Pharmaniaga Flumazenil 0.1 mg/mL Injection is to be administered intravenously by an anaesthetist or experienced physician.
Pharmaniaga Flumazenil 0.1 mg/mL Injection may also be administered as an infusion.
When Flumazenil Injection is to be used as an infusion, it must be diluted prior infusion. Pharmaniaga Flumazenil 0.1 mg/mL Injection should only be diluted with sodium chloride 0.9% solution and dextrose 5% solution. Intravenous infusion solution should be used immediately and be discarded after 24 hours.
Pharmaniaga Flumazenil 0.1 mg/mL Injection may also be used concomitantly with other resuscitative measures. Dosage should be titrated for the required effect. The action of some benzodiazepines may exceed the effect of flumazenil, repeated doses may be required if sedation recurs following awakening.
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 vary depending on the patient's characteristics, the dose and duration of effect of benzodiazepine used.
Intensive care: The recommended starting dose is 0.3 mg administered intravenously. If the required level of consciousness is not obtained within 60 seconds, a further dose 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, an intravenous infusion of 0.1-0.4 mg/h may be useful. The rate of infusion should be adjusted individually to achieve the desired level of consciousness.
If a significant improvement in consciousness and respiratory function is not obtained after repeated doses of flumazenil, a non-benzodiazepine aetiology must be assumed.
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. If symptoms of overstimulation arise during the use of flumazenil, then diazeparn or midazolam may be administered by slow intravenous injection.
Special Populations: Elderly: In the absence of data on the use of flumazenil in elderly patients, it should be noted that this population is generally more sensitive to the effects of medicinal products and should be treated with due caution.
Patients with renal or hepatic impairment: Since flumazenil is primarily metabolised in the liver, careful titration of dosage is recommended in patients with impaired hepatic function. No dosage adjustments are required in patients with renal impairment.
Paediatric population: Children above 1 year of age: For the reversal of conscious sedation induced by benzodiazepines in children older than 1 year, the recommended starting dose is 0.01 mg/kg (up to 0.2 mg) administered intravenously over a period of 15 seconds. If, after an additional waiting period of 45 seconds, the required level of consciousness is not obtained, a follow-up injection of 0.01 mg/kg (up to 0.2 mg) may be administered and if necessary, repeated at 60-second intervals (up to a maximum of 4 times) to a maximum dose of 0.05 mg/kg or 1 mg, depending on which is the lowest dose. The dose should be adjusted to the patient's response.
Children under the age of 1 year: There are insufficient data on the use of flumazenil in children younger than 1 year.
Therefore flumazenil should only be administered in children younger than 1 year if the potential benefits to the patient outweigh the possible risk.
Instruction for use/method of dilution: When flumazenil is to be used in infusion, it must be diluted prior to infusion. Flumazenil should only be diluted with sodium chloride (0.9%) solution and 5% dextrose solution. 50 mL of Pharmaniaga Flumazenil 0.1 mg/mL Injection (equivalent to 5 mg of Flumazenil) may be diluted into 50 mL infusion beg to get the concentration of 0.05 mg/mL. Compatibility between flumazenil and other solutions for injection has not been established.
Intravenous infusion solution should be used immediately and be discarded after 24 hours.
Route of Administration: Parenteral.
[For IV use only.]