VITAMIN D- ergocalciferol capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aidarex Pharmaceuticals LLC

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 capsule contains Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units. The green colored oval shaped transparent soft gelatin capsules are imprinted with '194' in white and contain clear light yellow oily liquid. Store at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature]. Protect from light. Repackaged by Aidarex Pharmaceuticals, LLC Corona, CA 92880

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

VITAMIN D- ERGOCALCIFEROL CAPSULE
AIDAREX PHARMACEUTICALS LLC
----------
VITAMIN D (ERGOCALCIFEROL CAPSULES, USP)
1.25MG (50,000 USP UNITS)
EACH CAPSULE CONTAINS VITAMIN D (ERGOCALCIFEROL) 1.25 MG EQUIVALENT TO
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 USP Units.
Each capsule contains Vitamin D (Ergocalciferol) 1.25 mg equivalent to
50,000 USP Units 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:
INACTIVE INGREDIENTS: FD&C Blue #1, FD&C Yellow #5, Gelatin, Glycerin,
Lecithin, Medium chain
triglyceride, Purified water, Shellac glaze, N-Butyl alcohol,
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
2
2
2
2
28
44
tubules.
There is a time lag of 10 to 24 ho