Ergocalciferol 50000 units capsule

Vitamin D Ergocalciferol

Dosage Form: capsule, liquid filled

Medically reviewed by Drugs.com. Last updated on Mar 22, 2019.

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Vitamin D Ergocalciferol Description

Ergocalciferol Capsules, USP are 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 USP Units.

Each capsule contains Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units in an edible vegetable oil.

Vitamin D Ergocalciferol – Clinical 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.

Indications and Usage for Vitamin D Ergocalciferol

Ergocalciferol Capsules, USP are indicated for use in the treatment of hypoparathyroidism, refractory rickets, also known as vitamin D resistant rickets, and familial hypophosphatemia.

Contraindications

Ergocalciferol Capsules, USP are contraindicated in patients with hypercalcemia, malabsorption syndrome, abnormal sensitivity to the toxic effects of vitamin D, and hypervitaminosis D.

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.

Precautions

General

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.

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 Capsules, USP may cause hypercalcemia.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term animal studies have been performed to evaluate the drug’s potential in these areas.

Pregnancy Category C

Animal reproduction studies have shown fetal abnormalities in several species associated with hypervitaminosis D. These are similar to the supravalvular aortic stenosis syndrome described in infants by Black in England (1963). This syndrome was characterized by supravalvular aortic stenosis, elfin facies, and mental retardation. For the protection of the fetus, therefore, the use of vitamin D in excess of the recommended dietary allowance during normal pregnancy should be avoided unless, in the judgment of the physician, potential benefits in a specific, unique case outweigh the significant hazards involved. The safety in excess of 400 USP Units of vitamin D daily during pregnancy has not been established.

Nursing Mothers

Caution should be exercised when Ergocalciferol Capsules, USP are administered to a nursing woman. In a mother given large doses of vitamin D, 25-hydroxycholecalciferol appeared in the milk and caused hypercalcemia in her child. Monitoring of the infant’s serum calcium concentration is required in that case (Goldberg, 1972).

Pediatric Use

Pediatric doses must be individualized (see DOSAGE AND ADMINISTRATION).

Geriatric Use

Clinical studies of Ergocalciferol Capsules, USP did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. A few published reports have suggested that the absorption of orally administered vitamin D may be attenuated in elderly compared to younger, individuals. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

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.stridesshasun.com

Overdosage

The effects of administered vitamin D can persist for two or more months after cessation of treatment.

Hypervitaminosis D is characterized by:

  • Hypercalcemia with anorexia, nausea, weakness, weight loss, vague aches and stiffness, constipation, mental retardation, anemia, and mild acidosis.
  • 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.
  • Widespread calcification of the soft tissues, including the heart, blood vessels, renal tubules, and lungs. 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).

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.

Vitamin D Ergocalciferol 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.

How is Vitamin D Ergocalciferol Supplied

Each capsule contains Vitamin D (Ergocalciferol) 1.25 mg equivalent to 50,000 USP Units. The green colored oval shaped transparent soft gelatin capsules are imprinted with ‘194’ in white and contain clear light yellow oily liquid.

Store at 20 to 25°C (68 to 77°F) .

Protect from light.

Repackaged by

Aidarex Pharmaceuticals, LLC

Corona, CA 92880

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SPL Image

VITAMIN D
ergocalciferol capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:53217-287(NDC:64380-737)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ERGOCALCIFEROL (ERGOCALCIFEROL) ERGOCALCIFEROL 1.25 mg
Inactive Ingredients
Ingredient Name Strength
FD&C YELLOW NO. 5
GELATIN
GLYCERIN
LECITHIN, SOYBEAN
MEDIUM-CHAIN TRIGLYCERIDES
WATER
ETHYLENE GLYCOL MONOETHYL ETHER
SOYBEAN OIL
TITANIUM DIOXIDE
SHELLAC
Product Characteristics
Color GREEN Score no score
Shape CAPSULE Size 12mm
Flavor Imprint Code 194
Contains
Packaging
# Item Code Package Description
1 NDC:53217-287-08 8 CAPSULE in 1 BOTTLE
2 NDC:53217-287-12 12 CAPSULE in 1 BOTTLE
3 NDC:53217-287-13 4 CAPSULE in 1 BOTTLE
4 NDC:53217-287-30 30 CAPSULE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090455 05/16/2014

Labeler – Aidarex Pharmaceuticals LLC (801503249)

Aidarex Pharmaceuticals LLC

Medical Disclaimer

More about ergocalciferol

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Consumer resources

  • Ergocalciferol
  • Ergocalciferol Capsules and Tablets
  • Ergocalciferol Solution

Professional resources

  • Ergocalciferol (AHFS Monograph)
  • Ergocalciferol (Wolters Kluwer)
  • Ergocalciferol (FDA)

Other brands: Drisdol

Related treatment guides

  • Familial Hypophosphatemia
  • Hypocalcemia
  • Hypoparathyroidism
  • Hypophosphatemia
  • … +5 more

Identification

Are you a new drug developer? Contact us to learn more about our customized products and solutions. Stay in the know! As part of our commitment to providing the most up-to-date drug information, we will be releasing #DrugBankUpdates with our newly added curated drug pages. #DrugBankUpdates Name Ergocalciferol Accession Number DB00153 (NUTR00005, APRD00426) Type Small Molecule Groups Approved, Nutraceutical Description

Ergocalciferol is an inactivated vitamin D analog.1 It is a form of vitamin synthesized by some plants in the presence of UVB light.6 The production of ergocalciferol was impulsed by the identification of dietary deficiency, more specifically vitamin D, as the main causative agent for rickets. Impulsed by this research, ergocalciferol was isolated for the first time from yeast in 1931 and its structure was elucidated in 1932.7

Ergocalciferol is considered the first vitamin D analog and it differentiates from cholecalciferol in the presence of a double bond between C22 and C23 and the presence of a methyl group at C24. These modifications reduce the affinity of ergocalciferol to vitamin D binding protein which derives in faster clearance, limits its activation and alters its catabolism.3

The first approved product containing ergocalciferol under the FDA records was developed by US Pharm Holdings and FDA approved in 1941.10

Structure 3D Download Similar Structures

Structure for Ergocalciferol (DB00153)

× Close Synonyms Product Images Prescription Products

Name Dosage Strength Route Labeller Marketing Start Marketing End
Unlock Additional Data
D-forte Capsule Oral Euro Pharm International Canada Inc 2017-08-16 Not applicable Canada
Drisdol Capsule 1.25 mg/1 Oral Sanofi Aventis 1974-11-11 2014-04-30 US
Drisdol Capsule, liquid filled 1.25 mg/1 Oral Validus Pharmaceuticals LLC 2018-04-01 Not applicable US
Drisdol Capsule, liquid filled 1.25 mg/1 Oral Validus Pharmaceuticals 1974-01-11 2018-03-31 US
Drisdol Capsule, liquid filled 1.25 mg/1 Oral Avera McKennan Hospital 2016-02-05 2018-07-05 US
Drisdol Capsule, liquid filled 1.25 mg/1 Oral Sanofi Aventis 1974-11-11 2017-02-28 US
Osto-D2 Capsule Oral Paladin Labs Inc 2008-02-08 2018-07-04 Canada
Radiostol Cap 50000iu Capsule Oral Allen & Hanburys A Glaxo Canada Ltd. Co. 1989-12-15 1996-09-10 Canada

Additional Data Available

  • Application Number Application Number

    A unique ID assigned by the FDA when a product is submitted for approval by the labeller.

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  • Product Code Product Code

    A governmentally-recognized ID which uniquely identifies the product within its regulatory market.

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Generic Prescription Products

Name Dosage Strength Route Labeller Marketing Start Marketing End
Unlock Additional Data
Ergocalciferol Capsule 1.25 mg/1 Oral Pd Rx Pharmaceuticals, Inc. 2009-08-17 2018-08-22 US
Ergocalciferol Capsule, liquid filled 1.25 mg/1 Oral Aphena Pharma Solutions – Tennessee, LLC 2015-07-23 Not applicable US
Ergocalciferol Capsule, liquid filled 1.25 mg/1 Oral bryant ranch prepack 2016-06-15 Not applicable US
Ergocalciferol Capsule, liquid filled 1.25 mg/1 Oral Bionpharma Inc. 2016-06-15 Not applicable US
Ergocalciferol Capsule, liquid filled 1.25 mg/1 Oral Av Kare, Inc. 2015-07-23 Not applicable US
Ergocalciferol Capsule, liquid filled 1.25 mg/1 Oral A-S Medication Solutions 2016-06-15 Not applicable US
Ergocalciferol Capsule 1.25 mg/1 Oral Physicians Total Care, Inc. 2007-07-12 Not applicable US
Ergocalciferol Capsule 1.25 mg/1 Oral Aphena Pharma Solutions Tennessee, Inc. 2011-11-15 Not applicable US
Ergocalciferol Capsule, liquid filled 1.25 mg/1 Oral St. Mary’s Medical Park Pharmacy 2016-06-15 Not applicable US
Ergocalciferol Capsule 1.25 mg/1 Oral Aphena Pharma Solutions – Tennessee, LLC 2009-05-20 Not applicable US

