Flumazenil Generic Name & Formulations
Legal Class
Rx
General Description
Flumazenil 0.1mg/mL; IV inj.
Pharmacological Class
Benzodiazepine antagonist.
How Supplied
Contact supplier.
Manufacturer
Flumazenil Indications
Indications
Reversal of benzodiazepine sedative effects in overdose, general anesthesia or conscious sedation.
Flumazenil Dosage and Administration
Adult
Overdose: Give dose over 30 seconds by IV infusion. Initially: 0.2mg. After 30 seconds (if needed), 0.3mg. Then 0.5mg at 60 second intervals up to 3mg cumulative dose. Usual range: 1–3mg. If partial response occurs at 3mg cumulative dose, may titrate up to 5mg cumulative dose. Conscious sedation, general anesthesia, resedation: see full labeling.
Children
<1yr: not recommended. 1–17yrs: for reversal of benzodiazepine-induced conscious sedation only. See full labeling.
Flumazenil Contraindications
Contraindications
Patients treated with benzodiazepines for life threatening conditions. Mixed overdose patients when seizures likely (esp. cyclic antidepressants).
Flumazenil Boxed Warnings
Boxed Warning
Occurrence of seizures.
Flumazenil Warnings/Precautions
Warnings/Precautions
Monitor for resedation (at least 2hrs), respiratory depression, other residual benzodiazepine effects, seizures. Seizure disorders or risk. Drug or alcohol dependence. Head injury. Panic disorder. Hepatic disease. Counsel on post-procedure period (see full labeling). Labor & delivery: not recommended. Pregnancy (Cat.C). Nursing mothers.
Flumazenil Pharmacokinetics
See Literature
Flumazenil Interactions
Interactions
Avoid use until neuromuscular blockade reversed. Avoid alcohol, sedatives for 18–24hrs after treatment. Potentiates toxicity of cyclic antidepressant or mixed drug overdose.
Flumazenil Adverse Reactions
Adverse Reactions
Seizures, local reactions, dizziness, increased sweating, headache, blurred vision, GI upset, agitation, benzodiazepine withdrawal syndrome.
Flumazenil Clinical Trials
See Literature
Flumazenil Note
Not Applicable
Flumazenil Patient Counseling
See Literature