Home Drug Guide Flumazenil

Drug Guide

Generic Name

Flumazenil

Brand Names Romazicon

Classification

Therapeutic: Antidote for benzodiazepine overdose

Pharmacological: GABA-A receptor antagonist

FDA Approved Indications

Reversal of benzodiazepine effects induced during anesthesia or in cases of benzodiazepine overdose

Mechanism of Action

Flumazenil competitively antagonizes the benzodiazepine binding at GABA-A receptor sites, reversing the sedative and anxiolytic effects of benzodiazepines.

Dosage and Administration

Adult: Initial dose: 0.2 mg IV over 15 seconds. If needed, administer additional 0.2 mg at 60-second intervals, up to a total dose of 1 mg.

Pediatric: Not generally recommended for children except under specific circumstances with expert consultation.

Geriatric: Same as adult dosing, but with caution due to increased sensitivity and risk of seizures.

Renal Impairment: Use with caution; no specific adjustments established.

Hepatic Impairment: Use with caution; no specific adjustments established.

Pharmacokinetics

Absorption: IV administration, complete bioavailability.

Distribution: Widely distributed, crosses the blood-brain barrier.

Metabolism: Rapidly metabolized mainly in the liver.

Excretion: Renal excretion of metabolites; parent drug has a short half-life.

Half Life: Approximately 54 minutes.

Contraindications

Known hypersensitivity to flumazenil or benzodiazepines.
Patients with seizure disorder (risk of seizures).

Precautions

Use cautiously in patients with history of seizures, on chronic benzodiazepine therapy, or with concomitant CNS depressants. Monitor closely for seizures or arrhythmias during reversal.

Adverse Reactions - Common

Nausea (Common)
Dizziness (Common)
Pain at injection site (Less common)

Adverse Reactions - Serious

Seizures (Less common but serious, especially in patients with seizure susceptibility or recent benzodiazepine use.)
Cardiovascular disturbances such as arrhythmias, hypertension, or hypotension (Rare)

Drug-Drug Interactions

Concurrent use with other CNS depressants may increase risk of adverse effects.
May precipitate withdrawal and seizures in benzodiazepine-dependent patients.

Drug-Food Interactions

N/A

Drug-Herb Interactions

N/A

Nursing Implications

Assessment: Monitor for resolution of sedation, respiratory status, heart rhythm, and seizure activity.

Diagnoses:

Risk for seizures related to abrupt reversal of benzodiazepine effects.
Potential airway compromise.

Implementation: Administer as ordered, monitor vital signs and neurological status closely, be prepared for seizures.

Evaluation: Effectiveness of reversal assessed by improved consciousness without adverse events.

Patient/Family Teaching

Inform that Flumazenil is used to reverse benzodiazepine sedation.
Report any seizures, chest pain, or abnormal feelings.
Warn against self-administering or using other CNS depressants without consulting healthcare provider.

Special Considerations

Black Box Warnings:

Risk of seizure: Flumazenil can precipitate seizures, especially in patients with pre-existing seizure disorders or chronic benzodiazepine use.
Use cautiously in patients with tricyclic antidepressant overdose, as it may increase seizure risk.

Genetic Factors: None specifically noted.

Lab Test Interference: May interfere with testing for benzodiazepine levels, but clinical effects are primary.

Overdose Management

Signs/Symptoms: Seizures, agitation, disorientation, abnormal heart rhythms.

Treatment: Supportive care including seizure management, airway support, cardiovascular monitoring. No specific antidote for overdose.

Storage and Handling

Storage: Store at room temperature, protected from light.

Stability: Stable under recommended conditions.