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AZITHROMYCIN Oral Suspension (single-dose packets) (GREENSTONE LLC) Indications and Usage

1 INDICATIONS AND USAGE

Azithromycin is a macrolide antibacterial drug indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below.

1.1 Sexually Transmitted Diseases

Non-gonococcal urethritis and cervicitis due to Chlamydia trachomatis.

1.2 Mycobacterial Infections

Prophylaxis of Disseminated Mycobacterium avium complex (MAC) Disease

Azithromycin, taken alone or in combination with rifabutin at its approved dose, is indicated for the prevention of disseminated MAC disease in persons with advanced HIV infection [see Dosage and Administration (2)].

Treatment of Disseminated MAC Disease

Azithromycin, taken in combination with ethambutol, is indicated for the treatment of disseminated MAC infections in persons with advanced HIV infection [see Use in Specific Populations (8.4) and Clinical Studies (14.1)].

1.3 Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin and other antibacterial drugs, azithromycin should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

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