doses where noted).

Presence in Human Milk

Trovafloxacin has been detected in the human milk of lactating subjects (See PRECAUTIONS: Nursing Mothers).

Metabolism

Trovafloxacin is metabolized by conjugation (the role of cytochrome P₄₅₀ oxidative metabolism of trovafloxacin is minimal). Thirteen percent of the administered dose appears in the urine in the form of the ester glucuronide, and 9% appears in the feces as the N-acetyl metabolite. (2.5% of the dose is found in the serum as the active N-acetyl metabolite.) Other minor metabolites (diacid, sulfamate, hydroxycarboxylic acid) have been identified in both urine and feces in small amounts (>4% of the administered dose).

Excretion

Approximately 50% of an oral dose is excreted unchanged (43% in the feces and 6% in the urine).

After multiple 200-mg doses, to healthy subjects, mean (±SD) cumulative urinary trovafloxacin concentrations were 12.1 ±3.4 mcg/mL. With these levels of trovafloxacin in urine, crystals of trovafloxacin have not been observed in the urine of human subjects.

Special Populations

Geriatric

The pharmacokinetics of trovafloxacin are not affected by age range (19-78 years).

Pediatric

The pharmacokinetics of trovafloxacin have not been fully characterized in pediatric populations less than 18 years of age.

Gender

There are no significant differences in trovafloxacin pharmacokinetics between males and females when differences in body weight are taken into account. After single 200-mg doses, trovafloxacin Cmax and AUC (0-¥) were 60% and 32% higher, respectively, in healthy females compared to healthy males. The clinical importance of the increases in serum levels of trovafloxacin in females has not been established (See PATIENT INFORMATION).

Chronic Hepatic Disease

No dosage adjustment is recommended in patients with mild (Child-Pugh Class A) to moderate (Child-Pugh Class B) cirrhosis receiving a 100-mg oral dose. There are no data in patients with severe cirrhosis (Child-Pugh Class C) (See DOSAGE AND ADMINISTRATION).

Renal Insufficiency

The pharmacokinetics of trovafloxacin are not affected by renal impairment. Trovafloxacin serum concentrations are not significantly altered in subjects with severe renal insufficiency (creatinine clearance <20 mL/min), including patients on hemodialysis.

Photosensitivity Potential

In a study of the skin response to ultraviolet and visible radiation conducted in 48 healthy volunteers (12 per group), the minimum erythematous dose (MED) was measured for ciprofloxacin, lomefloxacin, trovafloxacin, and placebo before and after drug administration for 5 days. In this study, trovafloxacin (200 mg q.d.) was shown to have a lower potential for producing delayed photosensitivity skin reactions than ciprofloxacin (500 mg b.i.d.) or lomefloxacin (400 mg q.d.), although greater than placebo (See PATIENT INFORMATION).

Drug-drug Interactions

The systemic availability of trovafloxacin following oral tablet administration is significantly reduced by the concomitant administration of antacids containing aluminum and magnesium salts, sucralfate, vitamins or minerals containing iron, and concomitant intravenous morphine administration.

Administration of trovafloxacin (300 mg p.o.) 30 minutes after administration of an antacid containing magnesium hydroxide and aluminum hydroxide resulted in reductions in systemic exposure to trovafloxacin (AUC) of 66% and peak serum concentration (Cmax) of 60% (See PRECAUTIONS: Drug Interactions, and DOSAGE AND ADMINISTRATION).

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