DESCRIPTION

Zithromax (azithromycin tablets, azithromycin capsules 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-a-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)-b-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 C₃₈H₇₂N₂O₁₂2H₂O 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.

CATEGORIES, BRAND NAMES

CATEGORIES: Cervicitis; Infection, cervix; Infection, lower respiratory tract; Infection, skin and skin structures; Infection, urethra, nongonococcal; Mycobacterium avium complex; Pharyngitis, streptococcal; Pneumonia; Pneumonia, community-acquired; Tonsillitis; Urethritis, nongonococcal; FDA Class 1B ("Modest Therapeutic Advantage"); FDA Approved 1991 Nov; Pregnancy Category B; Top 200 Drugs

FDA Drug Classes: Macrolides

BRAND NAMES:

BRAND NAMES: Aruzilina; Arzomicin; Azadose; Azenil; Azimin; Azithral; Azitrocin; Azitromax; Aziwok; Aztrin; Setron; Tobil; Tromix; Ultreon; Zeto; Zifin; Zistic; Zithromax; Zitrim; Zitromax
(Foreign Brand names outside U.S. in italics)

FOREIGN BRAND AVAILABILITY:
Arzomicin (Peru)
Azadose (France)
Azenil (Israel)
Azimin (Colombia)
Azithral (India)
Azitrocin (Italy; Mexico)
Azitromax (Sweden)
Aziwok (Benin; Burkina-Faso; Ethiopia; Gambia; Ghana; Guinea; India; Ivory-Coast; Kenya; Liberia; Malawi; Mali; Mauritania; Mauritius; Morocco; Niger; Nigeria; Senegal; Seychelles; Sierra-Leone; Sudan; Tanzania; Tunia; Uganda; Zambia; Zimbabwe)
Aztrin (Indonesia)
Setron (Peru)
Tobil (Colombia)
Tromix (Colombia)
Ultreon (Germany)
Zeto (Israel)
Zifin (Indonesia)
Zistic (Indonesia)
Zitrim (Colombia)
Zitromax (Colombia; Ecuador; Italy; Peru; Spain)

COST OF THERAPY: $39.24 (Pneumonia; Zithromax Tablet; 250 mg; 6 tablets total/day; 5 days)

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