Application Nr Approved Date Route Status External Links
ANDA076755 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage Adult Patients: Flumazenil Injection Is Indicated For The Complete Or Partial Reversal Of The Sedative Effects Of Benzodiazepines In Cases Where General Anesthesia Has Been Induced And/or Maintained With Benzodiazepines, Where Sedation Has Been Produced With Benzodiazepines For Diagnostic And Therapeutic Procedures, And For The Management Of Benzodiazepine Overdose. Pediatric Patients (Aged 1 To 17): Flumazenil Injection Is Indicated For The Reversal Of Conscious Sedation Induced With Benzodiazepines (See Precautions: Pediatric Use). Close Contraindications Flumazenil Injection Is Contraindicated: •in Patients With A Known Hypersensitivity To Flumazenil Or Benzodiazepines. •in Patients Who Have Been Given A Benzodiazepine For Control Of A Potentially Life-Threatening Condition (E.g., Control Of Intracranial Pressure Or Status Epilepticus). •in Patients Who Are Showing Signs Of Serious Cyclic Antidepressant Overdose (See Warnings).

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Flumazenil FLUMAZENIL ZINC1464

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