The TROVAN^Ò /ZITHROMAX^Ò Compliance Pak provides a single dose treatment for two separate Sexually Transmitted Diseases (See INDICATIONS). 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.

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 (1a, 5a, 6a)-7-(6-amino-3-azabicyclo[3.1.0]hex-3-yl)-1-(2,4-difluorophenyl)-6-fluoro-1,4-dihydro-4-ox-1,8-naphthyridine-3-carboxylic acid, monomethanesulfonate. Trovafloxacin mesylate differs from other quinolone derivatives by having a 1,8-naphthyridine nucleus.

Its empirical formula is C₂₀H₁₅F₃N₄O₃CH₃SO₃H 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-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 749.0.

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

This Compliance Pak also contains one ZITHROMAX^Ò 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.

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