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flumazenil (Rx)Brand and Other Names:Romazicon

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 0.1mg/mL
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Reversal of Conscious Sedation and General Anesthesia

0.2 mg IV over 15 sec

IF after 45 sec no response, administer 0.2 mg again over 1 min; may repeat at 1 min intervals; not to exceed 4 doses (1 mg)

IF resedation occurs, may repeat doses at 20-min intervals; not to exceed 1 mg/dose or 3 mg/hr

Benzodiazepine Overdose

0.2 mg IV over 15-30 sec

IF no response after 30 sec, administer 0.3 mg over 30 sec 1 min later; IF no response, repeat dose of 0.5 mg IV over 30 sec at 1-min intervals to max cumulative dose of 3 mg/hr

In the event of resedation, may repeat dose at 20-min intervals if needed; not to exceed 1 mg (administered as 0.5 mg/min) administered at any one time and no more than 3 mg/hr

Rarely patient may require titration up to total dose 5 mg; IF no response after 5 min, sedation unlikely to be secondary to benzodiazepines

Dosing Considerations

Slow infusion of lowest dose required to decrease adverse effects

Dosing Modifications

Renal impairment: Not studied

Hepatic impairment: Initial dose adjustment not necessary; reduce dose or frequency of subsequent doses

Dosage Forms & Strengths

injectable solution

  • 0.1mg/mL
more...

Reversal of Benzodiazepine Sedation

Initial dose: 0.01 mg/kg IV x1 dose over 15 sec 

May repeat after 45 sec and then every minute; not to exceed 4 doses for a maximum 0.05 mg/kg or 1 mg, whichever is lower 

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Interactions

Interaction Checker

flumazenil and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Nausea and vomiting (11%)

            1-10%

            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%)

            <1%

            Delirium

            Abnormal hearing

            Junctional tachycardia

            Thick tongue

            Tinnitus

            Coldness sensation

            Generalized seizure

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            Warnings

            Black Box Warnings

            The use of flumazenil has been associated with seizures. These are most frequent in patients who have been on benzodiazepines for long-term sedation or in overdose cases where patients are showing signs of serious cyclic antidepressant overdose. Practitioners should individualize the dosage of flumazenil and be prepared to manage seizures.

            Contraindications

            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)

            Cautions

            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

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            Pregnancy & Lactation

            Pregnancy category: C

            Lactation: Excretion in milk unknown; use with caution

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Competitive benzodiazepine receptor antagonist; inhibits activity at the benzodiazepine receptor site on the GABA/benzodiazepine receptor complex; does not reverse the effect of opioids

            Absorption

            Onset of action: 1-2 min; 80% response within 3 min

            Peak effect: 6-10 min

            Distribution

            Protein bound: 40-50%

            Vd: 0.5 L/kg

            Elimination

            Half-life: 53 min

            Excretion: Feces, urine

            First order elimination

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            Administration

            IV Administration

            Over 15-30 sec

            To minimize pain, administer through a freely running IV infusion line into a large vein

            Avoid extravasation

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            Images

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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