Vitamin D

Ergocalciferol Capsules, USP are contraindicated in patients with hypercalcemia, malabsorption syndrome, abnormal sensitivity to the toxic effects of vitamin D, and hypervitaminosis D.

• 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.
• General 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 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 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.
• Drug Interactions Mineral oil interferes with the absorption of fat-soluble vitamins, including vitamin D preparations.
• Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies have been performed to evaluate the drug's potential in these areas.
• Pregnancy Category C Animal 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 Mothers Caution should be exercised when Ergocalciferol Capsules, USP are administered to a nursing woman.
• Pediatric Use Pediatric doses must be individualized (see DOSAGE AND ADMINISTRATION ).
• Geriatric Use Clinical studies of Ergocalciferol Capsules, USP did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

• Caution should be exercised when Ergocalciferol Capsules, USP are 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 infant's serum calcium concentration is required in that case (Goldberg, 1972).

Mineral 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 Capsules, USP may cause hypercalcemia.

• The effects of administered vitamin D can persist for two or more months after cessation of treatment.
• Hypervitaminosis D is characterized by:
• Hypercalcemia with anorexia, nausea, weakness, weight loss, vague aches and stiffness, constipation, mental retardation, anemia, and mild acidosis.
• 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.
• Widespread calcification of the soft tissues, including the heart, blood vessels, renal tubules, and lungs.
• Bone demineralization (osteoporosis) in adults occurs concomitantly.
• Decline in the average rate of linear growth and increased mineralization of bones in infants and children (dwarfism).
• 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 50 in animals is unknown.
• The toxic oral dose of ergocalciferol in the dog is 4 mg/kg.