VITAMIN D- ergocalciferol capsule

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Preferred Pharmaceuticals, Inc.

INN (International ime):

ERGOCALCIFEROL

Sastav:

ERGOCALCIFEROL 1.25 mg

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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.

Proizvod sažetak:

Each softgel capsule contains Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units. The capsules are clear, dark green and oblong shaped, imprinted with “136” in white ink and are available as follows: Bottle of 12 - 68788-9256-2 Bottle of 100 - 68788-9256-1 Store at 20° - 25°C (68° - 77°F) excursions permitted between 15° - 30°C (59 - 86°F). (See USP Controlled Room Temperature). Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 6142T03 Rev. 11/2014 Repackaged By: Preferred Pharmaceuticals Inc.

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

VITAMIN D- ERGOCALCIFEROL CAPSULE
PREFERRED PHARMACEUTICALS, INC.
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DESCRIPTION
Ergocalciferol capsules, USP, is 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 IU.
Each capsule contains 1.25 mg (50,000 USP Units vitamin D) of
ergocalciferol, USP, 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:
The soft gelatin capsule and imprinting ink contain: ammonium
hydroxide, butyl alcohol, D&C Yellow
No. 10, FD&C Blue No. 1, gelatin, glycerin, isopropyl alcohol,
propylene glycol, purified water,
shellac glaze, 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
tubules.
There is a time lag of 10 to 24 hours between the administration of
vitamin D and the initiation of its
action in the body due to the necessity of synthesis