Ergocalciferol Information
Ergocalciferol ()
Ergocalciferol () 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 capsule, 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,(3β,5,7,22)-; (CHO) with a molecular weight of 396.65, and has the following structural formula:
Ergocalciferol () Clinical Pharmacology
The 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. Parathyroid hormone is responsible for the regulation of this metabolism in the kidneys.
Ergocalciferol () Indications And Usage
Ergocalciferol () Capsules, USP are indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.
Ergocalciferol () Contraindications
Ergocalciferol () Capsules, USP are contraindicated in patients with hypercalcemia, malabsorption syndrome, abnormal sensitivity to the toxic effects of vitamin D, and hypervitaminosis D.
Ergocalciferol () Warnings
Hypersensitivity to vitamin D may be one etiologic factor in infants with idiopathic hypercalcemia. In these cases vitamin D must be strictly restricted.
Keep out of the reach of children.
Ergocalciferol () Precautions
Vitamin D administration from fortified foods, dietary supplements, self-administered and prescription drug sources should be evaluated. Therapeutic dosage should be readjusted as soon as there is clinical improvement. Dosage levels must be individualized and great care exercised to prevent serious toxic effects. IN VITAMIN D RESISTANT RICKETS THE RANGE BETWEEN THERAPEUTIC AND TOXIC DOSES IS NARROW. When high therapeutic doses are used progress should be followed with frequent blood calcium determinations.
In the treatment of hypoparathyroidism, intravenous calcium, parathyroid hormone, and/or dihydrotachysterol may be required.
Maintenance of a normal serum phosphorous level by dietary phosphate restriction and/or administration of aluminum gels as intestinal phosphate binders in those patients with hyperphosphatemia as frequently seen in renal osteodystrophy is essential to prevent metastatic calcification.
Adequate dietary calcium is necessary for clinical response to vitamin D therapy.
Protect from light.
Ergocalciferol () Adverse Reactions
Hypervitaminosis D is characterized by effects on the following organ system:
Ergocalciferol () Overdosage
Hypervitaminosis D is characterized by:
The treatment of hypervitaminosis D with hypercalcemia consists of immediate withdrawal of the vitamin, a low calcium diet, generous intake of fluids, along with symptomatic and supportive treatment. Hypercalcemic crisis with dehydration, stupor, coma, and azotemia requires more vigorous treatment. The first step should be hydration of the patient. Intravenous saline may quickly and significantly increase urinary calcium excretion. A loop diuretic (furosemide or ethacrynic acid) may be given with the saline infusion to further increase renal calcium excretion. Other reported therapeutic measures include dialysis or the administration of citrates, sulfates, phosphates, corticosteroids, EDTA (ethylenediaminetetraacetic acid), and mithramycin via appropriate regimens. With appropriate therapy, recovery is the usual outcome when no permanent damage has occurred. Deaths via renal or cardiovascular failure have been reported.
The LD in animals is unknown. The toxic oral dose of Ergocalciferol () in the dog is 4 mg/kg.
Ergocalciferol () Dosage And Administration
THE RANGE BETWEEN THERAPEUTIC AND TOXIC DOSES IS NARROW.
DOSAGE MUST BE INDIVIDUALIZED UNDER CLOSE MEDICAL SUPERVISION.
Calcium intake should be adequate. Blood calcium and phosphorus determinations must be made every 2 weeks or more frequently if necessary. X-rays of the bones should be taken every month until condition is corrected and stabilized.
Ergocalciferol () How Supplied
Each green, oval softgel capsule is imprinted with A3 and contains 1.25 mg (50,000 USP units vitamin D) of Ergocalciferol () , USP.
Bottles of 100 Softgel Capsules (NDC 51991-604-01).
Ergocalciferol ()
Ergocalciferol () Principal Display Panel - . Mg Bottle Label
Vitamen D (Ergocalciferol () ) 1.25 mg equivalent to 50,000 USP Units.
One USP Unit of Vitamin D is equivalent to one International Unit (IU).
Store at controlled room temperature 20º-25ºC (68º-77ºF). [See USP Controlled Room Temperature] Protect from light. Protect from moisture.
Manufactured by: Swiss Caps AGKirchberg, SwitzerlandDistributed by: Breckenridge Pharmaceutical, Inc.Boca Raton, FL 33487
NDC# 51991-604
046301
Rev. 02/2011
