Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Each capsule contains Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units. The green colored oval shaped transparent soft gelatin capsules are imprinted with '194' in white and contain clear light yellow oily liquid. Bottles of 100 capsules (NDC: 51407-700-01) Store at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature]. Protect from light. Manufactured by: Strides Pharma Science Limited Bengaluru - 562106, India. Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816 Rx Only Revised: 08/2019 Marketed by: GSMS, Inc. Camarillo, CA 93012 USA; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Bottle of 100 capsules Rx only NDC 51407-700-01 Vitamin D (Ergocalciferol Capsules, USP) 1.25 mg* (50,000 USP Units) WARNING: DO NOT EXCEED RECOMMENDED DOSAGE Rx only 100 Capsules 51407-700-01OL.jpg
- HOW SUPPLIED Each capsule contains Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units. The green colored oval shaped transparent soft gelatin capsules are imprinted with '194' in white and contain clear light yellow oily liquid. Bottles of 100 capsules (NDC: 51407-700-01) Store at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature]. Protect from light. Manufactured by: Strides Pharma Science Limited Bengaluru - 562106, India. Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816 Rx Only Revised: 08/2019 Marketed by: GSMS, Inc. Camarillo, CA 93012 USA
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Bottle of 100 capsules Rx only NDC 51407-700-01 Vitamin D (Ergocalciferol Capsules, USP) 1.25 mg* (50,000 USP Units) WARNING: DO NOT EXCEED RECOMMENDED DOSAGE Rx only 100 Capsules 51407-700-01OL.jpg
Overview
Ergocalciferol Capsules, USP are 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 USP Units. Each capsule contains Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units in an edible vegetable oil. Ergocalciferol, also called vitamin D 2 , is 9,10-secoergosta-5,7,10(19), 22-tetraen-3-ol, (3β,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, Lecithin, Medium chain triglyceride, Purified water, Shellac glaze, N-Butyl alcohol, Simethicone, Soybean oil and Titanium dioxide. Vitamin D structure
Indications & 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.
Dosage & 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 stabilized.
Warnings & Precautions
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.
Contraindications
Ergocalciferol Capsules, USP are contraindicated in patients with hypercalcemia, malabsorption syndrome, abnormal sensitivity to the toxic effects of vitamin D, and hypervitaminosis D.
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. 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.strides.com
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, USP may cause hypercalcemia.
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