Ergocalciferol 1.25 mg/1
Ergocalciferol · CAPSULE, LIQUID FILLED · St. Mary's Medical Park Pharmacy
Ergocalciferol is a form of vitamin D (vitamin D2) used to treat or prevent vitamin D deficiency and related conditions affecting bone health and calcium absorption. It comes as an oral capsule and is available by prescription.
Key Facts
- Brand Name
- Ergocalciferol
- Generic Name
- Ergocalciferol
- NDC Code (Product)
60760-152- Manufacturer
- St. Mary's Medical Park Pharmacy
- Strength
- 1.25 mg/1
- Dosage Form
- CAPSULE, LIQUID FILLED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA080704
- Drug Class
- Provitamin D2 Compound [EPC]
- Marketing Start
- 06/15/2016
Recall History
Safecor Health, LLC
Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Natures Pharmacy & Compounding Center
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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.
Dosage & Administration
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 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.
Warnings
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
CONTRAINDICATIONS Ergocalciferol is contraindicated in patients with hypercalcemia, malabsorption syndrome, abnormal sensitivity to the toxic effects of vitamin D, and hypervitaminosis D.
Drug Interactions
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 may cause hypercalcemia.
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. To report SUSPECTED ADVERSE REACTIONS, contact Bionpharma Inc. at 1-888-235-2466 or FDA at 1-800-FDA-1088 or www.fda.gov/ medwatch.
Frequently Asked Questions
What is Ergocalciferol used for?
Ergocalciferol is a form of vitamin D (vitamin D2) used to treat or prevent vitamin D deficiency and related conditions affecting bone health and calcium absorption. It comes as an oral capsule and is available by prescription.
Is Ergocalciferol a controlled substance?
Ergocalciferol is not classified as a controlled substance by the DEA.
What is the generic name for Ergocalciferol?
The generic name for Ergocalciferol is Ergocalciferol. There are 7 other brand versions of Ergocalciferol.
What is the NDC code for Ergocalciferol 1.25 mg/1?
The NDC (National Drug Code) for Ergocalciferol 1.25 mg/1 is 60760-152, listed by St. Mary's Medical Park Pharmacy.