ZITHROMAX? (azithromycin tablets, azithromycin capsules and azithromycin for oral suspension) contains 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-(alpha)- 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)- (beta)- 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 C 38 H 72 N 2 O 12 , and its molecular weight is 749.00.
Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C 38 H 72 N 2 O 12 กค2H 2 O 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 250 mg azithromycin and the following inactive ingredients: dibasic calcium phosphate anhydrous, pregelatinized starch, sodium croscarmellose, magnesium stearate, sodium lauryl sulfate, hydroxypropyl methylcellulose, lactose, titanium dioxide, triacetin and D&C Red #30 aluminum lake.
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.
It is also supplied as a powder for oral suspension.
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.
