Powder for Oral Suspension: Azithromycin powder for oral suspension is presented as a white to off-white dry powder which yields, on reconstitution with water, off-white to orange to brown suspension containing the equivalent of 200 mg azithromycin per 5 mL.
When reconstituted as directed, each teaspoonful (5 mL) contains azithromycin dihydrate equivalent to 200 mg of azithromycin.
Film-coated Tablet 250 mg: Azithromycin film-coated tablets are capsular shaped and contain azithromycin dihydrate equivalent to 250 mg of azithromycin and engraved with "Pfizer" on one side and "ZTM 250" on the other side.
Each tablet contains azithromycin dihydrate equivalent to 250 mg azithromycin.
Film-coated Tablet 500 mg: Azithromycin film-coated tablets are capsular shaped and contain azithromycin dihydrate equivalent to 500 mg of azithromycin and engraved with "Pfizer" on one side and "ZTM 500" on the other side.
Each tablet contains azithromycin dihydrate equivalent to 500 mg azithromycin.
Powder for Intravenous (IV) Solution: Azithromycin is supplied in lyophilized form under a vacuum in a 10 mL vial equivalent to 500 mg azithromycin for intravenous administration. Upon reconstitution, azithromycin powder yields a solution containing the equivalent of 100 mg azithromycin per 1 mL.
Each vial contains azithromycin dihydrate, equivalent to 500 mg of azithromycin, providing 100 mg/mL solution following recommended reconstitution.
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-hepta-methyl-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, as the dihydrate, is a white crystalline powder with a molecular formula of C38H72N2O12·2H2O and a molecular weight of 785.0.
Excipients/Inactive Ingredients: Powder for Oral Suspension: The powder for oral suspension contains sucrose (1.94 g per 100 mg dose), sodium phosphate tribasic anhydrous, hydroxypropyl cellulose, xanthan gum, artificial cherry, creme de vanilla and banana flavors.
Film-coated Tablets: The tablets contain pregelatinized starch, calcium phosphate dibasic anhydrous, croscarmellose sodium, magnesium stearate and sodium lauryl sulfate. The film coating contains hydroxypropyl methylcellulose, triacetin and titanium dioxide (E171).
Powder for Intravenous Solution: The IV formulation contains citric acid (anhydrous) 384.6 mg, and sodium hydroxide 198.3 mg.
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