ERGOCALCIFEROL- VITAMIN D2 capsule

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Advanced Rx Pharmacy of Tennessee, LLC

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

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

Produktsammanfattning:

Capsules of 1.25 mg (50,000 IU vitamin D) of ergocalciferol, USP are clear green oval softgel capsules filled with a clear to pale yellow Bottles of 12 Capsules NDC: 80425-0130-03 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. Manufactured by: Humanwell PuraCap Pharmaceutical Co Ltd. Wuhan, Hubei 430206, China Distributed by: Epic Pharma, LLC Laurelton, NY 11413 PI547102018E Distributed by: Advanced Rx Pharmacy of Tennessee LLC Nashville, TN 37211 Rev. 10-2018-00

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

ERGOCALCIFEROL (VITAMIN D2)- ERGOCALCIFEROL (VITAMIN D2) CAPSULE
ADVANCED RX PHARMACY OF TENNESSEE, LLC
----------
ERGOCALCIFEROL (VITAMIN D2) 1.25MG CAPSULES
DESCRIPTION SECTION
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 D2 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 D2 is equivalent to one International Unit
(IU), and 1 mcg of
vitamin D2 is equal to 40 IU.
Each capsule contains 1.25 mg (50,000 International Units vitamin D)
of ergocalciferol,
USP, in an edible vegetable oil.
Ergocalciferol, also called vitamin D2, is 9, 10-secoergosta-5, 7,
10(19), 22-tetraen-3-ol,
(3ß, 5Z, 7E, 22E)-; (C28H44O) with a molecular weight of 396.65, and
has the following
structural formula:
Inactive Ingredients: Butylated hydroxytoluene, D&C Yellow #10, FD&C
Blue #1, Gelatin,
Glycerin, Propylene Glycol, Shellac, Simethicone, Soybean oil and
Titanium Dioxide.
CLINCAL 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 du