ZITHROMAX Powder for solution for injection Ref.[10632] Active ingredients: Azithromycin

ZITHROMAX for injection contains the active ingredient azithromycin, an azalide, a subclass of macrolide antibacterial drug, for intravenous injection. Azithromycin has the chemical name (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)13 [(2,6-dideoxy-3-C-methyl-3-O methylα-L-ribo-hexopyranosyl)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,6,8,10,12,14-hepta-methyl- 11- [[3,4,6-trideoxy-3-(dimethylamino)βD-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 for injection consists of azithromycin dihydrate and the following inactive ingredients: citric acid and sodium hydroxide. ZITHROMAX for injection is supplied in lyophilized form in a 10 mL vial equivalent to 500 mg of azithromycin for intravenous administration. Reconstitution, according to label directions, results in approximately 5 mL of ZITHROMAX for intravenous injection with each mL containing azithromycin dihydrate equivalent to 100 mg of azithromycin.