CALCIPROX calcitriol 0.25 microgram capsule bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

calcitriol, Quantity: 0.25 microgram

Available from:

Strides Pharma Science Pty Ltd

INN (International Name):

Calcitriol

Pharmaceutical form:

Capsule, soft

Composition:

Excipient Ingredients: butylated hydroxyanisole; iron oxide red; purified water; Gelatin; iron oxide yellow; fractionated coconut oil; glycerol; sorbitol solution (70 per cent) (non-crystallising); butylated hydroxytoluene

Administration route:

Oral

Units in package:

100 capsules

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Calciprox is indicated for the treatment of established osteoporosis diagnosed by objective measuring techniques, such as densitometry, or by radiographic evidence of atraumatic fracture. Calciprox is also indicated for the prevention of corticosteroid-induced osteoporosis in patients commencing oral steroid therapy in a dose and regimen expected to result in a significant bone loss. Calciprox is indicated in the treatment of hypocalcemia in patients with uremic osteodystrophy, hypoparathyroidism and in hypophosphataemic rickets.

Product summary:

Visual Identification: Red coloured, oval, soft-gelatin capsules containing a clear, oily liquid.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2008-09-25

Patient Information leaflet

calcitriol 0.25 microgram capsules
Calciprox
™
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common
questions about Calciprox™ 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 Calciprox™ 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 Calciprox™ is used for
Calciprox™ 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.
Calciprox™ 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.
Calciprox™ 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.
Calciprox™ increases calcium
absorption in the intestine and
stimulates healthy bone growth.
There are many different types
of medicines used to treat bone
conditions. Calciprox™ belongs to a
group of medicines known as vitamin D
compounds.
Your doctor may have prescribed
Calciprox™ for another purpose. Ask
your doctor if you have any questions
why Calciprox™ has been prescribed
for you.
This medicine is available only with a
doctor’s prescription.
Calciprox™ is not addictive.
Before you take Calciprox™
When you must not take it
Do not take Calciprox™ if:

You have had an allergic reaction
to Calciprox™, calcitriol or any
ingredients listed in the Ingredients
section of this leaflet

You have high blood calcium levels
(hypercalcaemia)

You have vitamin D toxicity

Summary of Product characteristics

Page 1 of 11
PRODUCT INFORMATION
CALCIPROX
TM
CAPSULES
_ _
NAME OF THE MEDICINE
_ _
The active ingredient in CALCIPROX
TM
is Calcitriol._ _
The structural formula is:
CAS 32222-06-3
Chemical name:
(5_Z_,7_E_)-9,10-secocholesta-5,7,10(19)-triene-1α,3β,25-triol
(calcitriol)
Molecular formula: 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 and iron oxide
yellow.
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

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
Page 2 of 11
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 binds to an intracellular receptor, a member of the steroid
receptor superfa