Romazicon Overdose, Contraindications and Information - Flumazenil

Romazicon Overdose, Contraindications and Information - Flumazenil

OVERDOSE

Large intravenous doses (exceeding those recommended) of ROMAZICON, when administered to healthy normal volunteers in the absence of a benzodiazepine agonist, produced no serious adverse reactions, severe signs or symptoms, or clinically significant laboratory test abnormalities. In clinical studies, most adverse reactions to flumazenil were an extension of the pharmacologic effects of the drug in reversing benzodiazepine effects.

Reversal with an excessively high dose of ROMAZICON may produce anxiety, agitation, increased muscle tone, hyperesthesia and possibly convulsions. Convulsions have been treated with barbiturates, benzodiazepines and phenytoin, generally with prompt resolution of the seizures (see WARNINGS).

ROMAZICON is contraindicated:

· in patients withaknownhypersensitivitytoflumazenil or benzodiazepines.

· in patients who have been given a benzodiazepine for control of a potentially life- threatening condition (eg, control of intracranial pressure or status epilepticus).

· in patients who are showing signs of serious cyclic antidepressant overdose (see WARNINGS).