ROCALTROL CAPSULE 0.5 mcg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

CALCITRIOL

Available from:

ROCHE SINGAPORE PTE. LTD.

ATC code:

A11CC04

Dosage:

0.5 mcg

Pharmaceutical form:

CAPSULE

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

Catalent Germany Eberbach GmbH

Authorization date:

1990-05-23

Patient Information leaflet

Jun 2013 

1 
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 
Orally. 
1.4 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
_Active ingredient:_ synthetic calcitriol (biologically active form
of vitamin D
3
). 
_Chemical names:  _1

, 25 - dihydroxycholecalciferol; 

(5Z-/E)- 9, 10-secocholesta - 5, 7, 10 (19) - triene - 1

, 3

, 25 - triol._ _
Capsules 0.25 µg and 0.5 µg. 
_Excipients:_ 
Capsules:  Butylhydroxyanisol,  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 Patient monitoring)._ 
Jun 2013 

2 
A prerequisite for optimal efficacy of Rocaltrol is adequate but not excessive calcium intake at the 
beginning  of  therapy.  C