The TROVANÒ /ZITHROMAXÒ
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 rectal gonorrhea in females caused by Neisseria gonorrhoeae
and non-gonoccocal urethritis/cervicitis caused by Chlamydia
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
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,
acid, monomethanesulfonate. Trovafloxacin mesylate differs from
other quinolone derivatives by having a 1,8-naphthyridine nucleus.
Its empirical formula
and its molecular weight
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
and magnesium stearate.
The tablet coating is
a mixture of hydroxypropyl
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-
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
with a molecular formula
of C38H72N2O12 x 2H2O
and a molecular weight
This Compliance Pak also contains one ZITHROMAXÒ
Single Dose Packet consisting of azithromycin
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
flavor, and sucrose.