All the Active Ingredient Drugs
benzodiazepine antidote. Flumazenil 0.1 mg/ml. Vial. Sol. for inj/inf 5/10X5/10 ml
Adults:
Anaesthesia
The recommended starting dose is 0.2 mg administered intravenously over 15 seconds. If the required level of consciousness is not obtained within 60 seconds, a further dose of 0.1 mg can be injected and repeated at 60-second intervals, up to a maximum dose of 1.0 mg. The usual dose required lies between 0.3 and 0.6 mg, but may deviate depending on the patient’s characteristics and the benzodiazepine used.
Intensive Care
The recommended starting dose is 0.3 mg administered intravenously over 15 seconds. If the required level of consciousness is not obtained within 60 seconds, a further dose of 0.1 mg can be injected and repeated at 60-second intervals, up to a total dose of 2 mg or until the patient awakes.
If drowsiness recurs, a second bolus injection may be administered.
An intravenous infusion of 0.1 – 0.4 mg/h has also been shown to be useful. The dosage and rate of infusion should be adjusted individually to achieve the desired level of consciousness.
If no clear effect on awareness and respiration is obtained after repeated dosing, it should be considered that the intoxication is not due to benzodiazepines.
Infusion should be discontinued every 6 hours to verify whether resedation occurs.
To avoid withdrawal symptoms in patients treated for a long period of time with high doses of benzodiazepines in the intensive care unit, the dosage of flumazenil has to be titrated individually and the injection has to be administered slowly
Children above 1 year of age
For the reversal of conscious sedation induced by benzodiazepines in children > 1 year of age, the recommended initial dose is 10 micrograms/kg (up to 200 micrograms), administered intravenously over 15 seconds. If the desired level of consciousness is not obtained after waiting an additional 45 seconds, further injection of 10 micrograms/kg may be administered (up to 200 micrograms) and repeated at 60 second intervals where necessary (a maximum of 4 times) to a maximum total dose of 50 micrograms/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.
Benzodiazepine antagonist for reversal of benzodiazepine anesthesia, as well as for patients with Benzodiazepine intoxication.
In a hospital setting: In anaesthesiology to neutralise the sedative effects of benzodiazepines on the central nervous system in adults and children older than 1 year:
• reversal of sedative effect during general anaesthesia induced and maintained by benzodiazepines,
• reversal of conscious sedation induced by benzodiazepines in short operations with a diagnostic or therapeutic objective.
In intensive care to neutralise the sedative effects of benzodiazepines on the central nervous system and treat a coma of unknown aetiology, in adults and children (including newborns) if the semiology is compatible with the hypothesis of a benzodiazepine or related substance-induced coma:
• diagnosis and/or treatment of intentional or accidental benzodiazepine overdose,
• aetiological diagnosis of an unexplained coma in order to differentiate what is caused by a benzodiazepine from another cause (pharmacological or neurological).
• specific cancellation of the effects on the central nervous system by excessive benzodiazepine doses (re-establishment of spontaneous ventilation to avoid intubation or interrupt ventilatory assistance).
In an emergency situation or medical transport, in adults and children older than 6 years: • reversal of benzodiazepine-induced conscious sedation in case of respiratory depression or apnoea
C/I: Hypersensitivity
- Patients receiving benzodiazepines for control of a potentially life-threatening condition (e.g. control of intracranial pressure or status epilepticus).
- In mixed intoxications with benzodiazepines and tricyclic and/or tetracyclic antidepressants, the toxicity of the antidepressants can be masked by protective benzodiazepine effects.
In the presence of autonomic (anticholinergic), neurological (motor abnormalities) or cardiovascular symptoms of severe intoxication with tricyclics/tetracyclics, Flumazenil should not be used to reverse benzodiazepine effect.
Flumazenil 0.1 mg/ml. AMPS: 10 x 5 ml, 10 ml. I.V.
Dose must be adjust. individ. for each
pt.
Reverse central sed. effect benzodiazepine
anesthes., benzodiazepine intox.
C/I: Known hypersens., intoler. to
benzodiazep., related subs.
Pts. who received benzodiazep., related
subst. for a pathology that represents a
vital risk (e.g. incr. in intracran. pres.,
epilep. seizure).
