Vitamin D Information
Vitamin d (Cholecalciferol (vitamin d3))
Vitamin d (Cholecalciferol (vitamin d3)) 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 (Cholecalciferol (vitamin d3)) 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 (Cholecalciferol (vitamin d3)) or antirachitic activity.
One USP unit of Vitamin d (Cholecalciferol (vitamin d3)) is equivalent to one International Unit (IU), and 1 mcg of Vitamin d (Cholecalciferol (vitamin d3)) is equal to 40 USP Units.
Each capsule contains Vitamin d (Cholecalciferol (vitamin d3)) (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units in an edible vegetable oil.
Ergocalciferol, also called Vitamin d (Cholecalciferol (vitamin d3)) , is 9,10-secoergosta-5,7,10(19), 22-tetraen-3-ol, (3β,5Z,7E,22)-; (CHO) with a molecular weight of 396.65, and has the following structural formula:
Vitamin d (Cholecalciferol (vitamin d3)) Clinical Pharmacology
The in vivo synthesis of the major biologically active metabolites of Vitamin d (Cholecalciferol (vitamin d3)) occurs in two steps. The first hydroxylation of ergocalciferol takes place in the liver (to 25-hydroxyVitamin d (Cholecalciferol (vitamin d3)) ) and the second in the kidneys (to 1,25-dihydroxyVitamin d (Cholecalciferol (vitamin d3)) ). Vitamin d (Cholecalciferol (vitamin d3)) 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 (Cholecalciferol (vitamin d3)) 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.
Vitamin d (Cholecalciferol (vitamin d3)) Indications And Usage
Ergocalciferol Capsules, USP are indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as Vitamin d (Cholecalciferol (vitamin d3)) resistant rickets, and familial hypophosphatemia.
Vitamin d (Cholecalciferol (vitamin d3)) Contraindications
Ergocalciferol Capsules, USP are contraindicated in patients with hypercalcemia, malabsorption syndrome, abnormal sensitivity to the toxic effects of Vitamin d (Cholecalciferol (vitamin d3)) , and hypervitaminosis D.
Vitamin d (Cholecalciferol (vitamin d3)) Warnings
Hypersensitivity to Vitamin d (Cholecalciferol (vitamin d3)) may be one etiologic factor in infants with idiopathic hypercalcemia. In these cases Vitamin d (Cholecalciferol (vitamin d3)) must be strictly restricted.
Keep out of the reach of children.
Vitamin d (Cholecalciferol (vitamin d3)) Precautions
Vitamin d (Cholecalciferol (vitamin d3)) 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 (Cholecalciferol (vitamin d3)) 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 phosphorus 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 (Cholecalciferol (vitamin d3)) therapy.
This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.
Protect from light.
Mineral oil interferes with the absorption of fat-soluble vitamins, including Vitamin d (Cholecalciferol (vitamin d3)) preparations.
Administration of thiazide diuretics to hypoparathyroid patients who are concurrently being treated with Ergocalciferol Capsules, USP may cause hypercalcemia.
Vitamin d (Cholecalciferol (vitamin d3)) Adverse Reactions
Hypervitaminosis D is characterized by effects on the following organ system:
Decline in the average rate of linear growth and increased mineralization of bones in infants and children (dwarfism) vague aches, stiffness, and weakness.
Vitamin d (Cholecalciferol (vitamin d3)) Overdosage
Hypervitaminosis D is characterized by:
The treatment of hypervitaminosis D with hypercalcemia consists in 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.
Vitamin d (Cholecalciferol (vitamin d3)) 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.
Vitamin d (Cholecalciferol (vitamin d3)) How Supplied
Each capsule contains Vitamin d (Cholecalciferol (vitamin d3)) (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units. The green colored oval shaped transparent soft gelatin capsules are imprinted with '194' in white and contain clear light yellow oily liquid.
Bottles of 50 capsules (NDC 0574-0194-50).
Bottles of 100 capsules (NDC 0574-0194-01).
Vitamin d (Cholecalciferol (vitamin d3))
Vitamin d (Cholecalciferol (vitamin d3)) Principal Display Panel - . Mg Capsule Bottle
NDC 0574-0194-50
*Each capsule contains Vitamin d (Cholecalciferol (vitamin d3)) (Ergocalciferol)1.25 mg equivalent to 50,000 USP Units
50 Capsules
