flumazenil

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Pronunciation: floo MAZ e nil

Brand: Romazicon

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.

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 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.

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.

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.

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.

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