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Trovan-Zithromax

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Trovan - Zithromax

INDICATIONS

The TROVAN/ZITHROMAX Compliance Pak is indicated for single-dose treatment of infections caused by susceptible strains of the designated microorganisms in the conditions listed below.

Uncomplicated urethral gonorrhea in males and endocervical and rectal gonorrhea in females caused by Neisseria gonorrhoeae.

Non-gonoccocal urethritis and cervicitis due to Chlamydia trachomatis.

DOSAGE AND ADMINISTRATION

The recommended regimen is a single 100-mg tablet of TROVAN and a single 1-gram (1000 mg) dose of ZITHROMAX for oral suspension. (See INDICATIONS section.) These single-regimen medications are available together as a "Compliance Pak", containing a single 100-mg TROVAN (trovafloxacin) tablet and one ZITHROMAX (azithromycin for oral suspension) single-dose packet (1g).

TROVAN

TROVAN can be taken with or without food.

Oral doses should be administered at least two hours before or two hours after antacids containing magnesium or aluminum, as well as sucralfate, citric acid buffered with sodium citrate (e.g., Bicitra®), metal cations (e.g., ferrous sulfate) and Videx® (Didanosine), chewable/buffered tablets, buffered powder for solution, or the pediatric powder for oral solution.

Intravenous morphine should be administered at least 2 hours after oral TROVAN dosing in the fasted state and at least 4 hours after oral TROVAN is taken with food.

IMPAIRED RENAL FUNCTION: No adjustment in the dosage of TROVAN is necessary in patients with impaired renal function. Trovafloxacin is eliminated primarily by biliary excretion. Trovafloxacin is not efficiently removed from the body by hemodialysis.

CHRONIC HEPATIC DISEASE (cirrhosis): No dosage adjustment is necessary for patients with mild or moderate cirrhosis (Child-Pugh Class A and B) receiving the 100-mg TROVAN dose. There are no data in patients with severe cirrhosis (Child-Pugh Class C).

ZITHROMAX

ZITHROMAX® for oral suspension (single-dose 1-g packet) can be taken with or without food after constitution. Not for pediatric use

The ZITHROMAX dose should not be taken with aluminum- or magnesium-containing antacids. Caution should be used when prescribing ZITHROMAX to patients with impaired renal or hepatic function.

Directions For Compliance Pak Aministration

The entire contents of the ZITHROMAX single-dose 1-g (1000 mg) packet should be mixed thoroughly with two ounces (approximately 60 mL) of water. Drink the entire contents immediately; add an additional two ounces of water, mix, and rinse. Use the rinse to swallow the TROVAN 100-mg tablet and drink the entire contents to assure complete consumption of dosage. The single-dose packet should not be used to administer doses other than 1000 mg of azithromycin. This packet is not for pediatric use.

HOW SUPPLIED

Compliance Pak: One ZITHROMAX® single-dose packet of azithromycin dihydrate is equivalent to 1 gram of azithromycin and a single TROVAN® tablet containing trovafloxacin mesylate is equivalent to 100-mg trovafloxacin. The Compliance Pak is available as follows:

Boxes of 3 Compliance Paks..............NDC 0049-3770-89

Store Compliance Paks between 15° and 30°C (59° and 86°F).

Pfizer version. 12-16-1998. FDA Rev date: 12/18/1998

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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