Ergocalciferol (Lexi-Drugs)

Pronunciation

(er goe kal SIF e role)

Brand Names: US

Calcidol [OTC]; Calciferol [OTC]; Drisdol; Drisdol [OTC] [DSC]

Brand Names: Canada

D-Forte; Osto-D2 [DSC]; SANDOZ D-Forte

Pharmacologic Category

Vitamin D Analog

Dosing: Adult

Note: 1 mcg = 40 units

Osteoporosis prevention (off-label use): Oral: Adults ≥50 years of age: 800 to 1,000 units/day (NOF [Cosman 2014])

Vitamin D insufficiency/deficiency treatment (off-label use): Note: Repletion strategies may vary depending on desired target serum 25(OH)D levels as well as the clinical status of the patient. The optimal serum 25(OH)D level is controversial; the Institute of Medicine recommends a 25(OH)D level >20 ng/mL as sufficient in nearly all persons (IOM 2011), whereas others have suggested targeting a level of ~30 ng/mL to minimize the risk of fractures, particularly in patients with osteoporosis (AACE/ACE [Camacho 2016]; NOF [Cosman 2014]). However, some data suggest levels >40 ng/mL (median level in one trial: ~48 ng/mL) are associated with increased risk of falls in postmenopausal women (Sanders 2010; Smith 2017).

Therefore, some experts recommend a range of 20 to 40 ng/mL as a reasonable target in most patients (Dawson-Hughes 2018). Ergocalciferol (vitamin D2) is considered an alternative agent to the use of cholecalciferol (vitamin D3) by some experts due to limited data showing slightly higher levels of serum 25(OH)D achieved with D3, especially when higher doses or longer intervals are used (Dawson-Hughes 2018; Tripkovic 2012). In patients with normal absorption, for every 100 units/day of vitamin D ingested the serum 25(OH)D level is expected to increase by ~0.7 to 1 ng/mL (ASPEN [McKeever 2017]; Dawson-Hughes 2018). The dose-response declines as the 25(OH)D concentration increases above 40 ng/mL (100 nmol/L) (Dawson-Hughes 2018). The following recommendations are based primarily on expert opinion and clinical experience:

Initial dosing (according to baseline serum 25(OH)D level):

Serum 25(OH)D 20 to 30 ng/mL: Initial: Supplementation dosing: Oral: 600 to 800 units once daily; a repeat serum 25(OH)D level is not required (Dawson-Hughes 2018) or1,000 to 2,000 units once daily; may consider a repeat serum 25(OH)D level in ~3 months to determine if the target level has been achieved (Khan 2010).

Serum 25(OH)D 10 to <20 ng/mL: Initial:

Supplementation dosing: Oral: 800 to 1,000 units once daily (Dawson-Hughes 2018) or 2,000 units once daily (Khan 2010); a repeat serum 25(OH)D level should be drawn after ~3 months. If target serum 25(OH)D level has not been achieved, may increase to 2,000 units once daily or administer therapeutic dosing of 50,000 units once weekly for 6 to 8 weeks (Dawson-Hughes 2018).

OR

Therapeutic dosing (ie, high-dose ergocalciferol): Oral: 50,000 units once weekly (or 5,000 to 7,000 units once daily) for ~8 weeks followed by decreased maintenance dosing as needed to maintain target serum 25(OH)D level (AACE/ACE [Camacho 2016]; NOF [Cosman 2014])

Serum 25(OH)D <10 ng/mL or in patients with deficiency symptoms: Initial: Therapeutic dosing (ie, high-dose ergocalciferol): Oral: 50,000 units once weekly (or 5,000 to 7,000 units once daily) for 6 to 8 weeks to achieve target serum 25(OH)D level; a repeat serum 25(OH)D level should be drawn after ~3 months to assure target serum 25(OH)D level has been met (AACE/ACE [Camacho 2016]; Dawson-Hughes 2018; NOF [Cosman 2014]).

Maintenance dosing: Maintenance dosing is highly patient specific and dependent on target 25(OH)D level and may range from 600 to 800 units/day (Dawson-Hughes 2018) to 1,000 to 2,000 units/day (AACE/ACE [Camacho 2016]); NOF [Cosman 2014]).

Special populations (eg, obese patients, patients on medications known to affect vitamin D metabolism, patients with malabsorption syndromes or gastrectomy): Higher doses or longer durations may be necessary for adequate repletion (AACE/ACE [Camacho 2016]; Dawson-Hughes 2018).

Vitamin D deficiency/insufficiency in patients with chronic kidney disease (off-label use): Oral:

Note: In patients without severe and progressive hyperparathyroidism, including chronic kidney disease (CKD) stages G3 to G5 and dialysis or transplant patients, KDIGO guidelines recommend correcting vitamin D deficiency and insufficiency with treatment strategies recommended for the general population using ergocalciferol (or cholecalciferol) while avoiding hypercalcemia and ensuring phosphate levels are in the normal range. An individualized monitoring approach to direct treatment is also recommended (KDIGO 2009; KDIGO 2017). In patients in whom serum parathyroid hormone levels are progressively rising and remain persistently elevated despite correction of modifiable factors (eg, hyperphosphatemia, vitamin D deficiency), calcitriol or vitamin D analogs are suggested instead of ergocalciferol (or cholecalciferol) (KDOQI commentary [Uhlig 2010]).

Hypoparathyroidism: Note: Active vitamin D preparations (ie, alfacalcidolcalcitriol) in conjunction with calcium supplementation are recommended therapy. Addition of ergocalciferol (or cholecalciferol) may be considered for supplemental therapy (Endocrine Society [Brandi 2016]).

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Pediatric

Note: 1 mcg = 40 USP units

Adequate Intake (AI): Oral: Infants: 400 units/day (IOM 2011)

Recommended Daily Allowance (RDA): Oral: Children and Adolescents: 600 units/day (IOM 2011)

Hypoparathyroidism: Oral: Infants, Children, and Adolescents: 50,000 to 200,000 units daily with calcium supplements

Vitamin D deficiency, prevention (eg, Rickets prevention) (AAP [Folsom 2017]; AAP [Wagner 2008]; Munns 2016): Oral:

Breast-fed infants (fully or partially): Oral: 400 units/day beginning in the first few days of life. Continue supplementation until infant is weaned to ≥1,000 mL/day or 1 qt/day of vitamin D-fortified formula or whole milk (after 12 months of age)

Formula-fed infants ingesting <1,000 mL of vitamin D-fortified formula or milk: Oral: 400 units/day

Children and Adolescents without adequate intake: Oral: 400 to 600 units/day. Note: Children with increased risk of vitamin D deficiency (chronic fat malabsorption, maintained on chronic antiseizure medications) may require higher doses. Use laboratory testing [25(OH)D, PTH, bone mineral status] to evaluate.

Vitamin D deficiency, treatment: Note: Treatment should also include calcium and phosphorus supplementation; some patients with chronic fat malabsorption, obesity, or who are maintained on chronic antiseizure medications, glucocorticoids, HIV medications, or antifungals may require higher doses of ergocalciferol (AAP [Golden 2014]); monitor vitamin D status closely:

Infants: Oral: 2,000 units daily for 6 weeks to achieve a serum 25(OH)D level >20 ng/mL; followed by a maintenance dose of 400 to 1,000 units daily. Note: For patients at high risk of fractures a serum 25(OH)D level >30 ng/mL has been suggested (AAP [Golden 2014])

Children and Adolescents: Oral: 2,000 units daily for 6 to 8 weeks to achieve a serum 25(OH)D level >20 ng/mL; followed by a maintenance dose of 600 to 1,000 units daily. Note:For patients at high risk of fractures a serum 25(OH)D level >30 ng/mL has been suggested (AAP [Golden 2014])

Vitamin D insufficiency or deficiency associated with CKD (stages 2 to 5, 5D); serum 25 hydroxyvitamin D (25[OH]D) level <30 ng/mL: (K/DOQI Guidelines 2009): Oral:

Serum 25(OH)D level 16 to 30 ng/mL: Infants, Children, and Adolescents: 2,000 units/day for 3 months or 50,000 units every month for 3 months

Serum 25(OH)D level 5 to 15 ng/mL: Infants, Children, and Adolescents: 4,000 units/day for 12 weeks or 50,000 units every other week for 12 weeks

Serum 25(OH)D level <5 ng/mL: Infants, Children, and Adolescents: 8,000 units/day for 4 weeks then 4,000 units/day for 2 months for total therapy of 3 months or 50,000 units/week for 4 weeks followed by 50,000 units 2 times monthly for a total therapy of 3 months

