DRISDOL®

(ergocalciferol, USP)

50,000 IU Capsule

DRISDOL brand of 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: FD&C Blue #1, FD&C Yellow #5, Gelatin, Glycerin, 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-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.

DRISDOL is indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.

DRISDOL is 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.

To report SUSPECTED ADVERSE REACTIONS, contact Validus Pharmaceuticals LLC at 1-866-982-5438 (1-866-9VALIDUS) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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 demineralization (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.

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.

Capsules of 1.25 mg (50,000 IU vitamin D) of ergocalciferol, USP are green and oval shaped, imprinted with "E 50" on one side and plain on the other. Supply in HDPE plastic bottles of 100 (NDC 30698-493-01).

Store at 77°F (25°C); excursions permitted between 59° to 86°F (15° to 30°C) [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP.

Rx Only

Manufactured for and Distributed by:
Validus Pharmaceuticals LLC
119 Cherry Hill Road, Suite 310
Parsippany, NJ 07054
info@validuspharma.com
www.validuspharma.com
1-866-982-5438 (1-866-9VALIDUS)

Product of Czech Republic

© 2018 Validus Pharmaceuticals LLC

60042-03                         July 2018

NDC 30698-493-01
Drisdol
(ergocalciferol, USP)
1.25
(50,000 IU vitamin D)
100 Capsules
Rx Only