SICAL calcitriol 0.25 microgram capsule bottle

Negara: Australia

Bahasa: Inggris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

calcitriol

Tersedia dari:

Alphapharm Pty Ltd

INN (Nama Internasional):

Calcitriol

Status otorisasi:

Registered

Selebaran informasi

SICAL
®
_contains the active ingredient calcitriol_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Sical 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 Sical 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 YOUR
MEDICINE.
You may need to read it again.
WHAT SICAL IS USED FOR
Sical 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.
Sical 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.
Sical 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.
Sical increases calcium absorption in
the intestine and stimulates healthy
bone growth.
There are many different types of
medicines used to treat bone
conditions. Sical belongs to a group
of medicines known as vitamin D
compounds.
Your doctor may have prescribed
Sical for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS WHY SICAL HAS BEEN
PRESCRIBED FOR YOU.
This medicine is available only with
a doctor's prescription.
Sical is not addictive.
BEFORE YOU TAKE SICAL
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE SICAL IF:
•
YOU HAVE HAD AN ALLERGIC
REACTION TO SICAL, 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.
Sical may pass into the breastmilk
and have

Karakteristik produk

SICAL
_Calcitriol _
PRODUCT INFORMATION
NAME OF THE MEDICINE
Active ingredient
:
Calcitriol
Chemical name
:
(5Z,7E)-9,10-secocholesta-5,7,10(19)-triene-1α,3β,25-triol
Structural formula
:
Molecular formula
:
C
27
H
44
O
3
Molecular weight
:
416.65
CAS Registry no.
:
32222-06-3
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 solution
(70 percent, non-crystallising), iron oxide red, iron oxide yellow and
purified water.
PHARMACOLOGY
PHARMACODYNAMICS
MECHANISM OF ACTION
The biological effects of calcitriol are mediated by the vitamin D
receptor, a nuclear hormone receptor expressed
in most cell types and functioning as a ligand-activated transcription
factor that binds to specific DNA sites to
modify the expression of target genes.
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

g and is
somewhat higher during periods of increased bone synthesis (e.g.
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
Sical - Product Information
3
(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 tiss