Label: FLUMAZENIL injection

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 10, 2024

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  • DESCRIPTION
    Flumazenil Injection, USP is a benzodiazepine receptor antagonist. Chemically, flumazenil is ethyl 8-fluoro-5,6-dihydro-5-methyl-6-oxo-4H-imidazo [1,5-a](1,4) benzodiazepine-3-carboxylate ...
  • CLINICAL PHARMACOLOGY
    Flumazenil, an imidazobenzodiazepine derivative, antagonizes the actions of benzodiazepines on the central nervous system. Flumazenil competitively inhibits the activity at the benzodiazepine ...
  • CLINICAL TRIALS
    Flumazenil injection has been administered in adults to reverse the effects of benzodiazepines in conscious sedation, general anesthesia, and the management of suspected benzodiazepine overdose ...
  • INDIVIDUALIZATION OF DOSAGE
    General Principles: The serious adverse effects of flumazenil are related to the reversal of benzodiazepine effects. Using more than the minimally effective dose of flumazenil is tolerated by ...
  • INDICATIONS AND USAGE
    Adult Patients: Flumazenil injection is indicated for the complete or partial reversal of the sedative effects of benzodiazepines in cases where general anesthesia has been induced and/or ...
  • CONTRAINDICATIONS
    Flumazenil injection is contraindicated: in patients with a known hypersensitivity to flumazenil or benzodiazepines. in patients who have been given a benzodiazepine for control of a potentially ...
  • WARNINGS
    THE USE OF FLUMAZENIL HAS BEEN ASSOCIATED WITH THE OCCURRENCE OF SEIZURES. THESE ARE MOST FREQUENT IN PATIENTS WHO HAVE BEEN ON BENZODIAZEPINES FOR LONG-TERM SEDATION OR IN OVERDOSE CASES ...
  • PRECAUTIONS
    Return of Sedation: Flumazenil may be expected to improve the alertness of patients recovering from a procedure involving sedation or anesthesia with benzodiazepines, but should not be ...
  • ADVERSE REACTIONS
    Serious Adverse Reactions: Deaths have occurred in patients who received flumazenil in a variety of clinical settings. The majority of deaths occurred in patients with serious underlying ...
  • DRUG ABUSE AND DEPENDENCE
    Flumazenil acts as a benzodiazepine antagonist, blocks the effects of benzodiazepines in animals and man, antagonizes benzodiazepine reinforcement in animal models, produces dysphoria in normal ...
  • OVERDOSAGE
    There is limited experience of acute overdose with flumazenil. There is no specific antidote for overdose with flumazenil. Treatment of an overdose with flumazenil should consist of general ...
  • DOSAGE AND ADMINISTRATION
    Flumazenil injection, USP is recommended for intravenous use only. It is compatible with 5% dextrose in water, lactated Ringer’s and normal saline solutions. If flumazenil injection is drawn into ...
  • HOW SUPPLIED
    Flumazenil Injection, USP, for Intravenous use is supplied in: For Intravenous Multiple-Dose Use: AIN00213 NDC 36000-148-10, 0.1 mg/mL, 5 mL vial; Pack of 10 Vials - For Intravenous ...
  • PRINCIPAL DISPLAY PANEL - Outer Package
    NDC 71872-7321-1 Rx Only - Flumazenil Injection, USP - 1 mg/10 mL - (0.1 mg/mL) Sterile - For Intravenous Use Only - 1 x 1 mL Multi-Dose Vial - Each mL contains:0.1 mg Flumazenil ...
  • INGREDIENTS AND APPEARANCE
    Product Information