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. |
| Molecular Weight | 416.5 |
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 | Contraindicated in first trimester due to evidence of fetal harm in animal studies and potential for teratogenicity. Use only if no safer alternative. |
| 2nd trimester | Avoid use in second trimester unless absolutely necessary; limited safety data show potential risk of fetal toxicity. |
| 3rd trimester | Contraindicated in third trimester; linked to risk of neonatal hemolysis, jaundice, and kernicterus in newborns. |
Clinical note
Comprehensive clinical and safety monograph for TROVAN PRESERVATIVE FREE (TROVAN PRESERVATIVE FREE).
| Placental transfer | Crosses the placenta readily. Documented in animal studies and human case reports. |
| Breastfeeding | Excreted into breast milk in small amounts. Potential for serious adverse effects in nursing infants, including hemolysis and hypersensitivity reactions. Discontinue breastfeeding during therapy and for 5 days after last dose. |
■ 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 fluoroquinolonePregnancy (all trimesters)LactationHistory of tendon disorders related to fluoroquinolonesPatients under 18 years of age
| 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). |
| Food/Dietary | Avoid dairy products (milk, yogurt, calcium-fortified juices) within 2 hours of taking oral trovafloxacin as they may decrease absorption. No other significant food interactions. |
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| Lactation Rating | Avoid (L5) |
| 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. |
| 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. |
| Clinical Pearls | Trovafloxacin, the active ingredient in Trovan, is a fluoroquinolone antibiotic associated with hepatotoxicity, including fatal liver injury. It is reserved for serious infections when benefits outweigh risks. Due to FDA restrictions, it is only available for use in hospitalized patients with life-threatening infections. Monitor LFTs closely. Avoid in patients with prior quinolone allergy, QTc prolongation, or history of tendon disorders. Rapid IV infusion can cause hypotension; administer over 60 minutes. |
| Patient Advice | This medication is for serious infections only and is given in the hospital due to risk of severe liver injury. · Report any signs of liver problems: jaundice, dark urine, abdominal pain, nausea, or unexplained fatigue. · Avoid driving or operating machinery if you feel dizzy or drowsy; may cause CNS effects. · Stay well-hydrated to prevent crystalluria; drink plenty of fluids unless told otherwise. · Notify your doctor immediately if you develop tendon pain, swelling, or rupture, especially in the Achilles tendon. · Do not take with antacids, iron, or zinc supplements; separate by at least 2 hours. |