Safety and effectiveness of repeated flumazenil administration in pediatric patients experiencing resedation has not been established.In clinical situations in adults where resedation must be prevented, physicians may wish to repeat the initial dose at 30 minutes and possibly at 60 minutes also although not studied in clinical trials, this was effective in preventing resedation in a pharmacologic study in normal volunteers.The initial dose for benzodiazepine reversal is not affected, but repeat doses should be reduced in size or frequency.The pharmacokinetics of this drug are not significantly affected by renal failure (CrCl under 10 mL/min).Use(s): Reversal of conscious sedation induced with benzodiazepines Renal Dose Adjustments Safety and efficacy of repeated administration for resedation in pediatric patients has not been established.Resedation occurred in 7 of 60 pediatric patients who were fully alert 10 minutes after starting this medication.About half of the patients required the maximum 5 doses.Mean total dose in pediatric clinical trials was 0.65 mg (range 0.08 to 1 mg).Maximum dose: 0.05 mg/kg or 1 mg, whichever is lower If desired level of consciousness is not achieved after an additional 45 seconds, a second 0.01 mg/kg dose may be given and repeated at 60 second intervals, if needed, up to a maximum of 4 doses.Initial dose: 0.01 mg/kg IV over 15 seconds Use(s): Management of benzodiazepine overdose Usual Pediatric Dose for Reversal of Sedation If a patient has not responded 5 minutes after receiving a cumulative dose of 5 mg, the major cause of sedation is unlikely to be benzodiazepines and additional doses of this drug are unlikely to help.On rare occasions, patients who partially respond to 3 mg may require additional titration up to a total dose of 5 mg, given in the same manner as above.Doses beyond 3 mg do not reliably produce additional effects.Most patients with a benzodiazepine overdose will respond to a cumulative dose of 1 to 3 mg.Patients should have secure airway and venous access before administration, and be awakened gradually.Resedation: Repeated doses may be given at 20 minute intervals as needed Further doses of 0.5 mg over 30 seconds may be given at 1 minute intervals, if needed.If desired level of consciousness is not achieved after waiting 30 seconds, a second dose of 0.3 mg may be given over another 30 seconds.Usual Adult Dose for Benzodiazepine Overdose Use(s): Complete or partial reversal of the sedative effects of benzodiazepines where general anesthesia has been induced and/or maintained with benzodiazepines, or where sedation has been produced with benzodiazepines for diagnostic and therapeutic procedures. Administer as a series of small injections as described to control reversal of sedation to desired endpoint and minimize adverse effects.Most patients respond to doses of 0.6 to 1 mg.Individualize dose based on patient response.Maximum dose: 1 mg total at any one time no more than 3 mg in any one hour Resedation: 0.2 mg every 20 minutes as needed Repeated doses: 0.2 mg may be given every minute until the desired level of consciousness is achieved. Initial dose: 0.2 mg IV one time over 15 seconds. Usual Adult Dose for Reversal of Sedation
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