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Over the Counter Products

Name Dosage Strength Route Labeller Marketing Start Marketing End
Unlock Additional Data
Vitamin D 400 I.U. Tablets Tablet Oral General Nutrition Canada Inc. 1997-04-18 2001-09-12 Canada

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  • Product Code Product Code

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Mixture Products Unapproved/Other Products International/Other Brands Deltalin (Lilly) Categories UNII VS041H42XC CAS number 50-14-6 Weight Average: 396.6484
Monoisotopic: 396.33921603 Chemical Formula C28H44O InChI Key MECHNRXZTMCUDQ-RKHKHRCZSA-N InChI InChI=1S/C28H44O/c1-19(2)20(3)9-10-22(5)26-15-16-27-23(8-7-17-28(26,27)6)12-13-24-18-25(29)14-11-21(24)4/h9-10,12-13,19-20,22,25-27,29H,4,7-8,11,14-18H2,1-3,5-6H3/b10-9+,23-12+,24-13-/t20-,22+,25-,26+,27-,28+/m0/s1 IUPAC Name (1S,3Z)-3-{2–7a-methyl-octahydro-1H-inden-4-ylidene]ethylidene}-4-methylidenecyclohexan-1-ol SMILES CC(C)(C)\C=C\(C)1()CC2()\C(CCC12C)=C\C=C1\C(O)CCC1=C

Pharmacology

Indication

Ergocalciferol is indicated for the treatment of hypoparathyroidism, refractory rickets, and familial hypophosphatemia.Label

Hypoparathyroidism is the result of inadequate parathyroid hormone production that occurs due to the presence of damage or removal of the parathyroid glands. This condition produces decreased calcium and increased phosphorus levels.11

Rickets is a condition produced due to a deficiency in vitamin D, calcium or phosphorus. However, this condition can also be related to renal diseases. It is characterized to present weak or soft bones.4

Familial hypophosphatemia is characterized by the impaired transport of phosphate and an altered vitamin D metabolism in the kidneys. The presence of this condition can derive in the presence of osteomalacia, bone softening and rickets.12

Associated Conditions

  • Hypophosphatemia, Familial
  • Vitamin D Resistant Rickets
  • Parathyroid deficiency

Associated Therapies

  • Dietary and Nutritional Therapies

Pharmacodynamics

After the activation of the vitamin D receptor, some of the biological changes produced by ergocalciferol include mobilization and accretion of calcium and phosphorus in the bone, absorption of calcium and phosphorus in the intestine, and reabsorption of calcium and phosphorus in the kidney.7

Some other effects known to be produced due to the presence of vitamin D are osteoblast formation, fetus development, induction of pancreatic function, induction of neural function, improvement of immune function, cellular growth and cellular differentiation.7

When compared to its vitamin D counterpart cholecalciferol, ergocalciferol has been shown to present a reduced induction of calcidiol and hence, it is less potent.2

Ergocalciferol supplementation in patients with end-stage renal disease has been shown to generate a significant benefit in lab parameters of bone and mineral metabolism as well as improvement in glycemic control, serum albumin levels and reduced levels of inflammatory markers.1

Mechanism of action

For its activity, ergocalciferol is required to be transformed to its major active circulating hydroxylated metabolite and transported to the target organs in order to bind to its target, the vitamin D receptor.7

The activation of the vitamin D receptor is part of the vitamin D endocrine system and it is described by the production of a change in the transcription rates of the vitamin D receptor target genes.7 The target genes in the DNA affected by the presence of ergocalciferol are called vitamin D response elements which are dependent on co-modulators.3

The vitamin D receptor is a transcription factor and member of the steroid hormone nuclear receptor family. It presents a DNA binding domain (VDRE) that, when activated, recruits coregulatory complexes to regulate the genomic activity.3

