and in active inflammatory bowel disease where oral preparations are ineffective.
• Treatment of iron deficiency anemia in pregnancy, non-dialysis dependent-chronic kidney disease (CKD) patients either receiving or not receiving an erythropoietin and hemodialysis dependent-CKD patients receiving an erythropoietin, or peritoneal dialysis-CKD patients receiving an erythropoietin.

Adults and the elderly: The total cumulative dose of Iron Sucrose, equivalent to the total iron deficit (mg), is determined by the haemoglobin level and body weight. The dose for Iron Sucrose must be individually determined for each patient according to the total iron deficit calculated with the following formula: Total iron deficit [mg]= body weight [kg] x (target Hb - actual Hb) [g/l] x 0.24* + depot iron [mg]

• Below 35 kg body weight: target Hb = 130 g/l and depot iron = 15 mg/kg body weight.
• 35 kg body weight and above: target Hb = 150 g/l and depot iron = 500 mg.

*Factor 0.24 = 0.0034 x 0.07 x 1000 (Iron content of haemoglobin 0.34%; Blood volume 7% of body weight; Factor 1000 = conversion from g to mg)

The total single dose must not exceed 200 mg of iron given not more than three times per week. If the total necessary dose exceeds the maximum allowed single dose, then the administration has to be split. Iron Sucrose must only be administered by the intravenous route. This may be by a slow intravenous injection or by an intravenous drip infusion. Before administering the first dose to a new patient, a test dose of Iron Sucrose should be given. Iron Sucrose must not be used for intramuscular injection.

Intravenous drip infusion: Iron Sucrose must be diluted only in sterile 0.9% m/V sodium chloride solution:

• 5 ml Iron Sucrose (100 mg iron) in max. 100 ml sterile 0.9% m/V sodium chloride solution
• 10 ml Iron Sucrose (200 mg iron) in max. 200 ml sterile 0.9% m/V sodium chloride solution

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For stability reasons, dilutions to lower Iron Sucrose concentrations are not permissible. Dilution must take place immediately prior to infusion and the solution should be administered as follows:

• 100 mg iron (5 ml Iron Sucrose) in at least 15 minutes
• 200 mg iron (10 ml Iron Sucrose) in at least 30 minutes

The first 25 mg of iron (i.e. 25 ml of solution) should be infused as a test dose over a period of 15 minutes. If no adverse reactions occur during this time then the remaining portion of the infusion should be given at an infusion rate of not more than 50 ml in 15 minutes.

Intravenous injection: Iron Sucrose may be administered by slow intravenous injection at a rate of 1 ml undiluted solution per minute (i.e. 5 minutes per ampoule) and not exceeding 2 ampoules Iron Sucrose (200 mg iron) per injection. Before administering a slow intravenous injection, a test dose of 1 ml (20 mg of iron) should be injected slowly over a period of 1 to 2 minutes. If no adverse events occur within 15 minutes of completing the test dose, then the remaining portion of the injection may be given.

Injection into dialyser: Iron Sucrose may be administered during a haemodialysis session directly into the venous limb of the dialyser under the same procedures as those outlined for intravenous injection.

The use of Iron Sucrose is contra-indicated in cases of known hypersensitivity to Iron Sucrose or any of its excipients, anaemias not attributable to iron deficiency, iron overload or disturbances in utilisation of iron, patients with a history of asthma, eczema or other atopic allergy, because they are more susceptible to experience allergic reactions, pregnancy first trimester.

Parenterally administered iron preparations can cause allergic or anaphylactoid reactions, which may be potentially fatal. Therefore, treatment for serious allergic reactions and facilities with the established cardio-pulmonary resuscitation procedures should be available. In patients with liver dysfunction, parenteral iron should only be administered after careful risk/benefit assessment. Parenteral iron administration should be avoided in patients with hepatic dysfunction where iron overload is a precipitating factor. Careful monitoring of iron status is recommended to avoid iron overload. Parenteral iron must be used with caution in case of acute or chronic infection. It is recommended that the administration of iron sucrose is stopped in patients with ongoing bacteraemia. In patients with chronic infection a risk/benefit evaluation has to be performed, taking into account the suppression of erythropoiesis. Hypotensive episodes may occur if the injection is administered too rapidly. Allergic reactions, sometimes involving arthralgia, have been more commonly observed when the recommended dose is exceeded. Paravenous leakage must be avoided because leakage of Iron Sucrose at the injection site may lead to pain, inflammation, tissue necrosis and brown discoloration of the skin. Do not save unused solution for future use. Do not administer if particular matter or discoloration noted.

Occasionally metallic taste, headache, nausea, vomiting, hypotension may occur. Parasthesia, abdominal disorders, muscular pain, fever, urticaria, flushing, edema of the extremities, anaphylactoid (pseudoallergic) reactions may occur rarely.

Iron Sucrose should not be administered concomitantly with oral iron preparations since the absorption of oral iron is reduced. Therefore, oral iron therapy should be started at least 5 days after the last injection of Iron Sucrose.
Incompatibility: Do not mix with other medications or therapeutic agents, which may potential for precipitation and/or interaction.

Use in pregnancy: Pregnancy Category B.
Use in lactation: It is not known whether this drug is excreted in human breast milk. Because many drugs are excreted in breast milk, exercise caution when iron sucrose is administered to a breastfeeding woman.
Use in children: Safety and effectiveness of Iron Sucrose in pediatric patients have not been established.

Anofer® IV Injection: Each box contains 1 amber ampoule containing 5ml Iron Sucrose injection in Alu-PVC blister, 1 disposable syringe (5cc), 1 infusion set with butterfly needle.

Pharmacological Action
Acryth® suspension is highly effective against most strains of the following microorganisms, both in vitro and in clinical infections:

Gram-positive microorganisms: Streptococcus pneumoniae, Streptococcus pyogenes, Staphylococcus aureus, Corynebacterium diphtheriae, Corynebacterium minutissimum and Listeria monocytogenes.
Gram-negative microorganisms: Haemophilus influenzae, Bordetella pertusis, Legionella pneumophilia, Campylobacter jejuni and Neisseria gonorrhoeae.
Other microorganisms: Mycoplasma pneumoniae, Chlamydia trachomatis, Entamoeba histolytica, Treponema pallidum and Ureaplasma urealyticum.

Mechanism of Action
The 5-nitro group of metronidazole undergoes reductive transformation to an active metabolite that exerts a lethal effect on DNA of bacteria and ultimately contributes to cell death.

Therapeutic Indications:
Anzole®400 (Metronidazole) is indicated in the prophylaxis and treatment of infections in which anaerobic bacteria have been identified or are suspected to be the cause. It is indicated in -

• Urogenital trichomoniasis in the female and male
• Intestinal and extra-intestinal amoebiasis
• Giardiasis
• Anaerobic bacterial infections
• Non-specific vaginitis
• Anaerobically-infected ulcers and pressure sores

Adults

Indications	Duration in days	Adults & children over 10 years
Amoebic dysentery	5-10 or 2	800mg t.i.d.
Asymptomatic amoebiasis	5-10	400-800mg t.i.d.
Hepatic and extra-intestinal amoebiasis	5-10 or 2	400-800mg t.i.d.
Trichomoniasis consort treatment is recommended	7 or 2 or 1	200mg t.i.d. 800mg morning
Vincent's infection /Acute ulcerative gingivitis	3	200mg t.i.d. or 400mg b.i.d.
Anaerobic infection	7	400mg t.i.d.
Non specific vaginitis	7	400mg t.i.d.
Leg ulcer and pressure sores	7	400mg t.i.d.

Indications	Duration in days	Children
		7-10 years	3-7 years	1-3 years
Amoebic dysentery	5-10 or 2	400mg t.i.d.	200mg q.i.d.	200mg t.i.d.
Asymptomatic amoebiasis	5-10	200-400mg t.i.d	100-200mg q.i.d	100-200mg t.i.d
Hepatic and extra-intestinal amoebiasis	5-10 or 2	200-400mg t.i.d	100-200mg q.i.d.	100-200mg t.i.d.
Giardiasis	3	1g once daily	600mg once daily	400mg once daily
Trichomoniasis consort treatment is recommended	7 or 2 or 1	100mg t.i.d.	100mg b.i.d	50mg t.i.d.
Vincent's infection / Acute ulcerative gingivitis	3	100mg t.i.d.	100mg t.i.d.	50mg t.i.d.
Anaerobic infection	7	7.5mg/kg body weight t.i.d.
Non specific vaginitis	7
Leg ulcer and pressure sores	7

Anzole®400 is contraindicated in patients with prior history of hypersensitivity to Metronidazole or other Nitroimidazole derivatives.

Reduction in the dosage of Anzole®400 is required only when liver function is very poor.

Pharmacokinetic studies have indicated that doses of Anzole®400 need not be altered in patients with renal impairment although an additional dose after haemodialysis is recommended to replace that lost during haemodialysis.

Metronidazole has been found to interact with alcohol and warfarin, phenytonin, phenobarbitone, fluorouracil, disulfiram, lithium, and cimetidine.

When metronidazole has been administered during pregnancy, no adverse effects have been noted in the mother or fetus. However, it is recommended that metronidazole not be given during the first trimester of pregnancy and avoided during the later trimesters if possible. If use is deemed necessary, short high-dose regimen is recommended. The efficacy of metronidazole in serious anaerobic infections has to be weighed against potential, but unproved, mutagenic and teratogenic effects. From limited data, metronidazole appears to cross the placenta, as would be expected from its lipid solubility. Metronidazole penetrates well into breast milk. If exposure of the neonates to metronidazole is to be avoided, breast-feeding should be delayed until 48 hours after discontinuing metronidazole in the mother.

Undesirable effects of Metronidazole include gastrointestinal discomfort, nausea, coated tongue, dryness of mouth and unpleasant metallic or bitter taste, headache, pruritus and skin rashes and less frequently, vertigo, depression, insomnia, drowsiness, urethral discomfort, and darkening of the urine. Occasionally there may be temporary moderate leucopenia. Peripheral neuropathy has been reported in patients on prolonged therapy.

Storage & Conditions
Store in cool (below 30ºC) and dry place, away from light. Keep out of reach of children.
Presentation & Packaging
Anzole®400 tablet: Each box Containing 10x10 tablets in Alu-PVC blister pack.

Each film-coated tablet contains:
Vitamin A - 5000 IU
Vitamin C - 60 mg
Vitamin D - 400 IU
Vitamin E - 30 IU
Vitamin K - 25 mg
Thiamine Mononitrate - 1.5 mg
Riboflavin - 1.7 mg
Niacin - 20 mg
Vitamin B6 - 2 mg
Folic acid - 400 mg
Vitamin B12 - 6 mg
Biotin - 30 mg
Calcium - 162 mg
Iron - 18 mg
Phosphorus - 109 mg
Iodine - 150 mg
Magnesium - 100 mg
Zinc - 15 mg
Selenium - 20 mg
Copper - 2 mg
Manganese - 2 mg
Chromium - 120 mg
Molybdenum - 75 mg
Chloride - 72 mg
Potassium - 80 mg
Boron - 150 mg
Nickel - 5 mg
Silicon - 2 mg
Tin - 10 mg
Vanadium - 10 mg
Lutein - 250 mg

AtoZin® tablet maintains a healthy body and active lifestyle and keeps nutrition covered for all. AtoZin® is a once-daily tablet indicated for use to improve the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and non-lactating mothers. This preparation can also be beneficial in improving the nutritional status of women prior to conception and geriatric patients.

AtoZin® may be administered once daily or as directed by the physician.

AtoZin® is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Long-term intake of high levels of vitamin A (excluding that sourced from b carotene) may increase the risk of osteoporosis in postmenopausal women.

No clinically significant drug interactions have been reported.

Generally well tolerated.

Pregnancy and lactation: AtoZin® is recommended in pregnancy and lactation.

AtoZin® Tablet: 30 tablets in HDPE container.

Pharmacological Action
Azithromycin is macrolides antibiotic. Macrolides are products of actinomycetes (soil bacteria) or semi-synthetic derivatives of them. Mechanism of Action
Azithromycin acts by binding to the 50s ribosomal subunit of susceptible microorganisms and interfering with microbial protein synthesis. Azithromycin interferes with ribosome function in susceptible bacteria by inhibiting the translocation of peptides.

Therapeutic Indications:
Azimon®500 is indicated for infections caused by susceptible organisms-

In upper respiratory tract infections including -

• Sinusitis
• Pharyngitis and tonsillitis
• Giardiasis

In lower respiratory tract infections including -

• Bronchitis and pneumonia
• Skin and soft tissue infections
• Acute bacterial exacerbations of chronic obstructive pulmonary disease

Adults

Diseases	Dose	Frequency	Duration
Community-acquired pneumonia	500 mg	Once daily	For day 1 and 250 mg once daily from day 2 through day 5
Pharyngitis/tonsillitis	500 mg	Once daily	For day 1 and 250 mg once daily from day 2 through day 5
Acute bacterial exacerbations of chronic obstructive pulmonary disease	500 mg	Twice daily	3 days
Skin and soft tissue infections	500 mg	Once daily	For day 1 and 250 mg once daily from day 2 through day 5
Acute sinusitis	500 mg	Twice daily	3 Days
Typhoid Fever	500 mg	Once daily	5 Days

For children over 6 months recommended dose is 10 mg/kg once daily for 3 days; or if body weight is 15-25 kg. Children above 15 years of age is applicable for the adult dose.

Azithromycin is contraindicated in patients hypersensitive to Azithromycin or any other macrolide antibiotic. Co-administration of ergot derivatives and Azithromycin is contraindicated.

No dosage adjustment is recommended for subjects with renal impairment.

The pharmacokinetics of Azithromycin in subjects with hepatic impairment has not been established.

Normal adult dosage is recommended.

Azithromycin absorption is reduced in presence of food and antacid. In patients receiving ergot alkaloids, Azithromycin should be avoided concurrently because of the possibility of ergotism resulting from interaction of Azithromycin with the cytochrome P450 system. However, no cases of such interaction have been reported. Macrolides have been known to increase the plasma concentration of Digoxin and Cyclosporin. There have been no pharmacokinetic drug interactions between Azithromycin and Warfarin, Theophylline, Carbamazepine, Methylprednisolone and Cimetidine.

Pregnancy: Animal reproduction studies have demonstrated that Azithromycin crosses the placenta, but have revealed no evidence of harm to the fetus. There are no adequate and well controlled studies in pregnant women. Since animal reproduction studies are not always predictive of human response, Azithromycin should be used during pregnancy only if adequate alternatives are not available.
Lactation: No data on secretion of Azithromycin in breast milk is available, so, Azithromycin should only be used in lactating mothers where adequate alternatives are not available.

Azithromycin is well tolerated with a low incidence of side effects. Majority of the side effects were mild to moderate in nature and of gastrointestinal in origin with nausea, abdominal discomfort, vomiting, flatulence and diarrhea. Allergic reaction such as rash have occurred and there have also been rare reports of serious hypersensitivity reactions.

Storage Conditions
Store in cool and dry place, away from light. Keep out of reach of children.
Presentation & Packaging
Azimon®500 tablet: Each commercial box contains 2 x 4's tablets in blister pack.

Pharmacological Action
Cefmix® is a broad spectrum cephalosporin antibiotic of third generation for oral administration. It is a bactericidal antibiotic and is stable to hydrolysis by many beta-lactamases. Cefmix® kills bacteria by interfering in the synthesis of the bacterial cell wall. Cefmix® is highly active against Nesseria gonorrhoeae, Haemophilus influenzae, Moraxella catarrhalis including betalactamase producers, most of the Enterobacteriacae, beta-haemolytic Streptococci (group A & B) and Streptococcus pneumoniae. Cefmix® is more active than other oral cephalosporins against Escherichia coli, Klebsiela spp., Proteus mirabilis and Streptococcus pyogenes. 40-50% of an oral dose is absorbed from gastro-intestinal tract, whether taken with meals or not. The plasma half-life is usually about 3 to 4 hours and may be prolonged when there is renal impairment. About 65% is bound to plasma protein. Cefmix® is mainly excreted unchanged in bile and urine.

inhibits bacterial cell wall synthesis by binding to one or more of the penicillin binding proteins (PBPs); which in turn inhibit the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls, thus inhibiting cell wall biosynthesis. Bacteria eventually lyse due to ongoing activity of cell wall autolytic enzymes (autolysins and murein hydrolases) while cell wall assembly is arrested.

Absorption: 40% to 50%
Distribution: Widely throughout the body and reaches therapeutic concentration in most tissues and body fluids, including synovial, pericardial, pleural, peritoneal; bile, sputum and urine; bone, myocardium, gallbladder, and skin and soft tissue.
Protein binding: 65%
Bioavailability: Bioavailability of suspension is higher than that of the tablet.
Half-life elimination: Normal renal function: 3-4 hours; Renal failure: Up to 11.5 hours.
Time to peak, serum: 2-6 hours; delayed with food.
Excretion: Urine (50% of absorbed dose as active drug); feces (10%).

Therapeutic Indications:
Cefmix® is indicated for the treatment of urinary tract infections, upper and lower respiratory tract infections, acute otitis media, gonococcal urethritis and enteric fever.

Cefmix® suspension: Child dose: 8mg/kg daily as a single dose or in two divided doses for 7-14 days, For children of age, 1/2 -1 year: 3.75ml or 75mg; 1-4 years: 5ml or 100mg; 5-10 years: 10ml or 200mg; 11-12 years: 15ml or 300mg; above 12 years: adult dose may be administered; For enteric fever in children, 10mg/kg/day for 14 days has been recommended.

Use in children:
Safety and effectiveness of cefixime in children aged less than six months old have not been established.

Contraindication:
It is contraindicated in patients with known hypersensitivity to cephalosporin group of drugs. Cefixime should be administered with caution in patients with markedly impaired renal function.

Use in patients with impaired renal function:
Dosage in Renal Impairment: Normal dose and schedule may be given in patients with creatinine clearances of 20ml/min or greater. In patients whose creatinine clearance is less than 20ml/min, it is recommended that a dose of 200mg once daily should not be exceeded.

Use in patients with impaired hepatic function:
Transient elevations in SGPT, SGOT, alkaline phosphatase, hepatitis, jaundice.

Use in elderly patients:
Elderly patients may be given the same dose as recommended for adults. Renal function should be assessed and dosage should be adjusted in severe renal impairment.

In common with other cephalosporins, increases in prothrombin times have been noted in a few patients. Care should therefore be taken in patients receiving anticoagulant therapy. A false positive reaction for glucose in the urine may occur with Benedict's or Fehling's solutions or with copper sulphate test tablets, but not with test based on enzymatic glucose oxidase reactions toxicity. Probenecid should not be administered concurrently with ketorolac tromethamine because of increases in ketorolac plasma level and half-life.

Use in Pregnancy & Lactation:
Reproduction studies have been performed in mice and rats at doses up to 400 times the human dose and have revealed no evidence of impaired fertility or harm to the foetus due to cefixime. There are no adequate and well controlled studies in pregnant women. Cefixime should therefore not be used in pregnancy or in nursing mothers unless considered essential by the physician.

Cefmix® is generally well tolerated. The majority of adverse reactions observed in clinical trials were mild and self-limiting in nature. Gastrointestinal disturbances include diarrhoea, nausea, abdominal pain, dyspepsia, vomiting and flatulence. CNS disturbances include headache and dizziness.

Storage Conditions:
Store in a cool (below 30C) and dry place, away from light. Keep out of reach of children.
Presentation & Packaging:
Cefmix® Suspension: Each amber glass bottle contains dry powder for preparation of 50ml suspension.

Pharmacological Action
Calcium is used as a pharmacological agent in humans almost entirely to remedy deficiency. Adequate calcium in the blood is so vital to a wide variety of bodily functions that our internal biochemistry will not tolerate a deficiency even for short periods. Clinical evidence suggests that calcium is useful for the prevention and treatment of osteoporosis and associated fractures. Vitamin-D is also essential for healthy bones as it aids in calcium absorption from the GI tract. In addition to this it stimulates bone formation. Clinical studies show that calcium and vitamin-D has synergistic effects on bone growth as well as in Osteoporosis and fracture prevention.

Mechanism of Action
Calsto D ® (Calcium with Vitamin D3) supports optimal calcium absorption and bone mineral composition, in addition of promoting potential cardiovascular and colon health. Several clinical trials reveal the positive effects of combined supplemental calcium and vitamin D for bone health. Vitamin D is important for its ability to promote intestinal calcium and phosphorous absorption, reduce urinary calcium loss and enhance healthy bone composition. Supplementation with calcium and vitamin D daily for one and a half years supported bone composition of the femur. Calcium and vitamin D supplementation promoted calcium utilization and maintained healthy bones in postmenopausal women. Vitamin D may also provide cardiovascular support for some individuals, which may be attributed to its effect on calcium metabolism or possibly by helping to maintain healthy plasma renin function. Additionally, calcium has been associated with supporting distal colon health. A role for vitamin D in supporting colon health by promoting healthy cellular function has also been suggested. Preliminary evidence suggests that vitamin D may also support healthy glucose metabolism, since vitamin D receptors are present on the islet cells of the pancreas.

Therapeutic Indication
Calcium and Vitamin-D is used for the treatment of osteoporosis, osteomalacia, rickets, tetany, and parathyroid disease. Also used in raised calcium requirement for children and adolescents at times of rapid growth, inadequate intake of calcium in the diet due to malnutrition, prevention and treatment of osteoporosis, disorders of osteogenesis and tooth formation (in addition to specific treatment),latent tetany and during pregnancy and lactation. It is also used as routine supplement and phosphate binder in chronic renal failure.

Use in children
Not recommended.

Two tablets daily or one tablet twice daily. It is best taken with or just after a meal to improve absorption. Each dose should be taken with a full glass of water.

Contraindication
Absolute contraindications are hypercalcaemia, primary hyperparathyroidism, kidney stone, severe renal failure, Calcium & Vitamin D overdose, hypersensitivity to any of the tablet ingredients.

Use in patients with impaired renal function
Patients with mild to moderate renal failure or mild hypercalcuria should be supervised carefully. Periodic checks of plasma calcium levels and urinary calcium excretion should be made in patients with mild to moderate renal failure or mild hypercalcuria. In patients with a history of renal stones urinary calcium excretion should be measured to exclude hypercalcuria. With long term treatment it is advisable to monitor serum and urinary calcium levels and kidney function, and reduce or stop treatment temporarily if urinary calcium exceeds 7.5 mmol/24 hours. Allowances should be made for calcium and vitamin-D supplements from other sources.

It has possible interaction with digoxin, antacids containing calcium, aluminum or magnesium, other calcium supplements, calcitriol or other vitamin-D supplements; tetracycline, Doxycycline, amino cycline or oxytetracycline etc. So before taking any of these drugs consultations of the physicians are needed.

Use in Pregnancy & Lactation
It should be used as directed by the physician during pregnancy and lactation.

