Trovafloxacin mesilate


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : PO Community-acquired pneumonia; Complicated skin and skin structure infections 200 mg once daily. Duration: 7-14 days (community acquired pneumonia); 10-14 days (complicated skin infections). IV Suscepitble infections 300 mg once daily, then PO 200 mg once daily. Duration: 10-14 days (nosocomial pneumonia); 7-14 days (gynaecological, pelvic and complicated intra-abdominal infections).
Dosage Details
Intravenous
Complicated intra-abdominal infections, Gynaecological infections, Nosocomial pneumonia, Pelvic infections
Adult: 300 mg once daily as slow IV infusion over 60 min followed by 200 mg once daily by mouth. Treat for 10-14 days for nosocomial pneumonia and 7-14 days for gynaecological, pelvic and complicated intra-abdominal infections. Transfer to oral admin as soon as patient is able to tolerate.

Oral
Community-acquired pneumonia, Complicated skin and skin structure infections
Adult: 200 mg once daily. May also be given as slow IV infusion over 60 minutes followed by 200 mg once daily orally. Treat for 7-14 days for community acquired pneumonia and 10-14 days for complicated skin and skin structure infections, including diabetic foot infections.
Hepatic Impairment
Child-Pugh Class A and B: Use 200 mg IV instead if the normal dose used is 300mg IV. Use 100 mg IV or oral instead if the normal dose used is 200mg IV or oral. Child-Pugh Class C: avoid.
Administration
May be taken with or without food.
Reconstitution
Dilute with a suitable volume of diluent (e.g. 5% Dextrose Inj, 0.45% Sodium Chloride Inj, 5% Dextrose and 0.45% Sodium Chloride Inj, 5% Dextrose and 0.2% Sodium Chloride Inj, Lactated Ringer's and 5% Dextrose Inj) to a concentration of 1-2 mg/ml and run as a infusion over 60 min.
Incompatibility
Do not dilute with 0.9% Sodium Chloride Inj or Lactated Ringer's.
Contraindications
Severe hepatic cirrhosis, hypersensitivity to quinolones. Adolescent<18 yr; lactation; pregnancy.
Special Precautions
Impaired hepatic function; G6PD deficiency; history of CNS disorders e.g. severe cerebral atherosclerosis, epilepsy. Avoid exposure to strong sunlight/sunlamp. Discontinue in case of pain, inflammation or rupture of tendon. Discontinue if phototoxicity or skin rash occurs. May impair ability to drive and operate machinery. Decrease incidence of drowsiness by taking at bedtime or with food. Perform liver function and pancreatic tests when symptoms develop. Increased risk of hepatotoxicity when used > 2 wk. Avoid rapid or bolus inj. Oral doses to be admin at least 2 hr before or 2 hr after magnesium or aluminum containing antacids, sucralfate, citric acid buffered with sodium citrate, metal cations (e.g. ferrous sulfate) and didanosine. IV morphine to be admin at least 2 hr after oral trovafloxacin in the fasted state and at least 4 hr after oral trovafloacin is taken with food.
Adverse Reactions
Dizziness, convulsions, increased intracranial pressure, CNS stimulation (e.g. tremor, restlessness, hallucinations), pseudomembranous colitis, phototoxicity, pancreatitis.
Potentially Fatal: Hapatotoxicity, anaphylactic reactions, severe hypotension, Stevens-Johnson syndrome.
Overdosage
Symptoms: decreased activity and respiration, ataxia, ptosis, tremors and convulsions. Management: Empty stomach by inducing vomiting or by gastric lavage. Treatment is symptomatic and supportive with close monitoring. Maintain adequate hydration. Haemodialysis unlikely to be useful.
Drug Interactions
Decreased oral absorption with antacids containing aluminum and magnesium salts, citric acid/sodium citrate, strontium, sucralfate, vitamins or minerals containing iron or zinc and concomitant admin of IV morphine. Increased risk of convulsions with NSAIDs. Increased anticoagulant effect with acenocoumarol, warfarin.
Potentially Fatal: Increased risk of severe hypotension with general anaesthetic agents.
Action
Description: Trovafloxacin has actions and uses similar to those of ciprofloxacin, but is more active against pneumococci. It is available as trovafloxacin mesilate for oral admin and as alatrofloxacin mesilate inj (a prodrug of trovafloxacin) for IV admin. Due to reported incidences of hepatotoxicity, trovafloxacin should be used only in serious, life- or limb-threatening infections caused by susceptible strains.
Pharmacokinetics:
Absorption: Readily absorbed from GI tract. Peak plasma concentration: 1-2 hr. Oral bioavailability: 88%.
Distribution: Widely distributed and found in breast milk. Protein binding: 76%.
Metabolism: Metabolised by conjugation. Half-life: 9-12 hr. After IV inj, alatrofloxacin, the prodrug of trovofloxacin, is rapidly converted to trovafloxacin.
Excretion: Excreted in urine and faeces as metabolites and unchanged drug.
Storage
Tab: Store at 15-30°C (59-86°F). Inj: Store at 15-30°C (59-86°F); protect from light; do not freeze.
MIMS Class
Disclaimer: This information is independently developed by MIMS based on Trovafloxacin mesilate from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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