Additionally, ergocalciferol presents nongenomic effects such as the stimulation of intestinal calcium transport via transcaltachia.3

Target Actions Organism
AVitamin D3 receptor agonist Humans
NVoltage-dependent calcium channel inducer Humans

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Learn more Absorption

Ergocalciferol is absorbed in the intestine and carried to the liver in chylomicrons. Its intestinal absorption does not present limitations unless the presence of conditions related to fat malabsorption.6 However, for absorption to take place, the presence of bile is required.13

Volume of distribution

The amount of circulating ergocalciferol is very limited as this compound is rapidly stored in fat tissue such as adipose tissue, liver and muscle. This is very obvious in reports that indicate that circulating ergocalciferol is significantly reduced in obese patients.6

Protein binding

Ergocalciferol is not found significantly distributed circulating in plasma. It is known to be found in its bound form to the vitamin D plasma protein.9 The parent compound of ergocalciferol does not bind directly to plasma proteins, however, 70-90% of its metabolites such as cholecalciferol and calcitriol are found in the bound form.5

Metabolism

Ergocalciferol is inactive and hence, the first step in the body is ruled by the conversion of this parent compound to 25-hydroxyvitamin D by the action of CYP2R1 followed by the generation of the major circulating metabolite, 1,25-dihydroxyvitamin D or calcitrol.6 The generation of this major metabolite is ruled by the activity of CYP27B1 which is a key 1-hydroxylase and CYP24A1 which is responsible for the 25-hydroxylation.3

As part of the minor metabolism, ergocalciferol is transformed into 25-hydroxyvitamin D in the liver by the activity of D-25-hydroxylase and CYP2R1. As well, the formation of 24(R),25dihydroxyvitamin D is performed mainly in the kidneys by the action of 25-(OH)D-1-hydroxylase and 25-(OH)D-24-hydroxylase.7

Additionally, there are reports indicating significant activity of 3-epimerase in the metabolism of ergocalciferol which modifies the hydroxy group in C3 from the alpha position to a beta. The epimers formed seemed to have a reduced affinity for the vitamin D plasma proteins and to the vitamin D receptor.3

An alternative activation metabolic pathway has been reported and this process is characterized by the activity of CYP11A1 and its hydroxylation in the C-20. This 20-hydroxylated vitamin D seems to have similar biological activity than calcitriol.3

  • Ergocalciferol 25-hydroxyvitamin D
    • 25-hydroxyvitamin D Calcitrol
  • Ergocalciferol 24(R),25dihydroxyvitamin D
  • Ergocalciferol beta-ergocalciferol
  • Ergocalciferol 20-hydroxyvitamin D

Route of elimination

The active form of ergocalciferol, calcitrol, cannot be maintained for long periods in storage tissue mainly in periods of dietary or UVB deprivation.6 Therefore, ergocalciferol and its metabolites are excreted via the bile with a minor contribution of renal elimination. This major fecal elimination is explained due to the cubilin-megalin receptor system-mediated renal reuptake of vitamin D metabolites bound to vitamin D binding protein.14

Half life

Ergocalciferol can be found circulation for 1-2 days. This quick turnover is presented due to hepatic conversion and uptake by fat and muscle cells where it is transformed to the active form.6

Clearance

There are no formal reports regarding the clearance rate of ergocalciferol. Due to the structural similarity, it is recommended to consult this parameter with cholecalciferol. On the other hand, the proposed renal clearance of calcitriol is of 31 ml/min.8

Toxicity

The reported LD50 for orally administered ergocalciferol in the rat is of 10 mg/kg.MSDS Overdosage with this agent is reported to produce hypervitaminosis characterized by hypercalcemia, renal impairment, calcification of soft tissues, a decline in the rate of linear growth and increase in bone mineralization.15

Once an overdose state is registered, immediate withdrawal of vitamin D is required along with a calcium diet, generous intake of fluids and symptomatic treatment. The administration of loop diuretics is an option to increase renal calcium excretion. On the other hand, dialysis and administration of citrates, sulfates, phosphates, corticosteroids, EDTA and mithramycin are recommended.15

There haven’t been long term studies analyzing the carcinogenic and mutagenic potential of ergocalciferol or its effects in fertility.

Affected organisms

  • Humans and other mammals

Pathways Not Available Pharmacogenomic Effects/ADRs Not Available

Interactions

Drug Interactions This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.

