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Flumazenil

    Brands

    DEA Class;  Rx

    Common Brand Names; Romazicon

    • Benzodiazepine Toxicity Antidotes

    Parenteral benzodiazepine antagonist
    Treats benzodiazepine overdose, reverses benzodiazepine-induced sedation, and antagonizes the actions of zolpidem
    Does not reverse the actions of barbiturates, opiate agonists, or tricyclic antidepressants

    Indicated for sedation reversal when sedation is secondary to benzodiazepine therapy.

    For reversal of benzodiazepine toxicity in suspected overdose.

    Hypersensitivity to flumazenil or benzodiazepines

    Possible concomitant: Cyclic antidepressant overdose

    Chronic benzodiazepine user; patients receiving a benzodiazepine for life-threatening condition (eg, intracranial pressure control, status epilepticus)

    • Nausea and vomiting (11%)
    • Dizziness (10%)
    • Abnormal/blurred vision (3-9%)
    • Agitation (3-9%)
    • Dyspnea (3-9%)
    • Hyperventilation (3-9%)
    • Pain at injection site (3-9%)
    • Xerostomia (3-9%)
    • Diaphoresis (1-3%)
    • Emotional lability (1-3%)
    • Fatigue (1-3%)
    • Headache (1-3%)
    • Paresthesia (1-3%)
    • Tremor (1-3%)
    • Weakness (1-3%)
    • Delirium
    • Abnormal hearing
    • Junctional tachycardia
    • Thick tongue
    • Tinnitus
    • Coldness sensation
    • Generalized seizure

    Head trauma

    History of seizures

    Chronic alcoholism

    Not for reversal of respiratory depression (need to establish an airway, assist ventilation, and continue to observe patient)-monitor for return of respiratory depression/sedation

    May not reverse amnesia

    May cause CNS depression and impair ability to perform hazardous tasks

    Resedation occurs frequently in patients who have received a large single dose or cumulative dose of a benzodiazepine administered along with a neuromuscular blocker and multiple anesthetic agents

    Agitation produced in some patients

    Patients rarely seize with 0.2 mg dose

    If seizure after flumazenil, recommend valium 20-30 mg, then immediately to barbiturates

    Use caution in patients with head injury

    Use caution in patients with hepatic dysfunction

    Use caution in patients with panic disorder

    Unmasking of seizures, precipitation of benzodiazepine withdrawal

    Not for diagnosis of benzodiazepine-induced sedation

    Pregnancy category: C

    Lactation: Excretion in milk unknown; use with caution

    Adults

    5 mg IV total cumulative dose for suspected benzodiazepine overdose. If patient unresponsive at this dose, cause of sedation not likely to be benzodiazepine. Max dose for reversal of conscious sedation is 1 mg IV.

    Geriatric

    5 mg IV total cumulative dose for suspected benzodiazepine overdose. If patient unresponsive at this dose, cause of sedation not likely to be benzodiazepine. Max dose for reversal of conscious sedation is 1 mg IV.

    Adolescents

    Single doses of 10 mcg/kg IV (Max: 200 mcg/dose); doses may be repeated as necessary up to a total cumulative dose of 50 mcg/kg IV (Max: 1 mg). Alternatively, 10 mcg/kg/hour via continuous IV infusion has been used off-label.

    Children

    Single doses of 10 mcg/kg IV (Max: 200 mcg/dose); doses may be repeated as necessary up to a total cumulative dose of 50 mcg/kg IV (Max: 1 mg). Alternatively, 10 mcg/kg/hour via continuous IV infusion has been used off-label.

    Infants

    Safety and efficacy have not been established. However, single doses of 30 mcg/kg IV (Max: 200 mcg/dose) have been used off-label; doses may be repeated as necessary up to a total cumulative dose of 50 mcg/kg IV (Max: 1 mg). Alternatively, 10 mcg/kg/hour via continuous IV infusion has been used off-label.

    Neonates

    Safety and efficacy have not been established. However, single doses of 20 mcg/kg IV have been used off-label; doses may be repeated as necessary up to a total cumulative dose of 50 mcg/kg IV. Alternatively, 20 mcg/kg/hour via continuous IV infusion has been used off-label.

    Flumazenil

    injectable solution

    • 0.1mg/mL