Generic Name: flumazenil (floo MAZ e nil)
Brand Name: Romazicon
What is Romazicon?
Romazicon 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.
Romazicon is used to reverse benzodiazepine sedation to help you wake up after your medical procedure. This medicine is also used to treat benzodiazepine overdose in adults.
Romazicon may also be used for purposes not listed in this medication guide.
Romazicon 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 this medicine. Talk to your doctor if you have concerns about the risk of seizure.
Before taking this medicine
Romazicon 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 Romazicon.
Talk to your doctor if you have concerns about the risk of seizure.
You should not receive this medication if you are allergic to Romazicon or any type of benzodiazepine sedative, or if you have taken an overdose of certain antidepressant medication.
To make sure Romazicon 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;
panic or anxiety disorder;
if you have been using benzodiazepine long-term.
FDA pregnancy category C. It is not known whether Romazicon 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 Romazicon given?
Romazicon 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 Romazicon is injected.
Your breathing, blood pressure, oxygen levels, and other vital signs will be watched closely after you receive Romazicon.
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 Romazicon 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 Romazicon?
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 Romazicon, 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 Romazicon.
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.
Romazicon 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:
headache, mild dizziness;
flushing (warmth, redness, or tingly feeling);
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 Romazicon?
Receiving Romazicon after taking large doses of certain antidepressants can cause dangerous or life-threatening side effects. Tell your doctor before you receive this medicine 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.
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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