Undesirable Effects
Orally administered Calcium Carbonate may be irritating to the GI tract. It may also cause constipation. Hypercalcemia is rarely produced by administration of calcium alone, but may occur when large doses are given to patients with chronic renal failure. Also there may be allergic reactions, irregular heartbeats, nausea, vomiting, decreased appetite dry mouth and drowsiness. Following administration of vitamin-D supplements occasion skin rash has been reported.

Storage Conditions
Store in a cool (below 30C) and dry place, away from light. Keep out of reach of children.

Presentation & Packaging
Calsto D® tablet: Each commercial box contains 30 tablet in HDPE container.

Pharmacological Action:

Calsto® 500 -Calcium Carbonate reacts with gastric acid to produce a salt and water. For calcium carbonate the postulated chemical reaction is:
CaCO3 + 2HCl = CaCl2 + H2O + CO2
Two grams of calcium carbonate will readily bring 100 ml of hydrochloric acid to a pH above 6. The increase in gastric pH diminishes the activity of pepsin in the gastric secretion. Up to 30% of the oral calcium load may be absorbed.
Calsto D® -Vitamin-D is also essential for healthy bones as it aids in calcium absorption from the GI tract.

Calsto® 500 as dietary supplement, used to prevent or treat negative calcium balance; in osteoporosis, it helps to prevent or decrease the rate of bone loss. The calcium in calcium salts moderates nerve and muscle performance and allows normal cardiac function. Also used to treat hyperphosphatemia in patients with advanced renal insufficiency by combining with dietary phosphate to form insoluble calcium phosphate, which is excreted in feces. Calcium salts as antacids neutralize gastric acidity resulting in increased gastric an duodenal bulb pH; they additionally inhibit proteolytic activity of peptic if the pH is increased >4 and increase lower esophageal sphincter tone.
Calsto D® (Calcium with Vitamin D3) supports optimal calcium absorption and bone mineral composition.

Therapeutic Indications:
Calsto® is used for the treatment or prevention of calcium depletion in patients in whom dietary measures are inadequate. Conditions that may be associated with calcium deficiency include hypoparathyroidism, achlorhydria, chronic diarrhea, vitamin D deficiency, steatorrhea, sprue, pregnancy and lactation, menopause, pancreatitis, renal failure, alkalosis, and hyperphosphataemia. Calcium Carbonate is being used increasingly often to treat hyperphosphataemia in chronic renal failure as well as those on continuous ambulatory peritoneal dialysis (CAPD) and haemodialysis. Many patients are unable to tolerate sufficient doses for complete phosphate control and require additional measures such as stringent dietary phosphate restriction or relatively small doses of aluminum hydroxide. Calcium Carbonate containing preparations can provide short- term relief of dyspeptic systems but are no longer recommended for long-term treatment of peptic ulceration.

Calsto® 500-Calcium Carbonate is always used orally and when used as an antacid the recommended doses for adults are equivalent to 540-2000mg Calcium Carbonate per day, doses for children being half of those for adults. As a dietary supplement, such as for the prevention of osteoporosis, 1250-3750mg Calcium Carbonate (500-1500mg calcium) daily is recommended in general, but again this will need to be tailored to the individual patient depending on any specific disease such as Calcium deficiency, malabsorption or parathyroid function. In pregnancy and lactation the recommended daily dose of calcium is 1200-1500mg. In chronic renal failure the doses used vary from 2.5 - 9.0gm Calcium Carbonate per day and need to be adjusted according to the individual patient. To maximize effective phosphate binding in this context the Calcium Carbonate should be given with meals.
Calsto D® -Calcium and Vitamin-D is used for the treatment of osteoporosis, osteomalacia, rickets, tetany, and parathyroid disease. Also used in raised calcium requirement for children and adolescents at times of rapid growth, inadequate intake of calcium in the diet due to malnutrition, prevention and treatment of osteoporosis, disorders of osteogenesis and tooth formation (in addition to specific treatment), latent tetany and during pregnancy and lactation. It is also used as routine supplement and phosphate binder in chronic renal failure.

USE IN CHILDREN:
Calcium Carbonate has been extensively studied in children and infants with chronic renal failure and is both safe and effective.

1. Hypercalcaemia and hyperparathyroidism
2. Hypercalciuria and nephrolithiasis
3. Zollinger-Ellison syndrome
4. Concomitant digoxin therapy (requires careful monitoring of serum calcium level).

When hypercalcaemia occurs, discontinuation of the drug is usually sufficient to return serum calcium concentrations to normal. Calcium salts should be used cautiously in patients with sarcoidosis, renal or cardiac disease, and in patients receiving cardiac glycosides

USE IN PATIENTS WITH IMPAIRED RENAL FUNCTION:
Dosage adjustments may be necessary depending on the serum calcium levels.

ELDERLY PATIENTS:
In case of elderly patients with renal failure when calcium carbonate is taken constipation may be troublesome one for this group. For this reason, monitoring of serum calcium and phosphate is of course indicated for elderly patients.

Calcium Carbonate may enhance the cardiac effects of digoxin and other cardiac glycosides, if systemic hypercalcaemia occurs. Calcium Carbonate may interfere with the absorption of concomitantly administered tetracycline preparations and in chronic renal failure modification of vitamin D therapy may be required to avoid hypercalcaemia when Calcium Carbonate is used as the primary phosphate binder.

USE IN PREGNANCY & LACTATION:
Calcium containing drugs have been widely used in pregnancy by way of oral calcium supplementation or antacid therapy. Calcium Carbonate can be used in lactating women too.

UNDESIRABLE EFFECTS:
Orally administered Calcium Carbonate may be irritating to the GI tract. It may also cause constipation. Hypercalcaemia is rarely produced by administration of calcium alone, but may occur when large doses are given to patients with chronic renal failure.

Storage Conditions:
Store in a cool and dry place, away from light. Keep out of reach of children.

PRESENTATION & PACKAGING
Calsto D® Tablet: Each commercial box contains 30's tablets in HDPE container.

Calsto® 500 Tablet: Box contains 50's tablet in Alu-PVC blister Pack.

Pharmacological Action:
Like other amino-glycosides, the bactericidal activity of Tobramycin is accomplished by specific inhibition of normal protein synthesis in susceptible bacteria, but at the present time, very little is known about this action. It is thought that inhibition of protein synthesis is due to an action on ribosome that causes bacterial misreading of messenger RNA.The action of Dexamethasone is to inhibit the phospholipase A2, the first step in prostaglandin synthesis. Also Dexamethasone inhibits the chemo-tactic infiltration of neutrophils into the site of inflammation. The result is that its anti-inflammatory activity is 25 times greater and its overall therapeutic effectiveness 8-10 times greater than that of hydrocortisone.

Therapeutic Indications:
Cotadex® Sterile Eye Drops is indicated for steroid responsive inflammatory ocular conditions (palpebral and bulbar conjunctiva, cornea and anterior segment of the globe) where superficial bacterial ocular infection exists.It is also indicated in chronic anterior uveities and corneal injury from chemical radiation or thermal burns, or penetration of foreign bodies.The use of combination with an anti-infective component is indicated where the risk of superficial ocular infection is high.

Adults: One drop instilled into the conjunctival sac every 4 to 6 hours while the patient is awake. During the initial 24 to 48 hours, the dosage may be increased to one drop every two hours while the patient is awake, for a maximum of 24 days. Frequency should be decreased gradually as the improvement in clinical signs.
Children: Safety and effectiveness in children below the age of 2 years have not been established.

Ancys® Sterile Eye Drops is contraindicated in patients with known hypersensitivity to any ingredient of the product.

Use in Pregnancy and Lactation:
Safety for use during pregnancy and lactation in humans has not been established.

Drug Interaction:
No known drug interaction has been demonstrated.

Storage Conditions:
Close the bottle immediately after use. Store at room temperature. Do not refrigerate or freeze. Keep out of reach of children. Do not use more than 1 month after opening the bottle.

Presentation & Packaging:
Cotadex® Sterile Eye Drops: Each plastic dropper bottle contains 5 ml eye drops.

Pharmacological Action
The proton pump inhibitor Omeprazole inhibits gastric acid by blocking the hydrogen-potassium adenosine triphosphatase enzyme system ( the protom pump) of the gastric parietal cell. Proton pump inhibitors are effective for short-term treatment of gastric and duodenal ulcers; it is also used in combination with antibacterials for the eradication of Helicobacter pylori. Omeprazole is also used in the prevention and treatment of NSAID-associated ulcers.

Mechanism of Action
Omeprazole is chemically a novel substituted benzimidazole derivative, which suppresses the final step in gastric acid production by forming a covalent bond to two sites of the H+K+- ATPase enzyme system at the secretory surface of the gastric parietal cell. This leads to inhibition of both basal and stimulated gastric acid secretion irrespective of the stimulus. The binding to the H+K+-ATPase results in duration of antisecretory effect that persists longer than 24 hours. Omeprazole is quantitatively absorbed and bioavailability does not change upon multiple dosing.

Therapeutic Indications
Omeprazole is indicated where suppression of acid secretion is of therapeutic benefit. Omeprazole is registered for the following Indications: -

• Duodenal ulcer
• Peptic ulcer diseases (PUD)
• Gastro esophageal reflux diseases (GERD)
• Treatment of ulcer resistant to H2 receptor antagonists (H2RAs)
• Treatment of ulcers induced by NSAIDs drugs
• Gastrointestinal (GI) bleeding from stress or peptic acid diseases
• Eradication of Helicobacter pylori (in combination with antibiotics)
• Prophylaxis for acid aspiration syndrome during induction of anesthesia
• Zollinger-ellison syndrome

Adults

Diseases	Dose	Frequency
Duodenal ulcer pneumonia	20 mg	Once daily for 4 to 8 weeks
Gastric ulcer	40 mg	Once daily for 4 to 8 weeks
Gastro esophageal reflux diseases (GERD)	20 mg	Once daily for 4 weeks
Maintenance of healing of erosive esophagitis	20 mg	Once daily for 4 to 8 weeks
Zollinger-Ellison syndrome	60 mg	*
Resistant ulcer	*	Once daily for 4 to 8 weeks
Eradication of Helicobacter Pylori (in combination with antibiotics)	20 mg or 40 mg	*
Lesions associated with NSAIDs	20 mg or 40 mg	Once daily
Prevention of acid aspiration syndrome	*	*

The safety and effectiveness of Omeprazole capsule in children have not yet been established.

Contraindications
Patiens who are hypersensitive to Omeprazole or any of the inactive ingredients of Omeprazole are contraindicated to use of Omeprazole.

Use in patient with Impaired Hepatic Function
Dosage reduction may be required in patients with impaired liver fuction as Omeprazole is extensively metabolized in the liver and its elimination rate is prolonged in such patients when compared to normal persons. The daily dose of 10-20 mg is recommended in patients with severe liver disease.

Use in patient with Impaired Renal Function
It is not necessary to adjust the dose of Omeprazole in patients with renal insufficiency.

Elderly Patients
Dosage adjustment is not needed in the elderly patients.

Omeprazole is metabolized through the cytochrome P-450 system, and subsequently undergoes Phase II conjugation but no interaction has been observed and no dosage adjustment is needed with concomitant use of the following drugs; theophylline, antipyrine, caffeine, carbamazepine, diclofenac, digoxin, ethanol, glyburide, an oral contraceptive (Levonorgestrel/ethinyl estradiol), metoprolol, nifedipine.

Use in Pregnancy & lactation
Pregnant women: No data are available on administration of Omeprazole to pregnant women. However this drug should be used during pregnancy, only if clearly needed.
Lactating mother: There are no data on the excretion of Omeprazole into the breast milk. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the benefit of the drug to the mother.

Undesirable Effects
Potentially life-threatening effects: None has been reported with respect to Omeprazole. Severe or irreversible adverse effects: No serious adverse reactions have been described yet to date. Symptomatic adverse effects: Headache (1.3%) and diarrhoea (1.5%) are the two commonest reported adverse events. Peripheral edema has occasionally been reported in female patients. Other side effects may include abdominal pain, dizziness, nausea, epigastric discomfort, flatulence, skin rash, pruritus etc.

Storage Conditions
Store in a cool and dry place, away from light. Keep out of reach of children.
Presentation & Packaging
DEU®20 capsule: Each commercial box contains 12x4's in blister pack.

Pharmacological Action:

Dxproxil® (Cefpodoxime) is an orally administered prodrug that is de-esterified in the intestinal wall to release Cefpodoxime, a third generation Cephalosporin. Cefpodoxime is a broad spectrum antibiotic and is active against beta lactamase producing staphylococci.

MECHANISM OF ACTION:
Inhibits bacterial cell wall synthesis by binding to one or more of the penicillin-binding proteins (PBPs) which in turn inhibits the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls, thus inhibiting cell wall biosynthesis.

Therapeutic Indications:
Dxproxil® is indicated in the following diseases:
1. Lower Respiratory Tract Infection - Acute Community Acquired Pneumonia, Acute Bacterial Exacerbation of Chronic Bronchitis.
2. Upper Respiratory Tract Infection - Acute Otitis Media, Acute Maxillary Sinusitis, Pharyngitis, Tonsillitis.
3. Sexually Transmitted Diseases - Acute Uncomplicated Urethral & Cervical Gonorrhoea, Acute Ano-rectal Infection in women caused by N. gonorrhoeae.
4. Uncomplicated Urinary Tract Infection - Cystitis, Pyuria.
5. Skin & Soft Tissue Infections - Furuncle, Cellulitis, Subcutaneous Abscess, Infectious Atheroma, Periproctal Abscess.
6. Childhood Infections.
7. Enteric fever.

Dxproxil® (Cefpodoxime) should be administered orally with food to enhance absorption & Dxproxil® (Cefpodoxime) suspension may be given without regard to food. The recommended doses, duration of treatment, applicable patient population are as below:

Adults (Including children of aged 13 years & older):

Type of Infection	Total daily dose	Dose Frequency	Duration
Acute community acquired pneumonia	400 mg	200mg 12 hourly	14 days
Acute bacterial exacerbation of chronic bronchitis	400 mg	200mg 12 hourly	10 days
Uncomplicated gonorrhea (Men/Women)	200 mg	Single dose 200mg
Rectal gonococcal infection in women	200 mg	Single dose 200mg
Skin & Soft tissue infection	800 mg	400mg 12 hourly	7 to 14
Pharyngitis and/or tonsilitis	200 mg	100mg 12 hourly	5 to 10 days
Uncomplicated urinary tract infection	200 mg	100mg 12 hourly	7 days
Acute maxillary sinusitis	400 mg	200mg 12 hourly	10 days

USE IN CHILDREN:
15 days-6 months: 4mg/kg every 12 hours
6 months-2 years: 40mg every 12 hours
2-8 years: 80mg every 12 hours
Over 9 years: 100mg every 12 hours

Dxproxil® (Cefpodoxime) is contraindicated in patients with known allergy to the Cephalosporin group of antibiotics.

USE IN PATIENTS WITH IMPAIRED RENAL FUNCTION:
In patients with transient or persistent reduction in urinary output due to renal insufficiency, the total daily dose of Cefpodoxime should be reduced because high and prolonged serum antibiotic concentration can occur in such individuals following usual doses. Cefpodoxime should be administered with caution to patients receiving concurrent treatment with potent diuretics. As with other antibiotics, prolonged use of Cefpodoxime may result in overgrowth of nonsusceptible organisms. If superinfection occurs during therapy, appropriate measures should be taken.

USE IN PATIENTS WITH IMPAIRED HEPATIC FUNCTION:
The dosage does not require modification in cases of hepatic impairment.

Antacids: Concomitant administration of high doses of antacids (Sodium bicarbonates and aluminium hydroxide) or H2 blockers reduce peak plasma level by 24% to 42% and the extent of absorption by 27% to 32% respectively.
Probenecid: Renal excretion of Cefpodoxime was inhibited by probenecid and resulted in an approximately 31% increase in AUC.
Nephrotoxic Drugs: Close monitoring of renal function is advised when Cefpodoxime proxetil is administered concomitantly with compounds of known nephrotoxic potential.

USE IN PREGNANCY & LACTATION:
There are no adequate and well-controlled studies on Cefpodoxime proxetil use in pregnant woman, but it was found neither teratogenic nor embryocidal in animal trial. However, the drug should be used during pregnancy only if clearly needed. In nursing mother, Cefpodoxime is excreted in breast milk & there is potential risk of serious reactions in nursing infants, so a decision should be made whether to discontinue breast feeding or to discontinue the drug.

UNDESIRABLE EFFECTS:
Dxproxil® (Cefpodoxime) has very few side effects. The side effects include diarrhea, nausea, skin & vaginal fungal infection, abdominal pain, headache, chest pain, myalgia, dyspepsia, dizziness, vertigo, cough etc. In children incidence of fungal skin rash is more than adults.

OVER DOSAGE & TREATMENT:
Overdosage may cause toxic reaction. Toxic symptoms include nausea, vomiting, epigastric distress, diarrhea.

Storage Conditions:
Store in a cool (below 30°C) and dry place, away from light. Keep out of reach of children.

PRESENTATION & PACKAGING
Dxproxil® suspension: Each amber glass bottle contains dry powder for prepation of 50ml suspension.

Essential Amino Acids
L-Isoleucine USP 0.352 g
L-Leucine USP 0.490 g
L-Lysine Hydrochloride USP 0.430 g
L-Methionine USP 0.225 g
L-Phenylalanine USP 0.533 g
L-Threonine USP 0.250 g
L-Tryptophan USP 0.090 g
L-Valine USP 0.360 g
L-Histidine Monohydrate USP 0.250 g
L-Tyrosine USP 0.025 g

Non-Essential Amino Acids
L-Arginine Hydrochloride USP 0.500 g
L-Aspartic Acid USP 0.250 g
L-Glutamic Acid BP 0.075 g
L-Alanine USP 0.200 g
L-Cystine BP 0.010 g
Glycine (Aminoacetic Acid) USP 0.760 g
L-Proline USP 0.100 g
L-Serine USP 0.100 g

Carbohydrate
D-Sorbitol BP 5.000 g

Electrolytes (mmol/L
Sodium (Na+) 35.5
Potassium (K+) 25.0
Magnesium (Mg++) 2.5
Chloride (Cl-) 53.4
Acetate (CH3COO-) 25.0

Esamin® contains all 18 essential and non-essential amino acid needed for protein synthesis. The amino acid composition is such that positive nitrogen balance can be achieved in the postoperative period and during extended periods of intravenous nutrition.

Esamin® is indicated as a source of amino acids for protein synthesis in patients needing intravenous nutrition. Esamin® is particularly suitable for patients with basal amino acid requirements. Esamin® is also indicated in faster recovery in surgery, burns, renal insufficiency, hepatic insufficiency and effective management of cancer.

Adults:
The nitrogen requirement for maintenance of body protein mass depends on the patient's condition (nutritional state and degree of metabolic stress). The requirements are 0.10-0.15g nitrogen/kg/day (no or minor metabolic stress and normal nutritional state), 0.15-0.20g nitrogen/kg/day (moderate metabolic stress with or without malnutrition) and up to 0.20-0.25g nitrogen/kg/day (severe catabolism as in burns, sepsis and trauma). The dosage range 0.10-0.25g nitrogen/kg/day corresponds to 15-35 ml Esamin® /kg/day. In obese patients, the dose should be based on the estimated ideal weight. Depending upon patients requirements, 1000-2000 ml Esamin® may be infused intravenously per 24 hours. Esamin® should be infused slowly, at rates 1.4-2.8 ml (30-60 drops) per minute.

Infants and children:
In children and infants, the rate of infusion of infusion is 28-35 ml/kg body weight per day is recommended, with a step wise increase in the rate of administration during the first week.

Esamin® (Cefpodoxime) is usually well tolerated. Nausea Occurs rarely. Vomiting, flushing and sweating have been observed during infusion of Esamin® at rates exceeding the recommended maximal rare. Transient increases liver test during intravenous nutrition have been reported. The reasons are at present unclear. The underlying disease and the components and their amount in the intravenous feeding regimens have been suggested. Hypersensitivity reactions have been reported. As with all hypertonic infusion solution, thrombophlebitis may occur when peripheral veins are used. The Incidence may be reduced by the simultaneous infusion of 10% fat emulsion. If given to severely ill, premature infants, hyperphenylalaninemia may occur.

Esamin® is contraindicated in patients with inborn errors of amino acids metabolism, irreversible liver damage and severe uremia when dialysis facilities are not available.

Successful and safe administration of amino acid solutions during pregnancy in the human has been reported. Animal reproduction studies have not been carried out with Esamin®.

At the recommended dosage the amino acid in Esamin® solutions have no pharmacological effects and is not expected to interact with other medicaments.

Esamin® containing amino acids should not be mixed with other preparations because of the increased risk of microbial contamination and incompatibility.

Hyperphenylaninemia has been noted in severely ill, premature infants. In these patients, monitoring of the phenylalanine levels is recommended and the infusion rate is adjusted as needed. Do not use if the solution is turbid or contains particles. Discard any unused portion.

Protect from light and store between 15 to 25 temperatures. Avoid freezing. Keep out of the reach of children.

Esamin® is available in 500 ml glass bottle.

Factiq® Tablet: Each flim coated tablet contains Gemifloxacin Mesylate INN equivalent to 320 mg Gemifloxacin.

Gemifloxacin mesylate is a synthetic broad spectrum antibacterial agent for oral administration. Gemifloxacin a compound related to the fluoroquinolone class of antibiotics is available as the mesylate salt in the sesquihydrate form.

Gemifloxacin is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below.

Acute bacterial exacerbation of chronic bronchitis caused by Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, or Moraxella catarrhalis.

Community-acquired pneumonia (of mild to moderate severity) caused by Streptococcus pneumoniae (including multi-drug resistant strains [MDRSP])*, Haemophilus influenzae, Moraxella catarrhalis, Mycoplasma pneumoniae, Chlamydia pneumoniae, or Klebsiella pneumoniae.

Gemifloxacin can be taken with or without food and should be swallowed whole with a liberal amount of liquid. The recommended dose of Gemifloxacin is 320 mg daily, according to the following table.
Recommended Dosage Regimen of Gemifloxacin:
The clinical decision regarding the use of a 5 day or 7 day regimen should be guided

INDICATION	DOSE	DURATION
Acute bacterial exacerbation of chronic bronchitis (AECB)	One 320 mg tablet daily	5 days
Community-acquired pneumonia (CAP) [of mild to moderate severity]
due to known or suspected S. pneumoniae, H. influenzae, M. pneumoniae, or C. pneumoniae infection	One 320 mg tablet daily	5 days
due to known or suspected MDRSP*, K. pneumoniae, or M. catarrhalis infection		7 days

*MDRSP, multi-drug resistant Streptococcus pneumoniae, includes isolates previously known as PRSP (penicillin-resistant Streptococcus pneumoniae), and are strains resistant to two or more of the following antibiotics: penicillin (MIC ? 2 µg/mL), 2nd generation cephalosporin's (e.g., cefuroxime), macrolides, tetracycline and trimethoprim/ sulfamethoxazole.

The recommended dose and duration of Gemifloxacin should not be exceeded.

