- Home
- /
- Drugs
- /
- E
- /
- Ergocalciferol (Vitamin D2)
- /
- Ergocalciferol (Vitamin D2) ERGOCALCIFEROL 1.25 mg/1 Advanced Rx Pharmacy of Tennessee, LLC
Ergocalciferol (Vitamin D2)
- Ergocalciferol ERGOCALCIFEROL 1.25 mg/1 NuCare Pharmaceuticals,Inc.
- Ergocalciferol ERGOCALCIFEROL 1.25 mg/1 A-S Medication Solutions
- Ergocalciferol (Vitamin D2) ERGOCALCIFEROL 1.25 mg/1 Advanced Rx Pharmacy of Tennessee, LLC
- Vitamin D ERGOCALCIFEROL 1.25 mg/1 NuCare Pharmaceuticals,Inc.
- VITAMIN D ERGOCALCIFEROL 1.25 mg/1 NuCare Pharmaceuticals,Inc.
- VITAMIN D ERGOCALCIFEROL 1.25 mg/1 Proficient Rx LP
- Ergocalciferol Capsules, ERGOCALCIFEROL 1.25 mg/1 Proficient Rx LP
- VITAMIN D ERGOCALCIFEROL 1.25 mg/1 Northwind Pharmaceuticals, LLC
- VITAMIN D ERGOCALCIFEROL 1.25 mg/1 Strides Pharma Science Limited
- VITAMIN D ERGOCALCIFEROL 1.25 mg/1 Preferred Pharmaceuticals, Inc.
- Ergocalciferol ERGOCALCIFEROL 1.25 mg/1 Chartwell RX, LLC
- Ergocalciferol Capsules, ERGOCALCIFEROL 1.25 mg/1 Northwind Pharmaceuticals
- VITAMIN D ERGOCALCIFEROL 1.25 mg/1 Aphena Pharma Solutions - Tennessee, LLC
- VITAMIN D ERGOCALCIFEROL 1.25 mg/1 PD-Rx Pharmaceuticals, Inc.
- ERGOCALCIFEROL ERGOCALCIFEROL 1.25 mg/1 Golden State Medical Supply, Inc.
- Ergocalciferol ERGOCALCIFEROL 1.25 mg/1 Bryant Ranch Prepack
- VITAMIN D ERGOCALCIFEROL 1.25 mg/1 REMEDYREPACK INC.
- ERGOCALCIFEROL ERGOCALCIFEROL 1.25 mg/1 Alembic Pharmaceuticals Inc.
- Ergocalciferol ERGOCALCIFEROL 1.25 mg/1 A-S Medication Solutions
- VITAMIN D ERGOCALCIFEROL 1.25 mg/1 Bryant Ranch Prepack
Summary of product characteristics
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.
Contraindications
Contraindications Ergocalciferol Capsules are contraindicated in patients with hypercalcemia, malabsorption syndrome, abnormal sensitivity to the toxic effects of vitamin D, and hypervitaminosis D.
Description
Description Section 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 capsule contains 1.25 mg (50,000 International Units vitamin D) of ergocalciferol, USP, in an edible vegetable oil. Ergocalciferol, also called vitamin D2, is 9, 10-secoergosta-5, 7, 10(19), 22-tetraen-3-ol, (3ß, 5Z, 7E, 22E)-; (C28H44O) 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. Structure
Dosage And Administration
Dosage and Administration Section 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.
Indications And Usage
Indications and Usage Section Ergocalciferol Capsules are indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.
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.
Clinical Pharmacology
Clincal 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 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.
Effective Time
20230412
Version
5
Spl Product Data Elements
Ergocalciferol (Vitamin D2) Ergocalciferol (Vitamin D2) ERGOCALCIFEROL ERGOCALCIFEROL PC7
Application Number
ANDA204276
Brand Name
Ergocalciferol (Vitamin D2)
Generic Name
Ergocalciferol (Vitamin D2)
Product Ndc
80425-0130
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Package Label Principal Display Panel
Principal Display Panel Label1
How Supplied
How Supplied/Storage and Handling 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 Bottles of 12 Capsules NDC: 80425-0130-03 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 Distributed by: Advanced Rx Pharmacy of Tennessee LLC Nashville, TN 37211 Rev. 10-2018-00
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
Disclaimer
The drug Prescribing Information (PI), including indications, contra-indications, interactions, etc, has been developed using the U.S. Food & Drug Administration (FDA) as a source (www.fda.gov).
Medthority offers the whole library of PI documents from the FDA. Medthority will not be held liable for explicit or implicit errors, or missing data.
Drugs appearing in this section are approved by the FDA. For regions outside of the United States, this content is for informational purposes only and may not be aligned with local regulatory approvals or guidance.