DECALCITROL- cholecalciferol tablet, coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)

Available from:

Pharmin USA, LLC

INN (International Name):

CHOLECALCIFEROL

Composition:

CHOLECALCIFEROL 50000 [iU]

Administration route:

ORAL

Authorization status:

Dietary Supplement

Summary of Product characteristics

DECALCITROL- CHOLECALCIFEROL TABLET, COATED
PHARMIN USA, LLC
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DECALCITROL CHOLECALCIFEROL (VITAMIN D3) 1.25 MG TABLETS (50,000
UNITS)
HIGH POTENCY SUPPLEMENT*
*WARNING: Cholecalciferol 50000 IU can be classified as either a
supplement or a medication in
accordance with regulations set by health ministries in different
countries. In USA, Cholecalciferol
50000 IU is a high potency supplement and SHOULD BE DISPENSED UNDER
DIRECT CLINICAL SUPERVISION.
DESCRIPTION
Decalcitrol (cholecalciferol-D3, Vitamin D3) is a fat-soluble high
potency vitamin that helps your body
absorb calcium and phosphorus.
Decalcitrol 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.
One Unit of vitamin D3 is equivalent to one International Unit (IU).
Each Tablet, for oral administration,
contains Cholecalciferol, 1.25 mg (equivalent to 50,000 USP units of
Vitamin D).
INACTIVE INGREDIENTS: Silica, magnesium stearate, cellulose,
hydroxypropyl methylcellulose
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 body due to the necessity of synthesis of the active
metabolites in the liver and kidneys.
INDICATIONS AND USAGE
Colecalciferol Tablets are essential for absorption of calcium and
necessary for healthy and strong
bones. Cholecalc