ERGOCALCIFEROL capsule, liquid filled

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Ergocalciferol (UNII: VS041H42XC) (Ergocalciferol - UNII:VS041H42XC)

Available from:

Banner Life Sciences LLC.

INN (International Name):

Ergocalciferol

Composition:

Ergocalciferol 1.25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Each green, oval softgel is imprinted with PA140 and contains 1.25 mg (50,000 USP units vitamin D) of ergocalciferol, USP, and is available in bottles of 100 (69387-106-01) Softgels. Store at 25° C (77° F); excursionns permitted to 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ERGOCALCIFEROL- ERGOCALCIFEROL CAPSULE, LIQUID FILLED
BANNER LIFE SCIENCES LLC.
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ERGOCALCIFEROL CAPSULES, USP
RX ONLY
DESCRIPTION
ERGOCALCIFEROL CAPSULES, USP, is a synthetic calcium regulator for
oral administration.
Ergocalciferol is a white, colorless crystal, insoluble in water,
soluble inorganic 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 softgel, for oral administration, contains Ergocalciferol, USP
1.25 mg (equivalent to 50,000 USP
units of Vitamin D), 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,22E)-;
(C
H O) with a molecular weight of 396.65, and has the following
structural formula:
INACTIVE INGREDIENTS : Refined soybean oil, gelatin, glycerin,
purified water, D&C Yellow #10, and
FD&C Blue #1.
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 phosphorous by the small intestine, thus elevating serum
calcium and phosphate levels
sufficiently to permit bone mineralization. Vitamin D metabolites also
mobilize calcium and phosphate
2
2
2
2
28
44
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 of the active
metabolites in the liver and