Use in Renally Impaired Patients: Dose adjustment in patients with creatinine clearance >40 mL/min is not required. Modification of the dosage is recommended for patients with creatinine clearance ≤ 40 mL/min. Below table provides dosage guidelines for use in patients with renal impairment:

Recommended Doses for Patients with Renal Impairment

Creatinine Clearance (mL/min)	Dose
>40	See Usual Dosage
≤40	160 mg every 24 hours

Use in Hepatically Impaired Patients: No dosage adjustment is recommended in patients with mild (Child-Pugh Class A), moderate (Child-Pugh Class B) or severe (Child-Pugh Class C) hepatic impairment.

Use in Elderly: No dosage adjustment is recommended.

Nausea, stomach upset, loss of appetite, diarrhea, drowsiness, dizziness, headache, dry mouth, altered taste, constipation, or trouble sleeping may occur. This medication may rarely cause a severe intestinal condition (pseudo membranous colitis) due to a resistant bacteria. This condition may occur while receiving therapy or even weeks after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have the following symptoms because these products may make them worse. Seek immediate medical attention if you develop: abdominal or stomach pain/cramping, blood/mucus in your stool, persistent diarrhea. A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, hives, itching, swelling, severe dizziness, trouble breathing.

Gemifloxacin is contraindicated in patients with a history of hypersensitivity to Gemifloxacin, fluoroquinolone antibiotic agents, or any of the product components.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: "blood thinners" (e.g., warfarin), corticosteroids (e.g., prednisone), diabetes medications (e.g., glyburide, insulin), probenecid, live vaccines. Report the use of drugs which might increase seizure risk (decrease seizure threshold) when combined with gemifloxacin, such as phenothiazines (e.g., thioridazine), tricyclic antidepressants (e.g., amitriptyline), isoniazid (INH), or theophylline. Other drugs besides gemifloxacin which may affect the heart rhythm include amiodarone, dofetilide, pimozide, quinidine, sotalol, procainamide, and sparfloxacin among others. QTc prolongation can infrequently result in serious, rarely fatal, irregular heartbeats. Consult your doctor or pharmacist for details. Ask for instructions about whether you need to stop any other QTc-prolonging drugs you may be using in order to minimize the risk of this effect. Do not start or stop any medicine without doctor or pharmacist approval.

Before taking gemifloxacin, tell your doctor or pharmacist if you are allergic to it; or to other quinolones such as ciprofloxacin, gatifloxacin, levofloxacin, or moxifloxacin; or if you have any other allergies. Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain or nervous system disorders (e.g., cerebral arteriosclerosis, tumors, increased intracranial pressure), heart problems (e.g., cardiomyopathy, slow heart rate, torsades de pointes, QTc prolongation), history of seizures, kidney disease, liver disease, muscle/joint/tendon problems, untreated mineral imbalance (e.g., low potassium or magnesium). This drug may make you dizzy or drowsy; use caution engaging in activities requiring alertness such as driving or using machinery. Limit alcoholic beverages. This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths or sunlamps. Caution is advised when using this drug in the elderly because they may be more sensitive to its side effects. Caution is advised when using this drug in children. Contact your doctor for more information. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. It is not known if this medication passes into breast milk. Consult your doctor before breast-feeding.

Any signs or symptoms of overdosage should be treated symptomatically. No specific antidote is known. In the event of acute oral overdosage, the stomach should be emptied by inducing vomiting or by gastric lavage; the patient should be carefully observed and treated symptomatically with appropriate hydration maintained. Hemodialysis removes approximately 20 to 30% of an oral dose of gemifloxacin from plasma.

Mortality occurred at oral gemifloxacin doses of 1600 mg/kg in rats and 320 mg/kg in mice. The minimum lethal intravenous doses in these species were 160 and 80 mg/kg, respectively. Toxic signs after administration of a single high oral dose (400 mg/kg) of gemifloxacin to rodents included ataxia, lethargy, piloerection, tremor, and clonic convulsions.

Store in cool dry place protected from light. Keep out of reach of children.

Factiq® Tablet: Box containing 8's, 10's & 12's tablet in blister pack.

Pharmacological Action:
Febux® (Febuxostat) is a non-purine selective inhibitor of Xanthine Oxidase. It works by non-competitively blocking the channel leading to the active site on Xanthine Oxidase. Xanthine Oxidase is needed to successively oxidize both hypoxanthine and xanthine to uric acid. Hence, Febuxostat inhibits Xanthine Oxidase, therefore reducing production of uric acid.

Therapeutic Indications:
Febux® is a Xanthine Oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in patients with gout.

Febux® is not recommended for the treatment of asymptomatic hyperuricemia.

Febux® is recommended at 40mg or 80mg once daily. The recommended starting dose of Febux® is 40mg once daily. For patients who do not achieve a serum Uric Acid (sUA) less than 6 mg per dL after 2 weeks with 40mg, Febux® 80mg is recommended.

Febux® can be administered without regard to food or antacid use.

No dose adjustment is necessary when administering Febux® to patients with mild to moderate renal or hepatic impairment.

Febux® is contraindicated in patients being treated with Azathioprine or Mercaptopurine.

Concomitant administration of Febux® with XO substrate drugs, Azathioprine or Mercaptopurine could increase plasma concentrations of these drugs resulting in severe toxicity.

Gout Flare: An increase in gout flares is frequently observed during initiation of anti-hyperuricemic agents, including Febux®. If a gout flare occurs during treatment, Febux® need not be discontinued. Prophylactic therapy (i.e. Non-Steroidal Anti-Inflammatory Drug (NSAID) or Colchicine upon initiation of treatment) may be beneficial for up to six months.

Cardiovascular Events: A higher rate of cardiovascular thromboembolic events was observed in patients treated with Febux® than allopurinol in clinical trials. Monitor for signs and symptoms of MI and stroke.

Liver Enzyme Elevation: Transaminase elevations have been observed in Febux® treated patients. Monitor liver function tests periodically.

The most common side effects of Febux® are liver problems, nausea, gout flares, joint pain and rash.

Pregnancy category of Febux® is C. There are no adequate and well-controlled studies in pregnant women. Febux® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Febux® is excreted in the milk of rats. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Febux® is administered to a nursing woman.

Safety and efficacy in children below the age of 12 years have not been studied.

Febux® was studied in healthy subjects in doses up to 300 mg daily for seven days without evidence of dose-limiting toxicities. No overdose of Febux® was reported in clinical studies. Patients should be managed by symptomatic and supportive care should there be an overdose.

Storage Conditions:
Store in a cool and dry place below 25°C & protect from light. Keep out of the reach of children.

Febux® Tablet: Each box contains 2X10's tablets in PVC blister pack.

Pharmacological Action:
Femixit® consists of two well known and well proven compounds; Flupentixol-a neuroleptic with anxiolytic and antidepressant properties of its own when given in small doses, and Melitracen-a bipolar thymoleptic with activating properties in low doses. In combination, the compounds render a preparation with antidepressant, anxiolytic and activating properties. Maximal serum concentration is reached in about 4 hours after oral administration of Flupentixol and in about 4 hours after oral administration of Melitracen. The biological half-life of Flupentixol is about 35 hours and that of Melitracen is about 19 hours. The combination of Flupentixol and Melitracen does not seem to influence the pharmacokinetic properties of the individual compounds.

Mechanism of Action:
Flupentixol acts by blocking the Dopamine (a neurotransmitter) receptors in the brain cells. Excess amount of dopamine receptors normally act to modify behavior and over-stimulation resulting in psychotic illness. Flupentixol blocks these receptors to control psychotic illness. Thus it is neuroleptic with anxiolytic and antidepressant properties. Melitracen acts by decreasing reuptake of norepinephrine and serotonin at the synapse resulting in high concentration of these neurotransmitters at the post-synaptic end. Thus it is antidepressant.

Therapeutic Indications:
Anxiety, depression, apathy. These include- Psychogenic depression. Depressive neuroses, masked depression, psychosomatic affections accompanied by anxiety and apathy, Menopausal depressions, Dysphoria and depression in alcoholics and drug-addicts.

Adults: Usually 2 tablets daily; morning and noon. In severe cases the morning dose may be increased to 2 tablets.
Elderly: 1 tablet in the morning.
Maintenance dose: Usually 1 tablet in the morning. In cases of insomnia or severe restlessness additional treatment with a sedative in the acute phase is recommended.
Use in Children: This tablet is not for paediatric use.

The immediate recovery phase after myocardial infarction, Defects in bundle-branch conduction, untreated narrow angle glaucoma, acute alcohol, barbiturate and opiate intoxications, Flupentixol-Melitracen should not be given to patients who have received a MAO-inhibitor within two weeks. Not recommended for excitable or overactive patients since its activating effect may lead to exaggeration of these characteristics.

In case of overdosage the symptoms of intoxifications by Melitracen, especially of anticholinergic nature, dominate. More rarely extrapyramidal symptoms due to Flupentixol occur.

Flupentixol-melitracen may enhance the response to alcohol, barbiturates and other CNS depressants. Simultaneous administration of MAO-inhibitors may cause hypertensive crises. Neuroleptics and thymoleptics reduce the antihypertensive effect of guanethidine and similar acting compounds and thymoleptics enhance the effects of adrenaline and noradrenaline.

Flupentixol-Melitracen should preferably not be given during pregnancy and lactation.

In the recommended doses side effects are rare. These could be transient restlessness and insomnia.

Storage Conditions:
Store in a cool and dry place, away from light. Keep out of reach of children.

Femixit® Tablet: Box containing 5X10's tablets in Alu-PVC blister pack.

Pharmacological Action:
Fesler® (Fexofenadine hydrochloride) is an antihistamine with selective peripheral H1- receptor antagonist activity. Fexofenadine is rapidly absorbed after oral dose with peak plasma concentration being reached in 2-3 hours. It is about 60% to 70% bound to the plasma protein .About 5% of the total dose is metabolized, mostly by the intestinal mucosa, with only 0.5% to 1.5% of the dose undergoing hepatic biotransformation by the cyto-chrome P450 system. Elimination half-life of 14 hours has been reported although this may prolonged in patients with renal impairment. Excretion is mainly in the faeces with only 10% being present in the urine. Fexofenadine does not appear to cross the blood brain barriers.

Therapeutic Indications:
Fesler® oral suspension is indicated for the relief of symptoms associated with seasonal allergic rhinitis in children 2 to 11 year of age symptoms to treat effectively: sneezing, rhinorrhea, itchy/nose/palate/throat, itchy/watery /red eyes/ Chronic Idiopathic Urticaria.

Fexofenadine Oral Suspension:
Seasonal Allergic Rhinitis:
Children 2 to 11 Years: The recommended dose of Fexofenadine Oral Suspension is 30mg twice daily. A dose of 30mg (5mL) once daily is recommended as the starting dose in pediatric patients with decreased renal function.

Chronic Idiopathic Urticaria:
Children 6 Months to 11 Years: The recommended dose of Fexofenadine Oral Suspension is 30mg (5ml) twice daily for patients 2 to 11 years of age and 15mg (2.5ml) twice daily for patients 6 months to less than 2 years of age. For pediatric patients with decreased renal function, the recommended starting doses of Fexofenadine Oral Suspension are 30mg (5ml) once daily for patients 2 to 11 years of age and 15mg (2.5ml), once daily for patients 6 months to less than 2 years of age.

Dosage of Fexofenadine tablet is as follows:
Seasonal Allergic Rhinitis and Chronic Idiopathic Urticaria:
Adults and Children 12 Years and Older: The recommended dose of fexofenadine is 60mg twice daily or 180mg once daily with water. A dose of 60mg once daily is recommended as the starting dose in patients with decreased renal function.

Children 6 to 11 Years: The recommended dose of fexofenadine is 30 mg twice daily with water. A dose of 30mg once daily is recommended as the starting dose in pediatric patients with decreased renal function.

Fexofenadine is contraindicated in patients with known hypersensitivity to any of the ingredients.

There are no adequate and well controlled studies in pregnant women. Fexofenadine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known if Fexofenadine is excreted in human milk.Caution should be exercised when Fexofenadine is administered to a nursing woman.

Plasma concentrations of Fexofenadine have been increased when given with Erythromycin or ketoconazole.Antacid containing aluminum and magnesium hydroxide reduces the absorption of Fexofenadine fruit juices including grapefruit may reduce the bioavailability of Fexofenadine and use together should be avoided.

Storage Conditions:
Store in a cool & dry place. Away from light. keep out of reach of children.

Fesler® Susp: Each pet bottle contains 50ml suspension.

Pharmacological Action
Folic acid is a B-complex vitamin needed to form healthy cells, especially red blood cells.FolicAcid is a complex organic compound present in liver, yeast and other substances, and which may be prepared synthetically. In man, an exogenous source of folate is required for nucleoprotein synthesis and the maintenance of normal erythropoiesis. Folic acid whether given by mouth or parenterally, stimulates specifically the production of red blood cells, white blood cells, and platelets in persons suffering from certain megaloblastic anemia.

Folic acid is necessary for formation of a number of coenzymes in many metabolic systems, particularly for purine and pyrimidine synthesis; required for nucleoprotein synthesis and maintenance in erythropoiesis; stimulates WBC and platelet production in folate deficiency anemia.

Therapeutic Indications
Folus® (Folic Acid) As prophylaxis: Folic acid is effective in the treatment of megaloblastic anemia due to a deficiency of folic acid as may be seen in tropical or non-tropical sprue, in anemia's of nutritional origin, pregnancy, infancy, or childhood. Chronic hemolytic states, Prevention of neural tube defects, Myelofibrosis, Prematurity and Renal dialysis. In megaloblastic anemia due to: Nutritional deficiency, Pregnancy, Coeliac disease, Haemolytic anaemia, Chronic myelofibrosis, Extensive exfoliative skin disorder such as psoriasis, Tropical sprue, Anticonvulsant drug therapy, Sideroblastic anaemia, Scurvy, Antimalarial therapy with pyrimethamine & Methotrexate (folate antagonist) therapy. Oral Administration: Folic acid is well absorbed and may be administered orally with satisfactory results except in severe instances of intestinal malabsorption.

Usual Therapeutic Dosage: Adults and children regardless of age, up to 1.0 mg daily. Resistant cases may require larger doses.
Maintenance Level: When clinical symptoms have subsided and the blood picture has become normal, a maintenance level should be used, i.e., 0.1 mg for infants and up to 0.3 mg for children under four years of age, 0.4 mg for adults and children four or more years of age, and 0.8 mg for pregnant and lactating women, per day, but never less than 0.1 mg per day. Patients should be kept under close supervision and adjustment of the maintenance level made if relapse appears imminent.In the presence of alcoholism hemolytic anemia, anticonvulsant therapy, or chronic infection, the maintenance level may need to be increased.

Folus® is contraindicated in patients with prior history of hypersensitivity to Folic Acid.

No information provided.

No information provided.

Decreased effect:
In folate-deficient patients, folic acid therapy (>15 mg/day) may increase phenytoin metabolism. Phenytoin, primidone, para-aminosalicylic acid, and sulfasalazine may decrease serum folate concentrations and cause deficiency. Concurrent administration of chloramphenicol and folic acid may result in antagonism of the haematopoietic response to folic acid; dihydrofolate reductase inhibitors (eg, methotrexate, trimethoprim) may interfere with folic acid utilization.

Folus® (Folic Acid) is used for the production of DNA and red blood cells, making it essential during pregnancy for normal fetal development.

Folic acid usually has little side effects. Symptoms of a serious allergic reaction include: rash, itching, swelling, dizziness, drowsiness, trouble breathing.

Storage & Conditions
Store in cool and dry place, away from light. Keep out of reach of children.

Folus® Tablet: Each box Containing: 10x10 tablets in Alu-PVC blister pack.

Pharmacological Action:
Fomox®Sterile Eye Drops is a 4th generation fluorinated quinolone. It is bactericidal with a broad spectrum of antibacterial activity. The antimicrobial action of Moxifloxacin results from inhibition of the topoisomerase II (DNA gyrase) and topoisomerase IV. DNA gyrase is an essential enzyme that is involved in the replication, transcription and repair of bacterial DNA. Topoisomerase IV is an enzyme known to play a key role in the partitioning of the chromosomal DNA during bacterial cell division.

Therapeutic Indications:
Fomox® Sterile Eye Drops is indicated for the treatment of bacterial infections including bacterial conjunctivitis, blepharitis, and blepharo-conjunctivitis which are due to Moxifloxacin susceptible germs.

Adults and children (1 year of age and older): One drop in infected eye(s) three times a day for 7 days.
Children up to 1 year of age: Use and dose must be determined by doctor.

Fomox® Sterile Eye Drops is contraindicated in patients with a history of hypersensitivity to Moxifloxacin, to other Quinolones or to any of the components in this medication.

No adequate and well-controlled studies are established in pregnant women. Fomox® Sterile Eye Drops should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Studies have not been conducted.

Storage & Conditions:
Close the bottle immediately after use. Do not use more than 1 month after opening the bottle. Keep in a cool and dry place, protect from light. Keep all the medicines out of reach of children.

Fomox® Sterile Eye Drops: Each plastic dropper bottle contains 5 ml eye drops.

Pharmacological Action
Fluconazole (USP) is a triazole antifungal drug used in the treatment and prevention of superficial and systemic fungal infections. Fluconazole is active against the following microorganisms: Blastomyces dermatitidis, Candida spp. (except C. krusei and C. glabrata) Coccidioides immitis, Cryptococcus neoformans, Epidermophyton spp., Histoplasma capsulatum, Microsporum spp. Trichophyton spp. Following oral dosing, fluconazole is almost completely absorbed within two hours. Bioavailability is not significantly affected by concomitant intake of meals or the use of H2-antagonists (eg. ranitidine). The elimination half-life of fluconazole follows zero order kinetics and only 10% of elemination is due to metabolisim, the remainder is excreted in urine and sweat.

Like other imidazole and triazole-class antifungals, fluconazole inhibits the fungal cytochrome P450 enzyme 14a-demethylase. Mammalian demethylase activity is much less sensitive to fluconazole than fungal demethylase. This inhibition prevents the conversion of lanosterol to ergosterol, an essential component of the fungal cell wall, and subsequent accumulation of 14a-methyl sterols. Fluconazole is primarily fungistatic, however may be fungicidal against certain organisms in a dose-dependent manner.

Therapeutic Indications
Funzole® is indicated for the treatment and prophylaxis of fungal infections where other antifungals have failed or are not tolerated (eg. due to adverse effects), including: Candidiasis caused by susceptible strains of Candida, Tinea corporis, tinea cruris or tinea pedis, Onychomycosis, Cryptococcal meningitis.

Fluconazole can be used first-line for the following indications: Coccidioidomycosis, Cryptococcosis, Histoplasmosis, Prophylaxis of candidiasis in immunocompromised people.

Acute or recurrent vaginal candidiasis - a single dose of 150mg . Mucosal candidiasis (except vagina) : 50mg daily (100mg daily in unusually difficult infection) given for 7-14 days in other mucosal infections (e.g Oesophagitis, candiduria ). Systemic candidiasis and cryptococcal infections(including meningitis )- 400mg initially then 200mg daily . Increased if necessary to 400mg daily , treatment continued according to response.

Child over 1 year - superficial candidal infections , 1-2 mg/kg body weight daily , systemic candidiasis and cryptococcal infections , 3-6 mg/kg body weight daily (in serious life threatening infections upto 2 mg/kg body weight daily has been given to children aged 4-13 years-max. 400 mg daily).

Contraindication
Fluconazole is contraindicated in patients with known hypersensitivity to fluconazole or other azole antifungals, concomitant use of cisapride, due to risk of serious cardiac arrhythmias.

Precautions
Fluconazole therapy has been associated with QT interval prolongation, which may lead to serious cardiac arrhythmias. Thus it is used with caution in patients with risk factors for prolonged QT interval such as electrolyte imbalance or use of other drugs which may prolong the QT interval (particularly cisapride).

Fluconazole has also rarely been associated with severe or lethal hepatotoxicity and liver function tests are usually performed regularly during fluconazole therapy. Additionally, it is used with caution in patients with pre-existing liver disease.

High concentrations of fluconazole have been detected in human breast milk from patients receiving fluconazole therapy, thus its use is not recommended in breastfeeding mothers.

Adverse effects
Adverse drug reactions associated with fluconazole therapy include: Common (>1% of patients): rash, headache, dizziness, nausea, vomiting, abdominal pain, diarrhoea, and/or elevated liver enzymes, Infrequent (0.1-1% of patients): anorexia, fatigue, constipation. Rare (<0.1% of patients): oliguria, hypokalaemia, dizziness, paraesthesia, seizures, alopecia, Stevens-Johnson syndrome, thrombocytopaenia, other blood dyscrasias, serious hepatotoxicity including hepatic failure, anaphylactic/anaphylactoid reactions.

Fluconazole is an inhibitor of the human cytochrome P450 system, particularly the isozymes CYP2C9 and CYP3A4. Fluconazole may decreases the metabolism and increases the concentration of any drug metabolised by these enzymes. Additionally, its potential effect on QT interval increases the risk of cardiac arrhythmia if used concurrently with other drugs that prolong the QT interval.

Storage Conditions
Store in a cool (below 30ºC) and dry place, away from light. Keep out of reach of children

Funzole® 50mg Capsule: Each commercial box contains 3x10's capsules in Alu-PVC blister pack.
Funzole® Oral suspension: Each box contains dry poweder for preparation of 35ml suspension with a mesaring cup.

Pharmacological Action:
The primary mechanism of action of Gifon® (Glimepiride) is lowering of blood glucose by stimulating the release of insulin from functioning beta cells. In addition, expancreatic effects may also play vital role in the activity of Gifon® (Glimepiride). Administration of Gifon® (Glimepiride) can lead to increased sensitivity of peripheral tissues to insulin. After oral administration, Gifon® (Glimepiride) is completely (100%) absorbed from GI tract. When Gifon® (Glimepiride) is given with meals , the mean Cmax and AUC are slightly decreased. Glimepiride is completely metabolized by oxidative biotransformation after oral dose. When 14c-Glimepiride is given orally, approximately 60% of the total radioactivity is recovered in the urine in 7 days and 80-90% of the metabolites are recovered in the urine.

Therapeutic Indications:
Non-insulin dependent (type-II) diabetes, whenever blood sugar levels cannot be controlled adequately by diet, physical exercise and weight reduction. Gifon® (Glimepiride) is also indicated for use in combinaton with insulin to lower blood glucose in patients whose hyperglycemia cannot be controlled by diet and exercise.

Initial dose and dose titration : the usual initial dose is 1mg once daily. If necessary, the daily dose can be increased. Any increase can be based on regular blood sugar monitoring, and should be gradual, i.e., at intervals of one to two weeks, and carried out stepwise, as follows : 1 mg - 2 mg. Dose range in patients with well controlled diabetes : The usual dose range in patients with well controlled diabetes is 1 to 4 mg daily. Normally, a single daily dose is sufficient. This should be taken immediately before a substantial breakfast or - if none is taken - immediately before the first main meal. Secondary dosage adjustment : As the control of diabetes improves, sensitivity to insulin increases; therefore, Glimepiride requirement may fall as treatment proceeds. To avoid hypoglycemia, timely dose reduction or cessation of Glimepiride therapy must be considered. Glimepiride tablets must be swallowed without chewing and with sufficient amounts of liquid (approximately one or two glass).

