Azin 250 mg cap

Azin 250 cap

DESCRIPTION

AZIN (Azithromycin) is an azalide, a subclass of macrolide antibiotics, active against Gram-positive and Gram-negative organisms for oral administration. Following oral administration, it is rapidly absorbed and widely distributed throughout the body. AZIN (Azithromycin) acts by binding to the 50s ribosomal subunit of susceptible organisms and thus interfering with microbial protein synthesis.

COMPOSITION

Capsule 250 : Each capsule contains Azithromycin USP 250 mg. Tablet 500 : Each tablet contains Azithromycin USP 500 mg. Powder for 15 ml Suspension : When reconstituted, each 5 ml suspension contains Azithromycin USP 200 mg. Powder for 30 ml Suspension : When reconstituted, each 5 ml suspension contains Azithromycin USP 200 mg.

INDICATIONS

AZIN (Azithromycin) is indicated in upper respiratory tract infections, including pharyngitis, tonsillitis, sinusitis, otitis media; lower respiratory tract infections including bronchitis, pneumonia; skin and soft tissue

infections and typhoid fever. In sexually transmitted diseases in men and women AZIN (Azithromycin) is indicated in the treatment of uncomplicated genital infections due to Chlamydia trachomatis.

DOSAGE AND ADMINISTRATION

Adults :

Infections Dose

Upper respiratory tract infections, including sinusitis, pharyngitis, tonsillitis, otitis media; lower respiratory tract infections including bronchitis, pneumonia; Skin and soft tissue

infections.

2 capsules of AZIN 250 mg or 1 tablet of AZIN 500 mg once daily for 3 days. An alternative to this dosage schedule is 2 capsules of AZIN 250 mg or 1 tablet of AZIN 500 mg once for first day, followed by 1 capsule of AZIN 250 mg once daily for next 4 days.

Sexually transmitted diseases caused by Chlamydia trachomatis. 4 capsules of AZIN 250 mg or 2 tablets of AZIN 500 mg given as a single dose. Typhoid fever. 500 mg once daily for 7 days.

Children :

The dose of AZIN in children over 6 months of age is 10 mg/kg body weight once daily for 3 days. Alternatively, 10 mg/ kg on day 1, followed by 5 mg / kg for next 4 days is also recommended. There is no information on use of AZIN (Azithromycin) on children under 6 months of age. The dose is as for adults.

OR AS DIRECTED BY THE PHYSICIAN.

SIDE EFFECTS

Azithromycin is well tolerated with a low incidence of side effects. Majority of the side effects is mild to moderate in nature and of gastrointestinal in origin with nausea, abdominal discomfort, vomiting, flatulence, diarrhoea and loose motion. Allergic reactions, such as rash may be occurred in case of hypersensitive patients.

CONTRAINDICATIONS

Azithromycin is contraindicated in patients with known hypersensitivity to Azithromycin and with hepatic disease.

PRECAUTION

Azithromycin absorption is reduced by 50% in presence of food in the stomach. It should therefore be taken 1 hour before or 2 hours after meal. Macrolides have been known to increase the plasma concentration of digoxin and cyclosporin. Therefore, if coadministration is necessary caution should be exercised and serum level of digoxin and cyclosporin should be checked. Precaution should be taken in patients with hepatic and severe renal impairment.

USE IN PREGNANCY & LACTATION

Pregnancy Category B. There is no adequate and well-controlled studies of Azithromycin in pregnant women. Azithromycin should be used during pregnancy only if clearly needed. It is not known whether Azithromycin is excreted in brest milk. Because many drugs are excreted in breast milk, caution should be exercised when Azithromycin is administered to a nursing woman.

DRUG INTERACTIONS

Azithromycin absorption is reduced in presence of antacid. So, Azithromycin should be administered 1 hour before or 2 hours after taking antacid.

DIRECTION FOR RECONSTITUTION OF SUSPENSION

15 ml : Shake the bottle to loosen the powder. Pour 8 ml (measure with the provided 8 ml marked cylinder) boiled & cooled water into the bottle in two times and shake well until all the powder is dispersed. The reconstituted suspension should be used within 5 days of preparation and keep it at room temperature. 30 ml : Shake the bottle to loosen the powder. Pour 16 ml (measure with the provided 8 ml marked cylinder two times) boiled & cooled water into the bottle in two times and shake well until all the powder is dispersed. The reconstituted suspension should be used within 5 days of preparation and keep it at room temperature. Shake the bottle before each use.

SUPPLY

Capsule 250 : Each box contains 2x3 capsules in Alu-PVC blister.

Tablet 500 : Each box contains 1x6 Tablets in Alu-Alu blister.

Powder for 15 ml Suspension : Each carton contains required

amount of powder to prepare 15 ml suspension in glass bottle, a

measuring cylinder, a measuring spoon and a dropper.

Powder for 30 ml Suspension : Each carton contains required

amount of powder to prepare 30 ml suspension in glass bottle, a

measuring cylinder and a measuring cup.