Romazicon

DRUG DESCRIPTION

ROMAZICON® (flumazenil) is a benzodiazepine receptor antagonist. Chemically, flumazenil is ethyl 8-fluoro-5,6-dihydro-5-methyl-6-oxo-4H-imidazo[1,5-a](1,4) benzodiazepine-3-carboxylate. Flumazenil has an imidazobenzodiazepine structure, a calculated molecular weight of 303.3, and the following structural formula:

ROMAZICON® (flumazenil) structural formula illustration

Flumazenil is a white to off-white crystalline compound with an octanol:buffer partition coefficient of 14 to 1 at pH 7.4. It is insoluble in water but slightly soluble in acidic aqueous solutions. ROMAZICON (flumazenil) is available as a sterile parenteral dosage form for intravenous administration. Each mL contains 0.1 mg of flumazenil compounded with 1.8 mg of methylparaben, 0.2 mg of propylparaben, 0.9% sodium chloride, 0.01% edetate disodium, and 0.01% acetic acid; the pH is adjusted to approximately 4 with hydrochloric acid and/or, if necessary, sodium hydroxide.

What are the possible side effects of flumazenil (Romazicon)?

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:

    ...

Read All Potential Side Effects and See Pictures of Romazicon »


Romazicon Patient Information Including Side Effects

Brand Names: Romazicon

Generic Name: flumazenil (Pronunciation: floo MAZ e nil)

  • What is flumazenil (Romazicon)?
  • What are the possible side effects of flumazenil (Romazicon)?
  • What is the most important information I should know about flumazenil (Romazicon)?
  • What should I discuss with my health care provider before receiving flumazenil (Romazicon)?
  • How is flumazenil given (Romazicon)?
  • What happens if I miss a dose (Romazicon)?
  • What happens if I overdose (Romazicon)?
  • What should I avoid while receiving flumazenil (Romazicon)?
  • What other drugs will affect flumazenil (Romazicon)?
  • Where can I get more information?

What is flumazenil (Romazicon)?

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 are the possible side effects of flumazenil (Romazicon)?

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 is the most important information I should know about flumazenil (Romazicon)?

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.

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