In the initial weeks of treatment, the risk of hypoglycemia may be increased and necessitates especially careful monitoring. If such risk is present it may be necessary to adjust the dosage of Glimepiride. Hypoglycemia can almost always be promptly controlled by immediate intake of carbohydrates (glucose or sugar, e.g., in the form of sugar lumps, sugar-sweetened fruit juice or sugar-sweetened tea.

Glimepiride is not suitable for the treatment of insulin dependent (type-I) diabetes mellitus, or of diabetic precoma or coma. Glimepiride must not be used in patients hypersensitive to Glimepiride, other sulphonylureas, other sulphonamides. In patients with severe impairment of renal or hepatic function, a changeover to insulin is indicated.

Hypoglycemia, temporary visual impairment, nausea, vomiting, diarrhoea, abdominal pain, urticaria, fall in blood pressure.

Potentiation of the blood-sugar-lowering effect may occur with insulin and other oral anti-diabetic, ACE inhibitors, allopurinol, anabolic steroids and male sex hormones, chloramphenicol, coumarin derivatives, fluoxetine, MAO inhibitors, miconazole, paraaminosalicylic acid, pentoxifylline (high dose parenteral) , phenylbutazone, oxyphenbutazone, quinolones, salicylates, sulfonamides, tetracyclines, beta blockers. Weakening of the blood sugar-lowering effect may occur with acetazolamide, barbiturates, corticosteriods, diazoxide, diuretics, epinephrine and other sympathomimetic agents, laxatives, oestrogens and progesterone, phenothiazines,phenytoin, rifampicin, thyroid hormones, H2- receptor antagonists, clonidine and reserpine may lead to either potentiation or weakening of the bloodsugar-lowering effect. Both acute and chronic alcohol intake may potentiate or weaken the blood-sugar lowering action of glimepiride unpredictably.

Pregnancy: Glimepiride must not be taken during pregnancy; a changeover to insulin is necessary. Patients planning a pregnancy must inform their physician, and should changeover to insulin.
Nursing mothers: Ingestion of Glimepiride with breast milk may harm the child. Therefore, Glimepiride must not be taken by breast-feeding women. Either a changeover or a complete discontinuation of breast-feeding is necessary.

Storage Conditions:
Keep away from light and store at cool and dry place.

Gifon® 1: Each box contains 3x10's tablet in blister pack.
Gifon® 2: Each box contains 3x10's tablet in blister pack.

CLINICAL INFORMATION:
Therapeutic Indications
Hizin® is indicated for the treatment and prevention of B-vitamins and Zinc deficiencies. B Vitamins are needed to release energy from food. They play an important role in ensuring healthy brain and nerve function, healthy red blood cells formation in children & adults. They are specially needed for healthy growth and development of children. B vitamin deficiencies in adult cause profound fatigue and various types of neurologic manifestations, which may include weakness, poor balance, confusion, irritability, memory loss, nervousness, tingling of the limbs, and loss of coordination. Depression may be an early sign of significantly low levels of pyridoxine, as well as other B vitamins. Additional symptoms of vitamin B deficiency are sleep disturbances, nausea, poor appetite, frequent infections, and skin lesions.In children, Zinc is necessary to maintain a healthy immune system. It ensures normal growth & sexual development of children. It is further necessary for the growth and maintenance of muscles. In adult, typical signs of zinc deficiency are loss of appetite, poor sense of smell and taste, tendency towards depression, white marks on fingernails, pale skin, frequent infections, low fertility, stretch marks, prostate problems, stunted growth, mental problems, poor wound healing, a poor immune system, diarrhoea, mental lethargy, poor appetite, rough skin, weight loss, ache and greasy skin.

Hizin® Syrup
Adults : 10 ml (2 teaspoonful) 2 to 3 times daily or as advised by the physician.
Children : 10 ml (2 teaspoonful) 1 to 3 times daily or as advised by the physician.
Infants : 5 ml (1 teaspoonful) 1 to 2 times daily or as advised by the physician.

Hizin® is contraindicated in patients with a known hypersensitivity to any of the ingredients of this product.

Generally no interactions have been observed.

Recommended.

Hizin® is generally well tolerated.

Storage Conditions:
Store in a cool and dry place, away from light. Keep out of reach of children.

Hizin® Syrup: Each amber glass bottle contains of 100ml syrup with a measuring cup.

Pharmacological Action:
Corticosteroids inhibit the inflammatory response to a variety of inciting agents and probably delay or slow healing. They inhibit the edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation. There is no generally accepted explanation for the mechanism of action of ocular corticosteroids. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2.

Therapeutic Indications:
Inomet® Sterile Ophthalmic Suspension is indicated for the treatment of corticosteroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe.

1 drop instilled into the conjunctival sac 2-4 times daily. During the initial 24 to 48 hours the dosage may be safely increased to 1 drop every four hour. Care should be taken not to discontinue therapy prematurely. Shake well before use.

Acute superficial herpes simplex keratitis, fungal diseases of ocular structures, vaccinia, varicella and most other viral diseases of the cornea and conjunctiva, tuberculosis of the eye, hypersensitivity to the component of this medication.

Safety of the use of topical steroids during pregnancy and lactation has not been established.

No information is available.

Storage & Conditions:
Protect from light. Store in cool & dry place
Keep out of the reach of children
Do not use more than 1 month after opening.
Shake well before using. Store at 25°c

Inomet® Sterile Ophthalmic Suspension: Each plastic dropper bottle containing 5ml sterile ophthalmic suspension.

Pharmacological Action
Inran®(Ranitidine) is a group of H2-receptor antagonist. It acts by blocking histamine receptors which are present on the cells in the stomach lining. Generally a substance called histamine binds to these receptors. Histamine is a chemical, produced throughout the body and has many effects. When histamine binds to H2 receptors on cells in the stomach lining, it causes them to produce acid. Inran® (Ranitidine) binds to H2 receptors, replacing some of the histamine. As a result, the amount of stomach acid produced by these cells is decreased. Stomach acid is present as a normal part of the digestive process. If large amounts of stomach acid are produced this can cause the pain in the abdomen commonly known as indigestion. The excess acid may also flow back into the food pipe (Oesophagus) causing pain and a burning sensation known as heartburn. Normally the lining of the stomach and duodenum (an area of the intestine directly after the stomach) have a protective layer which resists acid attack. If this layer is damaged, or large amounts of stomach acid are formed, a peptic ulcer develop. Inran® (Ranitidine) decreases the amount of acid in the stomach and duodenum. As a result, Inran® (Ranitidine) helps relieve the symptoms of indigestion and aids the healing of ulcers. It is also used to depress acid production in various other conditions.

Absorption
Inran® (Ranitidine) is 50% absorbed after oral administration, compared to an intravenous (IV) injection with mean peak levels of 440 to 545 mg/mL occurring 1 to 3 hours after a 150-mg dose. Absorption is not significantly impaired by the administration of food or antacids. Propantheline slightly delays and increases peak blood levels of Inran® (Ranitidine), probably by delaying gastric emptying and transit time. Simultaneous administration of high-potency antacid (150 mmol) in fasting subjects has been reported to decrease the absorption of Inran® (Ranitidine)..

Distribution
The volume of distribution is about 1.4 L/kg. Serum protein binding averages 15%.

Metabolism
In humans, the N-oxide is the principal metabolite in the urine; however, this amounts to <4% of the dose. Other metabolites are the S-oxide (1%) and the desmethyl Inran® (Ranitidine) (1%). The remainder of the administered dose is found in the stool. Studies in patients with hepatic dysfunction (compensated cirrhosis) indicate that there are minor, but clinically insignificant, alterations in Inran® (Ranitidine) half-life, distribution, clearance, and bioavailability.

Excretion
The principal route of excretion is the urine, with approximately 30% of the orally administered dose collected in the urine as unchanged drug in 24 hours. Renal clearance is about 410 mL/min, indicating active tubular excretion. The elimination half-life is 2.5 to 3 hours.

Therapeutic Indications
Inran® (Ranitidine) is indicated in the treatment of Gastric and Duodenal ulcer (Peptic Ulcer), Esophageal Reflux Diseases, Zollinger-Ellison Syndrome, Dyspepsia, Recurrent Ulcer, NSAID Gastropathy and ,In such condition where gastric acidity reduction is beneficial.

Doses and Administration
2-4 mg/kg twice daily, maximum 300 mg daily. Peptic ulcer150 mg 3 times daily and the dose is increased if necessary up to 6 g daily in divided doses. Zollinger-Ellison Syndrome 150 mg twice daily for up to 8 weeks and if necessary for up to 12 weeks Reflux Oesophagitis150 mg twice daily for up to 8 weeks NSAID-associated Ulcer 150 mg twice daily for up to 6 weeks Chronic Episodic Dyspepsia. The usual adult dosage is 150 mg twice daily taken in the morning and evening for up to 4 to 8 weeks.

Use in Pregnancy & Lactation

Pregnancy:
This drug should be used during pregnancy only if clearly needed.

Lactation:
Inran® (Ranitidine) is secreted in human milk. Caution should be exercised when Inran® (Ranitidine) is administered to a nursing mother.

Side effects:
Inran® (Ranitidine), the following side effects are observed. Minor: headache, dizziness, nausea, stomach pain, constipation, rash. Major: weakness, fever, sore throat, abnormal skin bruising, yellow color to skin or eyes, confusion, agitation.

Contraindications
Inran® (Ranitidine) is contraindicated for patients known to have hypersensitivity to the drug or any of the ingredients.

Precautions
Symptomatic response to therapy with Inran® (Ranitidine) does not preclude the presence of gastric malignancy. Since Inran® (Ranitidine) is excreted primarily by the kidney, dosage should be adjusted in patients with impaired renal function. Caution should be observed in patients with hepatic dysfunction since Inran® (Ranitidine) is metabolized in the liver. Rare reports suggest that Inran® (Ranitidine) may precipitate acute porphyric attacks in patients with acute porphyria. Inran® (Ranitidine) should therefore be avoided in patients with a history of acute porphyria.

Drug Interactions
Interaction generally means that one drug may increase or decrease the effect of another drug. Also, the more medications a person takes, the morelikely there will be a drug interaction. Interactions with this drug may occur with the following: antacids, blood thinners, diazepam, glipizide, glyburide, itraconazole, ketoconazole, metoprolol, nifedipine, phenytoin, procainamide, sucralfate, theophylline.

Storage Conditions
Store in a cool and dry place, away from light. Keep out of reach of children. Presentation & Packaging
Inran® Tablet: Each commercial box contains 10 x 10's tablets in Alu-Alu blister pack.

Pharmacological Action
Inran®(Ranitidine) is a group of H2-receptor antagonist. It acts by blocking histamine receptors which are present on the cells in the stomach lining. Generally a substance called histamine binds to these receptors. Histamine is a chemical, produced throughout the body and has many effects. When histamine binds to H2 receptors on cells in the stomach lining, it causes them to produce acid. Inran® (Ranitidine) binds to H2 receptors, replacing some of the histamine. As a result, the amount of stomach acid produced by these cells is decreased. Stomach acid is present as a normal part of the digestive process. If large amounts of stomach acid are produced this can cause the pain in the abdomen commonly known as indigestion. The excess acid may also flow back into the food pipe (Oesophagus) causing pain and a burning sensation known as heartburn. Normally the lining of the stomach and duodenum (an area of the intestine directly after the stomach) have a protective layer which resists acid attack. If this layer is damaged, or large amounts of stomach acid are formed, a peptic ulcer develop. Inran® (Ranitidine) decreases the amount of acid in the stomach and duodenum. As a result, Inran® (Ranitidine) helps relieve the symptoms of indigestion and aids the healing of ulcers. It is also used to depress acid production in various other conditions.

Absorption
Inran® (Ranitidine) is 50% absorbed after oral administration, compared to an intravenous (IV) injection with mean peak levels of 440 to 545 mg/mL occurring 1 to 3 hours after a 150-mg dose. Absorption is not significantly impaired by the administration of food or antacids. Propantheline slightly delays and increases peak blood levels of Inran® (Ranitidine), probably by delaying gastric emptying and transit time. Simultaneous administration of high-potency antacid (150 mmol) in fasting subjects has been reported to decrease the absorption of Inran® (Ranitidine)..

Distribution
The volume of distribution is about 1.4 L/kg. Serum protein binding averages 15%.

Metabolism
In humans, the N-oxide is the principal metabolite in the urine; however, this amounts to <4% of the dose. Other metabolites are the S-oxide (1%) and the desmethyl Inran® (Ranitidine) (1%). The remainder of the administered dose is found in the stool. Studies in patients with hepatic dysfunction (compensated cirrhosis) indicate that there are minor, but clinically insignificant, alterations in Inran® (Ranitidine) half-life, distribution, clearance, and bioavailability.

Excretion
The principal route of excretion is the urine, with approximately 30% of the orally administered dose collected in the urine as unchanged drug in 24 hours. Renal clearance is about 410 mL/min, indicating active tubular excretion. The elimination half-life is 2.5 to 3 hours.

Therapeutic Indications
Inran® (Ranitidine) is indicated in the treatment of Gastric and Duodenal ulcer (Peptic Ulcer), Esophageal Reflux Diseases, Zollinger-Ellison Syndrome, Dyspepsia, Recurrent Ulcer, NSAID Gastropathy and ,In such condition where gastric acidity reduction is beneficial.

Doses and Administration
2-4 mg/kg twice daily, maximum 300 mg daily. Peptic ulcer150 mg 3 times daily and the dose is increased if necessary up to 6 g daily in divided doses. Zollinger-Ellison Syndrome 150 mg twice daily for up to 8 weeks and if necessary for up to 12 weeks Reflux Oesophagitis150 mg twice daily for up to 8 weeks NSAID-associated Ulcer 150 mg twice daily for up to 6 weeks Chronic Episodic Dyspepsia. The usual adult dosage is 150 mg twice daily taken in the morning and evening for up to 4 to 8 weeks.

Use in Pregnancy & Lactation

Pregnancy:
This drug should be used during pregnancy only if clearly needed.

Lactation:
Inran® (Ranitidine) is secreted in human milk. Caution should be exercised when Inran® (Ranitidine) is administered to a nursing mother.

Side effects:
Inran® (Ranitidine), the following side effects are observed. Minor: headache, dizziness, nausea, stomach pain, constipation, rash. Major: weakness, fever, sore throat, abnormal skin bruising, yellow color to skin or eyes, confusion, agitation.

Contraindications
Inran® (Ranitidine) is contraindicated for patients known to have hypersensitivity to the drug or any of the ingredients.

Precautions
Symptomatic response to therapy with Inran® (Ranitidine) does not preclude the presence of gastric malignancy. Since Inran® (Ranitidine) is excreted primarily by the kidney, dosage should be adjusted in patients with impaired renal function. Caution should be observed in patients with hepatic dysfunction since Inran® (Ranitidine) is metabolized in the liver. Rare reports suggest that Inran® (Ranitidine) may precipitate acute porphyric attacks in patients with acute porphyria. Inran® (Ranitidine) should therefore be avoided in patients with a history of acute porphyria.

Interaction generally means that one drug may increase or decrease the effect of another drug. Also, the more medications a person takes, the morelikely there will be a drug interaction. Interactions with this drug may occur with the following: antacids, blood thinners, diazepam, glipizide, glyburide, itraconazole, ketoconazole, metoprolol, nifedipine, phenytoin, procainamide, sucralfate, theophylline.

Storage Conditions
Store in a cool and dry place, away from light. Keep out of reach of children. Presentation & Packaging
Inran® Tablet: Each commercial box contains 10 x 10's tablets in Alu-Alu blister pack.

Pharmacological Action
Inran® (Ranitidine) is a histamine H2-receptor antagonist. As a result of its H2-receptor blocking action Inran® (Ranitidine) promotes rapid and effective ulcer healing with sustained pain relief, both day and night by reduction of gastric acid output. After oral administration Ranitidine is rapidly absorbed from the GI tract. After IM administration the drug is absorbed very rapidly and almost completely from the site of injection. Therapeutic concentration, necessary to inhibit gastric secretion, is maintained for 6-8 hours both after IV/IM Injection.

Therapeutic Indications
Inran® tablet is indicated in the treatment of Gastric and Duodenal ulcer (Peptic Ulcer), Esophageal Reflux Diseases, Zollinger-Ellison Syndrome, Dyspepsia, Recurrent Ulcer, NSAID Gastropathy and ,In such condition where gastric acidity reduction is beneficial Doses and Administration 2-4 mg/kg twice daily, maximum 300 mg daily. Peptic ulcer150 mg 3 times daily and the dose is increased if necessary up to 6 g daily in divided doses.Zollinger-Ellison Syndrome 150 mg twice daily for up to 8 weeks and if necessary for up to 12 weeks Reflux Oesophagitis150 mg twice daily for up to 8 weeks NSAID-associated Ulcer 150 mg twice daily for up to 6 weeks Chronic Episodic Dyspepsia. The usual adult dosage is 150 mg twice daily taken in the morning and evening for up to 4 to 8 weeks.

Inran® injection may be given either as a slow (over a period of at least two minutes) intravenous injection of 50mg, after dilution to a volume of 20 ml per 50mg dose, which may be repeated every six to eight hours; or as an intermittent intravenous infusion at a rate of 25 mg per hour for two hours; the infusion may be repeated at six to eight hour intervals; or as an intramuscular injection of 50mg (2 ml) every six to eight hours. In the prophylaxis of haemorrhage from stress ulceration in seriously ill patients or the prophylaxis of recurrent haemorrhage in patients bleeding from peptic ulceration, parenteral administration may be continued until oral feeding commences. In the prophylaxis of upper gastrointestinal haemorrhage from stress ulceration in seriously ill patients a priming dose of 50mg as a slow intravenous injection followed by a continuous intravenous infusion of 0.125-0.250mg/kg/hour may be preferred. In patients considered to be at risk of developing aspiration syndrome Inran® injection 50mg may be given intramuscularly or by slow intravenous injection 45 to 60 minutes before induction of general anaesthesia.

Pregnancy: This drug should be used during pregnancy only if clearly needed.

Lactation:
Inran® (Ranitidine) is secreted in human milk. Caution should be exercised when Inran® (Ranitidine) is administered to a nursing mother.

Side effects:
Inran® (Ranitidine), the following side effects are observed. Minor: headache, dizziness, nausea, stomach pain, constipation, rash. Major: weakness, fever, sore throat, abnormal skin bruising, yellow color to skin or eyes, confusion, agitation.

Contraindications
Inran® (Ranitidine) is contraindicated for patients known to have hypersensitivity to the drug or any of the ingredients.

Precautions
It should be used with caution in patients with impaired renal function, hepatic dysfunction, pregnancy, lactating mothers and suspected malignancy.

Storage conditions Store in a cool and dry place, away from light. Keep out of reach of children.

Inran® 150 Tablet: Each commercial box contains 10 x 10's tablets in Alu-Alu blister pack.
Inran® 50 Injection: Box containing 2x5's ampoules in Alu-PVC blister pack.

Pharmacological Action:
Kepros® is a potent analgesic of the non-steroidal anti-inflammatory drugs (NSAID). It inhibits the cyclo-oxygenase enzyme system and hence prostaglandin synthesis. Thus it gives minimal inflammatory effect at its analgesic effect.

Mechanism of Action:

• Peripheral inhibition of prostaglandin synthesis resulting in a decreased amount of prostaglandin to sensitize pain receptors.
• Does not alter the pain threshold or affect existing prostaglandins. Ketorolac's pain attenuation would appear to be a peripheral effect.
• The onset and efficacy of analgesia after systemic administration are claimed to be comparable to that of morphine, but ketorolac causes less drowsiness, nausea, and vomiting.

Pharmacokinetics:
Kepros® (Ketorolac tromethamine) is a racemic mixture of [-]S- and [+]R-enantiomeric forms, with the S-form having analgesic activity.

Therapeutic Indication:
Kepros® is indicated to relief pain associated with surgical procedures such as a major abdominal, orthopedic, dental or gynecological surgery; acute and chronic musculoskeletal pain, renal colic, cancer pain.

Dosage & Administration:
Tablets: Kepros® (Ketorolac) tablets are recommended for short-term use only (up to 7 days) and are not recommended for chronic use. 10mg every 4 to 6 hours as required. Doses exceeding 40mg per day are not recommended. For patients receiving parenteral Ketorolac tromethamine, and who are converted to Ketorolac tromethamine oral tablets, the total combined daily dose should not exceed 90mg (60mg for the elderly, renally-impaired patients and patients less than 50 kg) and the oral component should not exceed 40mg on the day the change of formulation is made. Patients should be converted to oral treatment as soon as possible.
Injection: For adult patients (< 65 years): Initial dose is 60 IM (single) or 30mg IV (single). Maintenance dose is 30mg IM/ IV 6 hourly. Maximum dose is 120mg/day. For elderly patients (> 65 years): Initial dose is 30mg IM. Maintenance dose is 60mg/ day. The duration of treatment should not exceed two days.

Use in children:
Child- under 16 years not recommended.

Contraindication:
Kepros® (Ketorolac tromethamine) is contraindicated in patients having hypersensitivity to this drug or other NSAIDs and those patients in whom aspirin or other prostaglandin synthesis inhibitors induce allergic reactions. It is also contraindicated in a history of peptic ulcer or gastro-intestinal bleeding, moderate or severe renal impairment (serum creatinine> 160 micromol/l), a history of asthma, children under 16 years of age. Ketorolac tromethamine is contraindicated as prophylactic analgesia before surgery due to inhibition of platelet aggregation and is contra-indicated intraoperatively because of the increased risk of bleeding. It is also contraindicated during pregnancy, labor, delivery or lactation.

Use in patients with impaired renal function:
Since Kepros® (ketorolac tromethamine) and its metabolites are excreted primarily by the kidney, patients with moderate to severe impairment of renal function (serum creatinine greater than 160 micromol/l) should not receive. Fluid retention and oedema have been reported with the use of Ketorolac tromethamine.

Use in patients with impaired hepatic function:
Kepros® (Ketorolac Tromethamine) should be used with caution in patients with impaired hepatic function, or a history of liver disease.

Use in elderly patients:
Patients over the age of 65 years may be at a greater risk of experiencing adverse events than younger patients. Ketorolac tromethamine can cause gastro-intestinal irritation, ulcers or bleeding in patients with or without a history of previous symptoms. Bronchospasm may be precipitated in patients with a history of asthma.

Drug Interaction:
Kepros® (Ketorolac tromethamine) should not be used with other NSAIDs or in patients receiving aspirin because of the potential for additive side-effects. Care should be taken when administering Ketorolac tromethamine with anti-coagulants since co-administration may cause an enhanced anti-coagulant effect. Kepros® (Ketorolac tromethamine) and other non-steroidal anti-inflammatory drugs can reduce the anti-hypertensive effect of beta-blockers and may increase the risk of renal impairment when administered concurrently with ACE inhibitors, particularly in volume depleted patients. Caution is advised when methotrexate is administered concurrently, since some prostaglandin synthesis inhibiting drugs have been reported to reduce the clearance of methotrexate, and thus possibly enhance its toxicity. Probenecid should not be administered concurrently with ketorolac tromethamine because of increases in ketorolac plasma level and half-life.

