Azimon®500
Azithromycin

COMPOSITION:
Azimon®500 tablet: Each film coated tablet contains Azithromycin dihydrate USP equivalent to 500 mg Azithromycin.

PHARMACOLOGICAL INFORMATION:
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.

CLINICAL INFORMATION:
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

Doses and Administration
Adults

Use in Children
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.

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

Use in patients with impaired renal function
No dosage adjustment is recommended for subjects with renal impairment.

Use in patients with impaired hepatic function
The pharmacokinetics of Azithromycin in subjects with hepatic impairment has not been established.

Elderly Patients
Normal adult dosage is recommended.

Drug Interactions
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.

Use in pregnancy & lactation
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.

Undesirable Effects
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.

PHARMACEUTICAL INFORMATION
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.