ROCALTROL ORAL SOLUTION 1MCG/ML

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

CALCITRIOL

Disponível em:

HOFFMANN-LA ROCHE LIMITED

Código ATC:

A11CC04

DCI (Denominação Comum Internacional):

CALCITRIOL

Dosagem:

1MCG

Forma farmacêutica:

SOLUTION

Composição:

CALCITRIOL 1MCG

Via de administração:

ORAL

Unidades em pacote:

10 ML

Tipo de prescrição:

Prescription

Área terapêutica:

VITAMIN D

Resumo do produto:

Active ingredient group (AIG) number: 0113628002; AHFS:

Status de autorização:

CANCELLED POST MARKET

Data de autorização:

2013-06-24

Características técnicas

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
_ _
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_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