Use in Pregnancy & Lactation:
Safety in human pregnancy has not been established. Ketorolac has been detected in human milk at low levels. Ketorolac is therefore contraindicated during pregnancy, labour or delivery, or in mothers who are breast feeding.

Undesirable Effects:
Commonly occurring side-effects are nausea, vomiting, gastro-intestinal bleeding,melaena, peptic ulcer, pancreatitis, anxiety, drowsiness, dizziness, headache, hallucinations,excessive thirst, inability to concentrate, insomnia, malaise, fatigue, pruritus, urticaria, skin photosensitivity, Lyell's syndrome, Stevens-Johnson syndrome, flushing, bradycardia, hypertension, palpitations, chest pain, infertility in female, dyspnoea, asthma, pulmonary oedema, fever, injection site pain.

Storage Conditions:
Store in a cool (below 30ºC) and dry place, away from light. Keep out of reach of children.

Presentation & Packaging:
Kepros® tablet: Each commercial box contains 3 X 10's tablets in Alu-PVC blister pack.

Pharmacological Action
Kepros® is a potent analgesic of the non-steroidal anti-inflammatory drugs (NSAID). It inhibits the cyclo-oxygenase enzyme system and hence prostaglandin synthesis. Thus it gives minimal inflammatory effect at its analgesic effect. Kepros® is not an anesthetic agent and possesses no sedative or anxiolytic properties; therefore it is not recommended as a preoperative medication for the support of anesthesia when these effects are required. It is not an opioid and has no known effects on opioid receptors. Ketorolac Tromethamine 30mg intramascularly appears to be similar in efficacy to morphine 10mg and superior to pethidine 100mg.

Mechanism of Action

• Peripheral inhibition of prostaglandin synthesis resulting in a decreased amount of prostaglandin to sensitize pain receptors.
• Does not alter the pain threshold or affect existing prostaglandins. Ketorolac's pain attenuation would appear to be a peripheral effect.
• The onset and efficacy of analgesia after systemic administration are claimed to be comparable to that of morphine, but ketorolac causes less drowsiness, nausea, and vomiting.

Pharmacokinetics
Ketorolac tromethamine is a racemic mixture of [-] S- and [+] R-enantiomeric forms, with the S-form having analgesic activity.

Therapeutic Indication
Kepros® is indicated to relief pain associated with surgical procedures such as a major abdominal, orthopedic, dental or gynecological surgery; acute and chronic musculoskeletal pain, renal colic, cancer pain.

Dosage & Administration
Injection: For adult patients (< 65 years): Initial dose is 60 IM (single) or 30 mg IV (single). Maintenance dose is 30 mg IM/ IV 6 hourly. Maximum dose is 120 mg/day. For elderly patients (> 65 years): Initial dose is 30 mg IM. Maintenance dose is 60 mg/ day. The duration of treatment should not exceed two days.
Tablets: Ketorolac tablets are recommended for short-term use only (up to 7 days) and are not recommended for chronic use. 10mg every 4 to 6 hours as required. Doses exceeding 40 mg per day are not recommended. For patients receiving parenteral Ketorolac tromethamine, and who are converted to Ketorolac tromethamine oral tablets, the total combined daily dose should not exceed 90 mg (60 mg for the elderly, renally-impaired patients and patients less than 50 kg) and the oral component should not exceed 40 mg on the day the change of formulation is made. Patients should be converted to oral treatment as soon as possible.

Use in children:
Child- under 16 years not recommended.

Contraindication:
Ketorolac tromethamine is contraindicated in patients having hypersensitivity to this drug or other NSAIDs and those patients in whom aspirin or other prostaglandin synthesis inhibitors induce allergic reactions. It is also contraindicated in a history of peptic ulcer or gastro-intestinal bleeding, moderate or severe renal impairment (serum creatinine> 160 micromol/l), a history of asthma, children under 16 years of age. Ketorolac Tromethamine is contraindicated as prophylactic analgesia before surgery due to inhibition of platelet aggregation and is contra-indicated intraoperatively because of the increased risk of bleeding. It is also contraindicated during pregnancy, labor, delivery or lactation.

Use in patients with impaired renal function
Since ketorolac tromethamine and its metabolites are excreted primarily by the kidney, patients with moderate to severe impairment of renal function (serum creatinine greater than 160 micromol/l) should not receive. Fluid retention and oedema have been reported with the use of Ketorolac tromethamine.

Use in patients with impaired hepatic function
Ketorolac Tromethamine should be used with caution in patients with impaired hepatic function, or a history of liver disease.

Use in elderly patients
Patients over the age of 65 years may be at a greater risk of experiencing adverse events than younger patients. Ketorolac tromethamine can cause gastro-intestinal irritation, ulcers or bleeding in patients with or without a history of previous symptoms. Bronchospasm may be precipitated in patients with a history of asthma.

Drug Interaction
Ketorolac tromethamine should not be used with other NSAIDs or in patients receiving aspirin because of the potential for additive side-effects. Care should be taken when administering Ketorolac tromethamine with anti-coagulants since co-administration may cause an enhanced anti-coagulant effect. Ketorolac tromethamine and other non-steroidal anti-inflammatory drugs can reduce the anti-hypertensive effect of beta-blockers and may increase the risk of renal impairment when administered concurrently with ACE inhibitors, particularly in volume depleted patients. Caution is advised when methotrexate is administered concurrently, since some prostaglandin synthesis inhibiting drugs have been reported to reduce the clearance of methotrexate, and thus possibly enhance its toxicity. Probenecid should not be administered concurrently with ketorolac tromethamine because of increases in ketorolac plasma level and half-life.

Use in pregnancy & lactation
Safety in human pregnancy has not been established. Ketorolac has been detected in human milk at low levels. Ketorolac is therefore contraindicated during pregnancy, labour or delivery, or in mothers who are breast feeding.

Undesirable Effects
Commonly occurring side-effects are nausea, vomiting, gastro-intestinal bleeding,melaena, peptic ulcer, pancreatitis, anxiety, drowsiness, dizziness, headache, hallucinations,excessive thirst, inability to concentrate, insomnia, malaise, fatigue, pruritus, urticaria, skin photosensitivity, Lyell's syndrome, Stevens-Johnson syndrome, flushing, bradycardia, hypertension, palpitations, chest pain, infertility in female, dyspnoea, asthma, pulmonary oedema, fever, injection site pain.

Storage Conditions
Store in a cool (below 30ºC) and dry place, away from light. Keep out of reach of children. and dry place, away from light. Keep out of reach of children.

Presentation & Packaging
Kepros® tablet: Each box contains 3X10's tablet in Alu-PVC blister pack.
Kepros® 30 Injection: Each outer box contains 1X5's ampoule in an individual Alu-PVC blister pack.

Pharmacological Action:
Kepronol® Sterile Eye Drops is a non steroidal anti-inflammatory drug which has analgesic, anti-inflammatory, and anti-pyretic activity. The mechanism of its action is thought to be due to its ability to inhibit prostaglandin biosynthesis which acts as mediators of certain kinds of intraocular inflammation. Studies performed in animal eyes, prostaglandins have been shown to produce disruption of the blood-aqueous humor barrier, vasodilation, increased vascular permeability, leukocytosis, and increased intraocular pressure. Prostaglandins also appear to play a role in the miotic response produced during ocular surgery by constricting the iris sphincter independently of cholinergic mechanisms.

Therapeutic Indications:
Kepronol® Sterile Eye Drops is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. It is also indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction.

Dosage and Administration:
1 drop in each eye 4 times daily for relief of ocular itching due to seasonal allergic conjunctivitis.For the treatment of postoperative inflammation in patients who have undergone cataract extraction, one drop should be applied to the affected eye(s) four times daily beginning 24 hours after cataract surgery and continuing through the first 2 weeks of the postoperative period. Kepronol® Sterile Eye Drops has been safely administered in conjunction with other ophthalmic medications such as antibiotics, beta blockers, carbonic anhydrase inhibitors, cycloplegics, and mydriatics.

Contraindications:
Kepronol® Sterile Eye Drops is contraindicated in patients with known hypersensitivity to NSAIDs and any of the components of Ketorolac Tromethamine. Moreover, the patient with the history of asthma, nasal polyp, angioedema, peptic ulcer and bleeding, bleeding disorders are contraindicated for this drug.Sterile Eye Drops is contraindicated in patients with known hypersensitivity to NSAIDs and any of the components of Ketorolac Tromethamine. Moreover, the patient with the history of asthma, nasal polyp, angioedema, peptic ulcer and bleeding, bleeding disorders are contraindicated for this drug.

Use in Pregnancy and Lactation:
The safety of this medicine during pregnancy and breast feeding is not established. It is not recommended for use during pregnancy or breast feeding unless considered essential by your doctor.

Drug Interaction:
No drug interactions have been described with Kepronol® Sterile Eye Drops.

Storage & Conditions:
Store at room temperature and protect from light. Close the bottle immediately after use. Do not use more than 1 month after opening the bottle. Keep all the medicines out of reach of children.

Presentation & Packaging:
Kepronol® Sterile Eye Drops: Each plastic dropper bottle contains 5 ml eye drops

Pharmacological Action:
Kidivit® Syrup contains eight essential vitamins with Cod-Liver Oil. Kidivit® Syrup provides extra protection for the children. Kidivit® Syrup ensures for getting enough vitamins to children that help them to be grown up strong & stay healthy. Cod-Liver Oil contains Vitamin A, Vitamin D, EPA (Eicosapentaenoic Acid) & DHA (Docosahexaenoic Acid). Vitamin A is essential for the immune system, bone growth, night vision, and cellular growth, testicular and ovarian function. Vitamin D is essential for the absorption and utilization of calcium, which is also required for skeletal growth. EPA and DHA are omega 3 fatty acids, which are converted in the body to produce prostaglandins that affect a wide variety of physiological processes due to their modulating effect on the action of hormones. Omega 3 fatty acids relieve the symptoms of osteoarthritis; rheumatoid arthritis which is also enhances immune function and promotes healthy blood circulation as well as helping to nourish skin, hair, and nails. It is thought that EPA and DHA may reduce the risk of coronary heart disease. DHA seems essential for normal brain development in unborn babies. Vitamin C is necessary for the overall healthy growth and development of the body as well as boosts our immune system and helps the absorption of iron. Vitamin E is a natural antioxidant and hence helps to protect the body's tissues from attack by free radicals. Vitamin E is also found to help build a healthy heart and immune system. Vitamin B1 is necessary for proper functioning of the heart, muscles, and nervous system. Vitamin B2 is vital for turning carbohydrates into energy; it's necessary for antibody production, respiration, the production of red blood cells, and in the regulation of growth and reproduction. Vitamin B6 is crucial to normal brain and nerve function; it aids in the breakdown of proteins and muscle growth, and makes red blood cells.

Therapeutic Indications:
Kidivit® Syrup is indicated for growing children. It helps in development and proper functioning of their vital organs. It helps to prevent vitamin deficiency and restore lost vitality after illness, in case of lack of appetite or tiredness of growing children. It also increases immunity and helps to maintain healthy skin, hair, nail, teeth, bone, eye and nervous system. In adults it helps to treat and prevent chronic diseases like heart diseases, rheumatoid arthritis, COPD, cancer etc. In pregnant and nursing mothers it helps in proper development of the baby.

Babies at 1 month to 5 month: 2.5 ml daily (1/2 teaspoon)
6 month & onwards: 10 ml daily (2 teaspoon)
Adults: 10 ml daily (2 teaspoon)
Kidivit® Syrup can be taken with water or milk

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

SIDE EFFECTS:
Generally well tolerated. However, a few allergic reactions may be seen.

PRECAUTIONS:
This medicine may accumulate in the body. So, should not be taken in overdose.

Some drug interaction may occur with- Erythromycin, Conjugated estrogens, Sodium bicarbonate, Chloramphenicol etc.

USE IN PREGNANCY & LACTATION:
Should be taken on physician advice.

PHARMACEUTICAL INFORMATION:
Storage Conditions:
Store in a (below 25oC) dry place, away from light. Keep out of reach of children.

Presentation & Packaging:
Kidivit® Syrup: Each Amber color PET bottle contains 100 ml syrup with a measuring cup.

Pharmacological Action:
Lactomose® is a disaccharide, which is not hydrolyzed in the small intestine. Therefore it can not be absorbed and is transported to the colon with water to retain the osmotic balance. It provides a natural substrate for the saccharolytic bacterial flora in the colon. In the colon, several species of bacteria can hydrolyze Lactulose to the monosaccharides galactose and fructose. By encouraging this normal metabolic activity of the bacteria, the osmotic pressure of the colonic contents is doubled and more water is drawn into the bowel. Further metabolism of the monosaccharides leads to the production of acetic acids and the subsequent lowering of colonic pH. This acidification of the colonic contents is considered to be the main reason for the effectiveness of Lactulose solution. In chronic portal systemic encephalopathy it may be associated with the decrease in the relative concentration of free ammonia, the major agent involved in the cerebral disturbance.

Mechanism of Action:
Lactulose reaches the colon virtually unchanged. There it is metabolised by colonic bacteria to lactic acid and other shortchain carboxylic acids. The end result is a change in the osmotic pressure and acidification of the colonic contents resulting in an increase in stool water content with resultant distention and softening of the stool which in turn promotes increased peristalsis and bowel evacuation.

Therapeutic Indications: Constipation
Hepatic encephalopathy (Portal systemic encephalopathy): Hepatic coma

Constipation: Initially Lactomose® solution may be given twice daily. In due course the dose should be adjusted according to the needs of the individual, but the following serves as a guide:-
Starting dose:
Adults: (including the elderly) - 15 ml twice daily.
Children: 5 to 10 years - 10 ml twice daily
Children under 5 years - 5 ml twice daily.
Babies under 1 year - 2.5 ml twice daily.
Lactomose® solution may, if necessary, be taken with water, fruit juice etc. Hepatic encephalopathy: Adults (including the elderly): Initially 30-50 ml three times a day. Subsequently adjust the dose to produce two or three soft stools each day.
Use in Children
Children: No dosage recommended for this indication. Because of Lactulose's physiological mode of action it may take up to 48 hours before effects are obtained. However, clinical experience has shown that this medicament does exhibit a 'carry-over' effect, which may enable the patient to reduce the dose gradually over a period of time. A maintenance dose of 15 ml per day provides only 14 kilocalories and is therefore, unlikely to adversely affect diabetic patients.
Contraindications
Galactosaemia. In common with other preparations used for the treatment of constipation, Lactulose should not be used when there is evidence of gastro-intestinal obstruction.Use in Patients with impaired renal function: No specific dosage recommendations for patients with renal impairment. Use in Patients with impaired hepatic function: No specific dosage recommendations for patients with hepatic impairment.
Elderly Patients
No specific dosage recommendations for geriatric patients.

Do not administer laxatives concomitantly; resultant loose stools may be falsely interpreted as an indication that adequate dosage of lactulose has been achieved. Theoretical concern that concomitantly administered oral neomycin and possibly other anti-infective agents could eliminate colonic bacteria necessary to metabolize lactulose and thereby prevent acidification of the colon contents. However, lactulose appears to remain active when administered with neomycin to patients with PSE, and some reports suggest that such concomitant therapy may be more effective than either drug alone in the treatment of PSE.Patients receiving lactulose and an oral anti-infective agent should be closely monitored for possible inadequate response to lactulose.

Wide clinical experience, together with data from animal reproduction studies has not revealed any increase in embryotoxic hazard to the foetus if used in the recommended dosage during pregnancy. If laxative therapy is needed in pregnancy, use of this drug is acceptable.

During the first few days of treatment, meteorism and increased flatulence may occur. These symptoms usually disappear under continued therapy. Diarrhoea may occur especially when used higher dosages, e.g. during treatment of portal systemic encephalopathy. Dosage should then be adjusted to obtain two or three formed stools per day.

Storage Conditions:
Store in a cool and dry place, away from light. Keep out of reach of children.

Lactomose® oral solution: Each amber color glass bottle contains 100ml concentrated oral solution.

Pharmacological Action:
Corticosteroids inhibit the inflammatory response to a variety of inciting agents and probably delay or slow healing. They inhibit the edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation. There is no generally accepted explanation for the mechanism of action of ocular corticosteroids. However, corticosteroids are thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2. Corticosteroids are capable of producing a rise in intraocular pressure.

Loteprednol etabonate is structurally similar to other corticosteroids. However, the number 20 position ketone group is absent. It is highly lipid soluble which enhances its penetration into cells. It is synthesized through structural modifications of prednisolone-related compounds so that it will undergo a predictable transformation to an inactive metabolite. Based upon in vivo and in vitro preclinical metabolism studies, loteprednol etabonate undergoes extensive metabolism to inactive carboxylic acid metabolites.

Results from a bioavailability study in normal volunteers established that plasma levels of loteprednol etabonate and Δ 1 cortienic acid etabonate (PJ 91), its primary, inactive metabolite, were below the limit of quantitation (1 ng/mL) at all sampling times. The results were obtained following the ocular administration of one drop in each eye of 0.5% loteprednol etabonate 8 times daily for 2 days or 4 times daily for 42 days. This study suggests that limited ( < 1 ng/ml) systemic absorption occurs with Loprenol® (loteprednol etabonate ophthalmic suspension).

Therapeutic Indications:
Loprenol® Sterile Eye Suspension is indicated for the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe such as:Allergic conjunctivitis,Acne rosacea,Superficial punctate keratitis,Herpes zoster keratitis,Iritis,Cyclitis.It is also indicated for the treatment of post-operative inflammation following ocular surgery.

Dosage and Administration:
Shake the bottle vigorously before using
Steroid responsive disease treatment:
Apply 1 to 2 drops of Loprenol® Sterile Eye Suspension into the conjunctival sac of the affected eye(s) four times daily. During the initial treatment within the first week, the dosing may be increased, up to 1 drop every hour, if necessary. Care should be taken not to discontinue therapy prematurely.
Post-Operative Inflammation:
Apply 1 to 2 drops of Loprenol® Sterile Eye Suspension into the conjunctival sac of the operated eye(s) four times daily beginning 24 hours after surgery and continuing throughout the first 2 weeks of the post-operative period.

Contraindications:
It is contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures.

Loprenol® Sterile Eye Suspension is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

Use in Pregnancy and Lactation:
Pregnancy: It is Pregnancy Category C.
Lactation: It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk.Pediatric use.Safety and effectiveness in pediatric patients have not been established.

Drug Interaction:
No specific drug interaction has been demonstrated.

Storage & Conditions:
Protect from light. Store in cool & dry place.
Keep out of reach of children.
Do not use more than 1 month after opening.
Shake well before using. Store at 25°c.

Presentation & Packaging:
Loprenol® Sterile Eye Suspension: Each plastic dropper bottle contains
5 ml sterile eye suspension.

Pharmacological Action:
L-con® eye drop is a difluorinated quinolone. It is bactericidal with a broad spectrum of antibacterial activity. Lomefloxacin interferes with bacterial DNA related processes like initiation, elongation, and termination phases of replication, transcription, DNA repair, recombination, transposition, supercoiling and relaxation of DNA. The target molecule for quinolones is the A subunit of bacterial enzyme gyrase (topoisomerase II). The forming of a stable complex between the quinolone and the whole gyrase tetramer A2B2 leads to impaired enzyme functions, resulting in a rapid killing of sensitive bacteria. Plasmid mediated transfer of resistance has not been observed so far. Cross-resistance has only been reported with other quinolones, but not with any other group of antibiotics.

Therapeutic Indications:
L-con® Sterile Eye Drops is indicated for bacterial infections, including bacterial conjunctivitis, blepharitis, and blepharo-conjunctivitis which are due to Lomefloxacin susceptible germs. It is also indicated for the treatment of keratitis and corneal ulcer.

Dosage and Administration:
Adults and children (above 1 year of age)
At the beginning of therapy on day one instill 5 drops into the conjunctival sac within 20 minutes. Thereafter, until day 7-9 instill 1 drop 3 times daily into the conjunctival sac.

Contraindications:
L-con® Sterile Eye Drops is contraindicated in patients with a history of hypersensitivity to L-con® eye drop, quinolone or any other components of this product.

Use in Pregnancy and Lactation:
There are no adequate and well-controlled studies of Lomefloxacin in pregnant woman and nursing mother. It should be used only if the potential benefit justifies the potential risk to the child.

Drug Interaction:
In order to avoid reduction of efficacy, no ophthalmic preparations containing heavy metals, such as zinc, should be used during 15 minutes preceding and following application of the eye drops.

Storage & Conditions:
Protect from light. Store in cool & dry place.
Keep out of reach of children.
Do not use more than 1 month after opening. Store at 25oc.

Presentation & Packaging:
L-con® Sterile Eye Drops: Each Plastic dropper bottle contains 5 ml eye drops.

Pharmacological Action
MOSET® (Cetirizine) is a metabolite of hydroxyzine. It is a second-generation, reversible, competitive inhibitor of histamine at the histamine-1 (H1) receptor. Cetirizine prevents, but does not reverse, pharmacological responses mediated by histamine, at the H1-receptor.

Mechanism of Action
MOSET® (Cetirizine) is a potent histamine H1 receptor antagonist. In usual dosages cetirizine penetrate the blood brain barrier only to a slight extent, and that is why cetirizine & other newer antihistamines do not cause central sedation & psychomotor impairment.
MOSET® (Cetirizine) inhibits the histamine mediated 'early' phase of the allergic reaction and also reduces the migration of inflammatory cells and the release of mediators associated with the 'late' phase of the allergic pathway. Cetirizine also provides a protective effect from bronchospasm induced by inhaled histamine in asthmatics.

Therapeutic Indications

• Seasonal Allergic Rhinitis: MOSET®(Cetirizine) is indicated for the relief of symptoms associated with seasonal allergic rhinitis due to allergens such as ragweed, grass and tree pollens in adults and children 2 years of age and older. Symptoms treated effectively include sneezing, rhinorrhea, nasal pruritus, ocular pruritus, tearing, and redness of the eyes.
• Perennial Allergic Rhinitis: MOSET® (Cetirizine) is indicated for the relief of symptoms associated with perennial allergic rhinitis due to allergens such as dust mites, animal dander and molds in adults and children 2 years of age and older. Symptoms treated effectively include sneezing, rhinorrhea, postnasal discharge, nasal pruritus, occular pruritus, and tearing.
• Chronic Urticaria: MOSET® (Cetirizine) is indicated for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 2 years of age and older. It significantly reduces the occurrance, severity, and duration of hives and significantly reduces pruritus.

