ROCALTROL 0,25 ug CAPSULES

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Pharmaco Distribution (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

CAPSULES

Composition:

EACH CAPSULE CONTAINS CALCITRIOL 0,25 ug

Authorization status:

Registered

Authorization date:

1980-07-06

Patient Information leaflet

Page 1 of 7
SCHEDULING STATUS
S4
PROPRIETARY NAME, STRENGTH AND DOSAGE FORM
ROCALTROL
® 0,25 ΜG (calcitriol 0,25 µg capsule)
ROCALTROL
® 0,50 ΜG (calcitriol 0,50 µg capsule)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING ROCALTROL
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
ROCALTROL has been prescribed for you personally and you should not
share your medicine with
other people. It may harm them, even if their symptoms are the same as
yours.
1.
WHAT DOES ROCALTROL CONTAIN?
The active substance is calcitriol.
The other ingredients are: butylhydroxyanisole, butylhydroxytoluene,
medium-chain triglycerides.
Composition of capsule shell: gelatin, glycerol, mannitol, sorbitol,
starch, red and yellow iron oxide E172,
titanium dioxide E171.
2. WHAT ROCALTROL IS USED FOR?
ROCALTROL contains a medicine called calcitriol. This belongs to a
group of medicines called ‘vitamin D
metabolites’.
ROCALTROL is used to treat the following:
Bone disease in people with kidney problems (renal osteodystrophy).
Weakening of the bones in women after the menopause (change of life).
This is also known as post-menopausal
osteoporosis.
ROCALTROL works by making your body absorb more calcium from your
diet. This helps to form healthy bones
and reduce bone damage.
Page 2 of 7
3.
BEFORE TAKING ROCALTROL
DO NOT TAKE ROCALTROL IF:
•
You are allergic (hypersensitive) to calcitriol or any of the other
ingredients of ROCALTROL (listed in
Section 1 above), or to other ‘vitamin D metabolite’ medicines
(used to treat bone disease). These
include alfacalcidol and colecalciferol.
•
You have extra deposits of calcium in your body (metastatic
calcification).
•
You have high levels of calcium in your blood (hypercalcaemia).
•
You are unwell because of high levels of vitamin D in your body.
TAKE SPECIAL CARE WITH ROCALTROL:
•
If you are finding it difficult to move about (for example, after an
operation).
TAKING ROCALTROL WITH FOOD AND DRINK:

Summary of Product characteristics

Page 1 of 10
SCHEDULING STATUS
S4
PROPRIETARY NAME AND DOSAGE FORM
ROCALTROL
®
0,25 µg (capsules)
ROCALTROL
®
0,50 µg (capsules)
COMPOSITION
Each ROCALTROL
®
0,25 µg capsule contains 0,25 µg calcitriol.
Each ROCALTROL
®
0,50 µg capsule contains 0,50 µg calcitriol.
Excipients of capsule contents: butylhydroxyanisole,
butylhydroxytoluene, medium-chain triglycerides.
Composition of capsule shell: gelatin, glycerol, sorbitol, mannitol,
starch, titanium dioxide E171, red and yellow iron
oxide E172.
PHARMACOLOGICAL CLASSIFICATION
A 22.1.4 Vitamin.
PHARMACOLOGICAL ACTION
PHARMACODYNAMIC PROPERTIES
Calcitriol is the most active known form of vitamin D
3
in stimulating intestinal calcium transport and osteoblastic
activity in the skeleton.
The biological effects of calcitriol are mediated via the vitamin D
receptor.
The two known sites of action of calcitriol are the intestine and
bone, but additional evidence suggests that it also
acts on the kidney and the parathyroid gland.
PHARMACOKINETIC PROPERTIES
_Absorption: _
Peak plasma concentrations following a single oral dose of 0,25 to 1,0
µg of calcitriol were reached within 2 to
6 hours.
Page 2 of 10
_Metabolism: _
Calcitriol is hydroxylated and oxidised in the kidney and in the liver
by specific cytochrome P450 isoenzyme,
CYP24A1.
Several metabolites with different degrees of vitamin D activity have
been identified.
_Elimination: _
The elimination half-life of calcitriol in plasma ranges between 5 to
8 hours. The elimination and absorption
kinetics of calcitriol remain linear. Calcitriol is excreted in the
bile and may undergo an enterohepatic circulation.
_Pharmacokinetics in special clinical situations: _
In patients with nephrotic syndrome or in those undergoing
haemodialysis, serum levels of calcitriol were
reduced and time to peak levels was prolonged.
INDICATIONS
•
As
an
adjunct
treatment
of
established
post-menopausal
osteoporosis
where
hormones
or
bisphosphonates cannot be used.
•
Renal bone disease (renal osteodystrophy) such as in chronic renal
f