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Drug Interaction
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1alpha-Hydroxyvitamin D5 The risk or severity of adverse effects can be increased when Ergocalciferol is combined with 1alpha-Hydroxyvitamin D5.
1alpha,24S-Dihydroxyvitamin D2 The risk or severity of adverse effects can be increased when Ergocalciferol is combined with 1alpha,24S-Dihydroxyvitamin D2.
Acetyldigitoxin The risk or severity of ventricular arrhythmias and Cardiac Arrhythmia can be increased when Ergocalciferol is combined with Acetyldigitoxin.
Acetyldigoxin The risk or severity of ventricular arrhythmias and Cardiac Arrhythmia can be increased when Ergocalciferol is combined with Acetyldigoxin.
Aldosterone The therapeutic efficacy of Ergocalciferol can be decreased when used in combination with Aldosterone.
Alfacalcidol The risk or severity of adverse effects can be increased when Ergocalciferol is combined with Alfacalcidol.
Aluminum hydroxide The serum concentration of Aluminum hydroxide can be increased when it is combined with Ergocalciferol.
Beclomethasone dipropionate The therapeutic efficacy of Ergocalciferol can be decreased when used in combination with Beclomethasone dipropionate.
Becocalcidiol The risk or severity of adverse effects can be increased when Ergocalciferol is combined with Becocalcidiol.
Bendroflumethiazide The risk or severity of hypercalcemia can be increased when Bendroflumethiazide is combined with Ergocalciferol.

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Food Interactions Not Available Synthesis Reference US5789397 General References External Links Human Metabolome Database HMDB0000900 KEGG Drug D00187 KEGG Compound C05441 PubChem Compound 5280793 PubChem Substance 46505053 ChemSpider 4444351 ChEBI 28934 ChEMBL CHEMBL1536 Therapeutic Targets Database DAP000291 PharmGKB PA449484 HET D2V RxList RxList Drug Page Drugs.com Drugs.com Drug Page PDRhealth PDRhealth Drug Page Wikipedia Ergocalciferol ATC Codes A11CC01 — Ergocalciferol

  • A11CC — Vitamin D and analogues
  • A11C — VITAMIN A AND D, INCL. COMBINATIONS OF THE TWO
  • A11 — VITAMINS
  • A — ALIMENTARY TRACT AND METABOLISM

AHFS Codes

  • 88:16.00 — Vitamin D

PDB Entries 3czh FDA label (125 KB) MSDS (167 KB)

