BIO-DOMPERIDONE TABLET

Country: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

DOMPERIDONE (DOMPERIDONE MALEATE)

Доступно од:

BIOMED PHARMA

АТЦ код:

A03FA03

INN (Међународно име):

DOMPERIDONE

Дозирање:

10MG

Фармацеутски облик:

TABLET

Састав:

DOMPERIDONE (DOMPERIDONE MALEATE) 10MG

Пут администрације:

ORAL

Јединице у пакету:

500

Тип рецептора:

Prescription

Терапеутска област:

PROKINETIC AGENTS

Резиме производа:

Active ingredient group (AIG) number: 0116957001; AHFS:

Статус ауторизације:

APPROVED

Датум одобрења:

2015-09-15

Карактеристике производа

Page 1 of 26
PRODUCT MONOGRAPH
PR
BIO-DOMPERIDONE
DOMPERIDONE TABLETS BP 10 MG
(AS DOMPERIDONE MALEATE)
MODIFIER OF UPPER GASTROINTESTINAL
MOTILITY
Biomed Pharma Date of Revision:
1B-9450 Boulevard Langelier September 25, 2020
Montreal, Quebec
H1P 3H8
CONTROL # 243621
Page 2 of 26
PRODUCT MONOGRAPH
Pr
BIO-DOMPERIDONE
Domperidone Tablets BP
Domperidone 10 mg
(as domperidone maleate)
THERAPEUTIC CLASSIFICATION
Modifier of Upper Gastrointestinal Motility
ACTIONS AND CLINICAL PHARMACOLOGY
Domperidone is a peripheral dopamine antagonist structurally related
to the butyrophenones
with
antiemetic and gastroprokinetic properties.
Domperidone effectively increases oesophageal peristalsis and lower
oesophageal sphincter
pressure (LESP), increases gastric motility and peristalsis, enhances
gastroduodenal coordination
and consequently facilitates gastric emptying and decreases small
bowel transit time.
The mechanism of action of domperidone is related to its peripheral
dopamine receptor blocking
properties. Emesis induced by apomorphine, hydergine, morphine or
levodopa through stimulation
of the chemoreceptor trigger zone (situated outside the blood-brain
barrier) can be blocked by
domperidone. There is indirect evidence that emesis is also inhibited
at the gastric level, since
domperidone also inhibits emesis induced by oral levodopa, and local
gastric wall concentrations
following oral domperidone are much greater than those of the plasma
and other organs.
Domperidone does not readily cross the blood-brain barrier and
therefore is not expected to have
central effects.
A thorough QT study was performed in healthy subjects. This study
included a placebo, active
comparator and positive control and was conducted using 10 to 20 mg
administered 4 times per
day. The study found a maximal difference of QTc between domperidone
and placebo in LS-mean
in the change from baseline of 3.4 msec for 20 mg domperidone
administered 4 times a day on
Day 4. The 2-sided 90% CI (1.0 to 5.9 msec) did not exceed 10 msec.
Although the results of t