Generic name: flumazenil [ floo-MAZ-e-nil ]
Brand name: Romazicon
Dosage form: intravenous solution (0.1 mg/mL)
Drug class: Antidotes
What is flumazenil?
Flumazenil is used to help you wake up after a surgery or medical procedure in which a benzodiazepine was used as a sedative.
Flumazenil is also used to treat benzodiazepine overdose in adults.
Flumazenil may also be used for purposes not listed in this medication guide.
Flumazenil may cause seizures, 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.
Before taking this medicine
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 have concerns 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;
panic or anxiety disorder;
if you have been using benzodiazepine long-term.
Tell your doctor if you are pregnant or breastfeeding.
How is flumazenil given?
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.
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?
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.
Flumazenil side effects
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;
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:
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.
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 affect flumazenil, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
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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.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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