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Zithromax - Drug Description

[Azithromycin]




DESCRIPTION

ZITHROMAX (azithromycin capsules, azithromycin tablets and azithromycin for oral suspension) contain the active ingredient azithromycin, an azalide, a subclass of macrolide antibiotics, 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- -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)- -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, as the dihydrate, is a white crystalline powder with a molecular formula of C38H72N2O122H2O and a molecular weight of 785.0. ZITHROMAX capsules contain azithromycin dihydrate equivalent to 250 mg of azithromycin. The capsules are supplied in red opaque hard-gelatin capsules (containing FD& C Red #40). They also contain the following inactive ingredients: anhydrous lactose, corn starch, magnesium stearate, and sodium lauryl sulfate.

ZITHROMAX tablets contain azithromycin dihydrate equivalent to 600 mg azithromycin. The tablets are supplied as white, modified oval-shaped, film-coated tablets. They also contain the following inactive ingredients: dibasic calcium phosphate anhydrous, pregelatinized starch, sodium croscarmellose, magnesium stearate, sodium lauryl sulfate and an aqueous film coat consisting of hypromellose, titanium dioxide, lactose and triacetin.

ZITHROMAX for oral suspension is supplied in a single dose packet containing azithromycin dihydrate equivalent to 1 g azithromycin. It also contains the following inactive ingredients: colloidal silicon dioxide, sodium phosphate tribasic, anhydrous; spray dried artificial banana flavor, spray dried artificial cherry flavor, and sucrose.
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