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Generic Name: flumazenil (FLOO-may-ze-nil)
Brand Name: Romazicon

Romazicon may cause seizures, especially in patients who have been on benzodiazepines (eg, diazepam) for a long time or if a patient has taken too much of a benzodiazepine (overdose).

Romazicon is used for:

Reversing drowsiness, sedation, and other effects caused by benzodiazepines.

Romazicon is a benzodiazepine antagonist. It works by blocking receptors in the brain and central nervous system that benzodiazepines need to reach to be active, which helps reduce drowsiness and sedation.

Do NOT use Romazicon if:

  • you are allergic to any ingredient in Romazicon or to benzodiazepines (eg, alprazolam)
  • you have been given a benzodiazepine for control of a potentially life-threatening condition (eg, increased pressure in the head, seizures)
  • you are experiencing side effects due to an overdose of a medicine used to treat depression

Contact your doctor or health care provider right away if any of these apply to you.

Before using Romazicon:

Some medical conditions may interact with Romazicon. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine (especially benzodiazepines), herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of seizures, panic disorder, liver problems, alcohol or other substance abuse, or you have had a recent head injury

Some MEDICINES MAY INTERACT with Romazicon. However, no specific interactions with Romazicon are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Romazicon may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Romazicon:

Use Romazicon as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Romazicon is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Romazicon at home, carefully follow the injection procedures taught to you by your health care provider.
  • If Romazicon contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
  • If Romazicon accidentally spills on your skin, wash it off immediately with soap and water.
  • Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.
  • If you miss a dose of Romazicon, contact your doctor immediately.

Ask your health care provider any questions you may have about how to use Romazicon.

Important safety information:

  • Romazicon may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Romazicon. Using Romazicon alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
  • Avoid drinking alcohol or taking other medicines that cause drowsiness (eg, sedatives, tranquilizers) for at least 24 hours after receiving Romazicon. Romazicon will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.
  • Although Romazicon is given to reverse drowsiness, you may experience a return of drowsiness for up to 24 hours after Romazicon is given. If you notice a return of drowsiness or experience shortness of breath, contact your doctor as soon as possible.
  • Romazicon is not recommended for use in CHILDREN younger than 1 year of age. Safety and effectiveness in this age group have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant while taking Romazicon, discuss with your doctor the benefits and risks of using Romazicon during pregnancy. It is unknown if Romazicon is excreted in breast milk. If you are or will be breast-feeding while you are using Romazicon, check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Romazicon:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Abnormal or blurred vision; abnormal skin sensations; changes in vision; clumsiness; dizziness; dry mouth; feeling of a whirling motion; flushing; general body discomfort; headache; hot flashes; increased sweating; nausea; nervousness; pain at the injection site; restlessness; sleeplessness; sweating; tiredness; tremors; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; change in behavior, mood, or emotions (eg, anxiety, depression); pounding in the chest; rapid deep breathing; seizures.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include agitation; anxiety; emotional or mood changes; increased sensitivity to pain or touch; seizures.

Proper storage of Romazicon:

Romazicon is usually handled and stored by a health care provider. If you are using Romazicon at home, store Romazicon as directed by your pharmacist or health care provider. Keep Romazicon out of the reach of children and away from pets.

General information:

  • If you have any questions about Romazicon, please talk with your doctor, pharmacist, or other health care provider.
  • Romazicon is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Romazicon or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Romazicon. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Romazicon. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Romazicon.

Issue Date: June 3, 2015

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.