flumazenil

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

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 antidepressant medication such as Elavil, Janimine, Tofranil, Norpramin, Desyrel, Ascendin, Anafranil, Sinequan, Pamelor, Vivactil, or Surmontil.

Before receiving flumazenil, tell your doctor if you have a seizure disorder, liver disease, a history of head injury, uncontrolled muscle twitches, a breathing disorder, anxiety or panic disorder, or a history of drug or alcohol addiction.

You may have temporary amnesia while you are coming out of sedation after a surgery. You may not remember everything going on around you during this time.

Flumazenil can cause side effects that may impair your thinking or reactions. For at least 18 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).

Even though you may feel alert after waking up from sedation, your judgment or reactions may still be impaired. Follow your caregivers' instructions about limiting activities after receiving flumazenil.

Do not drink alcohol for at least 18 hours after receiving flumazenil, or if you still feel sedated.

What is flumazenil?

Flumazenil reverses the effects of certain types of sedatives from the benzodiazepine (ben-zo-dye-AYZ-e-peen) group of drugs. This includes Valium, Xanax, Tranxene, Librium, ProSom, Dalmane, Ativan, Restoril, Halcion, and others.

Flumazenil is used to reverse the sedative effects of a benzodiazepine when used during surgery or other medical procedure. Flumazenil is also used to treat benzodiazepine overdose.

Flumazenil may also be used for purposes other than those listed in this medication guide.

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

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 antidepressant medication such as Elavil, Janimine, Tofranil, Norpramin, Desyrel, Ascendin, Anafranil, Sinequan, Pamelor, Vivactil, or Surmontil.

Before receiving flumazenil, tell your doctor if you are allergic to any drugs, or if you have:

• epilepsy or other seizure disorder;
• liver disease;
• a history of head injury;
• uncontrolled muscle twitches;
• asthma or other breathing disorder;
• panic or anxiety disorder; or
• a history of drug or alcohol addiction.

If you have any of these conditions, you may not be able to use flumazenil, or you may need dosage adjustments or special tests during treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether flumazenil passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How is flumazenil given?

Flumazenil is given as an injection through a needle placed into a vein. You will receive this injection in a hospital or surgical clinic.

Flumazenil is usually effective in reversing sedation within 2 hours.

You may have temporary amnesia while you are coming out of sedation after a surgery. You may not remember everything going on around you during this time.

What happens if I miss a dose?

Since this medication is given as needed by a healthcare professional, it is not likely that you will miss a dose.

What happens if I overdose?

Seek emergency medical attention if you think you have received too much of this medicine.

Overdose symptoms may include feeling anxious or agitated, muscle tightness, or seizure (convulsions).

What should I avoid while receiving flumazenil?

Flumazenil can cause side effects that may impair your thinking or reactions. For at least 18 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).

Even though you may feel alert after waking up from sedation, your judgment or reactions may still be impaired. Follow your caregivers' instructions about limiting activities after receiving flumazenil.

Do not drink alcohol for at least 18 hours after receiving flumazenil, or if you still feel sedated.

What are the possible side effects of flumazenil?

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.

Call your doctor at once if you have any of these serious side effects:

• seizures (convulsions);
• weak or shallow breathing;
• continued drowsiness for longer than 2 hours after receiving flumazenil;
• confusion, fear, panic attack; or
• fast or uneven heart rate.

Less serious side effects include:

• pain or irritation where the medicine was injected;
• agitation or tremors (shaking);
• warmth, redness, or tingly feeling under your skin;
• dizziness;
• sweating or shivering;
• headache;
• blurred vision; or
• ringing in your ears.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect flumazenil?

Before receiving flumazenil, tell your doctor if you have recently drank an alcoholic beverage, or if you are using any of the following drugs:

• seizure medication;
• eszopiclone (Lunesta);
• antidepressants such as amitriptyline (Elavil, Etrafon), amoxapine (Ascendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Sinequan), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), protriptyline (Vivactil), or trimipramine (Surmontil); or
• diazepam (Valium) or similar medicines such as alprazolam (Xanax), chlordiazepoxide (Librium), clorazepate (Tranxene), estazolam (ProSom), flurazepam (Dalmane), lorazepam (Ativan), midazolam (Versed), temazepam (Restoril), triazolam (Halcion), and others.

If you are using any of these drugs, you may not be able to use flumazenil, or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect flumazenil. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your doctor or pharmacist has information about flumazenil written for health professionals that you may read.