Zemplar Capsule 2mcg

Држава: Сингапур

Језик: Енглески

Извор: HSA (Health Sciences Authority)

Активни састојак:

Paricalcitol

Доступно од:

ABBVIE PTE. LTD.

АТЦ код:

H05BX02

Дозирање:

2mcg

Фармацеутски облик:

CAPSULE

Састав:

Paricalcitol 2mcg

Пут администрације:

ORAL

Тип рецептора:

Prescription Only

Произведен од:

Catalent Pharma Solutions, LLC

Статус ауторизације:

ACTIVE

Датум одобрења:

2007-11-13

Информативни летак

Page 1 of 16 
ZEMPLAR®  
(PARICALCITOL) CAPSULES

DESCRIPTION  

Paricalcitol, USP, the active
ingredient in Zemplar Capsules, is a
synthetically manufactured, 
metabolically active vitamin D analog of calcitriol with
modifications to the side chain (D2) and 
the A (19 
– nor) ring, indicated for the prevention and
treatment of secondary 
hyperparathyroidism in chronic kidney disease. Zemplar is available
as soft gelatin capsules for 
oral administration containing 1 microgram, 2 micrograms or 4 micrograms of paricalcitol. Each 
capsule also contains medium chain triglycerides, alcohol, and
butylated hydroxytoluene. The 
medium chain triglycerides
are fractionated from coconut oil or palm kernel oil. The capsule 
shell is composed of gelatin, glycerin, titanium dioxide, iron oxide
red (2 microgram capsules 
only), iron oxide yellow (2
microgram and 4 microgram capsules), iron oxide black (1 microgram 
capsules only), and water.   

Paricalcitol is a white, crystalline powder with
the empirical formula of C
27
H
44
O
3
, which 
corresponds to
a molecular weight of 416.64. Paricalcitol is chemically designated as 19-nor-1 
α,3β,25-trihydroxy-9,10-secoergosta-5(Z),7(E),22(E)-triene.  

PHARMACOLOGIC PROPERTIES 

PHARMACODYNAMIC PROPERTIES 

Secondary hyperparathyroidism is characterized by an elevation in
parathyroid hormone (PTH) 
associated with inadequate levels of active
vitamin D hormone. The source of vitamin D in the 
body is from synthesis in the skin as vitamin D
3
 and from dietary intake as either vitamin D
2

or 
D
3
. Both Vitamin D
2
 and D
3
 require two sequential hydroxylations
in the liver and the kidney to 
bind to and to activate the
vitamin D receptor (VDR). The endogenous VDR activator, calcitriol 
[1,25(OH)
2
D
3
], is a hormone that binds to VDRs

Карактеристике производа

Page 1 of 16
ZEMPLAR®
(PARICALCITOL) CAPSULES
DESCRIPTION
Paricalcitol, USP, the active ingredient in Zemplar Capsules, is a
synthetically manufactured,
metabolically active vitamin D analog of calcitriol with modifications
to the side chain (D2) and
the A (19 – nor) ring, indicated for the prevention and treatment of
secondary
hyperparathyroidism in chronic kidney disease. Zemplar is available as
soft gelatin capsules for
oral administration containing 1 microgram, 2 micrograms or 4
micrograms of paricalcitol. Each
capsule also contains medium chain triglycerides, alcohol, and
butylated hydroxytoluene. The
medium chain triglycerides are fractionated from coconut oil or palm
kernel oil. The capsule
shell is composed of gelatin, glycerin, titanium dioxide, iron oxide
red (2 microgram capsules
only), iron oxide yellow (2 microgram and 4 microgram capsules), iron
oxide black (1 microgram
capsules only), and water.
Paricalcitol is a white, crystalline powder with the empirical formula
of C
27
H
44
O
3
, which
corresponds to a molecular weight of 416.64. Paricalcitol is
chemically designated as 19-nor-1
α,3β,25-trihydroxy-9,10-secoergosta-5(Z),7(E),22(E)-triene.
PHARMACOLOGIC PROPERTIES
PHARMACODYNAMIC PROPERTIES
Secondary hyperparathyroidism is characterized by an elevation in
parathyroid hormone (PTH)
associated with inadequate levels of active vitamin D hormone. The
source of vitamin D in the
body is from synthesis in the skin as vitamin D
3
and from dietary intake as either vitamin D
2
or
D
3
. Both Vitamin D
2
and D
3
require two sequential hydroxylations in the liver and the kidney to
bind to and to activate the vitamin D receptor (VDR). The endogenous
VDR activator, calcitriol
[1,25(OH)
2
D
3
], is a hormone that binds to VDRs that are present in the parathyroid
gland,
intestine, kidney, and bone to maintain parathyroid function and
calcium and phosphorus
homeostasis, and to VDRs found in many other tissues, including
prostate, endothelium and
immune cells. VDR activation is essential for the proper format