ERGOCALCIFEROL capsule, liquid filled

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Carilion Materials Management

INN (International Name):

ERGOCALCIFEROL

Sammensetning:

ERGOCALCIFEROL 1.25 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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.

Produkt oppsummering:

NDC:68151-0490-0 in a PACKAGE of 1 CAPSULE, LIQUID FILLEDS

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

ERGOCALCIFEROL - ERGOCALCIFEROL CAPSULE, LIQUID FILLED
CARILION MATERIALS MANAGEMENT
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VITAMIN D (ERGOCALCIFEROL CAPSULES, USP) 1.25 MG (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 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 D , is 9, 10-secoergosta-5, 7, 10
(19), 22-tetraen-3-ol,(3β,5Z,7E,22
)-; (C H O) with a molecular weight of 396.65, and has the following
structural formula:
_E_
Each capsule contains soybean oil. The capsule shell and/or band
contains FD and C Blue No.1, D and C
Yellow No.10,Sodium Lauryl Sulfate, Gelatin, Polysorbate 80, Benzyl
Alcohol, Methylparaben,
Butylparaben and Propylparaben. INACTIVE INGREDIENTS:
CLINICAL PHARMACOLOGY
The synthesis of the major biologically active metabolites of vitamin
D occurs in two steps. The first
2
22
2
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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. _in_
_vivo_
There is a time lag of 10 to 24 hours between the