500mg Film Coated Tablet
It is given in the treatment of respiratory- tract infections (including otitis media), in skin and soft-tissue infections, and in uncomplicated genital infections.
Azithromycin may also be used for the prophylaxis, and as a component of regimens in the treatment, of Mycobacterium avium complex (MAC) infections
DOSAGE AND ADMINISTRATION
It is given orally or by intravenous infusion usually as the dihydrate; doses are expressed in terms of the anhydrous substance. Azithromycin dihydrate 524 mg is equivalent to about 500 mg of anhydrous azithromycin. The capsule formulation should be given at least 1 hour before, or 2 hours after, meals.
The usual oral adult dose of azithromycin is 500 mg as a single dose daily for 3 days. Alternatively, an initial dose of 500 mg may be followed by 250 mg daily for a further 4 days.
For uncomplicated genital infections caused by Chlamydia trachomatis and for chancroid, 1 g of azithromycin is given as a single dose. A single dose of 2 g has been given for uncomplicated gonorrhoea. For the treatment of granuloma inguinale, an initial dose of 1 g followed by 500 mg daily may be given, or 1 g may be given once a week for at least 3 weeks, until all lesions have completely healed.
For prophylaxis of disseminated MAC infections, azithromycin 1.2 g may be given once weekly. For treatment or secondary prophylaxis, 500 mg once daily should be given with other antimycobacterials.
For mild or moderate typhoid caused by multidrugresistant strains, 500 mg once daily may be given for 7 days.
Concurrent administration of antacids containing aluminium or magnesium salts can reduce the rate, but not the extent, of absorption of Azithromycin; Azithromycin should be given at least 1 hour before or 2 hours after the antacid.
ADVERSE EFFECTS AND PRECAUTIONS
Gastrointestinal disturbances are the most frequent adverse effect but are usually mild and less frequent than with erythromycin. Headache may occur and taste disturbances have been reported rarely. Severe hypersensitivity reactions occur rarely but may be prolonged. Transient reductions in neutrophil counts have been seen in patients receiving Azithromycin.
Licensed product information states that azithromycin should be used with caution in patients with hepatic or renal impairment. It should not be given to those with severe hepatic impairment as safety has not been established. Although plasma concentrations may be increased in renal impairment dosage adjustment is not usually required
Store at a temperature not exceeding 30°C.