For infections caused by susceptible organisms in lower respiratory tract infection including bronchitis and pneumonia, skin and soft tissue infections, acute otitis media, upper respiratory tract infections including sinusitis and pharyngitis/tonsilitis. (Penicillin is the usual drug of choice in the treatment of Streptococcus pyogenes pharyngitis including the prophylaxis of rheumatic fever. Azithromycin is generally effective in the eradication of streptococci from the oropharynx, however, data establishing the efficacy of azithromycin and the subsequent prevention of rheumatic fever are not available at present).
In sexually transmitted disease in men and women, treatment of uncomplicated genital infections due to Chlamydia trachomatis. Treatment of Chancroid due to H. ducreyi and uncomplicated genital infection due to non-multiresistant Neisseria gonorrhoea, concurrent infection with Treponema pallidum should be excluded.
Either alone or in combination with rifabutin, for prophylaxis against Mycobacterium avium-intracellulare complex (MAC) infection, an opportunistic infection prevalent in patients with advanced HIV.
Adults and Elderly: For the treatment of sexually transmitted diseases (STD) caused by Clamydia trachomatis or susceptible Neisseria gonnorhoea and chancroid due to H. ducreyi, 1 g as a single oral dose. Prophylaxis against MAC infections in patients with HIV infection, 1200 mg once weekly.
For all other indications, the total dosage of 1500 mg should be given as 500 mg daily for 3 days or can be given over 5 days with 500 mg given on day 1, then 250 mg daily on days 2-5.
For the treatment of DMAC infections in patients with advanced HIV infection, the recommended dose is 600 mg once daily. Azithromycin should be administered in combination with other antimycobacterial agents that have shown in vitro activity against MAC, eg, ethambutol at the approved dose.
Children: With a single exception of the treatment of Streptococcal pharyngitis, the total dose in children is 30 mg/kg which should be given as a single daily dose of 10 mg/kg daily for 3 days or as an alternative, given over 5 days with a single dose of 10 mg/kg on 1 day, then 5 mg/kg on days 2-5. Treatment of acute otitis media in children may be given as either a single dose of 30 mg/kg. Zithrolide tablets should only be administered to children weighing >45 kg. Safety and efficacy for the prevention of MAC in children have not been established.