Flumazenil

INTENSIVE CARE regimen (same SPC): starting dose 300 micrograms intravenously; if the required level of consciousness is not obtained within 60 seconds, a further 100 micrograms may be injected and repeated at 60-second intervals up to a total dose of 2,000 micrograms or until the patient awakes. If drowsiness recurs, a second bolus injection may be given. An intravenous infusion of 100 to 400 micrograms/hour may be useful, with the dosage and rate of infusion adjusted individually to achieve the desired level of consciousness; the infusion should be discontinued every 6 hours to verify whether re-sedation occurs. To avoid withdrawal symptoms in patients treated for a long period with high doses of benzodiazepines in the ICU, titrate the dose individually and inject slowly. If significant improvement in consciousness or respiratory function is not obtained after repeated doses, a non-benzodiazepine aetiology must be assumed. Rapid injection should be avoided — rapid injection of doses equal to or higher than 1,000 micrograms has led to withdrawal symptoms in patients with high-dose and/or long-term benzodiazepine exposure. Because the action of flumazenil is usually shorter than that of benzodiazepines and sedation may recur, keep the patient closely monitored (ECG, pulse, oximetry, alertness, heart rate, respiratory rate, blood pressure), preferably in intensive care, until the effect has presumably worn off. When used at the end of surgery, do not give until the effects of peripheral muscle relaxants have been fully reversed. Elderly: no data — this population is generally more sensitive and should be treated with due caution. Hepatic impairment: careful titration of dosage is recommended (flumazenil is primarily metabolised in the liver) and elimination may be delayed. Source: eMC SPC for Flumazenil 100 micrograms/ml solution for injection/infusion (§4.2).

Children above 1 year of age, for reversal of conscious sedation induced with benzodiazepines: recommended initial dose 10 micrograms/kg (up to 200 micrograms) intravenously over 15 seconds. 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. Children under 1 year: insufficient data — administer only if the potential benefits outweigh the possible risk. Use in children for indications other than reversal of conscious sedation is not recommended, as no controlled studies are available. Because of the potential for resedation and respiratory depression, children previously sedated with midazolam should be monitored for at least 2 hours after flumazenil; for other sedating benzodiazepines the monitoring time must be adjusted to their expected duration. Verify against a children's formulary.