Flumazenil

Adults: Flumazenil is recommended for intravenous (IV) use only and should be administered by an anaesthesiologist or an experienced physician. In anaesthesia: The recommended initial dose of Flumazenil is 0.2 mg, administered IV over 15 seconds. If the desired degree of consciousness is not obtained within 60 seconds, a second dose of 0.1 mg can be injected. This may be repeated at 60 second intervals where necessary, up to a total dose of 1 mg. The usual dose is 0.3 to 0.6 mg, but individual requirements may vary considerably, depending on the dose and duration of effect of the benzodiazepine administered and on patient characteristics. In intensive care and in the management of unconsciousness of unknown origin: The recommended initial dose of Flumazenil is 0.3 mg IV. If the desired level of consciousness is not obtained within 60 seconds, Flumazenil may be injected repeatedly until the patient awakes, up to a total dose of 2 mg. If drowsiness recurs, Flumazenil may be given as one or more bolus IV doses as above, or as an IV infusion of 0.1 to 0.4 mg per hour. The rate of infusion should be adjusted individually to the desired level of arousal. If repeated doses of Flumazenil do not bring a significant improvement in consciousness or respiratory function, a non benzodiazepine cause must be assumed. In the intensive care unit, in patients treated with high doses of benzodiazepines and/or for long periods, individually titrated injections of Flumazenil, given slowly, should not produce withdrawal symptoms. If unexpected symptoms occur, diazepam or midazolam can be carefully titrated intravenously according to the patient's response. Children above 1 year of age: For reversing conscious sedation induced with benzodiazepines in children above one year of age, the recommended initial dose is 0.01 mg/kg (up to 0.2 mg), administered IV over 15 seconds. If the desired level of consciousness is not obtained after an additional 45 seconds, further injections of 0.01 mg/kg (up to 0.2 mg) can be given and repeated at 60 second intervals where necessary, up to a maximum of four additional times, to a maximum total dose of 0.05 mg/kg or 1 mg, whichever is lower. The dose should be individualised based on the patient's response. No data are available on the safety and efficacy of repeated administration of Flumazenil to children for re sedation.