Dosages and administration
MOSET® (Cetirizine) can be taken without regard to food consumption. Moset is available as 5mg and 10mg tablets and 5mg and 10mg chewable tablets which can be taken with or without water.
Adults and Children 12 Years and Older: The recommended initial dose of Moset is 5mg or 10mg per day in adults and children 12 years and older, depending on symptom severity. Most patients in clinical trials started at 10 mg. MOSET® (Cetirizine) is given as a single daily dose. The time of administration may be varied to suit individual patient needs.
Children 6 to 11 Years: The recommended initial dose of MOSET® (Cetirizine) in children aged 6 to 11 years is 5mg or 10mg once daily depending on symptom severity. The time of administration may be varied to suit individual patient needs.
Children 2 to 5 Years: The recommended initial dose of MOSET® (Cetirizine) in children aged 2 to 5 years is 2.5mg once daily. The dosage in this age group can be increased to a maximum dose of 5mg per day.

Use in Children
MOSET® (Cetirizine) is effective and well tolerated in children. No special precautions are required in children over 6 years of age.

Contraindications
MOSET® (Cetirizine) is contraindicated in patients who have shown hypersensitivity or idiosyncrasy to it or its parent compound-Hydroxyzine.

Use in patients with Impaired Hepatic Function
In moderate to severe hepatic impairment, half the recommended daily dose should be used.

Use in patient with Impaired Renal Function
In patients with renal impairment, where the creatinine clearance is less than 40ml/min, the recommended daily dose of cetirizine should be 5mg.

Elderly Patients
No dose adjustment is necessary in healthy elderly patients with normal renal function.

Drug Interaction
There are no reports of hazardous interactions with other drugs to date. Concomitant administration with alcohol or diazepam does not impair psychomotor performance any more than the impairment of performance produced by alcohol alone.

Use In Pregnancy & Lactation
Pregnancy: MOSET® (Cetirizine) is not teratogenic in animals. Since the animal studies are not always predictive of human response, it should be used only if the potential benefit justifies the potential risk to the fetus.
Lactation: The extent of MOSET® (Cetirizine) excretion in human breast milk is unknown but some animal studies have shown excretion in breast milk. Nursing mothers are advised not to take this medication.

Undesirable Effects
No potentially life threatening effects have been encountered.

Storage & Conditions
Store in a cool (below 30ºC) and dry place, away from light. Keep out of reach of children.
Presentation & Packaging
MOSET® tablet: Each commercial box contains 5x10's tablet in blister pack.

Pharmacological Action:
Murtrum® is a centrally acting synthetic analgesic compound. It inhibits the re-uptake of neurotransmitters- serotonin and noradrenaline. Thus it modifies the transmission of pain impulses by activating both descending serotonergic pathways and noradrenergic pathways involved in analgesia. The analgesic effects of Tramadol are mediated via stimulation of µ-opioid receptors and indirect modulation of central monoaminergic inhibitory pain pathways.

Therapeutic Indications:
Murtrum®is used for the treatment of moderate to severe painful conditions. These include post-operative pain, colic and spastic pain, cancer pain, joint pain, neck and back pain, acute dental pain, pain associated with osteoporosis, chest pain (including pain associated with myocardial infarction and angina) etc.

Dosage and Administration:
A dose of 50-100 mg may be given every 4 to 6 hours by intramuscular or by intravenous infusion. For the treatment of post-operative pain, the initial dose is 100 mg followed by 50 mg every 10 to 20 minutes if necessary to a maximum of 250 mg in the first hour. Thereafter, doses are 50 to 100 mg every 4 to 6 hours up to a total daily dose of 600 mg. Liver and kidney insufficiency: In acute pain Tramadol hydrochloride 1 ml injection is only given once or a few times, and therefore a dose adjustment is not necessary. In patients with severe liver and/or kidney insufficiency Tramadol hydrochloride injection should not be given. In less severe cases extending the dosage interval should be considered.

Contraindications:
Murtrum®is contraindicated in known hypersensitivity to Tramadol Hydrochloride, or opioids, in acute intoxication with alcohol, hypnotics, analgesics or psychotropic medicines.

Side Effects:
Commonly occurring side-effects are dizziness, vertigo, nausea, constipation, headache, somnolence, vomiting, pruritus, CNS stimulation, asthenia, sweating, dyspepsia, dry mouth, diarrhoea. Less commonly occurring side-effects include- malaise, allergic reaction, weight loss, vasodilatation, palpitations, abdominal pain, anorexia, flatulence, GI bleeding, hepatitis, stomatitis etc.

Precautions:
Respiratory depression: When large doses of Tramadol are administered with anaesthetic medications or alcohol, respiratory depression may result. Therefore, Tramadol should be administered cautiously in patients at risk for respiratory depression. Opioid dependence: Tramadol is not recommended for patients who are dependent on opioids. Concomitant CNS depressants: Tramadol should be used with caution and in reduced dosages when administering to patients receiving CNS depressants such as alcohol, opioids, anesthetic agents, phenothiazines, tranquilizers or sedative hypnotics. Concomitant MAO inhibitors: Tramadol should be used with great caution in patients taking MAO inhibitors, since Tramadol inhibits the uptake of norepinephrine and serotonin. Tramadol should be used with caution in patients with increased intracranial pressure or head injury and patients with acute abdominal conditions.

Drug interactions:
In general, physician need not be concerned about drugs interacting with Tramadol. The Monoamine Oxidase (MAO) inhibitors represent the only drug class not recommended for combination with Tramadol. Concomitant administration of Carbamazepine with Tramadol causes a significant increase in Tramadol metabolism and it requires to increase the dose of Tramadol.

Use in pregnancy and lactation:
Safety in pregnancy and lactation has not been established. Tramadol may also cause serious or fatal side effects in a newborn if the mother uses the medication during pregnancy or labor. Tramadol can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Storage Conditions:
Store in a cool and dry place, away from light. Keep out of reach of children.

Presentation & Packaging:
Murtrum® IV/IM Injection : Box containing 1x 5's ampoules in Alu-PVC blister pack.

Pharmacological Action
It is fluoroquinolone anti-bacterial drugs. It is broad-spectrum anti-bacterial. It has restraining function on gram-positive bacterium. Its function principle is to have function on bacterial DNA gyrase and make bacterial DNA not form super helix and destroy chromosome so as to kill the bacterium.

Mechanism of Action
Quinolones are bacteriocidal drugs, meaning that they kill bacteria. This bactericidal action of ciprofloxacin results from inhibition of enzymes topoisomerase II (DNA gyrase) and topoisomerase IV, which are required for bacterial DNA replication, transcription, repair and recombination. Since a copy of DNA must be made each time a cell divides, interfering with replication makes it difficult for bacteria to multiply.
Bacteria supercoil DNA using DNA gyrase, and quinolones specifically target DNA gyrase, they do not interfere with human DNA.

Therapeutic Indications

Monipro is indicated for the treatment of -

• Urinary tract infections
• Infectious diarrhoea
• Lower respiratory tract infections
• Skin and soft tissue infections
• Bone and joint infections
• Acute sinusitis
• Typhoid fever

Doses and Administration
Adults

Diseases	Dose	Frequency	Duration
Urinary tract infections	500 mg	Twice daily	7 to 14 days
Infectious diarrhoea	500 mg	Twice daily	5 to7 days
Lower respiratory tract infections	500 mg	Twice daily	7 to 14 days
	750 mg	Twice daily	7 to 14 days
Skin and soft tissue infections	500 mg	Twice daily	7 to 14 days
	750 mg	Twice daily	7 to 14 days
Bone and joint infections	500 mg	Twice daily	> 4 to 6 weeks
	750 mg	Twice daily	> 4 to 6 weeks
Acute sinusitis	500 mg	Twice daily	10 Days
Typhoid Fever	500 mg	Twice daily	10 Days

Use in Children
Though not recommended for the children where benefit outweighs risk a dose of 7.5-15 mg/kg/day in two divided doses can be given.

Contraindication
Patients with a history of hypersensitivity to ciprofloxacin or to other quinolones.

Use in patients with impaired renal function
Ciprofloxacin is eliminated primarily by renal excretion; however, the drug is also metabolized and partially cleared through the biliary system of the liver and through intestine.

Drug Interactions
The toxicity of drugs that are metabolised by the cytochrome P450 system is enhanced by associate use of some quinolones. They may also interact with the GABA-A receptor and cause neurological symptoms; this effect is augmented by certain non-steroidal anti-inflammatory drugs.

Use in pregnancy & Lactation
The safety and effectiveness of ciprofloxacin in pregnant and lactating women have not yet been established.

Undesirable Effects
Adverse effects include nausea and other gastrointestinal disturbances, headache, dizziness and skin rashes. Crystalluria has occurred with high doses.

Storage Conditions
Store in cool and dry place, away from light. Keep out of reach of children.

Presentation & Packaging
Monipro® Tablet: Each commercial box contains 6 x 4's tablets in blister pack.

Pharmacological Action:
Monipro-E® Sterile Eye Drops has in vitro activity against a wide range of Gram-negative and Gram-positive organisms. Ciprofloxacin is bactericidal and acts by inhibiting the A subunits of DNA gyrase (topoisomerase) which is essential in the reproduction of bacterial DNA.

Therapeutic Indications:
Monipro-E® Sterile Eye Drops is indicated for the treatment of corneal ulcers, conjunctivitis, and blepharitis, which are caused by susceptible strains of bacteria.

Dosage and Administration:
Corneal Ulcers: The recommended dosage regimen for the treatment of corneal ulcers is 2 drops into the affected eye every 15 minutes for the first 6 hours and then 2 drops into the affected eye every 30 minutes for the remainder of the first day. On the second day, instill 2 drops in the affected eye hourly. On the third through the fourteenth day, place 2 drops in the affected eye every four hours. Treatment may be continued after 14 days if corneal re-epithelialization has not occurred.

Conjunctivitis: The recommended dosage regimen for the treatment of bacterial conjunctivitis is 1 or 2 drops instilled into the conjunctival sac(s) every 2 hours while awake for 2 days and one or 2 drops every 4 hours while awake for the next 5 days.

Contraindications:
A history of hypersensitivity to Ciprofloxacin or any other component of the medication is a contraindication to its use.

Use in Pregnancy and Lactation:
There are no adequate and well-controlled studies in pregnant women. Ciprofloxacin ophthalmic solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Drug Interaction:
Specific drug interaction studies have not been conducted with ophthalmic Ciprofloxacin. However, the systemic administration of some quinolones has been shown to elevate plasma concentrations of theophylline, interfere with the metabolism of caffeine, enhance the effects of the oral anticoagulant warfarin and its derivatives and have been associated with transient elevations in serum creatinine in patients receiving cyclosporin concomitantly.

Storage & Conditions:
Close the bottle immediately after use. Do not use more than 1 month after opening the bottle. Keep in a cool and dry place, protect from light. Keep all the medicines out of reach of children.

Presentation & Packaging:
Monipro-E® Sterile Eye Drops: Each plastic dropper bottle contains 10 ml eye drops.

Prevention and treatment of Vitamin B Complex deficiency states, manifested by glossitis, stomatitis, cheilosis, beriberi and polyneuritis.
Maintenance of normal growth and health during the early days of children.
Apathy and anorexia in elderly patients.
Prevention of vitamin deficiencies, particularly when depletion is suspected;
- Pregnancy and lactation
- Convalescence during debilitating illness
- Patients on restricted diets

Monoplex® tablet - usual recommended dose is 1-2 tablet/capsule 3 times daily or as directed by the physician.

No significant side effects have been reported.

Monoplex® should not be taken in case of hypervitaminosis and hypersensitivity to any of the ingredients of Monoplex®.

Safety margin has been established in taking Monoplex® during pregnancy and lactation.

Caution should be taken during concomitant use of vitamin B-complex and levodopa.

Store in a cool and dry place, protected from light.

Monoplex® Tablet (Blister): Each carton contains _________ tablets in blister pack.

Pharmacological Action
Aceclofenac a phenylacetic acid derivative, is a non-steroid substance, which belongs to anti-rheumatic, anti-inflammatory drugs with analgesic & antipyretic properties. Aceclofenac is generally well tolerated and is indicated for the treatment of rheumatic diseases of either inflammatory or degenerative origin. It is also recommended for the treatment of painful conditions not associated with rheumatic disease. The film coating of Nostrin® tablet: is resistant to gastric acid and therefore the active substance of Aceclofenac is released in the small intestine.

Mechanism of action
Its mode of action is largely based on inhibition of prostaglandin synthesis. Aceclofenac is a potent inhibitor of the enzyme cycloxygenase, which is involved in the production prostaglandins. It also stimulates cartilage matrix (glycosoaminoglycans) synthesis.

Therapeutic Indications
Rheumatology: Osteoarthritis, Rheumatoid arthritis, Ankylosing spondylitis, low back pain & other acute musculosketal disorders such as periarthritis, tendonitis.
Surgery and Traumatology: Bursitis, Sprains, strains, and dislocation, control pain and inflammation in orthopedic, dental and other minor surgery & postoperative pain.
Obstetrics and Gynaecology: Primary dysmenorrhoea, episiotomy, endometritis, parametrized and mastiffs.
Other indications: For the treatment of pain and inflammation and swelling of patients Operated in the urogenital tract, renal & billiard colic.
Feverish conditions and as an adjutant to chemotherapy of infectious diseases and painful conditions not associated with rheumatic disease.

Dosage if Administration
Adults: 1 tablet (100mg) twice daily - 1 tablet in morning & 1 tablet in the evening. Reduce the dosage to 100 mg once daily initially in patient with hepatic dysfunction.

Use in Children
Not recommended.

Contraindication
Aceclofenac is contraindicated in patients with peptic ulceration and in pregnancy & lactation. It is also contraindicated in patients with a history of hypersensitivity to any ingredient of the product, gastro-intestinal bleeding, Aspirin anti-inflammatory induced allergy.

Use in patients with impaired renal function
Renal impairment Patients with mild renal function should be monitored regularly since the use of NSAIDS may result in deterioration of renal function.

Use in patients with impaired hepatic function
There is some evidence that the dose of Aceclofenac should be reduced in patients with hepatic impairment and it is suggested that an initial daily dose of 100mg be used.

Use in Elderly patients
Aceclofenac should be used with caution in elderly patients with hepatic impairment.

Drug Interaction
Anticoagulants, lithium, methorexate, antacids, probenecid, frusemide, digoxin, corticosteroids, antidiabetics & quinolone antibiotics.

Use in Pregnancy & Lactation
Aceclofenac should not be administered during pregnancy & breast feeding, unless the potential benefits to the mother outweigh the possible risks to the fetus & child respectively.

Undesirable effects
Aceclofenac is generally well tolerated. In the initial stage of therapy, gastrointestinal disorders, vomiting or nausea may appear. These effects are usually mild and disappear with the continuation of the treatment. In the very rare cases in which treatment with Aceclofenac is associated with peptic ulceration or gastrointestinal bleeding, patients usually had history of such disorders or they were taking other medications responsible for the appearance of such disorders.

Storage Conditions
Store in a cool (below 30ºC) and dry place, away from light. Keep out of reach of children.
Presentation & packaging:
Each commercial box contains 5X10's tablet in Alu-PVC blister pack.

Pharmacological Action:
Esomeprazole (Nuloc® 20) is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/K+-ATPase in the gastric parietal cell. By acting specifically on the proton pump, Nuloc® 20 blocks the final step in acid production, thus reducing gastric acidity.

Therapeutic Indications:
Treatment of Gastro Esophageal Reflux Disease (GERD), Healing of Erosive Esophagitis, Maintenance of Healing of Erosive Esophagitis Symptomatic Gastroesophageal Reflux Disease, H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence, Zollinger-Ellison Syndrome, Acid Related Dyspepsia, Duodenal and Gastric Ulcer.

Dosage and Administration:
Tablet: Esomeprazole (Nuloc® 20) tablet should be swallowed whole and taken at least one hour before eating. The majority of patients are healed within 4 to 8 weeks. For patients who do not heal after 4-8 weeks, an additional 4-8 weeks of treatment may be considered.
If symptoms do not resolve completely after 4 weeks, an additional 4 weeks of treatment may be considered.

Geriatric: No dosage adjustment is necessary. Renal Insufficiency: No dosage adjustment is necessary. Hepatic Insufficiency: No dosage adjustment is necessary in patients with mild to moderate liver impairment. For patients with severe liver impairment, a dose of 20 mg of Esomeprazole (Nuloc® 20) should not be exceeded.

Contraindications:
Esomeprazole (Nuloc® 20) is contraindicated in patients with known hypersensitivity to any component of the formulation or to substituted Benzimidazoles.

Drug Interactions:
Drug interaction studies have shown that Esomeparzole does not have any clinically significant interactions with Phenytoin, Warfarin, Quinidine, Clarithromycin or Amoxicillin. Esomeprazole inhibits gastric acid secretion. Therefore, Esomeprazole may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (e.g. Ketoconazole, Iron salts and Dogoxin). Co-administration of oral contraceptives, Diazepam, Phenytoin or Quinidine did not seem to change the pharmacokinetic profile of Esomeprazole.

Precautions:
Symptomatic response to therapy with Esomeprazole does not preclude the presence of gastric malignancy. Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with omeprazole, of which Esomeprazole is an enantiomer.

Side Effects:
In general, Esomeprazole was well tolerated in both short- and long-term clinical trials. The most frequently occurring adverse events ( >1%) are headache and diarrhea. Nausea, flatulence, abdominal pain, constipation and dry mouth occurred at similar rates among patients taking Esomeprazole.

Use in pregnancy and lactation:
In Pregnancy: Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed.
In Lactation: The excretion of Esomeprazole in milk has not been studied. As Esomeprazole is likely to be excreted in human milk, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Presentation & Packaging:
Nuloc® 20 Tablet: Each box contains 10 x 10 tablets in blister pack.

Pharmacological Action:
Nicud® (Nitazoxanide), a synthetic antiprotozoal agent. Nitazoxanide is well absorbed from GIT. Itinterferes with the Pyruvate Ferredoxin Oxidoreductase (PFOR) enzyme dependent electron transfer reaction which is essential to anaerobic glucose energy metabolism. This results in cell swelling, membrane damage resulting in dysfunction of the parasite.

Therapeutic Indications:
1. Diarrhoea caused by Cryptosporidium parvum and Giardia lamblia.
2. Amebiasis and helminth infections.

Dosage and Administration:
Age 1 - 3 years : 5ml (100mg) twice daily for 3 days
Age 4 - 11 years: 10ml (200mg) twice daily for 3 days
Age >12 years : 25ml or 1 tablet (500mg) twice daily for 3 days
The suspension or tablet should be taken with food.

Contraindications:
Known hypersensitivity to Nicud® or any other ingredient in the formulations.

Drug Interactions:
Nicud® is highly bound to plasma protein (>99.9%). Therefore, caution should be used when administering Nitazoxanide concurrently with other highly plasma-protein bound drugs.

Precautions:
Nicud® should be administrated with caution to patients with hepatic, renal and biliary disease.

Side Effects:
Nicud® is generally well tolerated. However abdominal pain, diarrhoea vomiting and headache have been reported rarely.

Use in pregnancy and lactation:
Pregnancy category B: This drug should be used during pregnancy only if clearly needed.
Nursing mother: It is not known whether Nicud® is excreted in human milk.Because many drugs are excreted in human milk, caution should be exercised when.Nitazoxanide is administrated to a nursing woman.

Reconstitution for Suspension:
Nicud® (Nitazoxanide) 30ml suspension: Shake the bottle well before adding water. Then add 20ml of boiled and cooled water (with the help of provided cup) into the bottle and shake well to make 30ml suspension. Once reconstituted suspension should be used within 7 days.

Over Dosage:
Information on Nitazoxanide over dosage is not available. Single oral doses up to 4000mg Nitazoxanide have been administered to healthy adults without significant adverse effects.

Storage Conditions:
Store in cool below 300c and dry place, away from light. Keep out of reach of children.

Presentation & Packaging:
Nicud® suspension: Each amber glass bottle contains dry powder for preparation of 30ml suspension.

Pharmacological Action:
Gliclazide stimulates the release of insulin from pancreatic beta-cells by facilitating Ca2+ transport across the beta-cell membranes. It lowers blood glucose by stimulating the release of insulin from the pancreas, an effect dependent upon functioning beta cells in the pancreatic islets. Extrapancreatic effects also may play a part in the mechanism of action of oral sulfonylurea hypoglycemic drugs. Two extrapancreatic effects shown to be important in the action of Gliclazide are an increase in insulin sensitivity and a decrease in hepatic glucose production. The anti-oxidant, platelet inhibiting and fibrinolytic actions of Gliclazide involve processes which have been implicated in the pathogenesis of vascular complications of type 2 diabetes.

Therapeutic Indications:
Norglic® 80 is indicated for the treatment of type 2 diabetes in association with dietary measures when dietary measures alone are inadequate to control blood glucose.

Dosage and Administration:
The usual initial dose of Norglic® 80 is 80 mg daily, gradually increased, if necessary up to 320 mg daily until adequate control is achieved. A single dose should not exceed 160 mg. When higher doses are required it should be taken twice daily, according to the main meals of the day. Norglic® 80 should be taken with food because there is increased risk of hypoglycemia if a meal is taken late. It is recommended that the medication be taken at breakfast time. If a dose is forgotten, the dose taken on the next day should not be increased.

Precautions:
Care should be exercised with patients having hepatic and or renal impairment. In long term clinical trials, patients with renal insufficiency have been treated satisfactorily using Gliclazide.

Contraindications:
Gliclazide should not be used in juvenile onset diabetes, diabetes complicated by ketosis and acidosis, diabetes undergoing surgery, after severe trauma or during infections, patients known to have hypersensitivity to other sulfonylureas and related drugs, diabetic pre-coma & coma, severe renal or hepatic insufficiency, combination with miconazole tablets.

Side Effects:
Hypoglycemia may occur in concurrent conditions such as hepatic & renal diseases, alcohol intoxication and adrenal and pituitary insufficiency. Mild gastro-intestinal disturbances including nausea, dyspepsia, diarrhea, and constipation have been reported but these types of adverse reactions can be avoided if Gliclazide is taken during a meal. Allergic dermatological reactions including rash, pruritus, erythema, bullous eruption have been reported during treatment with the drug but are not known to be directly attributable to it. More serious reactions like leucopenia, thrombocytopenia, agranulocytosis, pancytopenia, hemolytic anemia, cholestatic jaundice, GI hemorrhage have not been reported with Gliclazide.

Drug Interaction:
The hypoglycemic effect of Gliclazide may be potentiated by NSAID (in particular aspirin), phenylbutazone, sulfonamides, coumarin derivatives, MAOIs, beta-adrenergic blockers, tetracyclines, chloramphenicol, clofibrate, cimetidine and miconazole tablets. Ingestion of alcohol may also increase the hypoglycemic effect of Gliclazide. Some drugs may on the contrary, reduce its activity e.g. barbiturates, corticosteroides, thiazide diuretics, thyroid hormones, laxatives and oral contraceptives.

Use in pregnancy and lactation:
Pregnancy: Gliclazide should not be used in pregnancy.
Nursing mothers: No study has reported its presence in human breast milk. However, other sulfonylureas have been found in milk and there is no evidence to suggest that gliclazide differs from the group in this respect.

