MINT-ENTACAPONE TABLET

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

ENTACAPONE

可用日期:

MINT PHARMACEUTICALS INC

ATC代码:

N04BX02

INN（国际名称）:

ENTACAPONE

剂量:

200MG

药物剂型:

TABLET

组成:

ENTACAPONE 200MG

给药途径:

ORAL

每包单位数:

15G/50G

处方类型:

Prescription

產品總結:

Active ingredient group (AIG) number: 0143623001; AHFS:

授权状态:

APPROVED

授权日期:

2023-03-08

产品特点

PRODUCT MONOGRAPH
PR
MINT-ENTACAPONE
(entacapone)
tablets, 200 mg
Manufacture’s Standard
Adjunct to levodopa and DDC inhibitor / COMT-Inhibitor
Mint Pharmaceuticals Inc.
6575 Davand Drive
Mississauga, Ontario, L5T 2M3
Submission Control No.: 260881
Date of Preparation:
March 3, 2023
PRODUCT MONOGRAPH
PR
MINT-ENTACAPONE
(ENTACAPONE)
tablets, 200 mg
Manufacture’s Standard
THERAPEUTIC CLASSIFICATION
Adjunct to levodopa and DDC inhibitor / COMT-Inhibitor
ACTION AND CLINICAL PHARMACOLOGY
MINT-ENTACAPONE (entacapone) is a reversible, selective and mainly
peripherally acting inhibitor of
catechol- O-methyltransferase (COMT). MINT-ENTACAPONE has no
antiparkinsonian effect of its own
and is designed for concomitant administration with levodopa
preparations.
COMT catalyzes the transfer of the methyl group of
S-adenosyl-L-methionine to the phenolic group of
substrates
that
contain
a
cathecol
structure.
Physiological
substrates
of
COMT
include
dopa,
catecholamines (dopamine, norepinephrine, epinephrine) and their
hydroxylated metabolites. In the
presence of a dopa decarboxylase (DDC) inhibitor, COMT becomes the
major enzyme which is responsible
for the metabolism of levodopa to 3-methoxy-4-hydroxy-l-phenylalanine
(3-OMD).
The mechanism of action of entacapone is believed to be related to its
ability to inhibit COMT and thereby
alter the plasma pharmacokinetics of levodopa. When administered with
levodopa and a DDC inhibitor
(carbidopa or benserazide), entacapone decreases the degradation of
levodopa in the peripheral tissues
further by inhibiting the metabolism of levodopa to 3-OMD through the
COMT pathway. This leads to
more sustained plasma concentrations of levodopa. It is believed that
at a given frequency of levodopa
administration, these more sustained plasma levels of levodopa result
in more constant dopaminergic
stimulation in the brain leading to greater effects on the signs and
symptoms of Parkinson’s Disease. The
higher levodopa levels also lead to increased levodopa adverse
effects, sometimes requiring a de