Azilab PFS
Generic : Azithromycin Dihydrate
Therapeutic : Azithromycin Dihydrate
Composition :
Azilab 500 Tablet: Each film coated tablet contains Azithromycin Dihydrate BP equivalent to 500 mg of Azithromycin.
Azilab Suspension: After reconstitution, each 5 ml suspension contains Azithromycin Dihydrate BP equivalent to 200 mg of Azithromycin.
Description :
Azithromycin is an azalide, a subclass of macrolide antibiotics active against gram-positive and gram-negative organisms. It prevents bacteria from growing by interfering with their protein synthesis. It binds to the 50s subunit of the bacterial ribosome and thus inhibits translation of mRNA.
Indications :
Respiratory tract infections, Otitis media, Skin and soft-tissue infections,Uncomplicated gonorrhoea, Uncomplicated genital chlamydial infections, Non-gonococcal urethritis, Typhoid fever, Community acquired pneumonia, Chronic obstructive pulmonary disease, Mycobacterium avium complex.
Dosage and administration :
Adults: 500 mg once daily orally for 3 days.
Children (Child over 6 months): 10 mg/kg once daily for 3 days or
- Uncomplicated gonorrhoea, uncomplicated genital chlamydial infections and non-gonococcal urethritis, 1 g as a single dose
- Typhoid fever, 500 mg once daily for 7 days
- Community aquired pneumonia and Chronic obstructive pulmonary disease, 500 mg as a single dose on day 1 followed by 250 mg once daily from day 2 to 5
Side effects :
Azithromycin is well tolerated with a low incidence of side effects. Most common side effects are nausea, abdominal discomfort, vomiting, flatulence and diarrhea.
Use in special group :
Pregnancy: Recent clinical studies have recommended that Azithromycin should be considered for the initial treatment of Chlamydial Cervicitis in pregnancy. In other infections, it should be used only when clearly needed. It is pregnancy
category B drug.
Lactation: It is not known whether Azithromycin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when it is administered to a nursing woman.
Pediatric use: Azithromycin has been administered to pediatric patients ranging in age from 6 months to 12 years.
Contraindications :
Azithromycin is contraindicated in patients hypersensitive to Azithromycin or other macrolide antibiotics.
Precautions :
Azithromycin is principally eliminated via liver. Caution should be exercised when it is administered to patients with impaired hepatic function.
Drug Interaction :
Food and antacid reduce the absorption of Azithromycin. So Azithromycin should be administered 1 hour before or 2 hours after taking food or antacid.
Macrolides have been known to increase the plasma concentration of digoxin and cyclosporine. So caution should be exercised while co-administration is necessary.
Storage :
Store in a cool and dry place, away from light. Keep out of the reach of children.
Commercial Pack :
Azilab 500 Tablet: Each box contains 2 x 3 tablets in Alu-Alu blister pack.
Azilab Powder for Suspension: Each bottle contains Azithromycin dry powder for 35 ml suspension.
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