Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
ERGOCALCIFEROL (UNII: VS041H42XC) (ERGOCALCIFEROL - UNII:VS041H42XC)
Carilion Materials Management
ERGOCALCIFEROL
ERGOCALCIFEROL 1.25 mg
ORAL
PRESCRIPTION DRUG
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.
NDC:68151-0490-0 in a PACKAGE of 1 CAPSULE, LIQUID FILLEDS
Abbreviated New Drug Application
ERGOCALCIFEROL - ERGOCALCIFEROL CAPSULE, LIQUID FILLED CARILION MATERIALS MANAGEMENT ---------- 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 )-; (C H O) with a molecular weight of 396.65, and has the following structural formula: _E_ 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. INACTIVE INGREDIENTS: CLINICAL PHARMACOLOGY The synthesis of the major biologically active metabolites of vitamin D occurs in two steps. The first 2 22 2 2844 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. _in_ _vivo_ There is a time lag of 10 to 24 hours between the Lugege kogu dokumenti