Cefmix®
Cefixime

COMPOSITION:
Cefmix® Suspension: Each 5ml reconstituted suspension contains Cefixime Trihydrate USP equivalent to 100mg Cefixime.

PHARMACOLOGICAL INFORMATION:
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.

Mechanism of Action
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.

Pharmacokinetics
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%).

CLINICAL INFORMATION:
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.

Dosage & Administration:
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.

Drug Interactions:
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.

Undesirable Effects:
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.

PHARMACEUTICAL INFORMATIONS :
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.