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Romazicon

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Romazicon

Romazicon

Romazicon Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Romazicon (flumazenil) is used to reverse the sedative effects of a benzodiazepine when used during surgery or other medical procedure. It is also used to treat benzodiazepine overdose. Romazicon is a benzodiazepine receptor antagonist. This medication is available in generic form. Common 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.

Romazicon is administered intravenously (IV) only. Dose is dependent upon the condition being treated, the age of the patient, and the patient's response to the medication. This medication is only used by a physician for the specific purpose of reversing the sedating effects of benzodiazepines. It is not a drug that patients administer to themselves or take on their own. Romazicon may interact with seizure medication, eszopiclone, antidepressants, or diazepam or similar medicines. Tell your doctor all medications you are taking. Romazicon is not recommended for use during pregnancy, as it may be harmful to a fetus. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether Romazicon passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Our Romazicon (flumazenil) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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 is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Romazicon in Detail - Patient Information: 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.

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.

Read the entire detailed patient monograph for Romazicon (Flumazenil) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Romazicon FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Serious Adverse Reactions

Deaths have occurred in patients who received ROMAZICON (flumazenil) in a variety of clinical settings. The majority of deaths occurred in patients with serious underlying disease or in patients who had ingested large amounts of non-benzodiazepine drugs (usually cyclic antidepressants), as part of an overdose.

Serious adverse events have occurred in all clinical settings, and convulsions are the most common serious adverse events reported. ROMAZICON (flumazenil) administration has been associated with the onset of convulsions in patients with severe hepatic impairment and in patients who are relying on benzodiazepine effects to control seizures, are physically dependent on benzodiazepines, or who have ingested large doses of other drugs (mixed-drug overdose) (see WARNINGS).

Two of the 446 patients who received ROMAZICON (flumazenil) in controlled clinical trials for the management of a benzodiazepine overdose had cardiac dysrhythmias (1 ventricular tachycardia, 1 junctional tachycardia).

Adverse Events in Clinical Studies

The following adverse reactions were considered to be related to ROMAZICON (flumazenil) administration (both alone and for the reversal of benzodiazepine effects) and were reported in studies involving 1875 individuals who received flumazenil in controlled trials. Adverse events most frequently associated with flumazenil alone were limited to dizziness, injection site pain, increased sweating, headache, and abnormal or blurred vision (3% to 9%).

Body as a Whole: fatigue (asthenia, malaise), headache, injection site pain*, injection site reaction (thrombophlebitis, skin abnormality, rash)

Cardiovascular System: cutaneous vasodilation (sweating, flushing, hot flushes)

Digestive System: nausea, vomiting (11%)

Nervous System: agitation (anxiety, nervousness, dry mouth, tremor, palpitations, insomnia, dyspnea, hyperventilation)*, dizziness (vertigo, ataxia) (10%), emotional lability (crying abnormal, depersonalization, euphoria, increased tears, depression, dysphoria, paranoia)

Special Senses: abnormal vision (visual field defect, diplopia), paresthesia (sensation abnormal, hypoesthesia)

All adverse reactions occurred in 1% to 3% of cases unless otherwise marked.

*indicates reaction in 3% to 9% of cases.

Observed percentage reported if greater than 9%.

The following adverse events were observed infrequently (less than 1%) in the clinical studies, but were judged as probably related to ROMAZICON (flumazenil) administration and/or reversal of benzodiazepine effects:

Nervous System: confusion (difficulty concentrating, delirium), convulsions (see WARNINGS), somnolence (stupor)

Special Senses: abnormal hearing (transient hearing impairment, hyperacusis, tinnitus)

The following adverse events occurred with frequencies less than 1% in the clinical trials. Their relationship to ROMAZICON (flumazenil) administration is unknown, but they are included as alerting information for the physician.

Body as a Whole: rigors, shivering

Cardiovascular System: arrhythmia (atrial, nodal, ventricular extrasystoles), bradycardia, tachycardia, hypertension, chest pain

Digestive System: hiccup

Nervous System: speech disorder (dysphonia, thick tongue)

Not included in this list is operative site pain that occurred with the same frequency in patients receiving placebo as in patients receiving flumazenil for reversal of sedation following a surgical procedure.

Additional Adverse Reactions Reported During Postmarketing Experience

The following events have been reported during postapproval use of ROMAZICON (flumazenil) .

Nervous System: Fear, panic attacks in patients with a history of panic disorders.

Withdrawal symptoms may occur following rapid injection of ROMAZICON (flumazenil) in patients with long-term exposure to benzodiazepines.

Drug Abuse And Dependence

ROMAZICON (flumazenil) acts as a benzodiazepine antagonist, blocks the effects of benzodiazepines in animals and man, antagonizes benzodiazepine reinforcement in animal models, produces dysphoria in normal subjects, and has had no reported abuse in foreign marketing.

Although ROMAZICON (flumazenil) has a benzodiazepine-like structure it does not act as a benzodiazepine agonist in man and is not a controlled substance.

Read the entire FDA prescribing information for Romazicon (Flumazenil) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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