Country: Kanada
Lingwa: Ingliż
Sors: Health Canada
DOMPERIDONE (DOMPERIDONE MALEATE)
BIOMED PHARMA
A03FA03
DOMPERIDONE
10MG
TABLET
DOMPERIDONE (DOMPERIDONE MALEATE) 10MG
ORAL
500
Prescription
PROKINETIC AGENTS
Active ingredient group (AIG) number: 0116957001; AHFS:
APPROVED
2015-09-15
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 Aqra d-dokument sħiħ