Flumazenil

Generic Name: flumazenil

Benzodiazepine Antagonist [EPC]Over-the-Counter (OTC)

Brand Names:

Flumazenil

Flumazenil Injection is a benzodiazepine receptor antagonist with imidazobenzodiazepine structure, available as sterile parenteral dosage form for intravenous administration.

Overview

Flumazenil Injection is a benzodiazepine receptor antagonist with imidazobenzodiazepine structure, available as sterile parenteral dosage form for intravenous administration.

Uses

Indicated for complete or partial reversal of benzodiazepine sedative effects in general anesthesia, conscious sedation procedures, and overdose management in adults. Also for reversal of conscious sedation in pediatric patients aged 1-17 years.

Dosage

Adults: Initial dose 0.2 mg IV over 15 seconds; repeat at 60-second intervals up to 1 mg maximum. Pediatric (over 1 year): 0.01 mg/kg up to 0.2 mg initial dose; maximum 0.05 mg/kg or 1 mg. Administer through freely running IV infusion into large vein.

Side Effects

Common: dizziness, injection site pain, increased sweating, headache, abnormal or blurred vision (3% to 9%). Serious: convulsions most frequently reported; cardiac dysrhythmias observed.

Interactions

No deleterious interactions with narcotics, anesthetics, or muscle relaxants. Caution with mixed overdoses; cyclic antidepressant toxicity may emerge.

Warnings

Seizures most frequent in patients on long-term benzodiazepines or showing signs of serious cyclic antidepressant overdose. Risk of resedation; monitor for respiratory depression up to 120 minutes post-administration. Contraindicated with hypersensitivity to flumazenil or benzodiazepines, benzodiazepine use for life-threatening conditions, and signs of serious cyclic antidepressant overdose.

Pregnancy

Category C. No adequate well-controlled studies in pregnant women. Use only if potential benefit justifies risk to fetus. Unknown if flumazenil excretes in human milk.

Storage

Store at 25C (77F); excursions permitted 15-30C. Discard if drawn into syringe or mixed with solutions after 24 hours.

Frequently Asked Questions

What is Flumazenil used for?

Indicated for complete or partial reversal of benzodiazepine sedative effects in general anesthesia, conscious sedation procedures, and overdose management in adults. Also for reversal of conscious sedation in pediatric patients aged 1-17 years.

What are the side effects of Flumazenil?

Common: dizziness, injection site pain, increased sweating, headache, abnormal or blurred vision (3% to 9%). Serious: convulsions most frequently reported; cardiac dysrhythmias observed.

Can I take Flumazenil during pregnancy?

Category C. No adequate well-controlled studies in pregnant women. Use only if potential benefit justifies risk to fetus. Unknown if flumazenil excretes in human milk.

What are the important warnings for Flumazenil?

Seizures most frequent in patients on long-term benzodiazepines or showing signs of serious cyclic antidepressant overdose. Risk of resedation; monitor for respiratory depression up to 120 minutes post-administration. Contraindicated with hypersensitivity to flumazenil or benzodiazepines, benzodiazepine use for life-threatening conditions, and signs of serious cyclic antidepressant overdose.

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Medical Disclaimer

This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.