Flumazenil

Flumazenil is indicated for the complete or partial reversal of the central sedative effects of benzodiazepines. It may therefore be used in anaesthesia and in the intensive care in the following situations: In anaesthesia - Termination of hypnosedative effects in general anaesthesia induced and/or maintained with benzodiazepines in hospitalized patients.

- Reversal of benzodiazepine sedation in short-term diagnostic and therapeutic procedures in ambulatory patients and hospitalized patients. - Reversal of paradoxical reactions due to benzodiazepines. - For the reversal of conscious sedation induced with benzodiazepines in children >1 year of age.

In intensive care situations - For the specific reversal of the central effects of benzodiazepines, in order to restore spontaneous respiration. - For treatment of intoxications or overdose with only or mainly benzodiazepines. - As a diagnostic measure in unconsciousness of unknown origin to differentiate between involvement of benzodiazepines, other medicines or drugs or brain damage.

FLUMAZENIL INJECTION SHOULD BE ADMINISTERED INTRAVENOUSLY BY A PHYSICIAN WITH EXPERIENCE IN ANESTHESIOLOGY. Flumazenil Injection is not indicated for epileptic patients who have been treated with benzodiazepines for a prolonged period.

The abrupt cessation of the protective effect of benzodiazepines may induce convulsions in epileptic patients. Caution should be exercised with initial and repeated dosing to patients with hepatic insufficiency as elimination of flumazenil can be delayed in these patients (see ACTION AND CLINICAL PHARMACOLOGY-Hepatic Impairment).

The dose of Flumazenil Injection should always be individually titrated to the desired response to avoid abrupt awakening. Particular care is needed with patients who are physically dependent on benzodiazepines, patients who have ingested multiple drugs, and patients who are prone to anxiety.

In the intensive care unit, in patients treated with high doses of benzodiazepines and/or for long periods of time, the individually titrated injections of Flumazenil Injection, slowly administered, should not produce withdrawal syndromes (see PRECAUTIONS).

INDICATIONS AND USAGE

Adult Patients Flumazenil Injection, USP is indicated for the complete or partial reversal of the sedative effects of benzodiazepines in cases where general anesthesia has been induced and/or maintained with benzodiazepines, where sedation has been produced with benzodiazepines for diagnostic and therapeutic procedures, and for the management of benzodiazepine overdose.

Pediatric Patients (aged 1 to 17) Flumazenil Injection, USP is indicated for the reversal of conscious sedation induced with benzodiazepines (see PRECAUTIONS: Pediatric Use ).