Maintenance dose [once repletion accomplished; serum 25(OH)D level >30 ng/mL]: Infants, Children, and Adolescents: 200 to 1,000 units/day

Rickets:

Nutritional rickets, treatment: Limited data available (Munns 2016): Administer in combination with calcium supplementation:

Daily therapy (preferred):

Infants: Oral: 2,000 units daily for ≥3 months, followed by maintenance dose of 400 units daily

Children: Oral: 3,000 to 6,000 units daily for ≥3 months, followed by maintenance dose of 600 units daily

Adolescents: Oral: 6,000 units daily for ≥3 months, followed by maintenance dose of 600 units daily

Single-dose therapy: Note: While ergocalciferol can be used, cholecalciferol is the preferred supplement for single-dose therapy due to longer half-life

Infants ≥3 months: Oral: 50,000 units once, or in divided doses over several days; after 3 months, initiate maintenance dose of 400 units daily

Children: Oral: 150,000 units once, or in divided doses over several days; after 3 months, initiate maintenance dose of 600 units daily

Adolescents: Oral: 300,000 units once, or in divided doses over several days; after 3 months, initiate maintenance dose of 600 units daily

Dosing: Renal Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling; however, ergocalciferol is not renally eliminated to a significant extent and dosage adjustment is not necessary.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling.

Use: Labeled Indications

Dietary supplement: For use as a vitamin D supplement.

Hypoparathyroidism: Treatment of hypoparathyroidism. Note: Since parathyroid hormone (PTH) is required for the conversion of vitamin D (ergocalciferol or cholecalciferol) to the active metabolite of vitamin D (1,25-dihydroxyvitamin D), alternative vitamin D preparations not dependent on this conversion (eg, alfacalcidol, calcitriol) are recommended for routine use (Endocrine Society [Brandi 2016]).

Use: Off-Label: Adult

  Osteoporosis preventionLevel of Evidence [G]

Based on the Clinician’s Guide to Prevention and Treatment of Osteoporosis from the National Osteoporosis Foundation (NOF), ergocalciferol (or cholecalciferol) is effective and recommended for the prevention of osteoporosis.

  Vitamin D insufficiency/deficiencyLevel of Evidence [G]

Based on the National Osteoporosis Foundation (NOF) Clinician’s Guide to Prevention and Treatment of Osteoporosis, supplemental cholecalciferol (or ergocalciferol) may be used for the prevention or treatment of vitamin D deficiency to achieve desired serum 25(OH)D levels.

  Vitamin D insufficiency/deficiency in patients with chronic kidney disease, treatmentLevel of Evidence [G]

Based on the Kidney Disease: Improving Global Outcomes (KDIGO) clinical practice guideline update for the diagnosis, evaluation, prevention, and treatment of chronic kidney disease–mineral and bone disorder (CKD-MBD), vitamin D insufficiency/deficiency in patients without severe and progressive hyperparathyroidism, including chronic kidney disease stages G3 to G5 and dialysis or transplant patients, should be corrected using treatment strategies recommended for the general population, which includes repletion with ergocalciferol (or cholecalciferol) Ref. In patients in whom serum parathyroid hormone levels are progressively rising and remain persistently elevated despite correction of modifiable factors, calcitriol or vitamin D analogs are suggested instead of ergocalciferol (or cholecalciferol) Ref.

Level of Evidence Definitions
  Level of Evidence Scale
Use: Unsupported: Adult
X-linked hypophosphatemia (ie, vitamin D-resistant rickets)

Although included as an FDA-approved use in the manufacturer’s labeling, ergocalciferol is not a recommended treatment for X-linked hypophosphatemia (ie, vitamin D-resistant rickets); treatment with activated forms of vitamin D (ie, calcitriol, alfacalcidol) and phosphorous are recommended (Carpenter 2011).

Clinical Practice Guidelines

Chronic Kidney Disease:

KDIGO Clinical Practice Guideline for the Diagnosis, Evaluation, Prevention, and Treatment of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD), 2009

KDIGO Clinical Practice Guideline for the Diagnosis, Evaluation, Prevention, and Treatment of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD), 2017

KDOQI Clinical Practice Guidelines for Bone Metabolism and Disease in Children With Chronic Kidney Disease

KDOQI Clinical Practice Guidelines for Bone Metabolism and Disease in Chronic Kidney Disease, Guideline 7. Prevention and Treatment of Vitamin D Insufficiency and Vitamin D Deficiency in CKD Patients

National Kidney Foundation, “KDOQI Clinical Practice Guideline for Nutrition in Children with CKD: 2008 Update,” 2009

Hypoparathyroidism:

Endocrine Society, “Management of Hypoparathyroidism: Summary Statement and Guidelines,” 2016

Osteoporosis:

American Association of Clinical Endocrinologists and American College of Endocrinology, “Clinical Practice Guidelines for the Diagnosis and Treatment of Postmenopausal Osteoporosis,” 2016

American College of Physicians, “Treatment of Low Bone Density or Osteoporosis to Prevent Fractures in Men and Women: A Clinical Practice Guideline Update from the American College of Physicians,” 2017

American College of Rheumatology, “Guideline for the Prevention and Treatment of Glucocorticoid-Induced Osteoporosis,” 2017

Endocrine Society, “Osteoporosis in Men: An Endocrine Society Clinical Practice Guideline,” 2012

National Osteoporosis Foundation, Clinician’s Guide to Prevention and Treatment of Osteoporosis, 2014

Administration: Pediatric

Oral: May be administered without regard to meals; for oral liquid, administer with an accurate measuring device; do not use a household teaspoon (overdosage may occur).

Dietary Considerations

Vitamin D is found in egg yolks, fatty fish, fortified milk, fortified cereal, and infant formulas; it is also produced by exposure to sunlight (IOM 2011).

Dietary Reference Intake for Vitamin D (IOM 2011):

Infants 0 to 12 months: Adequate intake: 10 mcg/day (400 units/day)

1 to 70 years: RDA: 15 mcg/day (600 units/day)

>70 years: RDA: 20 mcg/day (800 units/day)

Pregnancy/Lactating: RDA: 15 mcg/day (600 units/day)

Storage/Stability

Store at 15°C to 30°C (59°F to 86°F). Protect from light.

Medication Patient Education with HCAHPS Considerations

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Medication Safety Issues
  Sound-alike/look-alike issues:
  Administration issues:
Contraindications

Hypercalcemia; malabsorption syndrome; abnormal sensitivity to the toxic effects of vitamin D; hypervitaminosis D

Note: Although the manufacturer’s labeling lists use in malabsorption syndrome as contraindicated, when dosed appropriately, ergocalciferol may be used in these patients (AACE/ACE [Camacho 2016]; Dawson-Hughes 2018).

Documentation of allergenic cross-reactivity for vitamin D analogues is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Warnings/Precautions

Concerns related to adverse effects:

• Vitamin D toxicity: May occur with excessive doses; symptoms may include nausea, vomiting, loss of appetite, constipation, dehydration, fatigue, irritability, confusion, weakness, and/or weight loss. Effects of vitamin D can last ≥2 months after therapy is discontinued.

Disease-related concerns:

• Hyperphosphatemia: Normal serum phosphorous concentrations must be maintained in patients treated for hyperphosphatemia to prevent metastatic calcification.

• Obesity: Adults with a BMI >30 kg/m2 are at high risk for vitamin D deficiency due to storage of vitamin D in adipose tissue. Doses higher than the RDA may be required, but must be carefully monitored to avoid toxicity.

• Renal impairment: Metabolism of vitamin D may be altered in patients with chronic kidney disease. Supplementation with ergocalciferol may be needed; close monitoring is required (KDIGO 2009).

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Dosage form specific issues:

• Propylene glycol: Oral solutions may contain propylene glycol; toxicities may occur if large doses of vitamin D are required. Alternate dosage forms/products should be used (Misra 2008).

• Tartrazine: Products may contain tartrazine, which may cause allergic reactions in certain individuals.

Geriatric Considerations

Vitamin D, folate, and B12 (cyanocobalamin) have decreased absorption with age (clinical significance unknown); studies in ill geriatrics demonstrated that low serum concentrations of vitamin D result in greater bone loss. Calorie requirements decrease with age and therefore, nutrient density must be increased to ensure adequate nutrient intake, including vitamins and minerals. The use of a daily supplement with a multiple vitamin with minerals is recommended because elderly consume less vitamin D, absorption may be decreased, and many have decreased sun exposure. This is a recommendation of particular need to those with high risk for osteoporosis.

