Flumazenil

Indications

INDICATIONS AND USAGE Adult Patients Flumazenil Injection, USP 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, USP is indicated for the reversal of conscious sedation induced with benzodiazepines (see PRECAUTIONS: Pediatric Use ).

Dosage and administration (summary)

DOSAGE AND ADMINISTRATION Flumazenil injection is recommended for intravenous use only. It is compatible with 5% dextrose in water, lactated Ringer’s and normal saline solutions. If flumazenil injection is drawn into a syringe or mixed with any of these solutions, it should be discarded after 24 hours. For optimum sterility, flumazenil injection should remain in the vial until just before use. As with all parenteral drug products, flumazenil injection should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Contraindications

CONTRAINDICATIONS Flumazenil 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 ).

Warnings and precautions

WARNINGS Risk of Seizures The reversal of benzodiazepine effects may be associated with the onset of seizures in certain high-risk populations. Possible risk factors for seizures include: concurrent major sedative-hypnotic drug withdrawal, recent therapy with repeated doses of parenteral benzodiazepines, myoclonic jerking or seizure activity prior to flumazenil administration in overdose cases, or concurrent cyclic antidepressant poisoning.

Storage and supply

STORAGE Store at 25ºC (77ºF); excursions permitted to 15º to 30ºC (59º to 86ºF) . Manufactured by: HIKMA FARMACÊUTICA (PORTUGAL), S.A.. Estrada do Rio da Mó, nº 8, 8A e 8B - Fervença - 2705 – 906 Terrugem SNT, PORTUGAL Distributed by: Hikma Pharmaceutical USA Inc. Berkeley Heights, NJ 07922 Revised: July 2020 PIN216-WES/4

Source: Flumazenil (Flumazenil) — US FDA prescribing information, 2025-02-14, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.