l INDICATIONS AND DOSE

Reversal of sedative effects of benzodiazepines in anaesthesia and clinical procedures

 BY INTRAVENOUS INJECTION

 Adult: 200 micrograms, dose to be administered over 15 seconds, then 100 micrograms every 1 minute if required; usual dose 300–600 micrograms; maximum 1 mg per course Reversal of sedative effects of benzodiazepines in intensive care

 BY INTRAVENOUS INJECTION

 Adult: 300 micrograms, dose to be administered over 15 seconds, then 100 micrograms every 1 minute if required; maximum 2 mg per course Reversal of sedative effects of benzodiazepines in intensive care (if drowsiness recurs after injection)

 INITIALLY BY INTRAVENOUS INFUSION

 Adult: 100–400 micrograms/hour, adjusted according to response, alternatively (by intravenous injection) 300 micrograms, adjusted according to response

 IMPORTANT SAFETY INFORMATION

Flumazenil should only be administered by, or under the direct supervision of, personnel experienced in its use.

l CONTRA-INDICATIONS

Life-threatening condition (e.g. raised intracranial pressure, status epilepticus) controlled by benzodiazepines

l CAUTIONS

Avoid rapid injection following major surgery . avoid rapid injection in high-risk or anxious patients . benzodiazepine dependence (may precipitate withdrawal symptoms). elderly . ensure neuromuscular blockade cleared before giving . head injury (rapid reversal of benzodiazepine sedation may cause convulsions) . history of panic disorders (risk of recurrence). prolonged benzodiazepine therapy for epilepsy (risk of convulsions). short-acting (repeat doses may be necessary— benzodiazepine effects may persist for at least 24 hours)

l SIDE-EFFECTS

 Common or very common Anxiety . diplopia . dry mouth . eye disorders . flushing . headache . hiccups . hyperhidrosis . hyperventilation . hypotension . insomnia . nausea . palpitations . paraesthesia . speech disorder.tremor. vertigo . vomiting  Uncommon Abnormal hearing . arrhythmias . chest pain . chills . cough . dyspnoea . nasal congestion . seizure (more common in patients with epilepsy)  Frequency not known Withdrawal syndrome l PREGNANCY Not known to be harmful.

l BREAST FEEDING

Avoid breast-feeding for 24 hours.

l HEPATIC IMPAIRMENT

Manufacturer advises caution (risk of increased half-life). Dose adjustments Manufacturer advises cautious dose titration.

l DIRECTIONS FOR ADMINISTRATION

For continuous intravenous infusion, dilute with Glucose 5% or Sodium Chloride 0.9%.