Clinical Trials

Clinical Trials

Phase Status Purpose Conditions Count
0 Recruiting Treatment Ergocalciferol 1
1 Active Not Recruiting Treatment Peyronie’s Disease 1
1 Completed Diagnostic Hyperparathyroidism 1
1 Completed Treatment Inflammatory Reaction / Insulin Resistance 1
1, 2 Suspended Treatment Deficiency, Vitamin D / Orthopedic Disorders / Polytrauma 1
2 Completed Treatment Osteoporosis 1
2 Recruiting Prevention Osteopenia / Osteoporosis 1
2, 3 Recruiting Treatment Type 1 Diabetes Mellitus 1
2, 3 Withdrawn Treatment Calcium Nephrolithiasis / Deficiency, Vitamin D 1
3 Completed Treatment Chronic Kidney Disease Stage 3 and 4 1
3 Unknown Status Treatment Breast Cancer 1
4 Completed Basic Science 25-Hydroxyvitamin D Concentration / Deficiency, Vitamin D 1
4 Completed Treatment BMI >30 kg/m2 / Deficiency, Vitamin D / Hyperparathyroidism, Secondary 1
4 Completed Treatment Calcium Nephrolithiasis / Deficiency, Vitamin D / Disorder of Vitamin D / Idiopathic Hypercalciuria / Urolithiasis 1
4 Completed Treatment Chronic Kidney Disease (CKD) / Deficiency, Vitamin D 1
4 Completed Treatment Chronic Kidney Disease (CKD) / Hyperparathyroidism, Secondary 1
4 Completed Treatment Deficiency, Vitamin D 1
4 Completed Treatment Deficiency, Vitamin D / Hypercalcemia / Hypercalciuria / Osteopenia / Osteoporosis / Parathyroid deficiency 1
4 Completed Treatment Hip Fracture 1
4 Completed Treatment Pruritus 1
4 Enrolling by Invitation Treatment Vitamin D2 Supplementation in Vitamin D Insufficiency 1
4 Recruiting Treatment Myopathic Symptoms 1
4 Recruiting Treatment Sarcoidosis / Vitamin D Insufficiency 1
4 Terminated Treatment Deficiency, Vitamin D / Renal Failure Chronic Requiring Hemodialysis 1
4 Unknown Status Treatment Bone Mineralization Defect 1
4 Unknown Status Treatment Deficiency, Vitamin D / Diabetes 1
4 Unknown Status Treatment Deficiency, Vitamin D / Malnutrition 1
4 Withdrawn Treatment Anemias / Chronic Kidney Disease (CKD) / CKD / Ergocalciferol / Hepcidin / Iron-Deficiency / Vitamin D 1
Not Available Active Not Recruiting Treatment Asthma / Deficiency, Vitamin D 1
Not Available Completed Not Available Tuberculosis Infection 1
Not Available Completed Basic Science Blood Pressures / BMI >27 kg/m2 / BMI >30 kg/m2 / Endothelial Function / Renal Function 1
Not Available Completed Other Congestive Heart Failure / Ischaemic Cardiomyopathy 1
Not Available Completed Prevention End Stage Renal Disease (ESRD) 1
Not Available Completed Prevention Impaired Fasting Glucose (IFG) / Impaired Glucose Tolerance / Vitamin D Insufficiency 1
Not Available Completed Treatment BMI >30 kg/m2 1
Not Available Completed Treatment BMI >30 kg/m2 / Deficiency, Vitamin D / Psychosis / Schizoaffective Disorders / Schizophrenia 1
Not Available Completed Treatment Coronary Artery Disease / Deficiency, Vitamin D / Endothelial Dysfunction / Inflammatory Reaction 1
Not Available Completed Treatment Cystic Fibrosis (CF) 1
Not Available Completed Treatment Deficiency, Vitamin D 2
Not Available Completed Treatment Deficiency, Vitamin D / Healthy Volunteers 1
Not Available Completed Treatment Deficiency, Vitamin D / Osteoporosis 1
Not Available Completed Treatment End-Stage Renal Disease (ESRD) 1
Not Available Recruiting Prevention Bone Density 1
Not Available Terminated Not Available Fractures, Bone / Kidney Diseases / Muscle Weakness / Pain 1
Not Available Terminated Treatment Chronic Kidney Disease Stages 3-5 1
Not Available Terminated Treatment Leg Cramps, Nocturnal / Muscle Cramps 1
Not Available Unknown Status Treatment Chronic Kidney Disease (CKD) / Deficiency, Vitamin D 1
Not Available Unknown Status Treatment Deficiency, Vitamin D / Rheumatoid Arthritis 1
Not Available Withdrawn Treatment BMI >30 kg/m2 / Deficiency, Vitamin D / Insulin Resistance / Insulin Sensitivity 1
Not Available Withdrawn Treatment Chronic Kidney Disease (CKD) / Deficiency, Vitamin D 1

Pharmacoeconomics

Manufacturers

  • Eli lilly and co
  • Sanofi aventis us llc
  • Orit laboratories llc
  • Sigmapharm laboratories llc
  • Strides arcolab ltd
  • Sun pharmaceutical industries inc
  • Banner pharmacaps inc
  • Chase chemical co lp
  • Everylife
  • Impax laboratories inc
  • Lannett co inc
  • Vitarine pharmaceuticals inc
  • West ward pharmaceutical corp

Packagers

  • Banner Pharmacaps Inc.
  • Bayer Healthcare
  • Breckenridge Pharmaceuticals
  • Caraco Pharmaceutical Labs
  • Gallipot
  • Longs Drug Store
  • Major Pharmaceuticals
  • Optimum Pharmacueticals Inc.
  • PD-Rx Pharmaceuticals Inc.
  • Physicians Total Care Inc.
  • Pliva Inc.
  • Rising Pharmaceuticals
  • Sanofi-Aventis Inc.
  • Superior Pharmeceuticals
  • Walgreen Co.
  • Winthrop Us

Dosage forms

Form Route Strength
Solution / drops Oral
Capsule Oral 1.25 mg/1
Capsule, liquid filled Oral 1.25 mg/1
Liquid Oral 0.2 mg/1mL
Liquid Oral 8000 /1mL
Liquid Oral
Tablet, effervescent Oral
Injection, powder, lyophilized, for solution Intravenous
Kit Intravenous
Capsule Oral
Liquid Intravenous
Syrup Oral
Capsule Oral
Tablet Oral
Tablet, extended release Oral
Capsule Oral 1.25 1/1
Tablet Oral

