Ergocalciferol
Ergocalciferol Prescribing Information
Ergocalciferol is indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.
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 phosphorous 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 is contraindicated in patients with hypercalcemia, malabsorption syndrome, abnormal sensitivity to the toxic effects of vitamin D, and hypervitaminosis D.
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.
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 may cause hypercalcemia.
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
2is 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
2is equivalent to one International Unit (IU), and 1 mcg of vitamin D
2is equal to 40 IU.
Each softgel, for oral administration, contains Ergocalciferol, USP 1,250 mcg (equivalent to 50,000 USP units of Vitamin D), in an edible vegetable oil.
Ergocalciferol, also called vitamin D
2, is 9,10-secoergosta-5,7,10(19),22-tetraen-3-ol,(3
28H
44O) with a molecular weight of 396.65, and has the following structural formula:
