Flumazenil (Flumazenil)

Trade Name : Flumazenil

West-Ward Pharmaceuticals Corp

INJECTION, SOLUTION

Strength 0.1 mg/mL

FLUMAZENIL Benzodiazepine Antagonist [EPC]

Delivery Process

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Flumazenil (Flumazenil) which is also known as Flumazenil and Manufactured by West-Ward Pharmaceuticals Corp. It is available in strength of 0.1 mg/mL per ml. Read more

Flumazenil (Flumazenil) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Rx ONLY
  • 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 injection 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% 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.
  • 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.
  • Flumazenil has been administered in adults to reverse the effects of benzodiazepines in conscious sedation, general anesthesia, and the management of suspected benzodiazepine overdose. Limited information from uncontrolled studies in pediatric patients is available regarding the use of flumazenil to reverse the effects of benzodiazepines in conscious sedation only.
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  • Flumazenilu00a0is contraindicated:
  • No data
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  • Flumazenilu00a0acts as a benzodiazepine antagonist, blocks the effect of benzodiazepines in animals and man, antagonizes benzodiazepine reinforcement in animal models, produces dysphoria in normal subjects, and has had no reported abuse in foreign marketing.
  • Although flumazenil has a benzodiazepine-like structure it does not act as a benzodiazepine agonist in man and is not a controlled substance.
  • There is limited experience of acute overdosage with flumazenil.
  • There is no specific antidote for overdose with flumazenil. Treatment of an overdose with flumazenil injection should consist of general supportive measures including monitoring of vital signs and observation of the clinical status of the patient.
  • Intravenous bolus administration of doses ranging from 2.5 to 100 mg (exceeding those recommended) of flumazenil, when administered to healthy normal volunteers in the absence of a benzodiazepine agonist, produced no serious adverse reactions, severe signs or symptoms, or clinically significant laboratory test abnormalities. In clinical studies, most adverse reactions to flumazenil were an extension of the pharmacologic effects of the drug in reversing benzodiazepine effects.
  • Reversal with an excessively high dose of flumazenil injection may produce anxiety, agitation, increased muscle tone, hyperesthesia and possibly convulsions. Convulsions have been treated with barbiturates, benzodiazepines and phenytoin, generally with prompt resolution of the seizures (see ).
  • Flumazenil injection is recommended for intravenous use only. It is compatible with 5%dextrose in water, lactated Ringeru2019s 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.
  • To minimize the likelihood of pain at the injection site, flumazenil injection should be administered through a freely running intravenous infusion into a large vein.
  • 5 mL multiple doseu00a0vials containing 0.1 mg/mL flumazenil - boxes of 10 (NDC 0143-9784-10).10 mL multiple dose vials containing 0.1 mg/mL flumazenil - boxes of 10 (NDC 0143-9783-10).
  • Store at 25u00baC (77u00baF); excursions permitted to 15u00ba to 30u00baC (59u00ba to 86u00baF) [See USP Controlled Room Temperature].
  • Manufactured by:
  • Distributed by:
  • Revised 02/2012
  • PIN216-WES/3
  • NDC 0143-9784-01FLUMAZENILINJECTION, USP0.5 mg/5 mL(0.1 mg/mL)STERILEFOR IV USE ONLYRx ONLY
  • NDC 0143-9783-01FLUMAZENIL INJECTION, USP1 mg/10 mL(0.1 mg/mL)STERILEFOR IV USED ONLYRx ONLY
  • No data

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