Land: Canada
Taal: Engels
Bron: Health Canada
CALCITRIOL
HOFFMANN-LA ROCHE LIMITED
A11CC04
CALCITRIOL
1MCG
SOLUTION
CALCITRIOL 1MCG
ORAL
10 ML
Prescription
VITAMIN D
Active ingredient group (AIG) number: 0113628002; AHFS:
CANCELLED POST MARKET
2013-06-24
PRODUCT MONOGRAPH ROCALTROL ® (CALCITRIOL) Capsules 0.25 µg and 0.5 µg Solution 1.0 µg/mL VITAMIN D 3 METABOLITE Hoffmann-La Roche Limited Date of Preparation: June 6, 1979 2455 Meadowpine Boulevard Mississauga, Ontario L5N 6L7 Date of Revision: January 26, 2009 SUBMISSION CONTROL NUMBER: 125067 ® Registered Trademark of Hoffmann-La Roche Limited © Copyright 1979-2009 Hoffmann-La Roche Limited CDS Version 2.0 _ _ _ _ _Page 2 of 15 _ NAME OF DRUG ROCALTROL ® (calcitriol) THERAPEUTIC CLASSIFICATION Vitamin D 3 Metabolite ACTIONS AND CLINICAL PHARMACOLOGY The supply of vitamin D in man depends on dietary intake and/or exposure to the ultraviolet rays of the sun for conversion of 7-dehydrocholesterol to vitamin D 3 (cholecalciferol). 1 Vitamin D 3 must be metabolized in the liver and the kidney before it is fully active on its target tissues. 2,3,4 The initial transformation is catalyzed by a vitamin D 3 -25-hydroxylase enzyme (25-OHase) present in the liver, and the product of this reaction is 25-hydroxy-vitamin D 3 (25-OH-D 3 ). The latter undergoes hydroxylation in the mitochondria of kidney tissue. This reaction is activated by the renal 25-hydroxy-vitamin D 3 -1 alphahydroxylase (alpha-OHase) to produce 1,25-(OH) 2 D 3 (calcitriol). The two known sites of action of calcitriol are intestine and bone, but additional evidence suggests that it also acts on the kidney and the parathyroid gland. 5 In acutely uremic rats calcitriol has been shown to stimulate calcium absorption. 6 It is the most active known form of vitamin D 3 in stimulating intestinal calcium transport. This agent also promotes the intestinal absorption of phosphorus through stimulation of an active transport system distinct from the calcium transport process. 9 Calcitriol stimulates bone resorption which serves to mobilize calcium for the circulation, when an intestinal source of calcium is absent. 10 This effect is related to the role of vitamin D in maintaining the homeostasis of calcium and phosphorus in plasma. In addition, calcitriol may Lees het volledige document