ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS. Hypervitaminosis 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.Call your doctor for medical advice about side effects. You may report side effects to Strides Pharma Inc. at 1-877-244-9825 or go to www.stridesshasun.com.

CLINICAL PHARMACOLOGY SECTION.

CLINICAL PHARMACOLOGY. The in vivo synthesis of the major biologically active metabolites of vitamin 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 metabolites promote the active absorption of calcium and phosphorus by the small intestine, thus elevating serum calcium and phosphate levels sufficiently to permit bone mineralization. Vitamin 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 time lag of 10 to 24 hours between the administration of vitamin 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.

DESCRIPTION SECTION.

DESCRIPTION. Ergocalciferol Capsules, USP are synthetic calcium regulator for oral administration.Ergocalciferol is 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 group of steroid compounds, classified as having vitamin or antirachitic activity.One USP unit of vitamin D2 is equivalent to one International Unit (IU), and mcg of vitamin D2 is equal to 40 USP Units.Each capsule contains Vitamin (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units in an edible vegetable oil.Ergocalciferol, also called vitamin D2, is 9,10-secoergosta-5,7,10(19), 22-tetraen-3-ol, (3,5Z,7E,22E)-; (C28H44O) with molecular weight of 396.65, and has the following structural formula:Inactive Ingredients: FD&C Blue 1, FD&C Yellow 5, Gelatin, Glycerin, Lecithin, Medium chain triglyceride, Purified water, Shellac glaze, N-Butyl alcohol, Simethicone, Soybean oil and Titanium dioxide.. Vitamin structure.

GERIATRIC USE SECTION.

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. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. few published reports have suggested that the absorption of orally administered vitamin 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.

OVERDOSAGE SECTION.

OVERDOSAGE. The effects of administered vitamin can persist for two or more months after cessation of treatment.. Hypervitaminosis 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 with hypercalcemia consists in immediate withdrawal of the vitamin, 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. 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 mg/kg.. 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).

PRECAUTIONS SECTION.

PRECAUTIONS. General. Vitamin 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 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 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 therapy.This product contains FD&C Yellow No. (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of FD&C Yellow No. (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.Protect from light.. Drug Interactions. Mineral oil interferes with the absorption of fat-soluble vitamins, including vitamin preparations.Administration of thiazide diuretics to hypoparathyroid patients who are concurrently being treated with Ergocalciferol Capsules, USP may cause hypercalcemia.. Carcinogenesis, Mutagenesis, Impairment of Fertility. No long-term animal studies have been performed to evaluate the drugs 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 in excess of the recommended dietary allowance during normal pregnancy should be avoided unless, in the judgment of the physician, potential benefits in specific, unique case outweigh the significant hazards involved. The safety in excess of 400 USP Units of vitamin daily during pregnancy has not been established.. Nursing Mothers. Caution should be exercised when Ergocalciferol Capsules, USP are administered to nursing woman. In mother given large doses of vitamin D, 25-hydroxycholecalciferol appeared in the milk and caused hypercalcemia in her child. Monitoring of the infants serum calcium concentration is required in that case (Goldberg, 1972).. 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. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. few published reports have suggested that the absorption of orally administered vitamin 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.

SPL UNCLASSIFIED SECTION.

General. Vitamin 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 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 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 therapy.This product contains FD&C Yellow No. (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of FD&C Yellow No. (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.Protect from light.