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ergocalciferol
Overview
What is DRISDOL?
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 D 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 is equivalent to one International Unit (IU), and 1 mcg of vitamin D 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 D, is 9, 10-secoergosta-5,7,10 (19), 22-tetraen-3-ol, (3ß,5Z,7E,22)-; (C
H
O) with a molecular weight of 396.65, and has the following structural formula:
Inactive Ingredients:
What does DRISDOL look like?
What are the available doses of DRISDOL?
Sorry No records found.
What should I talk to my health care provider before I take DRISDOL?
Sorry No records found
How should I use DRISDOL?
DRISDOL is indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.
THE RANGE BETWEEN THERAPEUTIC AND TOXIC DOSES IS NARROW.
Vitamin D Resistant Rickets:
Hypoparathyroidism:
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.
What interacts with DRISDOL?
Sorry No Records found
What are the warnings of DRISDOL?
Sorry No Records found
What are the precautions of DRISDOL?
Sorry No Records found
What are the side effects of DRISDOL?
Sorry No records found
What should I look out for while using DRISDOL?
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.
What might happen if I take too much DRISDOL?
The effects of administered vitamin D can persist for two or more months after cessation of treatment.
Hypervitaminosis D is characterized by:
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 LD in animals is unknown. The toxic oral dose of ergocalciferol in the dog is 4 mg/kg.
How should I store and handle DRISDOL?
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) []. 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. HDPE plastic bottles of 100 capsules (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].Rx OnlyManufactured for and Distributed by:Product of Czech Republic© 2018 Validus Pharmaceuticals LLC60042-01 January 2018Capsules 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. HDPE plastic bottles of 100 capsules (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].Rx OnlyManufactured for and Distributed by:Product of Czech Republic© 2018 Validus Pharmaceuticals LLC60042-01 January 2018Capsules 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. HDPE plastic bottles of 100 capsules (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].Rx OnlyManufactured for and Distributed by:Product of Czech Republic© 2018 Validus Pharmaceuticals LLC60042-01 January 2018Capsules 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. HDPE plastic bottles of 100 capsules (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].Rx OnlyManufactured for and Distributed by:Product of Czech Republic© 2018 Validus Pharmaceuticals LLC60042-01 January 2018Capsules 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. HDPE plastic bottles of 100 capsules (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].Rx OnlyManufactured for and Distributed by:Product of Czech Republic© 2018 Validus Pharmaceuticals LLC60042-01 January 2018Capsules 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. HDPE plastic bottles of 100 capsules (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].Rx OnlyManufactured for and Distributed by:Product of Czech Republic© 2018 Validus Pharmaceuticals LLC60042-01 January 2018Capsules 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. HDPE plastic bottles of 100 capsules (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].Rx OnlyManufactured for and Distributed by:Product of Czech Republic© 2018 Validus Pharmaceuticals LLC60042-01 January 2018Capsules 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. HDPE plastic bottles of 100 capsules (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].Rx OnlyManufactured for and Distributed by:Product of Czech Republic© 2018 Validus Pharmaceuticals LLC60042-01 January 2018
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The
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.
Non-Clinical Toxicology
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.
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 DRISDOL may cause hypercalcemia.
Vitamin D administration from fortified foods, dietary supplements, self-administered and prescription drug sources should be evaluated. Therapeutic dosage should be readjusted as soon as there is clinical improvement. Dosage levels must be individualized and great care exercised to prevent serious toxic effects. IN VITAMIN D RESISTANT RICKETS THE RANGE BETWEEN THERAPEUTIC AND TOXIC DOSES IS NARROW. When high therapeutic doses are used progress should be followed with frequent blood calcium determinations.
In the treatment of hypoparathyroidism, intravenous calcium, parathyroid hormone, and/or dihydrotachysterol may be required.
Maintenance of a normal serum phosphorus level by dietary phosphate restriction and/or administration of aluminum gels as intestinal phosphate binders in those patients with hyperphosphatemia as frequently seen in renal osteodystrophy is essential to prevent metastatic calcification.
Adequate dietary calcium is necessary for clinical response to vitamin D therapy.
This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.
Protect from light.
Hypervitaminosis D is characterized by effects on the following organ system:
Renal
:
CNS
:
Soft Tissues
:
Skeletal
:
Decline in the average rate of linear growth and increased mineralization of bones in infants and children (dwarfism) vague aches, stiffness, and weakness.
Gastrointestinal
:
Metabolic
:
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.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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