Trade Name: AZOMAC TABLET 500 MG
Generic Name: Azithromycin USP

Azomac tablet: Each film-coated tablet contains Azithromycin USP 500 mg
Azomac Dry powder for Suspension: After reconstitution each 5 ml suspension contains 200 mg Azithromycin USP.

INDICATIONS:

Azomac (Azithromycin) is indicated for infections (caused by susceptible organisms) in lower respiratory tract infections including bronchitis and pneumonia, in upper respiratory tract infections including sinusitis and pharyngitis / tonsillities, in otitis media and in skin and soft tissue infections.

In sexually transmitted diseased in men and women, Azomac (Azithromycin) is indicated in the treatment of non-gonococcal urethritis and cervicitis dur to Chlamydia trachomatis.

DOSAGE & ADMINISTRATION

Azomac 500 mg tablets can be taken with or without food. To reconstitute Azomac suspension, add 10 ml or 2 teaspoonfuls of just boiled and cooled water to the bottle and shake well to mix uniformly.

Adults: For lower respiratory tract infections including bronchitis and pneumonia, upper respiratory track infections including sinusitis and pharyngitis / tonsillitis, otitis media and skin and soft tissue infections the total dose of Azomac is 1.5 gm given as 5000 mg once daily for 3 days. An alternative to this doses schedule is that 500 mg once daily on day 1 followed by 250 mg once daily for next 4 days.

For sexually transmitted diseases caused by Chlamydia trachomatis, The dose of Azomac is 1 gm given as a single dose, Alternatively, 500 mg once daily on day 1, followed by 250 mg once daily for next 2 days may also be given.

Use in the elderly: Normal adult dosage is recommended.

Children: The dose of Azomac in Children over 6 month of age is 10 mg / kg for next 4 days is also recommended. There is no information on use of Azithromycin on children under 6 months of age . For children with body weight 15-25 kg, the dose is 200 mg once daily for 3 days: For body eight 26-35 kg, the dose is 400 mg once daily for 3 days; For body weights over 45 kg. normal adult dosage is recommended.

CONTRAINDICATIONS & PRECAUTIONS:

Azithromycin is contra-indicated in patients with a know hypersensitivity to azithromycin or any other macrolide antibiotics. Because of the theroetical possibility of ergotism, azithromycin and ergot derivatives should not be co-administered. Azithromycin should not be used in patients with hepatic disease. Avoid concomitant administration with terrenadine or astemiaole precaution should be taken in patients with more severe renal impairment.

SIDE EFFECTS:

Azomac (Azithromycin) is well tolerated with a low incidence of side effects. The side effects include nausea, vomiting, abdominal discomfort (pain/cramps), flatulence, diarrrhoea, headache, dizziness and skin rashed and are reversible upon discontinuation of therapy.

DRUG INTERACTIONS:

Antacids: Peak serum levels but not the total extent of absorption are reduced by aluminum and magnesium containing antacids in the stomach. Azithromycin should therefore be taken at least 1 hour before or 2 hours after taking these antacids, Ergotderivatives: Bacause of the theretical possibility of ergotism, concomitant administrations of ergot derivatioves and azithromycin should be avoided, Dogoxin & Cyclosporin: Macrolides have been known to increase the plasma concentration of Digoxin & Cyclosporin and so caution should be exericised while co-administration is necessay . Anti-hismines: A potentially life threatening interaction between erythromycin and terfenadine or astemizole has been reported. Although such an interaction with azithromycin is not established yet, it is wise to aboid concomitant use of azithromycin and terfenadine or astemizole.

USE IN PREGNANCY AND LACTATION:

Recent clinical studies have recommentded that azithromycin should be considered for the initial treatment of chlamydial fervicities in pregnancy. In other infections, azithromycin should be used only when clearly needed. It is not know whether azithromycin is excreted in breast milk . Exericise caution when administering to nursing women.

Commercial pack:

Azomac tablet: Box containing 1x3 Azomac film coated tablets is Alu-Alu blister pack.
Azomac Dry powder for Suspension: Box containing sealed cap bottle containing Azomac Dry powder for reconstituting 15 ml Azomac suspension