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ERGOCALCIFEROL 1.25MG 100 CAPS - 1.25 mg/1 CAPSULE
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ERGOCALCIFEROL 1.25MG 100 CAPS

Generic: ergocalciferol

ERGOCALCIFEROL 1.25MG 100 CAPS

NDC:64380-0737-06
Manufacturer:Strides Pharma Science Limited
Strength:1.25 mg/1
Dosage Form:CAPSULE
Route:ORAL

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Drug Information

Identification

Generic Name

ergocalciferol

Brand Name

VITAMIN D

Labeler / Distributor

Strides Pharma Science Limited

Product Type

HUMAN PRESCRIPTION DRUG

Administration

Dosage Form

CAPSULE

Route of Administration

ORAL

FDA Application Number

ANDA090455

Active Ingredients

IngredientStrength
ERGOCALCIFEROL1.25 mg/1

Pharmacological Class

Ergocalciferols [CS]Provitamin D2 Compound

Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.

Clinical Drug Information

Indications & Usage

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.

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.

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 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.

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. 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

Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.