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Trovan-Zithromax

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Trovan - Zithromax

TROVAN®/ZITHROMAX® Compliance Pak
(trovafloxacin mesylate/azithromycin for oral suspension)

The TROVAN ®/ZITHROMAX® Compliance Pak provides a single dose treatment for two separate Sexually Transmitted Diseases. (See INDICATIONS section.) The Compliance Pak contains a single 100-mg TROVAN (trovafloxacin mesylate) tablet and one ZITHROMAX (azithromycin for oral suspension) Single-Dose Packet, 1 gram.

The TROVAN/ZITHROMAX Compliance Pak refers to a specific dual treatment for uncomplicated urethral gonorrhea in males and endocervical and rectal gonorrhea in females caused by Neisseria gonorrhoeae and non-gonoccocal urethritis/cervicitis caused by Chlamydia trachomatis.

The data provided in this prescribing information is specific only to these two indications. TROVAN and ZITHROMAX are each indicated for additional infections due to other susceptible microorganisms as individually administered products. For complete information on other available forms of TROVAN and ZITHROMAX as well as their uses, please consult the relevant product prescribing information.

DRUG DESCRIPTION

TROVAN TABLETS

TROVAN Tablets contain trovafloxacin mesylate, a synthetic broad-spectrum antibacterial agent for oral administration. Chemically, trovafloxacin mesylate, a fluoronaphthyridone related to the fluoroquinolone antibacterials, is (1α, 5α, 6α)-7-(6-amino-3-azabicyclo[3.1.0]hex-3-yl)-1-(2,4-difluorophenyl)-6-fluoro-1,4-dihydro-4-oxo-1,8-naphthyridine-3-carboxylic acid, monomethanesulfonate. Trovafloxacin mesylate differs from other quinolone derivatives by having a 1,8-naphthyridine nucleus.

The chemical structure is:

Trovafloxacin mesylate Structural Formula Illustration

Its empirical formula is C20H15F3N4O3•CH3SO3H and its molecular weight is 512.46.

Trovafloxacin mesylate is a white to off-white powder.

This Compliance Pak contains a single 100 mg (trovafloxacin equivalent) blue, film-coated TROVAN tablet. TROVAN Tablets contain microcrystalline cellulose, crosslinked sodium carboxymethyl cellulose, and magnesium stearate. The tablet coating is a mixture of hydroxypropyl cellulose, hydroxypropylmethyl cellulose, titanium dioxide, polyethylene glycol, and FD&C blue #2 aluminum lake.

ZITHROMAX SINGLE DOSE PACKET

ZITHROMAX SINGLE DOSE PACKET 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-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 749.0. Azithromycin has the following structural formula:

Azithromycin Structural Formula Illustration

Azithromycin, as the dihydrate, is a white crystalline powder with a molecular formula of C38H72N2O12 2H2O and a molecular weight of 785.0.

This Compliance Pak also contains one ZITHROMAX® Single Dose Packet consisting of azithromycin dihydrate equivalent to 1 g azithromycin. The Single Dose Packet also contains the following inactive ingredients: colloidal silicon dioxide, sodium phosphate tribasic, anhydrous; spray dried artificial banana flavor, spray dried artificial cherry flavor, and sucrose.

Last reviewed on RxList: 10/3/2008
This monograph has been modified to include the generic and brand name in many instances.

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