Description:

AZ contains Azithromycin Dihydrate USP, an azalide, a subclass of macrolide antibiotics, for oral administration. Following oral administration, Azithromycin is rapidly absorbed and widely distributed throughout the body. Azithromycin acts by binding to the 50S ribosomal subunit of susceptible microorganisms and thus interfering with microbial protein synthesis. Azithromycin is active against both gram-positive and gram-negative microorganism.

Composition:

AZ-250 Capsule: Each capsule contains Azithromycin Dihydrate USP equivalent to Azithromycin 250 mg.

AZ-500 Capsule: Each capsule contains Azithromycin Dihydrate USP equivalent to Azithromycin 500 mg.

Indications:

AZ is indicated for the treatment of infections caused by susceptible organisms, in lower respiratory tract infections including bronchitis and pneumonia, otitis media and upper respiratory tract infections including sinusitis and pharyngitis/tonsillitis, skin and soft tissue infections, sexually transmitted disease both in men and women. Azithromycin is indicated for the treatment of uncomplicated genital infections due to Chlamydia tracomatis and urethritis and cervicitis due to Chlamydia tracomatis and Neisseria gonorrhoeae.

Dosage & Administration:

AZ is common with many other antibiotics should be taken at least 1 hour before or 2 hours after food.

Adult: For sexually transmitted disease caused by Chlamydia tracomatis, the dose is 1g as a single dose. For all other indications, the total dose is 1.5 g, which should be given as 500 mg daily for 3 days, alternatively, initially, 500 mg as a single dose followed by a 250 mg single daily dose for the next 4 days.

Elderly: Normal adult dose is recommended.

Children > 6 months: The dose is 10 mg/Kg body weight as a single dose for 3 days; for body weight 15-25 Kg, 200 mg or 5 ml/day for 3 days: body weight 26-35 Kg, 300 mg or 7.5 ml/day for 3 days; body weight 36-46 Kg, 400 mg or 10 ml/day for 3 days.

Children < 6 months: Not recommended.

Contraindications:

AZ is contraindicated in patients with known hypersensitivity to Azithromycin or any of the macrolide antibiotics. Because of the theoretical possibility of ergotism, Azithromycin and ergot derivatives should not be co-administered. As with erythromycin and other macrolides, rare serious allergic reactions, including angioneurotic oedema and anaphylaxis, have resulted in recurrent symptoms and required a long period of observation and treatment.

Side-effects:

AZ is well tolerated with a low incidence of side effects. Majority of the side effects were 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 reports of serious hypersensitivity reactions. Reversible elevations of liver transaminases have been seen with a frequency similar to the comparative macrolides and penicillins used in clinical trials. Transient mild reductions in neutrophil counts have occasionally been observed in clinical trials, although a casual relationship to Azithromycin has not been established.

Precautions:

As with any antibiotic, observation for signs of superinfection with non-susceptible organisms, including fungi is recommended. No dosage adjustment is needed in patients with renal impairment.

Use in Pregnancy:

Animal reproduction studies have demonstrated that Azithromycin crosses the placenta, but have revealed no evidence of harm to foetus. There are no adequate and well-controlled studies in pregnant women. Since animal reproduction studies are not always predictive of human response. Azithromycin should not be used in pregnancy only if adequate alternatives are not available.

Use in Lactation:

No data on secretion of Azithromycin in breast milk are available, so that Azithromycin should only be used in lactating mother where alternatives are not available.

Drug Interactions:

Azithromycin absorption was reduced in the presence of food and antacid. So, Azithromycin should be administered 1 hour before or 2 hours after taking food or 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 P-450 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.

Overdosage:

There are no data on overdosage with Azithromycin. Typical symptoms of overdosage with macrolide antibiotics include hearing loss, severe nausea, vomiting and diarrhoea. Gastric lavage and general supportive measures are indicated.

Storage:

AZ should be stored at below 30º C.

Packing:

AZ-250 Capsule: Box containing 2x4’s capsules in alu/alu blister pack.

AZ-500 Capsule: Box containing 2x4’s capsules in alu/alu blister pack.