Vitamin D supplementation has been shown to increase muscle function and strength, as well as improve balance. Patients at risk for falls should have vitamin D serum concentrations measured and be evaluated for supplementation.

Warnings: Additional Pediatric Considerations

Some dosage forms may contain propylene glycol; in neonates large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Shehab 2009).

Pregnancy Considerations

Adverse events were observed in some animal reproduction studies. The ergocalciferol (vitamin D2) metabolite, 25(OH)D, crosses the placenta; maternal serum concentrations correlate with fetal concentrations at birth (Misra 2008; Wagner 2008).

Vitamin D deficiency in a pregnant woman may lead to a vitamin D deficiency in the neonate (Misra 2008; Wagner 2008). Serum 25(OH)D concentrations should be measured in pregnant women considered to be at increased risk of deficiency (ACOG 2011). The amount of vitamin D contained in prenatal vitamins may not be adequate to treat a deficiency during pregnancy; although larger doses may be needed, current guidelines recommend a total of 1000 to 2000 units/day until more safety data is available (ACOG 2011). In women not at risk for deficiency, doses larger than the RDA should be avoided during pregnancy (ACOG 2011).

Maternal vitamin D requirements are the same for breastfeeding and nonbreastfeeding females (IOM 2011). The maternal dose of vitamin D needed to provide the infant with an adequate amount of vitamin D is still under study (Wagner 2008)

Breast-Feeding Considerations

The 25(OH)D metabolite can be detected in breast milk. The manufacturer recommends that caution be used if ergocalciferol is administered to nursing women. Hypercalcemia has been noted in a breastfeeding infant following maternal use of large amounts of vitamin D; calcium serum concentrations should be monitored in nursing infants exposed to large doses.

Small quantities of vitamin D are found in breast milk following normal maternal exposure via sunlight and diet. The amount in breast milk does not correlate with serum levels in the infant and the vitamin D content of human milk is not enough to meet the recommended intake for a nursing infant. Therefore, vitamin D supplementation is recommended in all infants who are partially or exclusively breast fed (Misra 2008; Wagner 2008).

Briggs’ Drugs in Pregnancy & Lactation
Adverse Reactions

Frequency not defined: Endocrine & metabolic: Hypervitaminosis D

Allergy and Idiosyncratic Reactions
Toxicology
Metabolism/Transport Effects

None known.

Drug Interactions 

Aluminum Hydroxide: Vitamin D Analogs may increase the serum concentration of Aluminum Hydroxide. Specifically, the absorption of aluminum may be increased, leading to increased serum aluminum concentrations. Risk X: Avoid combination

Bile Acid Sequestrants: May decrease the serum concentration of Vitamin D Analogs. More specifically, bile acid sequestrants may impair absorption of Vitamin D Analogs. Management: Avoid concomitant administration of vitamin D analogs and bile acid sequestrants (eg, cholestyramine). Separate administration of these agents by several hours to minimize the potential risk of interaction. Monitor plasma calcium concentrations. Risk D: Consider therapy modification

Calcium Salts: May enhance the adverse/toxic effect of Vitamin D Analogs. Risk C: Monitor therapy

Cardiac Glycosides: Vitamin D Analogs may enhance the arrhythmogenic effect of Cardiac Glycosides. Risk C: Monitor therapy

Danazol: May enhance the hypercalcemic effect of Vitamin D Analogs. Risk C: Monitor therapy

Mineral Oil: May decrease the serum concentration of Vitamin D Analogs. More specifically, mineral oil may interfere with the absorption of Vitamin D Analogs. Management: Avoid concomitant, oral administration of mineral oil and vitamin D analogs. Consider separating the administration of these agents by several hours to minimize the risk of interaction. Monitor plasma calcium concentrations. Risk D: Consider therapy modification

Multivitamins/Fluoride (with ADE): May enhance the adverse/toxic effect of Vitamin D Analogs. Risk X: Avoid combination

Multivitamins/Minerals (with ADEK, Folate, Iron): May enhance the adverse/toxic effect of Vitamin D Analogs. Risk X: Avoid combination

