KOSTEO calcitriol 0.25 microgram capsule bottle

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

calcitriol

Disponible desde:

Arrow Pharma Pty Ltd

Designación común internacional (DCI):

Calcitriol

Estado de Autorización:

Registered

Ficha técnica

KOSTEO – Product Information
Page 1 of 11
Kosteo
PRODUCT INFORMATION
NAME OF THE MEDICINE
Calcitriol
CAS 32222-06-3
The chemical name for calcitriol is 1,25-dihydroxycholecalciferol, the
molecular formula is C
27
H
44
O
3
.
Calcitriol has a molecular weight of 416.65.
DESCRIPTION
Calcitriol is a white, crystalline compound, which occurs naturally in
humans. It is soluble in organic
solvents but practically insoluble in water.
Kosteo is available as soft gelatin capsules containing 0.25
micrograms of calcitriol. Each capsule
also contains butylated hydroxyanisole, butylated hydroxytoluene,
medium chain triglyceride,
gelatin, glycerol, sorbitol (70 percent, non-crystallising), iron
oxide red CI77491 and iron oxide
yellow CI77492.
PHARMACOLOGY
PHARMACODYNAMICS
Calcitriol is the most important active metabolite of vitamin D
3
. It is normally formed in the kidney
from its precursor 25-hydroxycholecalciferol (25-HCC). Physiological
daily production is normally
0.5 - 1.0
µ
g and is somewhat higher during periods of increased bone synthesis
(eg growth or
pregnancy).
The natural supply of vitamin D in humans depends mainly on exposure
to ultraviolet rays of the
sun for conversion of 7-dehydrocholesterol in the skin to vitamin D
3
(cholecalciferol). Vitamin D
3
must be metabolically activated in the liver and the kidney before it
is fully active as a regulator of
calcium and phosphorus metabolism at target tissues. The initial
transformation of vitamin D
3
is
catalysed by a vitamin D
3
-25-hydroxylase enzyme (25-OHase) present in the liver, and the
product
of this reaction is 25-hydroxyvitamin D
3
[25-(OH) D
3
]. Hydroxylation of 25-(OH) D
3
occurs in the
KOSTEO – Product Information
Page 2 of 11
mitochondria of kidney tissue, activated by the renal
25-hydroxyvitamin D
3
-1 alpha-hydroxylase
(alpha-OHase), to produce 1,25-(OH)2 D
3
(calcitriol), the active form of vitamin D
3
.
Calcitriol binds to an intracellular receptor, a member of the steroid
receptor superfamily. The
calcitriol-receptor complex interacts with s