KOSTEO calcitriol 0.25 microgram capsule blister pack

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

Werkstoffen:

calcitriol

Beschikbaar vanaf:

Arrow Pharma Pty Ltd

INN (Algemene Internationale Benaming):

Calcitriol

Autorisatie-status:

Registered

Bijsluiter

KOSTEO- Consumer Medicine Information
Page 1 of 3
Kosteo
Calcitriol
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about KOSTEO 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 KOSTEO
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 KOSTEO IS USED
FOR
KOSTEO 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.
KOSTEO 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.
KOSTEO 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.
KOSTEO increases calcium
absorption in the intestine and
stimulates healthy bone growth.
There are many different types of
medicines used to treat bone
conditions. KOSTEO belongs to a
group of medicines known as
vitamin D compounds.
Your doctor may have prescribed
this medicine for another purpose.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS WHY KOSTEO
HAS BEEN PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
KOSTEO is not addictive.
BEFORE YOU TAKE
KOSTEO
When you must not take it
DO NOT TAKE KOSTEO IF:
•
YOU HAVE HAD AN ALLERGIC
REACTION TO KOSTEO, CALCITRIOL
OR ANY INGREDIENTS LISTED IN THE
INGREDIENTS SECTION OF THIS
LEAFLET
•
YOU HAVE HIGH BLOOD CALCIUM
LEVELS (HYPERCALCAEMIA)
•
YOU HAVE VITAMIN D TOXICITY
•
YOU ARE BREASTFEEDING OR
WISH TO BREASTFEED.
KOST

Productkenmerken

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