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Romazicon Online, Description, Chemistry, Ingredients - Flumazenil

Romazicon Online, Description, Chemistry, Ingredients - Flumazenil

ROMAZICON®

(flumazenil)

INJECTION

THE USE OF ROMAZICON HAS BEEN ASSOCIATED WITH THE OCCURRENCE OF SEIZURES.

THESE ARE MOST FREQUENT IN PATIENTS WHO HAVE BEEN ON BENZODIAZEPINES FOR LONG-TERM SEDATION OR IN OVERDOSE CASES WHERE PATIENTS ARE SHOWING SIGNS OF SERIOUS CYCLIC ANTIDEPRESSANT OVERDOSE.

PRACTITIONERS SHOULD INDIVIDUALIZE THE DOSAGE OF ROMAZICON AND BE PREPARED TO MANAGE SEIZURES.

 

DESCRIPTION

ROMAZICONÒ (flumazenil) is a benzodiazepine receptor antagonist. Chemically, flumazenil is ethyl 8-fluoro-5, 6-dihydro-5-methyl-6-oxo-4H-imidazo[1,5-a](1,4) benzodiazepine-3-carboxylate. Flumazenil has an imidazobenzodiazepine structure, a calculated molecular weight of 303.3, and the following structural formula:

Flumazenil is a white to off-white crystalline compound with an octanol:buffer partition coefficient of 14 to 1 at pH 7.4. It is insoluble in water but slightly soluble in acidic aqueous solutions. ROMAZICON is available as a sterile parenteral dosage form for intravenous administration. Each mL contains 0.1 mg of flumazenil compoundedwith 1.8 mg of methylparaben, 0.2 mg of propylparaben, 0.9% sodium chloride, 0.01% edetate disodium, and 0.01% acetic acid; the pH is adjusted to approximately 4 with hydrochloric acid and/or, if necessary, sodium hydroxide.

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