FLUMAZENIL injection

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

FLUMAZENIL (UNII: 40P7XK9392) (FLUMAZENIL - UNII:40P7XK9392)

Tilgjengelig fra:

General Injectables and Vaccines, Inc.

Administreringsrute:

INTRAVENOUS

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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). 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). Flumazenil acts as a benzodiazepine antagonist, blocks the effects of benzodiazepines in animals and

Produkt oppsummering:

Flumazenil Injection, USP, for Intravenous use is supplied in: For Intravenous Multiple-Dose Use: AIN00213 NDC 36000-148-10, 0.1 mg/mL, 5 mL vial; Pack of 10 Vials For Intravenous Multiple-Dose Use: AIN00212 NDC 36000-149-10, 0.1 mg/mL, 10 mL vial; Pack of 10 Vials Sterile, Nonpyrogenic. The container closure is not made with natural rubber latex. Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] PROTECT FROM LIGHT. DO NOT FREEZE. Manufactured for: Baxter Healthcare Corporation Deerfield, IL 60015 USA Manufactured by: Baxter Pharmaceuticals India Private Ltd Ahmedabad 382213, India 1400006464 2018/08/09

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

FLUMAZENIL- FLUMAZENIL INJECTION
GENERAL INJECTABLES AND VACCINES, INC.
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FLUMAZENIL
DESCRIPTION
Flumazenil Injection, USP 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. Flumazenil is available as a sterile parenteral
dosage form for
intravenous administration. Each mL contains 0.1 mg of Flumazenil
compounded with
1.8 mg of Methylparaben , 0.2 mg of Propylparaben , 0.9% mg Sodium
Chloride , 0.01%
Edetate Disodium Dihydrate , and 0.1 mg Glacial Acetic Acid ; the pH
is adjusted to 3.4 to
4.6 with Hydrochloric Acid and/or, if necessary, Sodium Hydroxide and
Water for
Injection q.s. to 1 mL.
CLINICAL PHARMACOLOGY
Flumazenil, an imidazobenzodiazepine derivative, antagonizes the
actions of
benzodiazepines on the central nervous system. Flumazenil
competitively inhibits the
activity at the benzodiazepine recognition site on the
GABA/benzodiazepine receptor
complex. Flumazenil is a weak partial agonist in some animal models of
activity, but has
little or no agonist activity in man.
Flumazenil does not antagonize the central nervous system effects of
drugs affecting
GABA-ergic neurons by means other than the benzodiazepine receptor
(including
ethanol, barbiturates, or general anesthetics) and does not reverse
the effects of
opioids.
In animals pretreated with high doses of benzodiazepines over several
weeks, flumazenil
elicited symptoms of benzodiazepine withdrawal, including seizures. A
similar effect was
seen in adult human subjects.
Pharmacodynamics:
Intravenous flumazenil has been shown to antagonize sedation,
impairment of recall,
psychomotor impairment and ventilatory depre