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VITAMIN D ERGOCALCIFEROL Capsules, USP 1.25 mg SOFTGELS (Soft Gelatin Capsules) (50,000 USP Units) RX only
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 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 D2 is equivalent to one International Unit (IU), and 1
mcg of vitamin D2 is equal to 40 IU.
Each softgel, for oral administration,
contains Ergocalciferol, USP 1.25 mg (equivalent to 50,000 USP units of Vitamin D), in an edible
vegetable oil.
Ergocalciferol, also called vitamin D2, is
9, 10-secoergosta-5,7,10(19),22-tetraen-3-ol,(3β,5Z,7E,22E)-; (C28H44O)
with a molecular weight of 396.65, and has the following structural formula:
Inactive Ingredients:
Refined soybean oil, gelatin, glycerin, purified water,
D&C Yellow #10, and FD&C Blue #1.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.
There is a time lag of 10 to 24 hours between the administration of vitamin D and the initiation of
its action in the body due to the necessity of synthesis of the active metabolites in the liver and
kidneys. Parathyroid hormone is responsible for the regulation of this metabolism in the kidneys.
INDICATIONS AND USAGE
Ergocalciferol is indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.
CONTRAINDICATIONS
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.
PRECAUTIONS
General
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 Interactions
Administration of thiazide diuretics to hypoparathyroid patients who are concurrently being treated with ergocalciferol may cause hypercalcemia.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Pregnancy
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
Pediatric Use
ADVERSE REACTIONS
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.
DOSAGE AND ADMINISTRATION
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.
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.
OVERDOSAGE
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, 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 LD50 in animals is unknown. The toxic oral dose of ergocalciferol in the dog is 4 mg/kg.
HOW SUPPLIED
Each 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
Banner Pharmacaps, Inc.
4125 Premier Drive
High Point, NC 27265