Flumazenil

Flumazenil is used to reverse the effects of a benzodiazepine (BENZ-oh-dye-AYZ-e-peen) sedative like Valium, Versed, Xanax, Tranxene, and others.

Flumazenil helps you wake up after surgery or a medical procedure where a benzodiazepine was used as a sedative.

Flumazenil is also used to treat benzodiazepine overdose in adults.

Flumazenil may also be used for reasons not mentioned in this medication guide.

Flumazenil can lead to seizures, particularly in individuals who are experiencing withdrawal from sedatives, have recently overdosed on antidepressants, have recently been given injectable benzodiazepines, or have shown seizure symptoms right before getting flumazenil. If you are worried about the risk of seizures, speak with your doctor.

Flumazenil may cause seizures, 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 are worried about the risk of seizure.

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

Tell your doctor if you have ever had:

• epilepsy or other seizure disorder (especially if you take a benzodiazepine to treat seizures);
• a head injury;
• any type of breathing problem or lung disease;
• liver disease;
• panic or anxiety disorder;
• alcoholism or drug addiction; or
• if you have been using benzodiazepine long-term.

Tell your doctor if you are pregnant or breastfeeding.

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

Tell your caregiver right away if you have:

• weak or shallow breathing;
• ongoing drowsiness;
• confusion, agitation, tremors, dizziness;
• chest pain and severe dizziness, rapid pulse, fast or pounding heartbeats; or
• a light-headed feeling, like you might pass out.

Common side effects of flumazenil may include:

• headache, dizziness;
• nausea, vomiting;
• increased sweating;
• flushing (sudden warmth, redness, or tingly feeling);
• vision problems; 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.

Flumazenil is given as an infusion into a vein. 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.

Because you will receive flumazenil in a clinical setting, it is unlikely that you will miss a dose.

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

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. Your reactions could be impaired. Continue to limit these activities until you no longer feel sedated (weak, drowsy, or dizzy).

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

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

Receiving flumazenil after taking large doses of certain antidepressants can lead to serious or life-threatening side effects. Inform your doctor before you receive flumazenil if you have recently taken an antidepressant like amitriptyline, doxepin, clomipramine, desipramine, imipramine, or nortriptyline.

Other drugs may influence how flumazenil works, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all the medicines you are currently taking and any medicine you begin or stop using.