CALCITRIOL-PS

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

Calcitriol

Tilgængelig fra:

Scentia Pharmaceuticals Pty Ltd

Klasse:

Medicine Registered

Indlægsseddel

Calcitriol-PS CMI v4.docx v4 

Page 1 of 3 

CALCITRIOL-PS 
_calcitriol 0.25 µg _
_capsules _
_ _
_ _
CONSUMER  MEDICINE 
INFORMATION  

WHAT IS IN THIS LEAFLET 
This leaflet answers some common 
questions about Calcitriol-PS 
capsules.  
It does not contain all the available 
information.  
It does not take the place of talking 
to your doctor or pharmacist.  
All medicines have risks and 
benefits.  Your doctor has weighed 
the risks of you taking Calcitriol-
PS capsules against the benefits 
they expect it will have for you.  
IF YOU HAVE ANY CONCERNS ABOUT 
TAKING THIS MEDICINE, ASK YOUR 
DOCTOR OR PHARMACIST.  
KEEP THIS LEAFLET WITH THE 
MEDICINE.  You may need to read 
it again.  

WHAT CALCITRIOL-PS IS USED 
FOR 
Calcitriol-PS contains the active 
ingredient calcitriol, one of the 
naturally occurring and 
biologically active forms of 
Vitamin D.  Calcitriol acts in the 
body in a similar manner to 
Vitamin D. 
Calcitriol-PS is used to treat 
people with osteoporosis, a disease 
where the bones of the body 
weaken, and in the prevention of 
osteoporosis in people taking oral 
corticosteroids.  
Calcitriol-PS capsules are also 
prescribed for patients who have 
low blood calcium levels due to 
osteodystrophy (a type of bone 
disease), hypoparathyroidism (a 
condition where the parathyroid 
glands have decreased function) 
and rickets.  
Calcitriol-PS increases calcium 
absorption in the intestine and 
stimulates healthy bone growth.  
There are many different types of 
medicines used to treat bone 
conditions.  Calcitriol-PS belongs 
to a group of medicines known as 
vitamin D compounds.  
Your doctor may have prescribed 
Calcitriol-PS for another purpose.  
ASK YOUR DOCTOR IF YOU HAVE ANY 
QUESTIONS WHY CALCITRIOL-PS HAS 
BEEN PRESCRIBED FOR YOU.  
This medicine is available only 
with a doctor's prescription.  
Calcitriol-PS is not add

Produktets egenskaber

Calcitriol-PS PI v4 

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CALCITRIOL-PS 
_ _
_PRODUCT INFORMATION _

COMPOSITION:  
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.  

Calcitriol is available as soft gelatin capsules containing 0.25
micrograms of calcitriol.  Each 
capsule also contains butylated hydroxyanisole, butylated
hydroxytoluene, coconut oil - 
fractionated, 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 
μg 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 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-PS