Alfost 1.0mcg (Alfacalcidol Capsule)

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

ALFACALCIDOL

Available from:

UNIMED SDN BHD

INN (International Name):

ALFACALCIDOL

Units in package:

100 Capsules

Manufactured by:

XL Laboratories Pvt. Ltd.

Patient Information leaflet

ALFOST 0.25MCG & 1.0MCG
Alfacalcidol Capsules
1
_Consumer Medication Information Leaflet (RIMUP) _
WHAT IS IN THIS LEAFLET
1.
What Alfost is used for
2.
How Alfost works
3.
Before you use Alfost
4.
How to use Alfost
5.
While you are using it
6.
Side effects
7.
Storage and disposal of Alfost
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT ALFOST IS USED FOR
Alfost contains Alfacalcidol and belongs
to a group of medicines called vitamin D
analogues. It is a type of vitamin D.
Vitamin D controls the levels of two
substances
in
your
body.
These
substances
are
called
calcium
and
phosphate.
Your
body
needs
both
of
these substances for healthy bones and
teeth.
•
Low levels of calcium in the blood of
newborn babies (hypocalcaemia).
•
Softening and deformity of the bones
due
to
lack
of
calcium
(rickets
or
osteomalacia).
•
Disorders of the parathyroid glands
(Hypoparathyroidism)
•
Decrease in bone mass and density
(Osteoporosis)
•
Kidney bone
disease
(Osteodystrophy)
HOW ALFOST WORKS
Alfacalcidol works by increasing the
amount of vitamin D in your body. This
means the levels of calcium and
phosphate in your body will increase
too.
Alfacalcidol
is
used
to
treat
diseases
where the amount of calcium in your
body needs changing. It is used to treat:
•
Changes
in
bone
caused
by kidney
failure (osteodystrophy).
•
Changes to your parathyroid glands.
These are small glands found in your
neck. They make a substance called the
parathyroid hormone. This changes the
amount of calcium in your body.
•
The glands may make the amount of
calcium
in
your
blood
too
high.
(hyperparathyroidism).
•
The glands may make the amount of
calcium
in
your
blood
too
low
(hypoparathyroidism).
BEFORE YOU USE ALFOST
_-When you must not take it_
•
If
you
are
allergic
(hypersensitive)
to
alfacalcidol or any of the other ingredients.
•
If
you
know
you
have
a
condition
called hypercalcaemia. This means you
have
high
levels
of
calcium
in
your
blood.
•
If you know that you have a condition

Summary of Product characteristics

Size: 165x120 mm
COMPOSITION
Each soft gelatin capsule contains:
Alfacalcidol BP 0.25mcg
Each soft gelatin capsule contains:
Alfacalcidol BP 0.5mcg
Each soft gelatin capsule contains:
Alfacalcidol BP 1.0mcg
PHARMACOLOGICAL PROPERTIES:
PHARMACODYNAMIC PROPERTIES:
Pharmacotherapeutic group: Vitamin D and analogues, ATC code A11CC03.
Alfacalcidol is converted rapidly in the liver to
1,25-dihydroxyvitamin D. This is the metabolite of vitamin D which
acts as
a regulator of calcium and phosphate metabolism. Since this conversion
is rapid, the clinical effects of Alfacalcidol
Capsules and 1,25-dihydroxyvitamin D are very similar.
Impaired 1α-hydroxylation by the kidneys reduces endogenous
1,25-dihydroxyvitamin D production. This contributes to
the disturbances in mineral metabolism found in several disorders,
including renal bone disease, hypoparathyroidism,
neonatal hypocalcaemia and vitamin D dependent rickets. These
disorders, which require high doses of parent vitamin D
for their correction, will respond to small doses of Alfacalcidol
Capsules.
The delay in response and high dosage required in treating these
disorders with parent vitamin D makes dosage adjustment
difficult. This can result in unpredictable hypercalcaemia which may
take weeks or months to reverse. The major advantage
of Alfacalcidol Capsules is the more rapid onset of response, which
allows a more accurate titration of dosage. Should
inadvertent hypercalcaemia occur it can be reversed within days of
stopping treatment.
PHARMACOKINETIC PROPERTIES:
In patients with renal failure, 1-5 µg/day of 1α-hydroxyvitamin D
(1α-OHD3) increased intestinal calcium and phosphorus
absorption in a dose-related manner. This effect was observed within
3 days of starting the drug and conversely, it was
reversed within 3 days of its discontinuation.
In patients with nutritional osteomalacia, increases in calcium
absorption were noted within 6 hours of giving 1 µg 1α-
OHD3 orally and usually peaked at 24 hours. 1α-OHD3 also produced
increases in plasma inorganic p