Over Dosage:
Accidental or deliberate overdosage leads essentially to signs of hypoglycemia. The treatment is gastric lavage and correction of hypoglycemia.

Storage Conditions:
Keep away from light and store at cool and dry place.

Presentation & Packaging:
Norglic® 80 tablet : Each box contains 3X10's tablet in blister pack.

- Pharyngitis/tonsillitis caused by Streptococcus pyogenes.
- Acute bacterial otitis media caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta lactamase-producing strains), Moraxella Catarrhalis (including beta-lactamase-producing strains) or Streptococcus pyogenes
- Acute bacterial maxillary sinusitis caused by Streptococcus pneumoniae, or Haemophilus influenzae (nonbeta-lactamase-producing strains only)
- Lower respiratory tract infections including pneumoniae, caused by Streptococcus pneumoniae, Haemophilus influenzae (including beta lactamase-producing strains), Klebsiella spp., Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes, Escherichia coli.
- Acute bacterial exacerbations of chronic bronchitis and secondary bacterial infections of acute bronchitis caused by Streptococcus penumoniae, Haemophilus influenzae (beta-lactamase negative strains), or Haemophilus parainfluenzae (beta-lactamase negative strains).
- Skin and Skin-Structure Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pyogenes, Escherichia coli, Klebsiella spp., and Enterobacter spp.
- Urinary tract infections caused by Escherichia coli or Klebsiella pneumoniae.
- Bone and Joint Infections caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains).
- Gonorrhea : Uncomplicated and disseminated gonococcal infections due to Neiseria gonorrhoeae (penicillinase- and non-penicillinase-producing strains) in both males and females.
- Early Lyme disease (erythema migrans) caused by Borrelia burgdorferi.
- Septicemia caused by Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains), Streptococcus pneumoniae, Escherichia coli, Haemophilus influenzae (including ampicillin-resistant strains), and Klebsiella spp.
- Meningitis caused by Streptococcus pneumoniae, Haemophilus influenzae (including ampicillin-resistant strains), Neisseira menintitidis, and Staphylococcus aureus (penicillinase- and non-penicillinase-producing strains).
- Surgical Prophylaxis: Prophylaxis against infections in abdominal, pelvic, orthopedic, cardiac, pulmonary, esophageal and vascular surgery where there is increased risk for infection.

Dosage and Administration:
Tablet:
(May be administered without regard to meals).
Adolescents & adults(13 years & above)
Pharyngitis or Tonsillitis 250 mg twice daily 5-10 days
Acute bacterial maxillary sinusitis 250 mg twice daily 10 days
Acute bacterial exacerbation of chronic bronchitis 250-500 mg twice daily 10 days
Secondary bacterial infections of acute bronchitis 250-500 mg twice daily 5-10 days
Uncomplicated skin & skin-structure infections 250-500 mg twice daily 10 days
Uncomplicated urinary tract infection 125-250 mg twice daily 7-10 days
Uncomplicated gonorrhea 1000 mg single dose - - -
Lyme disease 500 mg twice daily 20 days

Paediatric patients (Upto12 years)
(Who can swallow tablets whole)
Pharyngitis or Tonsillitis 125 mg twice daily 5-10 days Acute otitis media 250 mg twice daily 10 days
Acute bacterial maxillary sinusitis 250 mg twice daily 10 days

Paediatric patients (3 months to 12 years)
Pharyngitis or Tonsillitis 20 mg/kg/day in two divided doses 5-10 days Acute otitis media 30 mg/kg/day in two divided doses 10 days
Acute bacterial maxillary sinusitis 30 mg/kg/day in two divided doses 10 days

Contraindications:
Patients with known allergy to cephalosporin group of antibiotics.

Drug Interactions:
Concomitant administration of probenecid with Cefuroxime increases the area under the serum concentration versus time curve by 50%. Drug that reduces gastric acidity may result in a lower bioavailability of Cefuroxime and tend to cancel the effect of postprandial absorption.

Use in pregnancy and lactation:
Pregnancy: While all antibiotics should be avoided in the first trimester if possible. However, Cefuroxime has been safely used in later pregnancy to treat urinary and other infections.
Nursing mothers: Cefuroxime is excreted into the breast milk in small quantities. However, the possibility of sensitizing the infant should be kept in mind.

Undesirable Effects:
Generally Cefuroxime is well tolerated. However, a few side effects like nausea,vomiting,diarrhoea, abdominal discomfort or pain may occur.as with other broad-spectrum antibiotics,prolonged administration of Cefuroxime may result in overgrowth of nonsusceptable microorganisms. Rarely (<0.2%) renal dysfunction, anaphylaxis, angioedema, pruritis, rash and serum sickness like urticaria may appear.

Storage Conditions:
Store in a cool and dry place,away from light.keep out of reach of children.

Presentation & Packaging:
Orextil® 250 Tablet: Each box contains 3x4's tablets in alu-alu blister pack.
Orextil® 500 Tablet: Each box contains 3x4's tablets in alu-alu blister pack.

Pharmacological Action:
Olopatadine inhibits the release of histamine from the mast cell for topical administration to the eyes and is a relatively selective histamine H1 -antagonist that inhibits the in vivo and in vitro type 1 immediate hypersensitivity reaction including inhibition of histamine induced effects on human conjunctival epithelial cells. Olopatadine has no effects on alpha-adrenergic, dopamine and muscarinic type 1 and 2 receptors. Olopatadine was shown to have low systemic exposure after topical administration.

Therapeutic Indications:
Olorid® Sterile Eye Drops is indicated for the treatment of signs and symptoms (itchy, watery, red and swollen eyes and/or eyelids) of allergic conjunctivitis including vernal keratoconjunctivitis, vernal keratitis, blepharitis, blepharoconjunctivitis and giant papillary conjunctivitis.

Dosage and Administration:
The recommended dose of Olorid® Sterile Eye Drops is 1 drop in the affected eye(s) two times daily.

Contraindications:
It is contraindicated in persons with a known hypersensitivity to any component of this product.

Use in Pregnancy and Lactation:
Olopatadine was found not to be teratogenic in rats and rabbits. There are, however, no adequate and well controlled studies in pregnant women. This drug should be used in pregnant women only if the potential benefit justifies the potential risk to the fetus.

It is not known whether topical ocular administration could result in sufficient systemic absorption to produce detectable quantities in the human breast milk. Nevertheless, caution should be exercised when Olorid® Sterile Eye Drops is administered to a nursing mother.

Drug Interaction:
Specific drug interaction studies have not been conducted with Olopatadine ophthalmic solution.

Storage & Conditions:
Store in a safe place.
Store at room temperature and protect from light.
Keep out of the reach of children.
Do not use more than 1 month after opening. Store at (4°c-25°c).

Presentation & Packaging:
Olorid® Sterile Eye Drops: Each plastic dropper bottle contains 5 ml eye drops.

Pharmacological Action:
Dexamethasone is a cortisone derivative whose high activity due to the presence of methyl group in the 16-alpha position and of a fluorine atom in the 9-alpha position. The result is that its anti-inflammatory activity is 30 times greater and its overall therapeutic effectiveness 8-10 times greater than that of hydrocortisone. Like other glucocorticoids, it is anti-allergic, anti-exudative and anti-proliferative.Therapeutic concentrations of Dexamethasone are found in both the cornea and aqueous humor 15-30 minutes after local application of single drop of 0.1% solution. These concentrations persist for 4-6 hours.The action of Dexamethasone is to inhibit the phospholipase A2, the first step in prostaglandin synthesis. Also, Dexamethasone inhibits the chemotactic infiltration of neutrophils into the site of inflammation.

Therapeutic Indications:
Allergic conjunctivitis, Acne rosacea, Superficial punctate keratitis, Herpes zoster keratitis, Iritis, Cyclitis, Selected infective conjunctivitides, Injury to the cornea, Preventing rejection of grafts in the eye.

Dosage and Administration:
1 or 2 drops in conjunctival sac.
Severe or acute inflammation: Every 30 to 60 minutes as initial therapy, reducing the dosage when favorable response is observed to every two to four hours. Further reduction may be made to one drop three or four times daily if sufficient to control inflammation.
Chronic inflammation: Every three to six hours, or as necessary.
Allergic inflammation: Every three to four hours until the desired response is obtained.

Contraindications:
Injuries and ulcerating processes of the cornea, particularly those of bacterial or viral origin (herpes simplex, vaccinia), purulent infections of the conjunctiva and eyelids, tuberculosis, mycosis, glaucoma.

Use in Pregnancy and Lactation:
Animal experiments with dexamethasone have shown adverse effect on the fetus. However, no control human studies are available. Dexamethasone ophthalmic preparation should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Drug Interaction:
No known drug interaction has been demonstrated.

Storage & Conditions:
Store at room temperature, protect from light. Close the bottle immediately after use. Do not use more than 1 month after opening the bottle. Keep all the medicines out of reach of children.

Presentation & Packaging:
Opler® Sterile Eye Drops: Each plastic dropper bottle contains 5 ml eye drops.

Pharmacological Action
Pregabalin is an analogue of the neurotransmitter gamma-aminobutyric acid (GABA). It has analgesic and anticonvulsant activity. It is also effective in treatment of anxiety, and also a sleep-modulating drug.

Mechanism of Action
Pregabalin subtly reduces the synaptic release of several neurotransmitters, apparently by binding to alpha2-delta subunits (The alpha2-delta protein an auxiliary subunit of voltage-gated calcium channels) and possibly accounting for its actions in vivo to reduce neuronal excitability & seizures.

Therapeutic Information:
Neuropathic pain
Fibromyalgia
Diabetic Peripheral Neuropathy
Seizures
Herpes Zoster Pain
Anxiety Disorder

Dosage and Administration:
Priga® capsule
The dose range is 150mg to 600 mg per day given either two or three divided doses. Priga® (Pregabalin) may be taken with food or without food.

Neuropathic pain: Priga® (Pregabalin) treatment can be started at a dose of 150mg per day given as two or three divided doses. Based on individual patient response amd tolerability, the dosage may be increased to 300mg per day after an interval of 3 to 7 days, and if needed, to a maximum dose of 600 mg per day after an additional 7-day interval.

Epilepsy: Priga® (Pregabalin) treatment can be started with a dose of 150mg per day given as two or three divided doses. Based on individual patient response and tolerability, the dose may be increased to 300mg per day after 1 week. The maximum dosage of 600mg per day may be achieved after an additional week.

Generalized Anxiety Disorder: The dose range is 150 to 600 mg per day given as two or three divided doses. The need for treatment should be reassessed regularly.

Patient with renal impairment: Pregabalin is eliminated from the systemic circulation primarily by renal excretion as unchanged drug. As Pregabalin clearance is directly proportional to creatinine clearance, dose reduction in patients with compromised renal function must be individualised according to creatinine clearance (CLcr), as indicated as following table:

Creatinine clearance(CLcr) (ml/min)	Community-acquired pneumonia (CAP) [of mild to moderate severity]		DURATION
	Starting dose (mg/day)	Maximum dose (mg/day)
	150	600	BID or TID
≥30 - <60	75	300	BID or TID
≥15 - <30	25-30	150	Once daily or BID
<15	25	75	Once daily
Supplementary dosage following haemodialysis (mg)
	25	100	Single dose+

TID= Three divided doses
BID= Two divided doses
*Total daily dose (mg/day)should be divided as indicated by dose regimen to provide mg/dose
+ Supplementary dose is a single additional dose.

Use in patients with hepatic impairment: No dose adjustment is required for patients with hepatic impairment.

Use in Children & Adolescents: Pregabalin is not recommended for use in children below the age of 12 years and adolescents (12-17 years of age) due to insufficient data on safety & efficacy.

Use in the elderly (over 65 years of age): Elderly patients may require a dose reduction of Pregabalin due to decreased renal function.

Contraindications:
Pregabalin is contraindicated in patients who have demonstrated hypersensitivity to pregabalin or its ingredients.

Drug Interactions:
In vivo studies no clinically relevant pharmacokinetic interactions were observed between pregabalin and phenytoin, carbamazepine, valproic acid, lamotrigine, gabapentin, lorazepam, oxycodone or ethanol.

Precautions:
Dizziness, somnolence, and blurred vision may impair a patient's ability to perform skilled tasks such as driving. Care is required when withdrawing pregabalin therapy, regardless of the indication.

Use in pregnancy:
Pregabalin has not been studied in pregnant women and Pregabalin should not be used during pregnancy unless the benefit to the mother clearly outweighs the potential risk to the fetus.

Use in lactation:
Breastfeeding is not recommended in women taking Pregabalin.

Undesirable Effects:
Most common adverse effects of pregabalin are dizziness and somnolence. Other common adverse effects include blurred vision, diplopia, increased appetite and weight gain, dry mouth, constipation, vomiting, flatulence, euphoria, confusion, irritability, vertigo, ataxia, tremor, dysarthria, paraesthesia, fatigue, and oedema.

Storage Conditions:
Store in cool and dry place. Away from light. Keep out of reach of children.

Presentation & Packaging:
Priga® 75 Capsule: Each box contains 7X4s capsules in Alu-Alu blister pack.
Priga® 100 Capsule: Each box contains 5X4s capsules in Alu-Alu blister pack.

Pharmacological Action
Both Naproxen and Naproxen Sodium are completely absorbed from the GIT, but the peak plasma concentration is attained about 1-2 hours after ingestion of Naproxen Sodium whereas that takes 2-4 hours after ingestion of Naproxen.

Mechanism of Action
Proxen® 250 is a non-steroidal anti-inflammatory agent. The drug exhibits anti-inflammatory, analgesic, and antipyretic activity by inhibiting the prostaglandin synthesis.

Therapeutic Information:
Naproxen is indicated for the relief of symptoms of rheumatoid arthritis, both of acute flares and long term management of the disease. It is also used in the diseases of rheumatoid osteoarthritis (degenerative arthritis), ankylosing spondilytis, juvenile rheumatoid arthritis, tendonitis, bursitis, acute gout, acute musculoskeletal disorders (such as sprains, direct trauma, and fibrositis), migraine, and dysmenorrhoea.

Dosage and Administration:
Rheumatoid arthritis, osteoarthritis, and ankylosing spondilytis; 250-500mg twice daily. May be increased to 1.50gm for limiting periods. Morning and evening doses do not have to be equal, and use of the drug more frequently than twice daily is not necessary. Symptomatic arthritis improvement usually begins in 2 weeks, if no improvement is seen; consider a trial for 2 more weeks.

Mild to moderate pain, primary dismenorrhoea, acute tendonitis, bursitis and dysmenorrhoea: 500mg initially, followed by 250mg every 6 to 8 hours as required. Do not exceed a 1.375gm total daily dose.

Acute gout: 750mg, then 250mg every 8 hours until attack subsides.

Juvenile arthritis (children over 5 years): 10mg/kg daily in two divided doses is recommended.

Use in Children:
Proxen® 250 250 is not recommended for use in any other indication in children under 16 years of age.

Contraindications:
The drug is contraindicated in patients with a history of hypersensitivity to aspirin or any other NSAIDs- which include those in whom attacks of asthma, angioedema, urticaria or rhinitis have been precipitated by aspirin or any other NSAIDs.

Use in patients with impaired hepatic function:
Proxen® 250 should be used with caution in patients with hepatic impairment.

Elderly Patients
Data not found.

Use in pregnancy & lactation:
There are no well controlled studies in pregnant women. The drug should not be used during pregnancy until clearly needed. Because of the possible adverse effects of prostaglandin inhibiting drugs on neonates, use in nursing mothers must be avoided.

Undesirable Effects:
Gastrointestinal discomfort: Nausea, diarrhea, and occasional bleeding & ulceration.
Hypersensitivity reactions: Notably with bronchospasm, rashes and angioedema. CNS side effect: Drowsiness, headache, fluid retention, vertigo, hearing disturbances such as tinnitus, & photosensitivity.

A few instances of jaundice, impairment of renal function, thrombocytopenia, and agranulocytosis have been reported.

Storage Conditions:
Store in a cool and dry place, away from light. Keep out of reach of children.

Presentation & Packaging:
Proxen® 250 tablet: Each commercial box contains 5X10 tablets in alu-alu blister pack.

Pharmacological Action:
Ebastine is a long-acting and selective H1 receptor antagonist. After repeated administration, inhibition of peripheral receptors remain at a constant level. Ebastine is almost totally converted to the pharmacologically active acid metabolite, Carebastine. Peak plasma levels of Carebastine occur at 2.6 to 4 hours and achieve levels of 80 to 100 ng/mL. The half-life of Carebastine is between 15 and 19 hours. Both Ebastine and Carebastine are highly protein bound, >95%.

Therapeutic Information:
Ebastine is indicated for the symptomatic treatment of:

• Seasonal and Perennial allergic rhinitis
• Chronic idiopathic urticaria
• Allergic skin disorders

and others-

• Allergic dermatitis
• Cold urticaria
• Dermographic urticaria
• Atopic asthma
• Mosquito bites
• Common cold

Dosage and Administration:
Children :
Children between 2 and 5 years: 2.5ml once daily (up to 5ml in severe cases such as perennial allergic)
Children between 6 and 11 years: 5ml (one teaspoonful) once daily (up to 10ml in severe cases such as perennial allergic rhinitis).
Adults :
Adults and older children more than 11 years: 1 tablet (10mg) or 10ml (two teaspoonfuls) once daily. Ebastine may be taken with or without food.

Contraindications:
Patients with a known hypersensitivity to Ebastine or any of its ingredients.

Drug Interactions:
Concomitant use of Ketoconazole, Itraconazole, Clarithromycin or Erythromycin may increase plasma levels of Ebastine and cause QTc interval prolongation.

Precautions:
Caution is advised when used in hepatic impairment, renal insufficiency, QTc interval prolongation.

Pregnant mothers:
The safety of Ebastine during pregnancy and lactation has not been established.

Pediatrics:
The safety and efficacy of Ebastine tablets in children less than 12 years has not been established

Overdosage:
In studies conducted at a high dosage, no clinically meaningful signs or symptoms were observed up to 100mg given once daily. There is not specific antidote for Ebastine. In case of accidental overdose, gastric lavage, monitoring of vital functions including ECG, and symptomatic treatment should be carried out.

Side effects:
The most common side-effects are headache, dry mouth and drowsiness. Less commonly reported side effects include abdominal pain, dyspepsia, nausea and insomnia.

Storage & Conditions:
Store below 300 C at a cool and dry place, away from light and moisture. Keep out of reach of children.

Presentation & Packaging:
Pvast® Tablet: Each box contains 5x10's tablet in blister pack.
Pvast® Syrup: Each amber color pet/glass bottle contains 50ml syrup.

Pharmacological Action
Ceftriaxone (PERIX®) is a semisynthetic third generation broad spectrum parenteral cephalosporin antibiotic. It has potent bactericidal activity against a wide range of Gram-positive and, especially, Gram-negative organisms. The spectrum of activity includes both aerobic and some anaerobic species.
Mechanism of Action
Ceftriaxone like other cephalosporins and penicillins, kills bacteria by interfering with the synthesis of bacterial cell wall. Ceftriaxone has a higher degree of stability in the presence of beta lactamases, both penicillanases and Cephalosporinases, of gram-positive and gram-negative bacteria.
Pharmacokinetics
Ceftriaxone (PERIX®) is not absorbed after oral administration and must be given parenterally. Following IV or IM administration, Ceftriaxone is widely distributed into body tissues and fluids including gallbladder, lungs, bone, bile, prostate adenoma tissue, uterine tissue, atrial appendage, sputum, tears, and pleural, peritoneal, synovial, ascitic and blister fluids. It is eliminated mainly as drug unchanged, approximately 60% of the dose being excreted in the urine (almost exclusively by glomerular filtration) and the reminder via the biliary and intestinal tracts.

Therapeutic Indications:
Renal and urinary tract infections; Lower respiratory tract infections, particularly pneumonia; Gonococcal infections; Skin and soft tissue, bone and joint infections; Bacterial meningitis; Serious bacterial infections e.g. septicemia; ENT infections; Typhoid fever; Infections in cancer patients; Prevention of postoperative infection; Pre operative prophylaxis of infections associated with surgery.

PERIX® (Ceftriaxone) can be administered either intravenously or intramuscularly.
Adults: The usual adult daily dose is 1-2g once daily, (or twice daily in equally divided doses) depending on the type and severity of infection. The daily dose may be increased, but should not exceed 4g. For preoperative use (surgical prophylaxis), a single dose of 1 gm administered intravenously 0.5-2 hours before surgery is recommended. In elderly patients, the dosages do not require modification provided that renal and hepatic functions are satisfactory. In patients with impaired renal function, there is no need to reduce the dosage of PERIX® provided liver function is intact. In patients with liver damage, there is no need for the dosage to be reduced provided renal function is intact. Gonorrhea: For the treatment of gonorrhea (penicillinase producing and non-penicillinase producing strains), a single intramuscular dose of 250mg is recommended.
Children under 12 years: The recommended total daily dose is 50 to 75mg/kg once daily (or twice daily in equally divided doses). In severe infections, up to 80mg/kg body weight daily may be given. The total daily dose should not exceed 2g. In the treatment of meningitis, the initial dose of 100mg/kg body weight (not to exceed 4g daily) once daily (or twice daily in equally divided doses), is recommended. As soon as the causative organism has been identified and its sensitivity, the doses can be reduced accordingly. The usual duration of therapy in meningitis is 7 to 14 days.

Use in children
PERIX® is contraindicated in premature infants during the first 6 weeks of life.

Contraindication
PERIX® should not be given to patients with a history of hypersensitivity to cephalosporin antibiotics. Its safety in human pregnancy has not been established. Therefore it should not be used in pregnancy unless absolutely indicated. Only minimal amount of Ceftriaxone has excreted in breast milk, so mothers receiving PERIX® should not breast-feed.

Use in patients with impaired renal function
In severe renal impairment accompanied by hepatic insufficiency, dosage reduction is required.

Use in patients with impaired hepatic function
The stated dosage should not be exceeded. In severe renal impairment accompanied by hepatic insufficiency, dosage reduction is required.

Drug Interactions
Potentially hazardous interactions: No impairment of renal function or increased nephrotoxicity has been observed in man after simultaneous administration of Ceftriaxone with diuretics, or with aminoglycosides. A possible disulfiram-like reaction may occur with alcohol.
Other significant interactions: PERIX® doesn't interfere with the protein binding of bilirubin. Simultaneous administration of probenecid doesn't alter the elimination of Ceftriaxone.toxicity. Probenecid should not be administered concurrently with Ketorolac tromethamine because of increases in ketorolac plasma level and half-life. Potentially useful interactions: Experimentally, in vivo, Ceftriaxone has been shown to enhance bacterial killing by human neutrophils.

Use in pregnancy & lactation
PERIX® has not been associated with adverse effects on fetal on fetal development in laboratory animals, but its safety in human pregnancy has not been established. Therefore, it should not be used in pregnancy unless absolutely indicated. Because Ceftriaxone is distributed into milk, the drug should be used with caution in nursing women.

