Trovafloxavin mesylate
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Gloria Picoy [2]
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Black Box Warning
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TITLE
See full prescribing information for complete Boxed Warning.
Trovafloxavin HAS BEEN ASSOCIATED WITH SERIOUS LIVER INJURY LEADING TO LIVER TRANSPLANTATION AND/OR DEATH. TROVAN-ASSOCIATED LIVER INJURY HAS BEEN REPORTED WITH BOTH SHORT-TERM AND LONG-TERM DRUG EXPOSURE. TROVAN USE EXCEEDING 2 WEEKS IN DURATION IS ASSOCIATED WITH A SIGNIFICANTLY INCREASED RISK OF SERIOUS LIVER INJURY. LIVER INJURY HAS ALSO BEEN REPORTED FOLLOWING TROVAN RE-EXPOSURE. TROVAN SHOULD BE RESERVED FOR USE IN PATIENTS WITH SERIOUS, LIFE- OR LIMB-THREATENING INFECTIONS WHO RECEIVE THEIR INITIAL THERAPY IN AN IN-PATIENT HEALTH CARE FACILITY (I.E., HOSPITAL OR LONG-TERM NURSING CARE FACILITY). TROVAN SHOULD NOT BE USED WHEN SAFER, ALTERNATIVE ANTIMICROBIAL THERAPY WILL BE EFFECTIVE.
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Overview
Trovafloxavin mesylate is {{{aOrAn}}} {{{drugClass}}} that is FDA approved for the {{{indicationType}}} of {{{indication}}}. There is a Black Box Warning for this drug as shown here. Common adverse reactions include {{{adverseReactions}}}.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
There is limited information regarding Trovafloxavin mesylate FDA-Labeled Indications and Dosage (Adult) in the drug label.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Trovafloxavin mesylate in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Trovafloxavin mesylate in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Trovafloxavin mesylate FDA-Labeled Indications and Dosage (Pediatric) in the drug label.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Trovafloxavin mesylate in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Trovafloxavin mesylate in pediatric patients.
Contraindications
There is limited information regarding Trovafloxavin mesylate Contraindications in the drug label.
Warnings
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TITLE
See full prescribing information for complete Boxed Warning.
Trovafloxavin HAS BEEN ASSOCIATED WITH SERIOUS LIVER INJURY LEADING TO LIVER TRANSPLANTATION AND/OR DEATH. TROVAN-ASSOCIATED LIVER INJURY HAS BEEN REPORTED WITH BOTH SHORT-TERM AND LONG-TERM DRUG EXPOSURE. TROVAN USE EXCEEDING 2 WEEKS IN DURATION IS ASSOCIATED WITH A SIGNIFICANTLY INCREASED RISK OF SERIOUS LIVER INJURY. LIVER INJURY HAS ALSO BEEN REPORTED FOLLOWING TROVAN RE-EXPOSURE. TROVAN SHOULD BE RESERVED FOR USE IN PATIENTS WITH SERIOUS, LIFE- OR LIMB-THREATENING INFECTIONS WHO RECEIVE THEIR INITIAL THERAPY IN AN IN-PATIENT HEALTH CARE FACILITY (I.E., HOSPITAL OR LONG-TERM NURSING CARE FACILITY). TROVAN SHOULD NOT BE USED WHEN SAFER, ALTERNATIVE ANTIMICROBIAL THERAPY WILL BE EFFECTIVE.
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There is limited information regarding Trovafloxavin mesylate Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Trovafloxavin mesylate Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Trovafloxavin mesylate Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Trovafloxavin mesylate Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Trovafloxavin mesylate in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Trovafloxavin mesylate in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Trovafloxavin mesylate during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Trovafloxavin mesylate in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Trovafloxavin mesylate in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Trovafloxavin mesylate in geriatric settings.
Gender
There is no FDA guidance on the use of Trovafloxavin mesylate with respect to specific gender populations.
Race
There is no FDA guidance on the use of Trovafloxavin mesylate with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Trovafloxavin mesylate in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Trovafloxavin mesylate in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Trovafloxavin mesylate in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Trovafloxavin mesylate in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Trovafloxavin mesylate Administration in the drug label.
Monitoring
There is limited information regarding Trovafloxavin mesylate Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Trovafloxavin mesylate and IV administrations.
Overdosage
There is limited information regarding Trovafloxavin mesylate overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Trovafloxavin mesylate Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Trovafloxavin mesylate Mechanism of Action in the drug label.
Structure
There is limited information regarding Trovafloxavin mesylate Structure in the drug label.
Pharmacodynamics
There is limited information regarding Trovafloxavin mesylate Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Trovafloxavin mesylate Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Trovafloxavin mesylate Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Trovafloxavin mesylate Clinical Studies in the drug label.
How Supplied
There is limited information regarding Trovafloxavin mesylate How Supplied in the drug label.
Storage
There is limited information regarding Trovafloxavin mesylate Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Trovafloxavin mesylate Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Trovafloxavin mesylate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Trovafloxavin mesylate Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Trovafloxavin mesylate Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.