Product Information
Registration Status: ActiveSIN14617P
FYCOMPA FILM-COATED TABLET 4MG is approved to be sold in Singapore with effective from 2014-12-09. It is marketed by EISAI (SINGAPORE) PTE LTD, with the registration number of SIN14617P.
This product contains Perampanel 4mg in the form of TABLET, FILM-COATED. It is approved for ORAL use.
This product is manufactured by Eisai Manufacturing Ltd. in UNITED KINGDOM.
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
Perampanel is a noncompetitive AMPA glutamate receptor antagonist. It is marketed under the name Fycompa™ and is indicated as an adjunct in patients over 12 years old for the treatment of partial-onset seizures that may or may not occur with generalized seizures. The FDA label includes an important black-boxed warning of serious or life-threatening behavioral and psychiatric reactions in patients taking Fycompa™.
Indication
Used in patients over 12 years old for the treatment of partial-onset seizures that may or may not occur with generalized seizures.
Mechanism of Action
The exact mechanism of action of perampanel in seizures is not yet determined, but it is known that perampanel decreases neuronal excitation by non-competitive ihibition of the AMPA receptor.
Pharmacokinetics
- Absorption
- After oral adminitration, perampanel is absorbed rapidly and completely.
- Distribution
- The volume of distribution of perampanel was not quantified.
- Metabolism
- Perampanel is highly metabolized by CYP3A4 and/or CYP3A5 primary oxidation and by sequential glucuronidation.
- Elimination
Clearance
In healthy patients, perampanel has a clearance of about 12 mL/min.
Toxicity
The FDA label includes an important warning of serious or life-threatening behavioral and psychiatric adverse reactions including aggression, hostility, irritability, anger, and homicidal thoughts in patients taking perampanel.
Active Ingredient/Synonyms
3-(2-Cyanophenyl)-5-(2-pyridyl)-1-phenyl-1,2-dihydropyridin-2-one | perampanel | pérampanel | Perampanelum | Perampanel |
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.