flumazenil (Rx)

Brand and Other Names:Romazicon
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 0.1mg/mL

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

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

and flumazenil

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 

            Contraindicated (0)

              Serious - Use Alternative (0)

                Monitor Closely (1)

                • amifampridine

                  flumazenil increases toxicity of amifampridine by Other (see comment). Modify Therapy/Monitor Closely. Comment: Amifampridine can cause seizures. Coadministration with drugs that lower seizure threshold may increase this risk.

                Minor (0)

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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

                  BRAND FORM. UNIT PRICE PILL IMAGE
                  flumazenil intravenous
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                  flumazenil intravenous
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                  flumazenil intravenous
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                  flumazenil intravenous
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                  flumazenil intravenous
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                  flumazenil intravenous
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                  flumazenil intravenous
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                  flumazenil intravenous
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                  flumazenil intravenous
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                  0.1 mg/mL vial
                  flumazenil intravenous
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                  0.1 mg/mL vial
                  flumazenil intravenous
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                  0.1 mg/mL vial
                  flumazenil intravenous
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                  0.1 mg/mL vial
                  flumazenil intravenous
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                  0.1 mg/mL vial

                  Copyright © 2010 First DataBank, Inc.

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                  Patient Handout

                  Patient Education
                  flumazenil intravenous

                  NO MONOGRAPH AVAILABLE AT THIS TIME

                  USES: Consult your pharmacist.

                  HOW TO USE: Consult your pharmacist.

                  SIDE EFFECTS: Consult your pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

                  PRECAUTIONS: Consult your pharmacist.

                  DRUG INTERACTIONS: Consult your pharmacist.Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

                  OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

                  NOTES: No monograph available at this time.

                  MISSED DOSE: Consult your pharmacist.

                  STORAGE: Consult your pharmacist.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

                  Information last revised July 2016. Copyright(c) 2021 First Databank, Inc.

                  IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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                  Formulary

                  FormularyPatient Discounts

                  Adding plans allows you to compare formulary status to other drugs in the same class.

                  To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

                  Adding plans allows you to:

                  • View the formulary and any restrictions for each plan.
                  • Manage and view all your plans together – even plans in different states.
                  • Compare formulary status to other drugs in the same class.
                  • Access your plan list on any device – mobile or desktop.

                  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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                  Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.