Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
ERGOCALCIFEROL (UNII: VS041H42XC) (ERGOCALCIFEROL - UNII:VS041H42XC)
Rising Pharamceuticals, Inc
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.
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 Rx only OS006-03 REV.1209
Abbreviated New Drug Application
ERGOCALCIFEROL- ERGOCALCIFEROL CAPSULE, LIQUID FILLED RISING PHARAMCEUTICALS, INC ---------- 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 The _in vivo _synthesis of the major biologically active metabolites of vitamin D occurs in two steps. The 2 2 2 2 28 44 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 admi Soma hati kamili