Undesirable Effects
PERIX® is generally well tolerated. A few side-effects such as Gastrointestinal effects include diarrhea, nausea and vomiting, stomatitis and glossitis; Cutaneous reactions include rash, pruritus, urticaria, and edema & erythema multiforme; Hematological reactions include eosinophilia, thrombocytosis, leukopenia, and neutropenia; CNS reactions include headache, hyperactivity, nervousness; sleep disturbances, confusion, hypertonia, and dizziness were reported.

Storage Conditions
Store in a cool (below 30ºC) and dry place, away from light. Keep out of reach of children.
Presentation & Packaging
PERIX® (Ceftriaxone) is supplied as sterile powder in glass vial.
PERIX®250mg IM injection: Box containing 1 combipack and a 5ml disposable syringe. Each combipack contains 1 vial of sterile Ceftriaxone Sodium USP equivalent to 250mg Ceftriaxone and 1 ampoule of 2ml 1% Lidocaine Hydrochloride BP injection.
PERIX®250mg IV injection: Box containing 1 combipack and a 5ml disposable syringe. Each combipack contains 1 vial of sterile Ceftriaxone Sodium USP equivalent to 250mg Ceftriaxone and 1 ampoule of 5ml Water for Injection BP.
PERIX®500mg IM injection: Box containing 1 combipack and a 5ml disposable syringe. Each combipack contains 1 vial of sterile Ceftriaxone Sodium USP equivalent to 500mg Ceftriaxone and 1 ampoule of 2ml 1% Lidocaine Hydrochloride BP injection.
PERIX® 500mg IV injection: Box containing 1 combipack and a 5ml disposable syringe. Each combipack contains 1 vial of sterile Ceftriaxone Sodium USP equivalent to 500mg Ceftriaxone and 1 ampoule of 5ml Water for Injection BP.
PERIX®1g IM injection: Box containing 1 combipack and a 5ml disposable syringe. Each combipack contains 1 vial of sterile Ceftriaxone Sodium USP equivalent to 1g Ceftriaxone and 1 ampoule of 3.5ml 1% Lidocaine Hydrochloride BP injection.
PERIX®1g IV injection: Box containing 1 combipack and a 10ml disposable syringe. Each combipack contains 1 vial of sterile Ceftriaxone Sodium USP equivalent to 1g Ceftriaxone and 1 ampoule of 10ml Water for Injection BP.
PERIX®2g IV injection: Box containing 1 combipack and a 20ml disposable syringe. Each combipack contains 1 vial of sterile Ceftriaxone Sodium USP equivalent to 2g Ceftriaxone and 2 ampoules of 10ml Water for Injection BP.

Pharmacological Action
Levofloxacin is a synthetic, broad-spectrum, third generation fluoroquinolone derivative antibacterial agent for oral administration. Chemically Levofloxacin is a chiral fluorinated carboxyquinolone.

Mechanism of Action
Quilev® (Levofloxacin) inhibits to bacterial IV topoisomerase and DNA gyrase, the enzyme that produces a negative super coil in DNA, permitting transcription, replication, repair and recombination.

Therapeutic Indications
Levofloxacin is indicated for the treatment of adults (18 years of age) with mild, moderate, and severe infections caused by susceptible strains of the designated micro-organisms in the condition listed below:

• Acute maxillary sinusitis due to Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis.
• Acute bacterial exacerbation of chronic bronchitis due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, or Moraxella catarrhalis.
• Community-acquired pneumonia due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Klebsiella pneumoniae, Moraxella cararrhalis, Chlamydia pneumoniae, Legionella pneumophila, or Mycoplasma pneumoniae.
• Complicated urinary tract infections due to Escherichia coli, Klebsiella pneumoniae, or Staphylococcus saprophyticus. Acute pyelonephritis caused by Escherichia coli.
• Uncomplicated & complicated skin and soft tissue infections including abscesses, cellulitis, furuncles, impetigo, pyoderma, wound infections, due to Staphylococcus aureus, Streptococcus pyogenes, Proteus mirabilis or Enterococcus faecalis.

Dosage and Administration

• Acute sinusitis, 500mg once daily for 10-14 days
• Exacerbation of chronic bronchitis, 250-500mg daily for 7 days
• Community-acquired pneumonia, 500mg once or twice daily for 7-14 days
• Complicated urinary-tract infections and acute pyelonephritis, 250mg daily for 7-10 days
• Uncomplicated skin and soft-tissue infections, 500mg once daily for 7-10 days
• Complicated skin and soft-tissue infections, 750mg once daily for 7-14 days.

Use in Children
Not recommended for children.

Contraindications
Levofloxacin is contraindicated in patients with a history of hypersensitivity to Levofloxacin, quinolone antimicrobial agents, or any other components of this product.

Use in Patients with impaired renal function
The following measures should be taken during administration of Levofloxacin:

• While taking Levofloxacin, adequate amount of water should be taken to avoid concentrated form of urine.
• Dose adjustment should be exercised during Levofloxacin ingestion in presence of renal insufficiency.

Use in Patients with impaired hepatic function
Pharmacokinetic studies in hepatically impaired patients have not been conducted. Due to the limited extent of Levofloxacin metabolism, the pharmacokinetics of Levofloxacin is not expected to be affected by hepatic impairment.

Elderly Patients
Geriatric patients are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolone such as Quilev®. This risk is further increased in patients receiving concomitant corticosteroid therapy. Tendinitis or tendon rupture can involve the Achilles, hand, shoulder, or other tendon sites and can occur during or after completion of therapy; cases occurring up to several months after fluoroquinolone treatment have been reported. Caution should be used when prescribing Quilev® to elderly patients especially those on corticosteroids.

Drug Interactions
Antacids, Iron and Adsorbents-reduce absorption of Levofloxacin. NSAID- may increase the risk of CNS stimulation.Warfarin- may increase the risk of bleeding.

Use in Pregnancy & Lactation
Levofloxacin is not recommended for use during pregnancy or nursing, as the effects on the unborn child or nursing infant are unknown.

Undesirable Effects
Levofloxacin is generally well tolerated. However, a few side effects can usually be seen. Side effects include: nausea, vomiting, diarrhea, abdominal pain, flatulence and rare occurrence of phototoxicity (0.1%). Side effects that may be seen very rarely include tremors, depression, anxiety, confusion etc.

Over Dosage & Treatment
In the event of an acute overdosage, the stomach should be emptied. The patient should be observed and appropriate hydration maintained. Levofloxacin is not efficiently removed by hemodialysis or peritoneal dialysis.

Storage Conditions
Store in a cool and dry place, away from light. Keep out of reach of children.

Presentation & Packaging
Quilev® tablet: Each box contains 6x4’s tablets in Alu-Alu blister pack.

Pharmacological Action:
Ambroxol is the active metabolite of bromhexine and it has been proven that this metabolite possesses a greater bronchosecretolytic effect than bromhexine. It improves sputum rheology by hydrating mechanism leading to liquefaction of mucus in the lumen of respiratory tract, thus facilitating expectoration of mucus and reducing dyspnea. It stimulates production of phospholipids of surfactant by alveolar cells, thus contributing to the lowering of superficial tension in the alveoli. It also reduces bronchial hyperactivity. Ambroxol has anti-inflammatory properties owing to the inhibitory effect on the production of cellular cytokines and arachidonic acid metabolites. In patients with COPD it traditionally improves airway patency.

Mechanism of Action:
Mechanism of action of the medicinal product is stipulated by stimulation of serous cells of tonsils of bronchial tubes' mucous membrane, increasing of mucous secretion content and changing of correlation of serous and mucous components of phlegm, breached under pathological processes in lungs.

Therapeutic Information:

Dosage and Administration:
2 -5 years old: 2.5 ml, 2-3 times a day
5 - 10 years old: 5 ml, 2-3 times a day
10 years old and adults: 10 ml, 3 times a day

Contraindications:
Contraindicated in known hypersensitivity to Ambroxol or Bromhexine.

Use in Patients with impaired renal function:
Patients with renal insufficiency should take it with caution.

Use in Patients with impaired hepatic function:
Patients with hepatic insufficiency should take it with caution.

Drug Interaction:
Ambroxol should not be taken simultaneously with antitussives (e.g. Codeine) because phlegm, which has been liquefied by Ambroxol might not be expectorated.

Use in Pregnancy & Lactation:
Teratogenic and foetal toxicity studies have shown no harmful effect of Ambroxol. However, it is advised not to use it in pregnancy, especially during the1st trimester. Safety during lactation has not been established yet.

Undesirable Effects:
Gastrointestinal side effects like epigastric pain, stomach overfills feeling may occur occasionally. Rarely allergic responses such as eruption, urticaria or angioneurotic edema have been reported.

Storage Conditions:
Store in a cool and dry place, away from light. Keep out of reach of children.

Presentation & Packaging:
Remap® Syrup: Each amber glass bottle contains of 100ml syrup with measuring cup.

Pharmacological Action
Diclofenac sodium is a non-steroidal compound, a phenylacetic acid derivative, with analgesic, antipyretic and anti-inflammatory effects. Diclofenac sodium inhibits the biosynthesis and release of prostaglandins, which are known to be implicated in the pathogenesis of inflammation, pain and fever. Diclofenac tablets are enteric-coated so that absorption occurs in the gastrointestinal tract to give peak plasma concentrations approximately 2 hours after ingestion. There is at least 99% binding to plasma-proteins and excretion of metabolites is mainly in the urine.

Mechanism of Action
Diclofenac sodium works by blocking the action of a substance (enzyme) in the body called cyclo-oxygenase. Cyclo-oxygenase is involved in the production of various chemicals in the body, some of which are known as prostaglandins. Prostaglandins are produced in response to injury or certain diseases and would otherwise go on to cause pain, swelling and inflammation.

Therapeutic Indications:
Inflammatory and degenerative forms of

• Rheumatism
• Rheumatoid arthritis
• Ankylosing spondylitis
• Osteoarthritis
• Painful post-operative and post-traumatic inflammation and swelling and dysmenorrhoea.

Dosage and Administration:
Adults:

Diseases	Dose	Frequency
Osteoarthritis	100 -150mg	Divided doses (50mg b.i.d. or t.i.d., or 75mg b.i.d.).
Rheumatoid arthritis	100 -125mg	Divided doses (50mg t.i.d. or q.i.d., or 75mg b.i.d.).
Ankylosing spondylitis	100 -125mg	Administered as 25mg with an extra 25mg dose at bedtime if necessary.

Use in Children
Diclofenac sodium is not recommended for use in children as safety and efficacy have not been established.

ContraindicationsDiclofenac sodium is contraindicated in patients with known hypersensitivity to diclofenac and in patients who respond to aspirin and aspirin-type drugs with sensitivity reactions like asthma, acute rhinitis and urticaria. Diclofenac sodium is absolutely contraindicated in patients with peptic ulceration or a history of such ulceration, and should be used with caution in patients with renal or hepatic insufficiency.

Use in patients with impaired hepatic function
Elevations of one or more liver tests may occur during the therapy.

Use in patients with impaired renal function
Long term administration of NSAIDs may result in renal papillary necrosis and other renal injury.

Elderly Patients
No significant difference in use between patients above 65 years and younger patients.

Drug Interactions
Serious interactions have been reported after the use of high dose methotrexate with diclofenac.
Blood concentrations of lithium are increased when Diclofenac is administered concommitantly.

Use in Pregnancy & Lactation
The safe use of Diclofenac in pregnancy has not been demonstrated. Regular use of NSAID's during the third trimester of pregnancy may result in premature closure of the foetal ductus arteriosus in utero and possibly in persistent pulmonary hypertension of the newborn. The onset of labour may be delayed and its duration increased.

Undesirable Effects
In view of the product's inherent potential to cause fluid retention, heart failure may be precipitated in some compromised patients.
Gastric or intestinal ulceration with associated bleeding has been reported - Diclofenac therapy should be discontinued immediately in such cases. Skin rashes and gastro-intestinal disturbances may occur. Headache, dizziness, oedema, nervousness, pruritus, tinnitus, insomnia, blurred vision and other ocular reactions, peripheral oedema, malaise, jaundice, elevated transaminase levels, drowsiness and hypersensitivity reactions (eg. bronchospasm) have occurred. Diclofenac should be given with care to patients with bleeding disorders, cardiovascular disease, and in those who are receiving coumarin anticoagulants. Patients who are sensitive to aspirin generally should not be given Diclofenac.

Storage & Conditions
Store in cool and dry place, away from light. Keep out of reach of children.

Presentation & Packaging
Refain®(Diclofenac Sodium) Tablet: Each commercial box contains 10 x10's tablets in Alu-PVC blister pack.
Refain®TR (Diclofenac Sodium) Capsule: Each commercial box contains 12 x 4's capsules in Alu-Alu blister pack.

Pharmacological Action:
The cysteinyl leukotrines (LTC4, LTD4, LTE4) are products of arachidonic acid metabolism and are release from various cells,including mast cells and eosinophils.these eocosanoids bind to cysteinyl leukortines receptors (CysLT) found in human airway. Montelucast is an orally active compound that binds with high affinity and selectivity to the CysLT1 receptor. Montelucast inhibits physiologic action of LTD4 at the Cys LT1 receptor without any agonist activity.

Therapeutic Information:
Montelukast is indicated for the prophylaxis and chronic treatment of asthma in adults and pediatric patients from 6 months of age and older.

Dosage and Administration:
Adults (15 years of age or over):10 mg daily to be taken in the evening.
Children (6-14 years of age): 5 mg chewable tablet daily to be taken in the evening.
Children (2 years-5 years of age): 4 mg chewable tablet daily to be taken in the evening. The safety and efficacy of Montelukast was demonstrated in clinical trials where it was administered in the evening without regard to the time of food ingestion.

Contraindications:
Montelukast is contraindicated to patients with hypersensitivity to any component of this product.

Precautions:
Montelukast is not indicated for use in the reversal of bronchospasm in acute asthma attacks (in case of status asthmaticus). Patients with known aspirin sensitivity should continue avoidance of aspirin or other NSAID, while taking Montelukast. In rare cases, patients on therapy with Montelukast may present with systemic eosinophilia, sometimes presenting with clinical features of vasculitis consistent with churg-strauss syndrome, a condition which is often treated with systemic corticosteroid therapy. Physician should be alert to eosinophilia, vasculitic rash, worsening pulmonary symptoms, cardiac complications, and/or neuropathy presenting in their patients. A causal association between Montelukast and these underlying conditions has not been established.

Use in Pregnancy & Lactation:
Pregnancy:There are no adequate and well-controlled studies of Montelukast in pregnant women. Because animal reproductive studies are not always predictive of human response, so Montelukast should be used during pregnancy only if clearly needed.

Lactation:It is not known if Montelukast is excreted in human milk. Because many drugs are excreted in human milk, so caution should be exercised when Montelukast is given to a nursing mother.

Side Effects:
Generally, Montelukast is well-tolerated. Side effects include dizziness, headache, diarrhea, restlessness, abdominal pain, cough, fever, asthenia, rash and upper respiratory tract infection.

Drug Interaction:
Montelukast has been administered with other therapies routinely used in the prophylaxis and chronic treatment of asthma with no appropriate increase in adverse reactions.
Cytochrome P-450 inducers: Although Phenobarbital induces hepatic metabolism, no dosage adjustment for Montelukast is recommended. It is reasonable to employ appropriate clinical monitoring when potent cytochrome P-450 enzyme inducers, such as Phenobarbital or Rifampin, are co-administered with Montelukast.

Overdose:
There were no adverse experiences reported in the majority of overdosage reports. The most frequent adverse experiences observed were thirst, mydriasis, hyperkinesia, and abdominal pain. In the event of overdose, it is reasonable to employ the usual supportive measures; e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive therapy, if required.

Storage Conditions:
Store in a cool (below 30°C) and dry place, away from light. Keep out of reach of children.

Presentation & Packaging:
Recast® 4: Each box contains 30's tablet in blister pack.
Recast® 5: Each box contains 30's tablet in blister pack.
Recast® 10: Each box contains 20's tablet in blister pack.

Pharmacological Action:
Beclofen is an effective muscle relaxant and antispastic agent with a spinal site of action. It exerts its action by inhibiting both monosynaptic and polysynaptic transmission in the spinal cord by stimulating GABAB receptors.

Therapeutic Information:
Baclofen is indicated for the alleviation of spasticity resulting from multiple sclerosis particularly for the relief of flexor spasm and concomitant pain, clonus and muscular rigidity, spinal cord diseases, muscle spasm of cerebral origin especially infantile cerebral palsy, stroke or neoplastic or degenerative brain diseases. It may be of some value in patients with trigeminal neuralgia, tardive dyskinesia, cluster headache & tension type headache.

Dosage and Administration:
Muscle relaxant & spasticity:
For adults: Initially 5mg three times daily for 3 days; then 10mg three times daily for 3 days, 15mg three times daily for 3 days and 20mg three times daily. Additional increases in dose may be required but should not exceed 20mg four times daily. Maximum daily dose for spasticity should not exceed 260mg.
For children (treatment of spasticity): Initially 1.0-1.5 mg/kg/day in 3 divided doses. Titrate to a maximum of 40 mg/day if less than 8 years of age and to a maximum of 80 mg/day if more than 8 years of age.
Trigeminal neuralgia: 50-60mg daily in divided doses.
Tardive dyskinesia: 40mg daily in divided doses combination with neuroleptics.

Contraindications:
Baclofen is contraindicated in patients who are hypersensitive to any component of this preparation.

Precautions/Warning:
Hallucinations and seizures may occur on abrupt withdrawal of Baclofen. Therefore, except for serious adverse reactions, the dose should be reduced slowly when the drug is discontinued.

High risk group:
Pregnancy: There are no adequate and well-controlled studies in pregnant women. So, Baclofen should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Lactation: It is not known whether this drug is excreted in human milk. Caution should be exercised when Baclofen is administered to lactating mother.
Elderly: Elderly patients are more likely to have decreased renal function. Thus care should be taken in dose selection and it may be useful to monitor renal function. Moreover, it may be necessary to reduce the dosage in patients with impaired renal function.

Side effects:
Baclofen may cause drowsiness, weakness, dizziness, headache, seizures, nausea, vomiting, low blood pressure, constipation etc.

Drug interactions:
The central nervous system depressant effects of Baclofen may be additive to those of alcohol and other CNS depressants.

Storage Conditions:
Store in a cool (below 30°C) and dry place, away from light. Keep out of reach of children.

Presentation & Packaging:
Rembac® Tablet: Each box contains 3X10's tablet in Alu-PVC blister pack.

Therapeutic Indications
Sefnin (Cephradine) is used in the treatment of infections caused by sensitive organisms.

• Upper respiratory tract infections: Pharyngitis, sinusitis, otitis media, tonsilitis, laryngotracheo-bronchitis.
• Lower respiratory tract infections: Acute and chronic bronchitis, lobar and bronchopneumonia.
• Urinary tract infections: Cystitis, urethritis, pyelonephritis. Skin and soft tissue infections: Abscess, cellulitis, furunculosis, impetigo.
• Gastrointestinal tract infections: Bacillary dysentery, enteritis, peritonitis.
• Bone and joint infection.
• Surgical prophylaxis: It is also used in preoperative prophylactic administration (pre-operatively, intra-operatively and post-
  operatively). In cesarean section, intra-operative (after clamping the umbilical cord) and post-operative use may reduce the incidence of certain post-operative infections.

Dosage And Administration
The dosage may be given without regard to meals.

Adult:
Oral: The usual dose is 1-2 gm daily in 2 to 4 divided doses. In severe and prolonged infection, the dose can be increased up to 4 gm daily which should be taken in equally divided doses.
Special dose in the following infections: Skin and Skin structures and respiratory tract infections: Usual dose is 250 mg every 6 hours or 500 mg every 12 hours.
Lobar pneumonia: 500 mg every 6 hours or 1 gm every 12 hours.
Urinary tract infection: Usual dose is 500 mg every 12 hours.
Gastro-intestinal tract infection: 500 mg three to four times daily.

Children:
Oral: The usual total dose is 25 to 50 mg/kg/day given in 2 to 4 equally divided doses.

Dose in renal impairment:
In patients with impaired renal function, doses and frequency of administration of Sefnin ® must be modified according to the degree of impairment, severity of infection, susceptibility of the causative organism and serum concentration of the drug. For adults, a loading dose of 750 mg should be given subsequently followed by 500 mg with the mentioned time interval.

Creatinine clearance (ml/min)	Time interval (hrs.)
>20	6-12
15-19	12-24
10-14	24- 40
5-9	40-50
<5	50-70

For children, dosage schedule may need to be adjusted.

Undiserable Effects
Side effects include nausea, vomiting, diarrhoea and abdominal discomfort. Allergic reactions including skin rashes, urticaria, eosinophilia, angioedema and anaphylaxis may occur and elevation of hepatic enzyme values have been noted. Neutropenia has been reported. Super-infection with resistant microorganisms, particularly candida, may follow the treatment. There is also a possibility of development of pseudomembranous colitis.

Use In Pregnancy And Lactation
Although there have been no reports of adverse effect on the fetus, safety of use during pregnancy has not been definitely established. The drug should be used during pregnancy only when clearly indicated. Cephalosporins are distributed into breast milk and the drug should be used with caution in nursing women.

Contraindication
It should not be used in patients hypersensitive to any cephalosporin antibiotic.

Storage & Conditions
Store in cool and dry place, away from light. Keep out of reach of children.

Presentation & Packaging
Sefnin 250 Capsule: Box containing 4x4's, 6x4's, 8x4's Capsules in Alu-Alu /blister Pack.
Sefnin 500 Capsule: Box containing 4x4's, 6x4's, 8x4's Capsules in Alu-Alu blister Pack.
Sefnin Dry Suspension: Each amber glass bottle contains dry powder for 100 ml suspension.

Pharmacological Action:
Prednisolone Acetate, a corticosteroid, is thought to act by inhibiting phospholipase A2, which controls the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes.

Therapeutic Indications:
Allergic conjunctivitis, acne rosacea, superficial keratitis, herpes zoster keratitis, iritis, cyclitis, & selected infective conjunctivitis. It is also effective in post-operative ocular inflammatory conditions.

Dosage and Administration:
Instill one drop into the conjunctival sac two to four times daily. During the initial 24 to 48 hours, the dosing frequency may be increased if necessary. Care should be taken not to discontinue the therapy before completing the course.
Paediatric Use: Safety and effectiveness in pediatric patients have not been established.

Contraindications:
Sterolon® Sterile Eye Drops is contraindicated in viral diseases of the cornea, conjunctiva and known hypersensitivity to any of the ingredients of this preparation or other corticosteroids.

Use in Pregnancy and Lactation:
Pregnancy: Prednisolone Acetate is pregnancy category C. So, this drug should be used during pregnancy only if clearly needed.

Lactation: It is not known whether topical administration of corticosteroids would result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Prednisolone Acetate is administered to a nursing woman.

Drug Interaction:
No significant drug interactions have been reported.

Storage & Conditions:
Store in a cool, dry place and protect from light.Keep out of the reach of children.Protect from freezing. Shake well before using.

Presentation & Packaging:
Sterolon® Sterile Eye Drops: Each plastic dropper bottle contains 5ml Ophthalmic Suspension.