Pharmaniaga Flumazenil Special Precautions

Elimination may be delayed in patients with hepatic impairment.
The patient should be monitored for an adequate period of time based on the dose and duration of effect of the benzodiazepine employed (ECG, pulse, oximetry, patient alertness and other vital signs such as heart rate, respiratory rate and blood pressure).
The antagonistic effect of flumazenil is specific to benzodiazepines; an effect is therefore not to be expected if the 'nonawakening' is caused by other substances.
When used in anaesthesiology at the end of surgery, flumazenil should not be given until the effects of peripheral muscle relaxants have been fully reversed.
As the action of flumazenil is usually shorter than that of benzodiazepines and sedation may possibly recur the patient should remain closely monitored, preferably in the intensive care unit, until the effect of flumazenil has presumably worn off.
In high-risk patients, the benefits of benzodiazepine-induced sedation should be weighed against the risks of rapid awakening. In patients (e.g. with cardiac problems) maintenance of a certain level of sedation may be preferable to being fully awake.
Rapid injection of flumazenil should be avoided. In patients with high-dose and/or long-term exposure to benzodiazepines ending at any time within the weeks preceding flumazenil administration, rapid injection of doses equal to or higher than 1 mg has led to withdrawal symptoms, including palpitations, agitation, anxiety, emotional labiality as well as mild confusion and sensory distortions.
In patients suffering from preoperative anxiety or having a history of chronic or episodic anxiety the dosage of flumazenil should be adjusted carefully.
After major surgery, postoperative pain must be taken into account and it may be preferable to keep the patient lightly sedated.
In patients treated for long periods with high doses of benzodiazepines, the advantages of the use of flumazenil should be weighed against the risk of withdrawal symptoms. If withdrawal symptoms occur despite careful dosing individually titrated low doses of benzodiazepines (diazepam or midazolam) should be given by slow intravenous injection.
Because of the potential for resedation and respiratory depression children previously sedated with midazolam should be monitored at least 2 hours after flumazenil administration. In case of other sedating benzodiazepines, the monitoring time must be adjusted according to their expected duration.
The use of the antagonist is not recommended in patients with epilepsy, who have been treated with benzodiazepines for a prolonged period of time. Although flumazenil has some intrinsic antiepileptic effects, the abrupt antagonizing effect can cause convulsions in patients with epilepsy.
In patients with severe brain injury (and/or instable intracranial pressure) receiving flumazenil - to reverse the effects of benzodiazepines - an increased intracranial pressure may develop.
Particular caution is necessary when using flumazenil in cases of mixed drug overdose. In particular in the case of an intoxication with benzodiazepines and cyclic antidepressants, certain toxic effects such as convulsions and cardiac arrhythmias, which are caused by these antidepressants but which emerge less readily on concomitant administration with benzodiazepines, are exacerbated on administration of flumazenil.
Patients who have received Flumazenil for the reversal of benzodiazepine effects should be monitored for resedation, respiratory depression or other residual benzodiazepine effects for an appropriate period based on the dose and duration of effect of the benzodiazepine employed. Because patients with underlying hepatic impairment may experience delayed effects as described above, an extended observation period may be required.
Flumazenil is not recommended for the treatment of benzodiazepine-dependence or for the treatment of long-term benzodiazepine abstinence-syndromes.
Panic attacks have been reported after the use of flumazenil in patients with a history of panic disorder.
Due to the increased frequency of benzodiazepines tolerance and dependence in patients with alcoholism and other drug dependencies, flumazenil should be used with caution in its population.
Effects On Ability To Drive And Use Machines: Patients who have received flumazenil to reverse the effects of benzodiazepine sedation should be warned not to drive, to operate machinery or to engage in other activities demanding physical or mental exertion for at least 24 hours, since the effect of the benzodiazepine may return.
Use in Children: Use in children for other indications than reversal of conscious sedation is not recommended as no controlled studies are available. Until sufficient data are available, flumazenil should only be administered to children below the age of 1 year if the risks to the patient (especially in the case of accidental overdose) have been weighed up against the benefits of the treatment.