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Flumazenil antidote dose7/23/2023 The dosage should be individualized based on the patient's response, with most patients responding to doses of 0.6 mg to 1 mg (see INDIVIDUALIZATION OF DOSAGE). If the desired level of consciousness is not obtained after waiting an additional 45 seconds, a further dose of 0.2 mg (2 mL) can be injected and repeated at 60-second intervals where necessary (up to a maximum of 4 additional times) to a maximum total dose of 1 mg (10 mL). Reversal of General Anesthesia in Adult Patientsįor the reversal of the sedative effects of benzodiazepines administered for general anesthesia, the recommended initial dose of ROMAZICON is 0.2 mg (2 mL) administered intravenously over 15 seconds. The safety and efficacy of ROMAZICON in the reversal of conscious sedation in pediatric patients below the age of 1 year have not been established. ![]() The safety and efficacy of repeated flumazenil administration in pediatric patients experiencing resedation have not been established. Resedation occurred in 7 of 60 pediatric patients who were fully alert 10 minutes after the start of ROMAZICON administration (see PRECAUTIONS: Pediatric Use). Approximately one-half of patients required the maximum of five injections. The mean total dose administered in the pediatric clinical trial of flumazenil was 0.65 mg (range: 0.08 mg to 1.00 mg). The dose should be individualized based on the patient's response. 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. ![]() It is recommended that ROMAZICON be administered as the series of small injections described (not as a single bolus injection) to allow the practitioner to control the reversal of sedation to the approximate endpoint desired and to minimize the possibility of adverse effects (see INDIVIDUALIZATION OF DOSAGE).įor the reversal of the sedative effects of benzodiazepines administered for conscious sedation in pediatric patients greater than 1 year of age, the recommended initial dose is 0.01 mg/kg (up to 0.2 mg) administered intravenously over 15 seconds. ![]() For repeat treatment, no more than 1 mg (given as 0.2 mg/min) should be administered at any one time, and no more than 3 mg should be given in any one hour. In the event of resedation, repeated doses may be administered at 20-minute intervals as needed. If the desired level of consciousness is not obtained after waiting an additional 45 seconds, a second dose of 0.2 mg (2 mL) can be injected and repeated at 60-second intervals where necessary (up to a maximum of 4 additional times) to a maximum total dose of 1 mg (10 mL). For the reversal of the sedative effects of benzodiazepines administered for conscious sedation, the recommended initial dose of ROMAZICON is 0.2 mg (2 mL) administered intravenously over 15 seconds.
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