vitamin D 50000 UNT Oral Capsule [Drisdol]
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.
DRUG INTERACTIONS
Drug Interactions 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 DRISDOL may cause hypercalcemia.
OVERDOSAGE
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.
DESCRIPTION
DRISDOL, brand of 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 D2 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 2 is equivalent to one International Unit (IU), and 1 mcg of vitamin D 2 is equal to 40 IU.
Each capsule contains 1.25 mg (50,000 International Units vitamin D) of ergocalciferol, USP, in an edible vegetable oil.
Ergocalciferol, also called vitamin D 2 , is 9,10-secoergosta-5,7,10(19),22-tetraen-3-ol,(3ß,5Z,7E,22 E )-; (C 28 H 44 O) with a molecular weight of 396.65, and has the following structural formula: Inactive Ingredients: FD&C Blue #1, FD&C Yellow #5, Gelatin, Glycerin, Soybean Oil.
Chemical Structure
HOW SUPPLIED
Capsules of 1.25 mg (50,000 IU vitamin D) of ergocalciferol, USP are green and oval shaped, imprinted with a circled W and “D 92” on one side and plain on the other.
HDPE plastic bottles of 100 capsules (NDC 0024-0393-10).
Store 25°C (77 F); excursions permitted between 15° – 30°C (59° – 86°F) [See USP Controlled Room Temperature].
GERIATRIC USE
Geriatric Use Clinical studies of DRISDOL did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
A few published reports have suggested that the absorption of orally administered vitamin D may be attenuated in elderly compared to younger, individuals.
In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
INDICATIONS AND USAGE
DRISDOL is indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.
PEDIATRIC USE
Pediatric Use Pediatric doses must be individualized (see DOSAGE AND ADMINISTRATION ).
PREGNANCY
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 IU of vitamin D daily during pregnancy has not been established.
NUSRING MOTHERS
Nursing Mothers Caution should be exercised when DRISDOL 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 infant’s serum calcium concentration is required in that case (Goldberg, 1972).
DOSAGE AND ADMINISTRATION
THE RANGE BETWEEN THERAPEUTIC AND TOXIC DOSES IS NARROW.
Vitamin D Resistant Rickets: 12,000 to 500,000 IU units daily.
Hypoparathyroidism: 50,000 to 200,000 IU units daily concomitantly with calcium lactate 4 g, six times per day.
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.