DOXERCALCIFEROL capsule

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

DOXERCALCIFEROL (UNII: 3DIZ9LF5Y9) (DOXERCALCIFEROL - UNII:3DIZ9LF5Y9)

Доступна з:

American Health Packaging

ІПН (Міжнародна Ім'я):

DOXERCALCIFEROL

Склад:

DOXERCALCIFEROL 0.5 ug

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

Dialysis Patients Doxercalciferol is indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis. Pre-Dialysis Patients Doxercalciferol is indicated for the treatment of secondary hyperparathyroidism in patients with Stage 3 or Stage 4 chronic kidney disease. Doxercalciferol should not be given to patients with a tendency towards hypercalcemia or current evidence of vitamin D toxicity.

Огляд продуктів:

Doxercalciferol Capsules are supplied as a clear, oily solution encapsulated in oval shaped, soft gelatin capsules. The 0.5 mcg capsules are orange, opaque with "r" imprinted in black ink along one side of the capsule. Unit dose packages of 30 (5 x 6) NDC 68084-872-25 Storage Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] FOR YOUR PROTECTION: Do not use if blister is torn or broken. Made in India.

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

DOXERCALCIFEROL- DOXERCALCIFEROL CAPSULE
AMERICAN HEALTH PACKAGING
----------
DOXERCALCIFEROL CAPSULES
8287225/0617OS
RX ONLY
DESCRIPTION
Doxercalciferol, the active ingredient in Doxercalciferol Capsules, is
a synthetic vitamin D
analog
that undergoes metabolic activation _in vivo _to form
1α,25-dihydroxyvitamin D
(1α,25-(OH)
D
), a
naturally occurring, biologically active form of vitamin D
. Doxercalciferol Capsules are available as
a soft gelatin capsule containing 0.5 mcg or 2.5 mcg doxercalciferol.
Each capsule also contains
butylated hydroxyanisole (BHA), dehydrated alcohol, and medium chain
triglyceride. The capsule
shells contain D&C Yellow No. 10 (0.5 mcg and 2.5 mcg), FD&C Yellow
No. 6 (1 mcg only), FD&C
Red No. 40 (0.5 mcg only), gelatin, glycerin, Opacode Black, purified
water, and titanium dioxide.
Opacode Black contains ammonium hydroxide, iron oxide black, isopropyl
alcohol, N-butyl alcohol,
propylene glycol, and shellac.
Doxercalciferol is a colorless crystalline compound with a calculated
molecular weight of 412.66 and
a molecular formula of C
H
O
. It is soluble in oils and organic solvents, but is relatively
insoluble
in water. Chemically, doxercalciferol is
(1α,3β,5Z,7E,22E)-9,10-secoergosta-5,7,10(19),22-tetraene-
1,3-diol and has the following structural formula:
Other names frequently used for doxercalciferol are 1α-hydroxyvitamin
D
, 1α-OH-D
, and 1α-
hydroxyergocalciferol.
CLINICAL PHARMACOLOGY
Vitamin D levels in humans depend on two sources: (1) exposure to the
ultraviolet rays of the sun for
conversion of 7-dehydrocholesterol in the skin to vitamin D
(cholecalciferol) and (2) dietary intake of
either vitamin D
(ergocalciferol) or vitamin D
. Vitamin D
and vitamin D
must be metabolically
activated in the liver and the kidney before becoming fully active on
target tissues. The initial step in the
activation process is the introduction of a hydroxyl group in the side
chain at C-25 by the hepatic
enzyme, CYP 27 (α vitamin D-25-hydroxylase). The products of this
reaction are 25-(OH)