Zithromax (Azithromycin) Description
To reduce the development of drug-resistant bacteria and maintain the effectiveness of
ZITHROMAX® (azithromycin) and other bacterial drugs, ZITHROMAX (azithromycin) should
be used only to treat or prevent infections that are proven or strongly suspected to be caused by
bacteria.
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ZITHROMAX (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-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 749.00. Azithromycin has the following
structural formula:

Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of
C38H72N2O12•2H2O and a molecular weight of 785.0.
ZITHROMAX is supplied for oral administration as film-coated, modified capsular shaped
tablets containing azithromycin dihydrate equivalent to either 250 mg or 500 mg azithromycin
and the following inactive ingredients: dibasic calcium phosphate anhydrous, pregelatinized
starch, sodium croscarmellose, magnesium stearate, sodium lauryl sulfate, hypromellose, lactose,
titanium dioxide, triacetin and D&C Red #30 aluminum lake.
ZITHROMAX for oral suspension is supplied in bottles containing azithromycin dihydrate
powder equivalent to 300 mg, 600 mg, 900 mg, or 1200 mg azithromycin per bottle and the
following inactive ingredients: sucrose; sodium phosphate, tribasic, anhydrous; hydroxypropyl
cellulose; xanthan gum; FD&C Red #40; and spray dried artificial cherry, creme de vanilla and
banana flavors. After constitution, each 5 mL of suspension contains 100 mg or 200 mg of
azithromycin.
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