Flumazenil is prescribed for the reversing the sedative-effects of certain benzodiazepines during surgical and other medical procedures. Flumazenil is also used for the treatment of benzodiazepine overdose or toxicity.
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The side effects of Flumazenil are confusion, panic attacks, shallow breathing, seizures, convulsions and persistent drowsiness. Other less serious adverse events of Flumazenil are tinnitus, dizziness, profuse sweating, injection-site reaction, warmth, dizziness, headache, lack of coordination, persistent sedation and vision changes.
Flumazenil is contraindicated in patients with history of drug and alcohol abuse/addiction, epilepsy, hepatic disorders, traumatic head injury, panic attacks, uncontrolled muscle twitching and breathing disorders. Avoid driving vehicles or operating machineries for at least 18 hours after administration of Flumazenil.
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Flumazenil may interact with diazepam, alprazolam, anti-epileptic medicines, eszopiclone, imipramine, amitriptyline, estazolam and doxepin.
Drinking alcoholic beverages will impair the amphetamine metabolism and increases the level of drug in the blood that may lead to serious side effects.
Reversal of Sedation (Adults):
Start with an initial dose of 0.2 mg, IV, one time over 15 seconds. If needed, the dosage can be repeated as 0.2 mg/minute until the achievement of desired level of unconsciousness. The maximum dose should not be exceeded to 1 mg. Most of the patients respond to 0.6 – 1.0 mg. For resedation, 0.2 mg, every minute should be administered with a total of 1 mg/dose and 3 mg/hour.
Benzodiazepine Overdose (Adults):
Start with an initial dose of 0.2 mg, IV, one time over 30 seconds. If needed, the dosage can be repeated as 0.5 mg/minutes until the achievement of desired level of unconsciousness. The maximum dose should not be exceeded to 3-5 mg. Most of the patients respond to 1 – 3 mg. For resedation, 0.5 mg, every twenty minutes should be administered with a total of 1 mg/dose and 3 mg/hour.
Reversal of Benzodiazepine-induced Sedation (Pediatric):
For Infants and children, start with an initial dose of 0.01 mg/kg given over 15 seconds. The dose can be repeated as 0.01 mg/kg after 45 seconds or a minute, and the cumulative dose should not exceed 0.08 to 1 mg. For the management of benzodiazepine overdose, start with an initial dose of 0.01 mg/kg with repeated dose of 0.01 mg/kg given every minute to a maximum total dosage of 1 mg.
Benzodiazepine Overdose (Pediatric):
For patients 1 – 17 years: Start with an initial dose of 0.01 mg/kg, IV, over 15 seconds. The dose should be repeated with 0.01 mg/kg, over 15 seconds and after 15 seconds. The total cumulative dose should not exceed 0.005 mg/kg.
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USFDA pregnancy category C. Flumazenil may be or may not be harmful to an unborn baby. Consult your doctor if you are pregnant or planning to become pregnant during treatment.
It is unclear whether the drug could pass through the breast milk to a breast feeding a baby. Consult your physician before taking Flumazenil, if you are nursing mother.
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Store at room temperature away from heat and moisture
Store at room temperature away from heat and moisture
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