Prices

Unit description Cost Unit
Ergocalciferol powder 234.4USD g
Doral 15 mg tablet 3.41USD tablet
Doral 7.5 mg tablet 3.37USD tablet
Drisdol 50000 unit capsule 2.34USD capsule
Drisdol 8288 unit/ml Liquid 0.48USD ml
Vitamin d 400 unit softgel 0.04USD softgel capsule
Longs vitamin d 400 unit tablet 0.03USD tablet

DrugBank does not sell nor buy drugs. Pricing information is supplied for informational purposes only. Patents Not Available

Properties

State Solid Experimental Properties Predicted Properties

Property Value Source
Water Solubility 0.000433 mg/mL ALOGPS
logP 7.59 ALOGPS
logP 7.05 ChemAxon
logS -6 ALOGPS
pKa (Strongest Acidic) 18.38 ChemAxon
pKa (Strongest Basic) -1.3 ChemAxon
Physiological Charge 0 ChemAxon
Hydrogen Acceptor Count 1 ChemAxon
Hydrogen Donor Count 1 ChemAxon
Polar Surface Area 20.23 Å2 ChemAxon
Rotatable Bond Count 5 ChemAxon
Refractivity 128.89 m3·mol-1 ChemAxon
Polarizability 50.73 Å3 ChemAxon
Number of Rings 3 ChemAxon
Bioavailability 1 ChemAxon
Rule of Five No ChemAxon
Ghose Filter No ChemAxon
Veber’s Rule Yes ChemAxon
MDDR-like Rule No ChemAxon

Predicted ADMET features

Property Value Probability
Human Intestinal Absorption + 1.0
Blood Brain Barrier + 0.9428
Caco-2 permeable + 0.8323
P-glycoprotein substrate Substrate 0.6628
P-glycoprotein inhibitor I Inhibitor 0.7614
P-glycoprotein inhibitor II Non-inhibitor 0.8391
Renal organic cation transporter Non-inhibitor 0.796
CYP450 2C9 substrate Non-substrate 0.8432
CYP450 2D6 substrate Non-substrate 0.9003
CYP450 3A4 substrate Substrate 0.7362
CYP450 1A2 substrate Non-inhibitor 0.9046
CYP450 2C9 inhibitor Non-inhibitor 0.8924
CYP450 2D6 inhibitor Non-inhibitor 0.9519
CYP450 2C19 inhibitor Non-inhibitor 0.8784
CYP450 3A4 inhibitor Non-inhibitor 0.8142
CYP450 inhibitory promiscuity Low CYP Inhibitory Promiscuity 0.8163
Ames test Non AMES toxic 0.9401
Carcinogenicity Non-carcinogens 0.9169
Biodegradation Not ready biodegradable 0.9742
Rat acute toxicity 3.6931 LD50, mol/kg Not applicable
hERG inhibition (predictor I) Weak inhibitor 0.8502
hERG inhibition (predictor II) Non-inhibitor 0.7513

ADMET data is predicted using admetSAR, a free tool for evaluating chemical ADMET properties. (23092397)

Spectra

Mass Spec (NIST) (9.78 KB) Spectra

Taxonomy

Description This compound belongs to the class of organic compounds known as vitamin d and derivatives. These are compounds containing a secosteroid backbone, usually secoergostane or secocholestane. Kingdom Organic compounds Super Class Lipids and lipid-like molecules Class Steroids and steroid derivatives Sub Class Vitamin D and derivatives Direct Parent Vitamin D and derivatives Alternative Parents Triterpenoids / Secondary alcohols / Cyclic alcohols and derivatives / Hydrocarbon derivatives Substituents Triterpenoid / Cyclic alcohol / Secondary alcohol / Organic oxygen compound / Hydrocarbon derivative / Organooxygen compound / Alcohol / Aliphatic homopolycyclic compound Molecular Framework Aliphatic homopolycyclic compounds External Descriptors hydroxy seco-steroid, seco-ergostane, vitamin D (CHEBI:28934) / Vitamin D2 and derivatives, Fat-soluble vitamins (C05441) / Vitamin D2 and derivatives (LMST03010000)

