TROVAN PRESERVATIVE FREE
Clinical safety rating: caution
Comprehensive clinical and safety monograph for TROVAN PRESERVATIVE FREE (TROVAN PRESERVATIVE FREE).
Inhibits DNA gyrase (topoisomerase II) and topoisomerase IV, thereby inhibiting bacterial DNA replication and transcription.
| Metabolism | Primarily hepatically metabolized via glucuronidation; does not involve CYP450 enzymes. Metabolites include glucuronide conjugates. |
| Excretion | Renal excretion accounts for approximately 90% of elimination, with ~50% as unchanged drug. Fecal/biliary excretion accounts for the remaining ~10%. |
| Half-life | Terminal elimination half-life is approximately 10–13 hours in patients with normal renal function; prolonged in renal impairment. |
| Protein binding | Approximately 50% bound to serum proteins, primarily albumin. |
| Volume of Distribution | Volume of distribution (Vd) is approximately 1.5–2.0 L/kg, indicating extensive tissue penetration. |
| Bioavailability | Oral bioavailability is approximately 85% (based on trovafloxacin; alatrofloxacin is a prodrug converted to trovafloxacin). |
| Onset of Action | Intravenous: within 30 minutes; oral: 1–2 hours. |
| Duration of Action | Duration of action is approximately 24 hours, supporting once-daily dosing. |
200 mg intravenously once daily.
| Dosage form | INJECTABLE |
| Renal impairment | No dosage adjustment required for any degree of renal impairment including dialysis. |
| Liver impairment | Child-Pugh Class A: no adjustment; Child-Pugh Class B or C: not recommended (no data). |
| Pediatric use | Safety and efficacy in pediatric patients not established; no recommended dosage. |
| Geriatric use | No dosage adjustment required based on age alone; monitor renal function as elderly often have decreased creatinine clearance. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for TROVAN PRESERVATIVE FREE (TROVAN PRESERVATIVE FREE).
| Breastfeeding | Trovafloxacin is excreted in human milk. The milk-to-plasma ratio is approximately 0.7. A nursing infant could potentially receive a significant dose. Because of the risk of serious adverse reactions (e.g., arthropathy, tendon rupture) in nursing infants, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. |
| Teratogenic Risk | Trovafloxacin (TROVAN) is classified as FDA Pregnancy Category C. In animal studies, trovafloxacin was not teratogenic in rats or rabbits at doses up to 100 mg/kg/day (approximately 1.7 times the human dose based on AUC). However, it caused fetal toxicity (decreased fetal weight, increased resorptions) in rabbits at maternally toxic doses. There are no adequate and well-controlled studies in pregnant women. The drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. |
■ FDA Black Box Warning
Fluoroquinolones, including trovafloxacin, have been associated with an increased risk of tendinitis and tendon rupture in all ages. Also, they may exacerbate muscle weakness in persons with myasthenia gravis, and serious adverse events including liver injury have been reported. Use should be reserved for patients with no alternative treatment options for serious infections.
| Serious Effects |
Hypersensitivity to trovafloxacin or any fluoroquinolone; history of tendinopathy with fluoroquinolones; myasthenia gravis; pregnancy; lactation; pediatric patients (except for specific indications like anthrax or plague).
| Precautions | Hepatotoxicity (potentially severe, including hepatic necrosis and death), tendinitis/tendon rupture, exacerbation of myasthenia gravis, CNS effects (dizziness, headache, seizures), peripheral neuropathy, QT prolongation, phototoxicity, hypersensitivity reactions, Clostridium difficile-associated diarrhea, renal impairment (adjust dose), drug interactions (e.g., NSAIDs may increase CNS stimulation, antacids reduce absorption). |
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| Fetal Monitoring | There are no specific monitoring guidelines for maternal-fetal effects during trovafloxacin therapy in pregnancy. Standard pregnancy monitoring is recommended. Given the potential for fetal toxicity, use only if clearly needed. |
| Fertility Effects | Trovafloxacin has been associated with reversible decreases in sperm motility and concentration in animal studies. In humans, no adequate studies exist; however, quinolones may affect fertility. Advise patients of potential reversible effects on fertility. |