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Flumazenil Dosage

Medically reviewed on December 13, 2017.

Applies to the following strengths: 0.1 mg/mL

Usual Adult Dose for Reversal of Sedation

Initial dose: 0.2 mg IV one time over 15 seconds.
Repeated doses: 0.2 mg may be given every minute until the desired level of consciousness is achieved.
Maximum total dose 1 mg.

Resedation: 0.2 mg every 20 minutes as needed
Maximum dose: 1 mg total at any one time; no more than 3 mg in any one hour

Comments:
-Individualize dose based on patient response.
-Most patients respond to doses of 0.6 to 1 mg.
-Administer as a series of small injections as described to control reversal of sedation to desired endpoint and minimize adverse effects.

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.

Usual Adult Dose for Benzodiazepine Overdose

Initial dose: 0.2 mg IV over 30 seconds
-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.
-Further doses of 0.5 mg over 30 seconds may be given at 1 minute intervals, if needed
Maximum cumulative dose: 3 mg total

Resedation: Repeated doses may be given at 20 minute intervals as needed
Maximum dose: 1 mg total at any one time; no more than 3 mg in any one hour


Comments:
-Do not rush administration.
-Patients should have secure airway and venous access before administration, and be awakened gradually.
-Most patients with a benzodiazepine overdose will respond to a cumulative dose of 1 to 3 mg.
-Doses beyond 3 mg do not reliably produce additional effects.
-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.
-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.

Use(s): Management of benzodiazepine overdose

Usual Pediatric Dose for Reversal of Sedation

1 to 17 years old:
Initial dose: 0.01 mg/kg IV over 15 seconds
-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
Maximum dose: 0.05 mg/kg or 1 mg, whichever is lower

Comments:
-Individualize dose based on patient response.
-Mean total dose in pediatric clinical trials was 0.65 mg (range 0.08 to 1 mg)
-About half of the patients required the maximum 5 doses.
-Resedation occurred in 7 of 60 pediatric patients who were fully alert 10 minutes after starting this medication.
-Safety and efficacy of repeated administration for resedation in pediatric patients has not been established.

Use(s): Reversal of conscious sedation induced with benzodiazepines

Renal Dose Adjustments

Data not available
-The pharmacokinetics of this drug are not significantly affected by renal failure (CrCl under 10 mL/min)

Liver Dose Adjustments

Use with caution.
-The initial dose for benzodiazepine reversal is not affected, but repeat doses should be reduced in size or frequency.

Dose Adjustments

Resedation:
-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.
-Safety and effectiveness of repeated flumazenil administration in pediatric patients experiencing resedation has not been established.

Precautions

US BOXED WARNING(S):
-Use of this drug has been associated with the occurrence of seizures.
-Seizures are most frequent in patients on benzodiazepines for long-term sedation or in overdose cases where patients are showing signs of serious cyclic anti-depressant overdose.
Recommendation:
-Individualized the dosage, and be prepared to manage seizures.

CONTRAINDICATIONS:
-Hypersensitivity to this drug or benzodiazepines
-Patients on benzodiazepines to control a potentially life-threatening condition (e.g. control of intracranial pressure or status epilepticus)
-Signs of serious cyclic antidepressant overdose

Safety and efficacy have not been established in patients younger than 1 year.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available
-The pharmacokinetics of this drug are not significantly affected by hemodialysis

Other Comments

Administration advice:
-For intravenous use only.
-Administer through a freely running intravenous infusion into a large vein to minimize injection site pain.

Storage requirements:
-Store at controlled room temperature.
-Protect from light
-Do not freeze

Reconstitution/preparation techniques:
-Once mixed or drawn into a syringe, use within 24 hours.

IV compatibility:
-Compatible with 5% dextrose, lactated Ringer's, and normal saline.

Patient advice:
-This drug does not consistently reverse amnesia.
-Patient instructions should be reinforced in writing or given to a responsible family member as patients cannot be expected to remember information told to them in the postprocedural period.
-Although the patient may feel alert at discharge, sedation may recur.
-Memory and judgement may be impaired; do not engage in activities requiring complete alertness, and do not operate hazardous machinery or a motor vehicle during the first 24 hours after discharge.
-Do not take any alcohol or non-prescription drugs during the first 24 hours after flumazenil administration or if benzodiazepine effects persist.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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