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:

ReadyMeds

INN (International Name):

ERGOCALCIFEROL

Composition:

ERGOCALCIFEROL 1.25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Capsules of 1.25 mg (50,000 USP Units vitamin D) of ergocalciferol, USP are transparent green banded capsules, imprinted with “Σ 6” on the cap and body. Bottles of 100 capsules (NDC 64980-157-01). Store at 20° - 25° C (68° - 77° F); excursions permitted between 15° - 30°C (59° - 86°F) [see USP Controlled Room Temperature]. Manufactured for: Rising Pharmaceuticals, Inc 3 Pearl Court Allendale, NJ 07401 Manufactured by: Sigmapharm Laboratories, LLC Bensalem, PA 19020 ReadyMeds Dothan, AL 36301 Rx only OS006-03 REV.1209

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ERGOCALCIFEROL - ERGOCALCIFEROL CAPSULE, LIQUID FILLED
READYMEDS
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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_E_)-; (C
H O) with a molecular weight of 396.65, and has the following
structural
formula:
INACTIVE INGREDIENTS: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.
CLINICAL PHARMACOLOGY
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2
2
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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
vit