AZ-250 Tablet: Each film coated tablet contains Azithromycin Dihydrate USP equivalent to Azithromycin 250 mg.
AZ-500 Tablet: Each film coated tablet contains Azithromycin Dihydrate USP equivalent to Azithromycin 500 mg.
AZ Taste Masked Powder for Suspension: After reconstitution each 5 ml contains Azithromycin Dihydrate USP equivalent to Azithromycin 200 mg.
Azithromycin is a macrolide antibiotic. It acts by binding to the 50S ribosomal subunit of susceptible microorganisms and interfering with microbial protein synthesis. It is effective against most of the pathogens like-Haemophilus influenzae, Staphylococcus aureus, Streptococcus mitis group & Streptococcus pneumoniee. It is also effective against most isolates of ocular pathogens like Chlamydia pneumoniae, Chlamydia trachomatis, Moraxella catarrhalis, Mycoplasma hominis, Mycoplasma pneumoniae & Neisseria gonorrhoeae.
AZ is indicated in lower respiratory tract infections including bronchitis and pneumonia, otitis media and in upper respiratory tract infections including sinusitis and pharyngitis/tonsillitis, skin and soft tissue infections, mild to moderate typhoid due to multiple-antibacterial resistant organisms, cholera in children & adult and sexually transmitted diseases both in men and women. Azithromycin is also indicated for the treatment of uncomplicated genital infections due to Chlamydia trachomatis and urethritis and cervicitis due to Chlamydia trachomatis and Neisseria gonorrhoea.
May be taken with or without food.
Antacids: in patients receiving Azithromycin and antacid. Azithromycin should be taken at least 1 hour before or 2 hours after antacid. Cyclosporin & Digoxin: Macrolides interfere with the metabolism of cyclosporin & digoxin. Ergot derivatives: Because of the theoretical possibility of ergotism, Azithromycin and ergot derivatives should not be coadministered. Terfenadine: As with other macrolides. Azithromycin should be administered with caution in combination with terfenadine.
Overdose: Adverse events experienced in higher than recommended doses were similar to those seen at normal doses. The typical symptoms of an overdose with macrolide antibiotics include reversible loss of hearing, severe nausea, vomiting and diarrhoea. In the event of overdose, the administration of medicinal charcoal and general symptomatic treatment and supportive measures are indicated.
AZ is contraindicatd in patients with known hypersensitivity to Azithromycin, erythromycin or any of the macrolide antibiotics.
AZ is well tolerated with a low incidence of side effects. Majority of the side effects are mild to moderate in nature and of gastro-intestinal in origin with nausea, abdominal discomfort, vomiting, flatulence and diarrhoea. Allergic reactions such as rash have occurred and there have also been rare reports of serious hypersensitivity reactions. Reversible elevations in liver transaminase have been seen with a frequency similar to the comparative macrolides and penicillins used in clinical trials.
Use in Pregnancy: Pregnancy category B.
Use in Lactation: Caution should be exercised when Azithromycin is administered to a nursing mother.
Drug Interactions: Antacids: in patients receiving Azithromycin and antacid, Azithromycin should be taken at least 1 hour before or 2 hours after antacid. Cyclosporin & Digoxin: Macrolides interfere with the metabolism of cyclosporin & digoxin. Ergot derivatives: Because of the theoretical possibility of ergotism, Azithromycin and ergot derivatives should not be coadministered. Terfenadine: As with other macrolides, Azithromycin should be administered with caution in combination with terfenadine.
It is indicated for topical ophthalmic use only and should not be administered systemically, injected subconjunctivally or introduced directly into the anterior chamber of the eye.
Use in pregnancy:
There are no adequate and well-controlled studies in pregnant women. Thus, it should be used during pregnancy only if clearly needed.
Use in lactation:
It is not known whether Azithromycin is excreted in human milk. Caution should be exercised when Azithromycin ophthalmic solution is administered during lactation.
Pediatric use:
The safety and effectiveness of Azithromycin ophthalmic solution in pediatric patients below 1 year of age have not been established. But in a clinical study it was found that Azithromycin 1% Ophthalmic Solution may be given to neonates for the treatment of ophthalmia neonatorum.
Store below 30 C, keep in dry place & protect from light. Keep out of the reach of children.