Product Information
Registration Status: ActiveSIN15209P
FLUMAZENIL-AFT SOLUTION FOR INJECTION 0.5mg/5ml is approved to be sold in Singapore with effective from 2017-04-11. It is marketed by BAXTER HEALTHCARE (ASIA) PTE LTD, with the registration number of SIN15209P.
This product contains Flumazenil 0.1mg/mL in the form of INJECTION, SOLUTION. It is approved for INTRAVENOUS use.
This product is manufactured by Claris Injectables LTD in INDIA.
It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.
Product Reference
Important Note: For generic product, the SPC/PIL provided may not be brand specific.
{{/items}} {{^items}}Description
Fumazenil is an imidazobenzodiazepine derivative and a potent benzodiazepine receptor antagonist that competitively inhibits the activity at the benzodiazepine recognition site on the GABA/benzodiazepine receptor complex, thereby reversing the effects of benzodiazepine on the central nervous system.
Indication
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, and where sedation has been produced with benzodiazepines for diagnostic and therapeutic procedures. Also for the management of benzodiazepine overdose as an adjunct for appropriate supportive and symptomatic measures.
Mechanism of Action
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.
Clearance
* 1 L/hr/kg [healthy volunteers receiving a 5-minute infusion of a total of 1 mg]
Toxicity
In clinical studies, most adverse reactions to flumazenil were an extension of the pharmacologic effects of the drug in reversing benzodiazepine effects.
Active Ingredient/Synonyms
Flumazenilo | Flumazenilum | Flumazepil | Flumazenil |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.