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|Vitamin D Ergocalciferol |
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ERGOCALCIFEROL CAPSULES, USP, is a synthetic calcium regulator for oral administration. Vitamin D Ergocalciferol - Clinical Pharmacology
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. Indications and Usage for Vitamin D ErgocalciferolErgocalciferol is indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia. ContraindicationsErgocalciferol is contraindicated in patients with hypercalcemia, malabsorption syndrome, abnormal sensitivity to the toxic effects of vitamin D, and hypervitaminosis D.Warnings
Hypersensitivity to vitamin D may be one etiologic factor in infants with idiopathic
hypercalcemia. In these cases vitamin D must be strictly restricted. PrecautionsGeneralVitamin 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 dihy-drotachysterol 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 metastatis calcification. Adequate dietary calcium is necessary for clinical response to vitamin D therapy. Protect from light. Drug InteractionsMineral oil interferes with the absorption of fat-soluble vitamins, including vitamin D preparations.Administration of thiazide diuretics to hypoparathyroid patients who are concurrently being treated with ergocalciferol may cause hypercalcemia. Carcinogenesis, Mutagenesis, Impairment of FertilityNo long-term animal studies have been performed to evaluate the drug"s potential in these areas.PregnancyPregnancy Category CAnimal reproduction studies have shown fetal abnormalities in several species associated with hypervitaminosis D. These are similar to the supravalvular aortic stenosis syndrome described in infants by Black in England (1963). This syndrome was characterized by supravalvular aortic stenosis, elfin facies, and mental retardation. For the protection of the fetus, therefore, the use of vitamin D in excess of the recommended dietary allowance during normal pregnancy should be avoided unless, in the judgment of the physician, potential benefits in a specific, unique case outweigh the significant hazards involved. The safety in excess of 400 USP units of vitamin D daily during pregnancy has not been established. Nursing MothersCaution should be exercised when ergocalciferol is administered to a nursing woman. In a mother given large doses of vitamin D, 25-hydroxycholecalciferol appeared in the milk and caused hypercalcemia in her child. Monitoring of the infants serum calcium concentration is required in that case (Goldberg, 1972).Pediatric UsePediatric doses must be individualized (see DOSAGE AND ADMINISTRATION).Adverse ReactionsHypervitaminosis D is characterized by effects on the following organ system:Renal:Impairment of renal function with polyuria, nocturia, polydipsia, hypercalciuria, reversible azotemia, hypertension, nephrocalcinosis, generalized vascular calcification, or irreversible renal insufficiency which may result in death. CNS:Mental retardation. Soft Tissues:Widespread calcification of the soft tissues, including the heart, blood vessels, renal tubules, and lungs. Skeletal:Bone demineralization (osteoporosis) in adults occurs concomitantly. Gastrointestinal:Nausea, anorexia, constipation. Metabolic:Mild acidosis, anemia, weight loss. Vitamin D Ergocalciferol Dosage and AdministrationTHE RANGE BETWEEN THERAPEUTIC AND TOXIC DOSES IS NARROW.Vitamin D Resistant Rickets:12,000 to 500,000 USP units daily. Hypoparathyroidism:
50,000 to 200,000 USP units daily concomitantly with calcium lactate 4 g, six
times per day. OverdosageThe effects of administered vitamin D can persist for two or more months after cessation of treatment.Hypervitaminosis D is characterized by:
The LD50 in animals is unknown. The toxic oral dose of ergocalciferol in the dog is 4 mg/kg. How is Vitamin D Ergocalciferol SuppliedEach 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 100 or 1000 Softgels. Store at controlled room temperature 15°-30°C (59°-86°F). Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP. Manufactured by
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