FLUMAZENIL KABI

What it is

FLUMAZENIL KABI is a solution for injection containing flumazenil 0.1 mg/mL.

Approved indications

— Reversal of acute benzodiazepine effects (overdose or therapeutic) in hospitalized patients.

Dosing overview

For reversal of benzodiazepine effects at therapeutic doses during anaesthesia or sedation, the recommended initial dose is 0.2 mg administered intravenously within 15 seconds. If the desired degree of consciousness is not obtained within 60 seconds, a second dose of 0.1 mg can be injected and repeated at 60 second intervals where necessary, up to a total dose of 1 mg, with a usual dose of 0.3–0.6 mg. For children over 1 year of age, the recommended initial dose is 0.01 mg/kg (or up to 0.2 mg, whichever is lower) administered intravenously over 15 seconds, with further injections of 0.01 mg/kg repeated at 60 second intervals where necessary to a maximum total dose of 0.05 mg/kg or 1 mg, whichever is lower. For reversal of benzodiazepine effects at overdose, the recommended initial intravenous dose is 0.3 mg. If the desired degree of consciousness is not obtained within 60 seconds, FLUMAZENIL KABI may be injected repeatedly until the patient awakes or up to a total dose of 2 mg. If drowsiness recurs, an intravenous infusion of 0.1–0.4 mg/h has been shown to be useful.

Key safety warnings

FLUMAZENIL KABI can precipitate benzodiazepine withdrawal at high doses and should be administered cautiously to patients with known or suspected benzodiazepine dependency or who have been treated with high doses of benzodiazepines for the weeks preceding treatment, as reversal of benzodiazepine effects may precipitate withdrawal symptoms or convulsions. FLUMAZENIL KABI may remove the protective effect of benzodiazepines in multiple drug overdose, and there have been several reports of tachyarrhythmia following flumazenil administration in the presence of known arrhythmogenic drug overdose. In mixed intoxications with benzodiazepines and cyclic antidepressants, the toxicity of the antidepressants can be masked by protective benzodiazepine effects, and in the presence of autonomic, neurological or cardiovascular symptoms of severe intoxication with tricyclics or tetracyclics, FLUMAZENIL KABI should not be used to reverse benzodiazepine effects. Patients with head injury or unstable intracranial pressure treated with FLUMAZENIL KABI to reverse the effects of benzodiazepines may develop raised intracranial pressure, and FLUMAZENIL KABI may be capable of precipitating convulsions or altering cerebral blood flow in patients with head injury receiving benzodiazepines. Use of FLUMAZENIL KABI is not recommended in epileptic patients who have been receiving benzodiazepine treatment for a prolonged period, as although flumazenil exerts a slight intrinsic anticonvulsant effect, its abrupt suppression of the protective effect of a benzodiazepine agonist can give rise to convulsions in epileptic patients.

Contraindications

FLUMAZENIL KABI is contraindicated in patients with known hypersensitivity to the drug. FLUMAZENIL KABI is contraindicated in patients who have been given a benzodiazepine for control of a potentially life-threatening condition such as control of intracranial pressure or status epilepticus.

Regulatory history

FLUMAZENIL KABI was first listed on the ARTG on 25 October 2016 in two strengths: 0.5 mg/5 mL and 1 mg/10 mL solution for injection in ampoules.