ERGOCALCIFEROL- ergocalciferol capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

KAISER FOUNDATION HOSPITALS

INN (International Name):

Ergocalciferol

Composition:

Ergocalciferol 1.25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Each green, oval softgel capsule is imprinted with A3 and contains 1.25 mg (50,000 USP units vitamin D) of ergocalciferol, USP. Bottles of 12 Softgel Capsules (NDC 0179-0204-12). Store at 20°– 25°C (68°–77°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
KAISER FOUNDATION HOSPITALS
----------
VITAMIN D,
ERGOCALCIFEROL
CAPSULES, USP,
1.25 MG SOFTGEL CAPSULES
(SOFT GELATIN CAPSULES)
(50,000 USP UNITS)
RX ONLY
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 softgel capsule, 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,5 _Z_,7 _E_,22
_E_)-; (C
H
O) with a molecular weight of 396.65, and has the following structural
formula:
INACTIVE INGREDIENTS: D&C Yellow #10, FD&C Blue #1, Gelatin, Glycerin,
Purified Water, Refined
Soybean Oil.
2
2
2
2
28
44
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-dihydroxy- vitamin 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 b