FLUMAZENIL

FLUMAZENIL INJECTION SHOULD BE ADMINISTERED INTRAVENOUSLY BY A PHYSICIAN WITH EXPERIENCE IN ANESTHESIOLOGY. Flumazenil Injection is not indicated for epileptic patients who have been treated with benzodiazepines for a prolonged period.

The abrupt cessation of the protective effect of benzodiazepines may induce convulsions in epileptic patients. Caution should be exercised with initial and repeated dosing to patients with hepatic insufficiency as elimination of flumazenil can be delayed in these patients (see ACTION AND CLINICAL PHARMACOLOGY-Hepatic Impairment).

The dose of Flumazenil Injection should always be individually titrated to the desired response to avoid abrupt awakening. Particular care is needed with patients who are physically dependent on benzodiazepines, patients who have ingested multiple drugs, and patients who are prone to anxiety.

In the intensive care unit, in patients treated with high doses of benzodiazepines and/or for long periods of time, the individually titrated injections of Flumazenil Injection, slowly administered, should not produce withdrawal syndromes (see PRECAUTIONS).

If unexpected symptoms occur, diazepam or midazolam could be carefully titrated intravenously according to patient’s response. Flumazenil Injection may be used concurrently with other resuscitative procedures (see Known or Suspected Benzodiazepine Overdose).

Flumazenil Injection is compatible with 5% dextrose in water and normal saline solutions. If Flumazenil Injection is drawn into a syringe or mixed with any of these solutions, it should be discarded after 24 hours (see PHARMACEUTICAL INFORMATION).

2 mg administered intravenously over 15 seconds. 1 mg can be injected and repeated at 60 second intervals, up to a maximum total dose of 1 mg. 6 mg. Known or Suspected Benzodiazepine Overdose Necessary measures should be taken to monitor the patient’s vital signs and institute supportive treatment as indicated by the patient’s clinical state.

In particular, patients may require symptomatic treatment for cardiorespiratory effects or central nervous system effects. , proper management of airway, assisted breathing, circulatory access and support, internal decontamination by charcoal and possibly lavage, and adequate clinical evaluation).

Flumazenil Injection Page 11 of 27 For the reversal of excessive sedative effects of benzodiazepines in overdose cases, titrate flumazenil as described below, until the patient clearly responds or until the maximum recommended dose has been reached.

3 mg injections, each administered over a 30-second period, at 60 second intervals. 0 mg. If a significant improvement in the level of consciousness and respiratory function is not achieved after repeated injections of flumazenil, a non-benzodiazepine aetiology must be assumed.