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Manufactured by: Swiss Caps AGKirchberg, SwitzerlandDistributed by: Breckenridge Pharmaceutical, Inc.Boca Raton, FL 33487Rev. 04/09
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 capsule, 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: Chemical StructureInactive Ingredients: D and C Yellow #10, FD and C Blue #1, Gelatin, Glycerin, Purified Water, Refined Soybean Oil.
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-dihydroxy- vitamin D). Vitamin D 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 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 Capsules, USP are indicated for use in the treatment of
hypoparathyroidism, refractory rickets, also known as vitamin D
resistant rickets, and familial hypophosphatemia.
Ergocalciferol Capsules, USP are contraindicated in patients with
hypercalcemia, malabsorption syndrome, abnormal sensitivity to the
toxic effects of vitamin D, and hypervitaminosis D.
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.
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.
- 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 of
- 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.
Dosage And Administration
THE RANGE BETWEEN THERAPEUTIC AND TOXIC DOSES IS NARROW.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 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
Each green, oval softgel capsule is imprinted with A3 and contains 1.25 mg (50,000 USP units vitamin D) of ergocalciferol, USP.Bottles of 100 Softgel Capsules (NDC 51991-604-01).
Storage And Handling
Store at 20°– 25°C (68°–77°F) [See USP Controlled Room Temperature].Protect from light and moisture.Dispense in a tight, light-resistant container as defined in the USP.
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