Flumazenil is indicated

In the hospital environment

In anesthesiology, to neutralize the effects, sedatives exerted by benzodiazepines on the central nervous system in adults and children over 6 months

· Reversion of a sedative effect during a general anesthesia induced and maintained by benzodiazepines

· Reversion of benzodiazepine-induced vigilant sedation in brief diagnostic or therapeutic interventions

In intensive care, to neutralize the sedative effects of benzodiazepines on the central nervous system and management of a coma of etiology unknown in adults and children (including the new- Born) if the semiology is compatible with the hypothesis of a coma by benzodiazepines or related

· Diagnosis and / or treatment of an intentional or accidental overdose of benzodiazepines

· Etiologic diagnosis of unexplained coma in order to distinguish what belongs to a benzodiazepine from another cause (pharmacological or neurological)

· Specific cancellation of the effects on the central nervous system caused by excessive doses of benzodiazepines (restoration of ventilation, spontaneous to avoid intubation or interrupting ventilatory assistance).

In an emergency or medical transport, in adults and children over 6 years

· Reversion of benzodiazepine induced vigilance sedation in the event of depression, respiratory, apnea

Flumazenil should be administered IV.

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

1. In anaesthesiology

Flumazenil should be administered by an anesthetist / resuscitator.
A) In adults

The recommended starting dose is 0.2 mg administered IV in 15 seconds. If the desired degree of consciousness is not achieved within 60 seconds, a second dose of 0.1 mg may be injected. If necessary, this action can be repeated at intervals of 60 seconds with a maximum total dose of 1 mg. The usual total dose is 0.3 to 0.6 mg, however inter-individual variations may be observed depending on the dose and duration of action of the benzodiazepine administered and the patient's characteristics. Code>
(B) In children over 6 months

The recommended starting dose is 0.01 mg / kg (up to 0.2 mg per injection), IV in 15 seconds. If a satisfactory state of consciousness is not obtained after awaiting another 45 seconds, further injections of 0.01 mg / kg (up to 0.2 mg per injection) may be administered and repeated all The maximum total dose being 0.05 mg / kg or 1 mg, if necessary (up to 4 administrations, additional).
2. In intensive care

Flumazenil should be administered by an anesthetist / resuscitator.
A) In adults

The recommended starting dose IV is 0.3 mg. If the desired degree of consciousness is not achieved within 60 seconds, further injections of flumazenil of 0.2 or 0.3 mg may be practiced until wake signs are obtained or up to Up to a maximum total dose of 2 mg. If the state of consciousness of the patient and his respiratory function do not show a significant improvement after administration of this total dose of 2 mg, it must be admitted that the clinical picture is not due to benzodiazepines.

In the case of the awakening, and in order to maintain the waking state, administration of flumazenil in one or more IV injections of 0.3 mg or an IV infusion of 0.1 At 0.4 mg per hour may be continued. The rate of perfusion must be individually adjusted according to the desired degree of arousal.

(B) In the child (including the newborn)

The recommended starting dose is 0.01 mg / kg intravenously slowly every 2 minutes until wake signs are obtained and followed, if necessary, by continuous infusion with an hourly dose equal to The total loading dose.

3. In emergency or medical transport in adults and children, over 6 years

Flumazenil should be administered only by doctors, experienced in emergency and transport, medical.

The aim is to correct respiratory depression, which is also treated by usual resuscitation measures (the use of flumazenil in hypoxia may increase the risk of seizures or disturbances in rhythm).

A) in the adult

The recommended starting dose is 0.2 mg administered IV in 15 seconds. If the desired degree of consciousness is not achieved within 60 seconds, a second dose of 0.1 mg may be injected. If necessary, this action can be repeated at intervals of 60 seconds with a maximum total dose of 1 mg. The usual total dose is 0.3 to 0.6 mg, however inter-individual variations may be observed depending on the dose and duration of action of the benzodiazepine administered and the patient's characteristics. Code>
(B) in children over 6 years of age

The recommended starting dose is 0.01 mg / kg (up to 0.2 mg per injection), IV in 15 seconds. If a satisfactory state of consciousness is not obtained after awaiting another 45 seconds, further injections of 0.01 mg / kg (up to 0.2 mg per injection) may be administered and repeated all The maximum total dose being 0.05 mg / kg or 1 mg, if necessary (up to 4 administrations, additional).
Pharmacotherapeutic group ANTIDOTES (V '= various) BENZODIAZEPINES ANTAGONIST

Flumazenil, imidazo-benzodiazepine, is an antagonist of benzodiazepines and related molecules (zolpidem, zopiclone): it specifically blocks, by competitive inhibition, the effects exerted on the central nervous system by the substances acting at the level Of the benzodiazepine receptors

In animal experiments, the effects produced by substances having no affinity for benzodiazepine receptors (eg, barbiturates, ethanol, meprobamate, GABA-mimetics, and receptor agonists Adenosine) have not been modified by flumazenil, but the effects exerted by non-benzodiazepine agonists of benzodiazepine receptors, such as cyclopyrrolones (eg, zopiclone) and triazolopyridazines have been blocked .

The hypnotic and sedative effects of benzodiazepines are rapidly neutralized by flumazenil injected intravenously (1, 2 minutes, for equimolar doses) and may reappear gradually within hours following the half-life of the products and The ratio between the doses of agonist and antagonist administered. Flumazenil is well tolerated even at high doses and especially on the hemodynamic plane.


Although intravenous administration of flumazenil does not cause drowsiness, patients should be warned against any activity requiring sustained attention, such as control of machinery or the operation of vehicles during 24 hours after the administration of this product, the effect of ingested or previously administered benzodiazepines may reappear.

Precautions for use

· When concomitant use of curarisers, the neuromuscular blockage must be completely neutralized before administration of flumazenil.

· Based on limited experience, flumazenil should be used with caution

O in children
This medicinal product contains sodium This medicinal product contains 37 mg sodium per 10 ml ampoule and should be taken into consideration for patients controlling their sodium intake. >
The data available to date do not imply the existence of clinically significant interactions.

In the absence of compatibility studies, this medicinal product should not be mixed with other medicinal products except those listed under the heading Instructions for use, handling and disposal: Flumazenil may be , Administered by infusion, diluted in glucose, 5%, Ringer lactate or 0.9% sodium chloride solution.
Even when flumazenil is administered at doses in excess of the recommended doses, no signs of overdose have been observed.


There is no reliable evidence of teratogenesis in animals. There are currently no adequate clinical data to evaluate a possible malformative or foetotoxic effect of flumazenil when administered during pregnancy. Therefore, in the absence of emergency situations, the use of flumazenil should be avoided during pregnancy.
Breastfeeding

Breast-feeding is not a contraindication to the administration of flumazenil in an emergency. However, continued breastfeeding should take account of the poisoning being treated.

During administration in anesthesiology, there have been reports of rare cases of nausea and / or vomiting.
Anxiety, palpitations and anxiety have usually been reported, and usually the side effects mentioned do not require special treatment.
Convulsions have been reported in some patients treated with long-term benzodiazepines, especially in the subject, epileptic or overdose, polymorphic.
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Symptoms of withdrawal may occur after rapid injection of flumazenil, in patients whose prolonged treatment with benzodiazepines has been discontinued in the weeks prior to the administration of flumazenil
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Flumazenil may cause panic attack in patients with a history.