Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
ERGOCALCIFEROL (UNII: VS041H42XC) (ERGOCALCIFEROL - UNII:VS041H42XC)
NuCare Pharmaceuticals, Inc.
ERGOCALCIFEROL
ERGOCALCIFEROL 1.25 mg
ORAL
PRESCRIPTION DRUG
Ergocalciferol is indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia. Ergocalciferol is contraindicated in patients with hypercalcemia, malabsorption syndrome, abnormal sensitivity to the toxic effects of vitamin D, and hypervitaminosis D.
Each green, oval softgel is imprinted with PA140 and contains 1.25 mg (50,000 USP units vitamin D) of ergocalciferol, USP, and is available in bottles of 8 NDC 68071-1951-8 bottles of 4 NDC 68071-1951-4 bottles of 12 NDC 68071-1951-2 Store at 25° C (77° F); excursions permitted to 15° - 30° C (59° - 86 ° F) [See USP Controlled Room Temperature.] Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP. Manufactured for: Bionpharma Inc. 600 Alexander Road Princeton, NJ 08540, USA Rev. 12/2015
Abbreviated New Drug Application
ERGOCALCIFEROL- ERGOCALCIFEROL CAPSULE, LIQUID FILLED NUCARE PHARMACEUTICALS, INC. ---------- ERGOCALCIFEROL CAPSULES, USP RX ONLY DESCRIPTION ERGOCALCIFEROL CAPSULES, USP, is 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 softgel, for oral administration, contains Ergocalciferol, USP 1.25 mg (equivalent to 50,000 USP units of Vitamin D), in an edible vegetable oil. Ergocalciferol, also called vitamin D , is 9,10-secoergosta-5,7,10(19),22-tetraen-3-ol,(3 _β_,5 _Z_,7 _E_,22 _E_)-; (C H O) with a molecular weight of 396.65, and has the following structural formula: INACTIVE INGREDIENTS: Refined soybean oil, gelatin, glycerin, purified water, D&C Yellow #10, and FD&C Blue #1. CLINICAL PHARMACOLOGY 2 2 2 2 28 44 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 phosphorous 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 i Прочитать полный документ