TROVAN
Clinical safety rating: caution
Comprehensive clinical and safety monograph for TROVAN (TROVAN).
Trovan (trovafloxacin) is a fluoroquinolone antibiotic that inhibits bacterial DNA gyrase (topoisomerase II) and topoisomerase IV, thereby blocking DNA replication and transcription.
| Metabolism | Trovafloxacin is primarily metabolized by the liver via glucuronidation and oxidation, with involvement of cytochrome P450 enzymes (minor contribution). It has a long half-life (~10-12 hours). |
| Excretion | Renal (approximately 60% unchanged) and fecal/biliary (approximately 35% as unchanged drug and metabolites). |
| Half-life | Terminal elimination half-life is approximately 10-12 hours in patients with normal renal function, supporting twice-daily dosing. |
| Protein binding | Approximately 88% bound to serum proteins, primarily albumin. |
| Volume of Distribution | Volume of distribution is approximately 1.3 L/kg, indicating extensive tissue penetration, including into lung, sinus, and prostate tissues. |
| Bioavailability | Oral bioavailability is approximately 88% (tablets) and 95% (oral suspension). |
| Onset of Action | Oral: ~1-2 hours; Intravenous: immediate (within minutes). |
| Duration of Action | 12 hours (consistent with dosing interval); clinical effects persist for at least 24 hours due to post-antibiotic effect. |
200 mg IV once daily for 7-14 days for community-acquired pneumonia; 200 mg orally once daily for 7-14 days for acute exacerbation of chronic bronchitis
| Dosage form | TABLET |
| Renal impairment | No adjustment necessary for mild to moderate renal impairment; not recommended for patients with creatinine clearance <40 mL/min |
| Liver impairment | Contraindicated in patients with Child-Pugh class C; use with caution in class A and B, no specific dose adjustment defined |
| Pediatric use | Not recommended for pediatric patients due to risk of arthropathy; no established dosing |
| Geriatric use | No specific dose adjustment required; monitor renal function as elderly may have decreased clearance |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for TROVAN (TROVAN).
| Breastfeeding | Unknown if trovafloxacin is excreted into human breast milk; however, other fluoroquinolones are excreted. Due to potential serious adverse effects in nursing infants (joint and cartilage damage), the manufacturer recommends discontinuing breastfeeding or the drug. M/P ratio is not established. |
| Teratogenic Risk | TROVAN (trovafloxacin) is contraindicated in pregnant women. In animal studies, trovafloxacin caused fetal toxicity (increased fetal loss, reduced fetal weight) and skeletal abnormalities at clinically relevant doses. Human data are insufficient, but fluoroquinolones as a class are associated with arthropathy in juvenile animals and potential cartilage damage in humans. Risk cannot be excluded; avoid use in all trimesters. |
■ FDA Black Box Warning
Trovan is associated with an increased risk of hepatotoxicity, including acute liver failure and death. Its use should be reserved for patients with serious infections who are hospitalized and for whom alternative treatments are not available or appropriate.
| Serious Effects |
Hypersensitivity to trovafloxacin or any fluoroquinolone; patients with a history of tendon disorders related to fluoroquinolones; children <18 years (except for specific serious infections); pregnancy; nursing mothers.
| Precautions | Hepatotoxicity (discontinue at first signs of hepatic injury); QT prolongation; tendon damage (increased risk in patients over 60, those on corticosteroids, and organ transplant recipients); peripheral neuropathy; CNS effects (seizures, dizziness); photosensitivity; Clostridium difficile-associated diarrhea; myasthenia gravis exacerbation. |
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| Fetal Monitoring | Monitor for signs of fetal distress if inadvertent exposure occurs. No specific monitoring required as drug is contraindicated. If used inadvertently, consider fetal ultrasound for skeletal development. |
| Fertility Effects | No human data on fertility effects. Animal studies show no impairment of fertility at therapeutic doses. However, fluoroquinolones may adversely affect spermatogenesis in some animal models; clinical significance unknown. |