Ergocalciferol Capsules,

Description

DESCRIPTION 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 2 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, 22E)-; (C 28 H 44 O) with a molecular weight of 396.65, and has the following structural formula: Inactive Ingredients: Butylated hydroxytoluene, D&C Yellow #10, FD&C Blue #1, Gelatin, Glycerin, Propylene Glycol, Shellac, Simethicone, Soybean oil and Titanium Dioxide. chemical-formula.jpg

What Is Ergocalciferol Capsules, Used For?

INDICATIONS AND USAGE Ergocalciferol Capsules are indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.

Dosage and Administration

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.

Side Effects (Adverse Reactions)

ADVERSE REACTIONS Hypervitaminosis 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. Decline in the average rate of linear growth and increased mineralization of bones in infants and children (dwarfism) vague aches, stiffness, and weakness. Gastrointestinal: Nausea, anorexia, constipation. Metabolic: Mild acidosis, anemia, weight loss.

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 Ergocalciferol Capsules may cause hypercalcemia.

Contraindications

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

Pregnancy and Breastfeeding

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.

Nursing Mothers Caution should be exercised when Ergocalciferol Capsules 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).

Overdosage

OVERDOSAGE The effects of administered vitamin D can persist for two or more months after cessation of treatment. Hypervitaminosis D is characterized by: 1. Hypercalcemia with anorexia, nausea, weakness, weight loss, vague aches and stiffness, constipation, mental retardation, anemia, and mild acidosis. 2. 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. 3. Widespread calcification of the soft tissues, including the heart, blood vessels, renal tubules, and lungs. Bone demin- eralization (osteoporosis) in adults occurs concomitantly. 4. 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 LD50 in animals is unknown. The toxic oral dose of ergocalciferol in the dog is 4 mg/kg.

How Supplied

HOW SUPPLIED Capsules of 1.25 mg (50,000 IU vitamin D) of ergocalciferol, USP are clear green oval softgel capsules filled with a clear to pale yellow Bottle of 100 capsules (NDC 42806-547-01) Bottle of 500 capsules (NDC 42806-547-05) Store at 20° - 25°C (68° - 77°F); excursions permitted between 15° - 30°C (59° - 86°F). [See USP Controlled Room Temperature] Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP. Manufactured by: Humanwell PuraCap Pharmaceutical Co Ltd. Wuhan, Hubei 430206, China Distributed by: Epic Pharma, LLC Laurelton, NY 11413 PI547102018E Rev. 10-2018-00