ROCALTROL CAP 0.25 mcg

Country: Jordan

Language: English

Source: JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

Active ingredient:

Calcitriol 0.25 mcg

Available from:

مستودع ادوية شاوي و رشيدات و مسنات - Shawi & Rushedat Drug Store

ATC code:

A11CC04

INN (International Name):

Calcitriol 0.25 mcg

Dosage:

0.25 mcg

Units in package:

100

Manufactured by:

CATALENT GERMANY EBERBACH GMBH/GERMANY (المانيا)

Product summary:

19.81 :سعر الجمهور + الضريبة

Patient Information leaflet

ROCALTROL
®
Calcitriol
1.
DESCRIPTION
1.1
THERAPEUTIC / PHARMACOLOGIC CLASS
OF DRUG
Biologically active form of vitamin D
3
.
ATC code: A11CC04.
1.2
TYPE OF DOSAGE FORM
Capsules containing 0.25 μg and 0.5 μg calcitriol.
1.3
ROUTE OF ADMINISTRATION
Oral.
1.4
QUALITATIVE AND QUANTITATIVE
COMPOSITION
_Active ingredient:_
synthetic calcitriol (biologically active form of
vitamin D
3
).
_Chemical names: _
1α, 25 - dihydroxycholecalciferol;
(5Z-/E)- 9, 10-secocholesta - 5, 7, 10 (19) -
triene - 1α, 3β, 25 - triol.
_Excipients:_
Butylhydroxyanisole, butylhydroxytoluene,
medium-chain triglycerides, gelatin, glycerol 85%,
hydrogenated products of partially hydrolyzed
starch, titanium dioxide (E 171), red and yellow
iron oxide (E 172).
2.
CLINICAL PARTICULARS
2.1
THERAPEUTIC INDICATION(S)
Established postmenopausal osteoporosis.
Renal osteodystrophy in patients with chronic renal
failure, particularly those undergoing hemodialysis.
Postsurgical hypoparathyroidism.
Idiopathic hypoparathyroidism.
Pseudohypoparathyroidism.
Vitamin D-dependent rickets.
Hypophosphatemic vitamin D-resistant rickets.
2.2
DOSAGE AND ADMINISTRATION
The optimal daily dose of Rocaltrol must be
carefully determined for each patient on the basis of
the serum calcium level. Rocaltrol therapy should
always be started at the lowest possible dose and
should not be increased without careful monitoring
of serum calcium
_(see below, Patient monitoring)._
A prerequisite for optimal effi cacy of Rocaltrol is
adequate but not excessive calcium intake at the
beginning of therapy. Calcium supplements may be
necessary and should be administered according to
local guidelines.
Because of improved calcium absorption from the
gastrointestinal tract, some patients on Rocaltrol
may be maintained on a lower calcium intake.
Patients who tend to develop hypercalcemia may
require only low doses of calcium or no
supplementation at all.
_Patient monitoring_
During the stabilization phase of treatment with
Rocaltrol, serum calcium levels should be checked
at least twice w