Country: United States
Language: English
Source: NLM (National Library of Medicine)
ergocalciferol (UNII: VS041H42XC) (ergocalciferol - UNII:VS041H42XC)
SigmaPharm Laboratories, LLC
ergocalciferol
ergocalciferol 1.25 mg
ORAL
PRESCRIPTION DRUG
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 D2 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 D2 is equivalent to one International Unit (IU), and 1 mcg of vitamin D2 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 D2, is 9, 10-secoergosta-5, 7, 10 (19), 22-tetraen-3-ol,(3β,5Z,7E,22E)-; (C28H44O) with a molecular weight of 396.65, and has the following structural formula:
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 42794-006-02). Store at 20° - 25° C (68° - 77° F); excursions permitted between 15° - 30°C (59° - 86°F) [see USP Controlled Room Temperature]. Sigmapharm Laboratories, LLC Bensalem, PA 19020 Rx only OS006-04 REV.0311
Abbreviated New Drug Application
ERGOCALCIFEROL - ERGOCALCIFEROL CAPSULE, LIQUID FILLED SIGMAPHARM LABORATORIES, LLC ---------- 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 D2 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 D2 is equivalent to one International Unit (IU), and 1 mcg of vitamin D2 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 D2, is 9, 10-secoergosta-5, 7, 10 (19), 22-tetraen-3- ol,(3β,5Z,7E,22E)-; (C28H44O) 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&C Blue No. 1, D&C Yellow No. 10, Sodium Lauryl Sulfate, Gelatin, Polysorbate 80, Benzyl Alcohol, Methylparaben, Butylparaben and Propylparaben. 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 tubules. There is a time lag of 10 to 24 hours between the administration of Read the complete document