NU-DOMPERIDONE 10 MG TABLETS

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DOMPERIDONE (DOMPERIDONE MALEATE)

Available from:

NU-PHARM INC

ATC code:

A03FA03

INN (International Name):

DOMPERIDONE

Dosage:

10MG

Pharmaceutical form:

TABLET

Composition:

DOMPERIDONE (DOMPERIDONE MALEATE) 10MG

Administration route:

ORAL

Units in package:

100/500

Prescription type:

Prescription

Therapeutic area:

PROKINETIC AGENTS

Product summary:

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

Authorization status:

CANCELLED POST MARKET

Authorization date:

2012-09-04

Summary of Product characteristics

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PRODUCT MONOGRAPH
PR
NU-DOMPERIDONE
DOMPERIDONE MALEATE TABLETS
DOMPERIDONE 10 MG
MODIFIER OF UPPER GASTROINTESTINAL MOTILITY
NU-PHARM INC.
DATE OF REVISION:
1165 CREDITSTONE ROAD, UNIT 2
May 4, 2012
VAUGHAN, ONTARIO
L4K 4N7
CONTROL NO.: 154537
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PRODUCT MONOGRAPH
PR
NU-DOMPERIDONE
Domperidone Maleate Tablets
Domperidone 10 mg
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.
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Domperidone does not readily cross the blood-brain barrier and
therefore is not expected to have central
effects. Domperidone elevates serum prolactin levels but has no effect
on circulating aldosterone levels.
In man, peak plasma levels of domperidone occur within 10 to 30
minutes following intramuscular
injection and 30 minutes after oral (fasted) administration. Plasma
concentrations two hours after oral
administration are lower than following intramuscular injection, and
this is likely the result of hepatic first-
pass and gut wall metabolism. Peak plasma concentrations are 40 ng/mL
fo