flumazenil

Pronunciation

Generic Name: flumazenil (floo MAZ e nil)
Brand Name: Romazicon

What is flumazenil?

Flumazenil reverses the effects of benzodiazepine (BENZ-oh-dye-AYZ-e-peen) sedatives such as Valium, Versed, Xanax, Tranxene, and others. Benzodiazepines are sometimes used as sedatives before surgery or other medical procedures.

Flumazenil is used to reverse benzodiazepine sedation to help you wake up after your medical procedure. Flumazenil is also used to treat benzodiazepine overdose in adults.

Flumazenil may also be used for purposes not listed in this medication guide.

What is the most important information I should know about flumazenil?

Flumazenil may cause seizures (convulsions), especially in people who have sedative-addiction withdrawal symptoms or recent antidepressant overdose, people who have recently received injectable benzodiazepines, or people who had symptoms of a seizure just before receiving flumazenil. Talk to your doctor if you have concerns about the risk of seizure.

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What should I discuss with my health care provider before receiving flumazenil?

Flumazenil may cause seizures (convulsions), especially:

  • in people withdrawing from sedative addiction;

  • in people who have recently taken an antidepressant overdose;

  • in people who have recently received injectable benzodiazepines; or

  • in people who had seizure-like symptoms just before receiving flumazenil.

Talk to your doctor if you have concerns about the risk of seizure.

You should not receive this medication if you are allergic to flumazenil or any type of benzodiazepine sedative, or if you have taken an overdose of certain antidepressant medication.

To make sure flumazenil is safe for you, tell your doctor if you have:

  • epilepsy or other seizure disorder (especially if you take a benzodiazepine to treat seizures);

  • a history of head injury;

  • any type of breathing problem or lung disease;

  • liver disease;

  • panic or anxiety disorder;

  • a history of alcoholism or drug addiction; or

  • if you have been using benzodiazepine long-term.

FDA pregnancy category C. It is not known whether flumazenil will harm an unborn baby. Tell your doctor if you are pregnant.

It is not known whether flumazenil passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How is flumazenil given?

Flumazenil is injected into a vein through an IV. A healthcare provider will give you this injection.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when flumazenil is injected.

Your breathing, blood pressure, oxygen levels, and other vital signs will be watched closely after you receive flumazenil.

You may have temporary amnesia while you are waking up from sedation. You may not remember everything going on around you for up to 2 hours.

What happens if I miss a dose?

Because you will receive flumazenil in a clinical setting, you are not likely to miss a dose.

What happens if I overdose?

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid after receiving flumazenil?

This medication may impair your thinking or reactions. For at least 24 hours after you leave the hospital or surgery center, do not drive or do anything else that requires you to be awake and alert. Continue to limit these activities until you no longer feel sedated (weak, drowsy, or dizzy).

Do not drink alcohol for at least 24 hours after receiving flumazenil, or if you still feel sedated.

Also avoid taking any over-the-counter medications for at least 24 hours, especially if you still feel sedated after receiving flumazenil.

Even though you may feel alert after waking up from sedation, your judgment or reactions may still be impaired. Follow your caregivers' instructions about how long to limit your activities.

Flumazenil side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Tell your caregiver right away if you have:

  • agitation, tremors, feeling suddenly hot;

  • chest pain and severe dizziness, rapid pulse, fast or pounding heartbeats; or

  • a light-headed feeling, like you might pass out.

Common side effects may include:

  • nausea, vomiting;

  • headache, mild dizziness;

  • flushing (warmth, redness, or tingly feeling);

  • increased sweating;

  • blurred vision; or

  • pain where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Flumazenil dosing information

Usual Adult Dose for Reversal of Sedation:

Initial dose: 0.2 mg IV one time over 15 seconds.
Repeated doses: 0.2 mg may be given every minute until the desired level of consciousness is achieved.
Maximum total dose 1 mg.
Most patients respond to 0.6 to 1 mg.
Resedation doses: 0.2 mg every minute to a total of 1 mg/dose and 3 mg/hour.

Usual Adult Dose for Benzodiazepine Overdose:

Initial dose: 0.2 mg IV one time over 30 seconds.
Repeated doses: 0.5 mg may be given every minute.
Maximum total dose 3 mg. Patients responding partially at 3 mg may receive additional doses up to 5 mg.
Most patients respond to 1 to 3 mg.
Resedation doses: 0.5 mg every 20 minutes to a total of 1 mg/dose and 3 mg/hour.

Usual Pediatric Dose for Reversal of Sedation:

IV:
Infants and Children:
Benzodiazepine reversal when used in conscious sedation or general anesthesia:
Initial dose: 0.01 mg/kg (maximum dose: 0.2 mg) given over 15 seconds; may repeat 0.01 mg/kg (maximum dose: 0.2 mg) after 45 seconds, and then every minute to a maximum total cumulative dose of 0.05 mg/kg or 1 mg, whichever is lower; usual total dose: 0.08 to 1 mg (mean: 0.65 mg)
Management of benzodiazepine overdose: Minimal information available; initial dose: 0.01 mg/kg (maximum dose: 0.2 mg) with repeat doses of 0.01 mg/kg (maximum dose: 0.2 mg) given every minute to a maximum total cumulative dose of 1 mg; as an alternative to repeat bolus doses, follow up continuous infusions of 0.005 to 0.01 mg/kg/hour have been used; further studies are needed.

Usual Pediatric Dose for Benzodiazepine Overdose:

1 to 17 years:
Initial dose: 0.01 mg/kg IV over 15 seconds.
Repeat doses: 0.01 mg/kg given over 15 seconds; may repeat 0.01 mg/kg after 45 seconds, then every minute to a maximum total cumulative dose of 0.05 mg/kg.

Continuous IV infusion: 0.005 to 0.01 mg/kg/hr was used in a premature neonate (gestational age: 32 weeks) exposed to high doses of diazepam intrapartum.
Myoclonus, benzodiazepine induced: IV: 0.078 mg/kg once was effective in a single full-term neonate who was receiving continuous infusion midazolam.

What other drugs will affect flumazenil?

Receiving flumazenil after taking large doses of certain antidepressants can cause dangerous or life-threatening side effects. Tell your doctor before you receive flumazenil if you have recently taken an antidepressant such as amitriptyline, doxepin, clomipramine, desipramine, imipramine, or nortriptyline.

Other drugs may interact with flumazenil, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your doctor or pharmacist can provide more information about flumazenil.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 2.01. Revision Date: 2013-12-13, 9:42:53 PM.

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