Posology : מינונים

4.2.    Posology and method of administration

Flumazenil must be administered by IV route.
Flumazenil may be administered in infusion, diluted in 5 % glucose, Ringer's lactate solution or 0.9 % NaCl solution.

It is recommended to use the titration method (see below).

1. In anaesthesiology
Flumazenil must be administered by an anaesthesiologist/intensive care physician.
 a) In adults:
The recommended initial dose is of 0.2 mg, administered by IV route in 15 seconds. If the consciousness level desired is not obtained within 60 seconds, a second 0.1 mg dose may be injected.
If necessary, this operation may be repeated at 60 second intervals, the maximum dose is 1 mg. The usual total dose is of 0.3 to 0.6 mg, depending on inter-individual variations that may be observed as a function of the dose and duration of action of the benzodiazepine administered and the characteristics of the patient.
 b) In children over 6 months old:
The recommended initial dose is of 0.01 mg/kg (up to 0.2 mg per injection) administered by IV route in 15 seconds. If a satisfactory consciousness level is not obtained after waiting 45 additional seconds, other 0.01 mg/kg (up to 0.2 mg per injection) injections may be administered and repeated every minute, if necessary (up to 4 additional administrations), the maximum total dose is 0.05 mg/kg or 1 mg.


2. In intensive care
Flumazenil must be administered by an anaesthesiologist/intensive care physician.
 a) In adults:
The recommended initial IV dose is of 0.3 mg. If the degree of consciousness desired is not obtained within 60 seconds, new injections of flumazenil of 0.2 or 0.3 mg may be performed, until obtaining signs of waking up or until attaining a maximum total dose of 2 mg. If the consciousness level of the patient and his/her respiratory function do not present a significant improvement after administration of this 2 mg total dose, it should admit that the clinical picture is not due to benzodiazepines.

If waking is obtained, and to maintain it, the administration of flumazenil in one or several IV injections of 0.3 mg or in IV infusion of 0.1 to 0.4 mg per hour may be continued. The infusion rate may be adjusted individually as a function of the degree of waking desired.
 b) In children (including infants):
The recommended initial dose is of 0.01 mg/kg in slow intravenous injection every 2 minutes until obtaining signs of waking and followed, if necessary, of a continuous infusion with an hourly dose equal to the total loading dose.

3. In an emergency situation or in medical transport in adults and children over 6 years old.

Flumazenil must only be administered by experienced emergency and medical transport doctors.
The objective is to rectify the respiratory depression, also treated with the usual intensive care measures (the use of flumazenil in a hypoxia situation could increase the risk of convulsions and rhythm disorders).
 a) In adults:
The recommended initial dose is of 0.2 mg, administered by IV route in 15 seconds. If the consciousness level desired is not obtained within 60 seconds, a second 0.1 mg dose may be injected.
If necessary, this operation may be repeated at 60 second intervals, the maximum dose is 1 mg. The usual total dose is of 0.3 to 0.6 mg, depending on inter-individual variations that may be observed as a function of the dose and duration of action of the benzodiazepine administered and the characteristics of the patient.
 b) In children over 6 years old:
The recommended initial dose is of 0.01 mg/kg (up to 0.2 mg per injection) administered by IV route in 15 seconds. If a satisfactory consciousness level is not obtained after waiting 45 additional seconds, other 0.01 mg/kg (up to 0.2 mg per injection) injections may be administered and repeated every minute, if necessary (up to 4 additional administrations), the maximum total dose is 0.05 mg/kg or 1 mg.