Equate Aspirin Chewable

To reduce the development of drug-resistant bacteria and maintain the effectiveness of azithromycin tablets USP and other antibacterial drugs, azithromycin tablets USP 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.

Azithromycin tablets USP are 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.

Prophylaxis of Disseminated Mycobacterium avium complex (MAC) Disease

Azithromycin tablets USP, 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 tablets USP, 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)].

Azithromycin tablets USP contains the active ingredient azithromycin, a macrolide antibacterial drug, for oral administration. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl -3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-heptamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranosyl]oxy]-1-oxa-6-azacyclopentadecan-15-one. Azithromycin is derived from erythromycin; however, it differs chemically from erythromycin in that a methyl-substituted nitrogen atom is incorporated into the lactone ring. Its molecular formula is C38H72N2O12, and its molecular weight is 749.0. Azithromycin has the following structural formula:

Azithromycin, as the monohydrate, is a white to almost white crystalline powder with a molecular formula of C38H72N2O12•H2O and a molecular weight of 767.0.

Azithromycin tablets USP contain azithromycin monohydrate equivalent to 600 mg azithromycin. They also contain the following inactive ingredients: croscarmellose sodium, dibasic calcium phosphate, hydroxypropyl methyl cellulose, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, titanium dioxide and triacetin.

Organic Impurities Test Pending.