Targets

Kind Protein Organism Humans Pharmacological action Yes Actions Agonist General Function Zinc ion binding Specific Function Nuclear hormone receptor. Transcription factor that mediates the action of vitamin D3 by controlling the expression of hormone sensitive genes. Recruited to promoters via its interaction with BAZ1B… Gene Name VDR Uniprot ID P11473 Uniprot Name Vitamin D3 receptor Molecular Weight 48288.64 Da Kind Protein group Organism Humans Pharmacological action No Actions Inducer General Function Voltage-gated calcium channel activity Specific Function This protein is a subunit of the dihydropyridine (DHP) sensitive calcium channel. Plays a role in excitation-contraction coupling. The skeletal muscle DHP-sensitive Ca(2+) channel may function only…

Components:
  1. Oxford Academic

Enzymes

Kind Protein Organism Humans Pharmacological action No Actions Substrate General Function Oxidoreductase activity Specific Function Has a role in maintaining calcium homeostasis. Catalyzes the NADPH-dependent 24-hydroxylation of calcidiol (25-hydroxyvitamin D(3)) and calcitriol (1-alpha,25-dihydroxyvitamin D(3)). The enzyme can… Gene Name CYP24A1 Uniprot ID Q07973 Uniprot Name 1,25-dihydroxyvitamin D(3) 24-hydroxylase, mitochondrial Molecular Weight 58874.695 Da Kind Protein Organism Humans Pharmacological action No Actions Substrate General Function Iron ion binding Specific Function Catalyzes the conversion of 25-hydroxyvitamin D3 (25(OH)D) to 1-alpha,25-dihydroxyvitamin D3 (1,25(OH)2D) plays an important role in normal bone growth, calcium metabolism, and tissue differentiation. Gene Name CYP27B1 Uniprot ID O15528 Uniprot Name 25-hydroxyvitamin D-1 alpha hydroxylase, mitochondrial Molecular Weight 56503.475 Da Kind Protein Organism Humans Pharmacological action Unknown Actions Substrate General Function Vitamin d3 25-hydroxylase activity Specific Function Catalyzes the first step in the oxidation of the side chain of sterol intermediates; the 27-hydroxylation of 5-beta-cholestane-3-alpha,7-alpha,12-alpha-triol. Has also a vitamin D3-25-hydroxylase a… Gene Name CYP27A1 Uniprot ID Q02318 Uniprot Name Sterol 26-hydroxylase, mitochondrial Molecular Weight 60234.28 Da Kind Protein Organism Humans Pharmacological action No Actions Substrate General Function Vitamin d3 25-hydroxylase activity Specific Function Has a D-25-hydroxylase activity on both forms of vitamin D, vitamin D(2) and D(3). Gene Name CYP2R1 Uniprot ID Q6VVX0 Uniprot Name Vitamin D 25-hydroxylase Molecular Weight 57358.82 Da Kind Protein Organism Humans Pharmacological action No Actions Substrate General Function Catalyzes the reversible epimerization of D-ribulose 5-phosphate to D-xylulose 5-phosphate. Specific Function Identical protein binding Gene Name RPE Uniprot ID Q96AT9 Uniprot Name Ribulose-phosphate 3-epimerase Molecular Weight 24927.555 Da Kind Protein Organism Humans Pharmacological action No Actions Substrate General Function Oxidoreductase activity, acting on paired donors, with incorporation or reduction of molecular oxygen, nad(p)h as one donor, and incorporation of one atom of oxygen Specific Function Catalyzes the side-chain cleavage reaction of cholesterol to pregnenolone. Gene Name CYP11A1 Uniprot ID P05108 Uniprot Name Cholesterol side-chain cleavage enzyme, mitochondrial Molecular Weight 60101.87 Da

Carriers

Kind Protein Organism Humans Pharmacological action No Actions Binder General Function Vitamin transporter activity Specific Function Involved in vitamin D transport and storage, scavenging of extracellular G-actin, enhancement of the chemotactic activity of C5 alpha for neutrophils in inflammation and macrophage activation. Gene Name GC Uniprot ID P02774 Uniprot Name Vitamin D-binding protein Molecular Weight 52963.025 Da

  1. Speeckaert M., Speeckaert R., Geel N. and Delanghe J. (2014). Advances in Clinical Chemistry. Elsevier.

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Drug created on June 13, 2005 07:24 / Updated on February 02, 2020 00:09

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