VITAMIN D- ergocalciferol capsule

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

ERGOCALCIFEROL (UNII: VS041H42XC) (ERGOCALCIFEROL - UNII:VS041H42XC)

Tillgänglig från:

Preferred Pharmaceuticals Inc.

INN (International namn):

ERGOCALCIFEROL

Sammansättning:

ERGOCALCIFEROL 1.25

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Ergocalciferol Capsules, USP are indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia. Ergocalciferol Capsules, USP are contraindicated in patients with hypercalcemia, malabsorption syndrome, abnormal sensitivity to the toxic effects of vitamin D, and hypervitaminosis D.

Produktsammanfattning:

Each capsule contains Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units. The green colored oval shaped transparent soft gelatin capsules are imprinted with '194' in white and contain clear light yellow oily liquid. Bottles of 14 capsules (NDC: 68788-6409-2) Bottles of 100 capsules (NDC: 68788-6409-1) Store at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature]. Protect from light. Manufactured By Strides Arcolab Limited Bangalore-560076, India Distributed by: Strides Pharma Inc 201 South Main Street, Suite 3 Lambertville, NJ 08530 USA (06-2014) Repackaged By: Preferred Pharmaceuticals Inc.

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

VITAMIN D- ERGOCALCIFEROL CAPSULE
PREFERRED PHARMACEUTICALS INC.
----------
VITAMIN D (ERGOCALCIFEROL CAPSULES, USP)
1.25MG (50,000 USP UNITS)
EACH CAPSULE CONTAINS VITAMIN D (ERGOCALCIFEROL) 1.25 MG EQUIVALENT TO
50,000 USP UNITS.
DESCRIPTION
Ergocalciferol Capsules, USP are a synthetic calcium regulator for
oral administration.
Ergocalciferol is a white, colorless crystal, insoluble in water,
soluble in organic solvents, and slightly
soluble in vegetable oils. It is affected by air and by light.
Ergosterol or provitamin D is found in
plants and yeast and has no antirachitic activity.
There are more than 10 substances belonging to a group of steroid
compounds, classified as having
vitamin D or antirachitic activity.
One USP unit of vitamin D is equivalent to one International Unit
(IU), and 1 mcg of vitamin D is equal
to 40 USP Units.
Each capsule contains Vitamin D (Ergocalciferol) 1.25 mg equivalent to
50,000 USP Units in an edible
vegetable oil.
Ergocalciferol, also called vitamin D , is
9,10-secoergosta-5,7,10(19), 22-tetraen-3-ol,
(3β,5Z,7E,22_E_)-; (C
H O) with a molecular weight of 396.65, and has the following
structural
formula:
_INACTIVE INGREDIENTS:_ 2-Ethoxyethanol, FD&C Blue #1, FD&C Yellow #5,
Gelatin, Glycerin, Lecithin,
Medium chain triglyceride, Purified water, Shellac glaze (modified) IN
SD-45, Simethicone, Soybean
oil and Titanium dioxide.
CLINICAL PHARMACOLOGY
The in vivo synthesis of the major biologically active metabolites of
vitamin D occurs in two steps. The
first hydroxylation of ergocalciferol takes place in the liver (to
25-hydroxyvitamin D) and the second in
the kidneys (to 1, 25-dihydroxyvitamin D). Vitamin D metabolites
promote the active absorption of
calcium and phosphorus by the small intestine, thus elevating serum
calcium and phosphate levels
sufficiently to permit bone mineralization. Vitamin D metabolites also
mobilize calcium and phosphate
from bone and probably increase the reabsorption of calcium and
perhaps also of phosphate by the renal
2
2
2
2
28
44
tubules.
There is