文档介绍：NDA 50-670/S-024
NDA 50-693/S-010
NDA 50-730/S-014
Page 3
ZITHROMAX®
(azithromycin tablets)
and
(azithromycin for oral suspension)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Zithromax®
(azithromycin) and other antibacterial drugs, Zithromax (azithromycin) should be used only to treat or
prevent infections that are proven or strongly suspected to be caused by bacteria.
DESCRIPTION
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 . Azithromycin has the following structural formula:
CH 3 H C
3 CH 3
N
H 3 C HO
N OH
H 3 C
CH 3
HO O CH
O 3
HO
CH 3