ANEXATE INJECTION 0.5 MG/5 ML [SIN01509P]

Product Info

ANEXATE INJECTION 0.5 MG/5 ML

[SIN01509P]

2.1 Therapeutic Indication(s)
Anexate is indicated for complete or partial reversal of the central sedative effects of benzodiazepines. It is therefore used in anesthesia and intensive care in the following indications:

In anesthesia

• Termination of general anesthesia induced and maintained with benzodiazepines in inpatients.

• Reversal of benzodiazepine sedation in short diagnostic and therapeutic procedures in both inpatients and outpatients.

In intensive care

• Anexate provides a diagnosis of benzodiazepine intoxication or rules out such intoxication.

• Anexate may also be used for specific reversal of the central effects of benzodiazepines in drug overdose (return to spontaneous respiration and consciousness in order to render intubation unnecessary or allow extubation).

2.2 Dosage and Administration
Anexate is recommended for intravenous use only and should be administered by an anesthesiologist or experienced physician.

For handling solution, see 4.2 Special Instructions for Use, Handling and Disposal – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Dosage should be titrated for the intended effect. Since the duration of action of some benzodiazepines may exceed that of Anexate, repeated doses may be required if sedation recurs following awakening.

In anesthesia: The recommended initial dose of Anexate is 0.2 mg administered i.v. over 15 seconds. If the desired degree of consciousness is not obtained within 60 seconds, a second dose of 0.1 mg can be injected; this may be repeated at 60-second intervals where necessary, up to a total dose of 1 mg. The usual dose is 0.3-0.6 mg, but individual requirements may vary considerably, depending on the dose and duration of effect of the benzodiazepine administered and patient characteristics.
In intensive care: The recommended initial dose of Anexate is 0.3 mg i.v. If the desired level of consciousness is not obtained within 60 seconds, Anexate may be injected repeatedly until the patient awakes or up to a total dose of 2 mg. If drowsiness recurs, Anexate may be administered as one or more bolus i.v. doses as above, or as an i.v. infusion of 0.1-0.4 mg per hour. The rate of infusion should be individually adjusted to the desired level of arousal.

If a significant improvement in consciousness or respiratory function is not obtained after repeated doses of Anexate, a nonbenzodiazepine etiology must be assumed.

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 Anexate, slowly administered, should not produce withdrawal syndromes. If unexpected symptoms occur, diazepam or midazolam could be carefully titrated intravenously according to patient’s response (see 2.4.1 General (Warnings and Precautions) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

2.2.1 Special Dosage Instructions
Children > 1 year of age:
For the reversal of conscious sedation induced with benzodiazepines in children > 1 year of age, the recommended initial dose is 0.01 mg/kg (up to 0.2 mg) administered i.v. over 15 seconds. If the desired level of consciousness is not obtained after waiting an additional 45 seconds, further injections of 0.01 mg/kg (up to 0.2 mg) can be administered and repeated at 60-second intervals where necessary (up to a maximum of 4 additional times) to a maximum total dose of 0.05 mg/kg or 1 mg, whichever is lower. The dose should be individualised based on the patient’s response. No data are available on the safety and efficacy of repeated administration of Anexate to children for re-sedation.

Hepatic impairment:
Since flumazenil is primarily metabolized in the liver, careful titration of dosage is recommended in patients with impaired hepatic function. (see 2.4.1 General (Warnings and Precautions) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

2.3 Contraindications
Anexate is contraindicated in patients with known hypersensitivity to the drug.

Anexate is contraindicated in patients who have been given a benzodiazepine for control of a potentially life-threatening condition (e.g. control of intracranial pressure or status epilepticus).