Orlistat: May decrease the serum concentration of Vitamin D Analogs. More specifically, orlistat may impair absorption of Vitamin D Analogs. Management: Monitor clinical response (including serum calcium) to oral vitamin D analogs closely if used with orlistat. If this combination must be used, consider giving the vitamin D analog at least 2 hrs before or after orlistat. Risk D: Consider therapy modification

Sucralfate: Vitamin D Analogs may increase the serum concentration of Sucralfate. Specifically, the absorption of aluminum from sucralfate may be increased, leading to an increase in the serum aluminum concentration. Risk X: Avoid combination

Thiazide and Thiazide-Like Diuretics: May enhance the hypercalcemic effect of Vitamin D Analogs. Risk C: Monitor therapy

Vitamin D Analogs: May enhance the adverse/toxic effect of other Vitamin D Analogs. Risk X: Avoid combination

Monitoring Parameters

Signs/symptoms of vitamin D toxicity (eg, hypercalcemia, hypercalciuria, confusion, psychosis, tremor, calcification of soft tissue, nausea, weakness) (ASPEN [McKeever 2017])

Adults:

Serum 25(OH)D: For patients being treated for vitamin D deficiency, measure ~3 months after initiation or dosage adjustment. In healthy patients initiating supplementation dosing, routine monitoring is not required (Dawson-Hughes 2018).

Additional monitoring of calcium, phosphorous, parathyroid hormone (PTH), and alkaline phosphatase may be required depending on severity of 25(OH)D deficiency and/or concomitant clinical condition (eg, chronic kidney disorder [CKD], hypoparathyroidism) (Dawson-Hughes 2018; Endocrine Society [Brandi 2016]; KDIGO 2017).

Infants, Children, and Adolescents:

Vitamin D deficiency: Serum calcium, phosphorus, and alkaline phosphatase (ALP) one month after starting therapy; serum calcium, phosphorous, magnesium, ALP, 25(OH)D, and PTH as well as x-ray (may also consider urine calcium/creatinine ratio) after 3 months; 25(OH)D yearly (Misra 2008).

Increased risk of vitamin D deficiency (eg, chronic fat malabsorption, chronic antiseizure medication use): Serum 25(OH)D, PTH, and bone mineral status (baseline); if vitamin D supplement is required, repeat 25(OH)D levels at 3-month intervals until normal. PTH and bone mineral status should be monitored every 6 months until normal (Wagner 2008).

CKD: Measure serum 25(OH)D levels after 3 months of treatment. Measure corrected total calcium and phosphorous after 1 month and then at least every 3 months (KDOQI 2009).

Reference Range

Vitamin D deficiency: There is no clear consensus on a reference range for total serum 25(OH)D concentrations or the validity of this level as it relates clinically to bone health. In addition, there is significant variability in the reporting of serum 25(OH)D levels as a result of different assay types in use. However, the following ranges have been suggested:

Adults:

<12 ng/mL (30 nmol/L): At risk for deficiency (IOM 2011)

12 to 20 ng/mL (30 to 50 nmol/L): Potentially at risk for inadequacy (IOM 2011)

≥20 ng/mL (50 nmol/L): Sufficient levels in practically all persons (IOM 2011)

>40 ng/mL (100 nmol/L): Increased risk of falls have been reported in elderly women with levels >40 ng/mL (Smith 2017) or ~48 ng/mL (120 nmol/mL) (Sanders 2010).

>50 ng/mL (125 nmol/L): There are insufficient data to determine the safe upper limit of serum 25(OH)D. Serum 25(OH)D levels above approximately 50 ng/mL (125 nmol/L) should be avoided (IOM 2011).

Osteoporosis patients (NOF [Cosman 2014]): ~30 ng/mL (75 nmol/L): Recommended level to reach and maintain

Children (Misra 2008):

<15 ng/mL (37.5 nmol/L): At risk for deficiency

15 to 20 ng/mL (37.5 to 50 nmol/L): Potentially at risk for inadequacy

≥20 ng/mL (50 nmol/L): Sufficient levels in practically all children

>100 ng/mL (250 nmol/L): Concern for risk of toxicity

Advanced Practitioners Physical Assessment/Monitoring

Provide patient appropriate nutritional counseling. Assess calcium and phosphate levels. Assess renal function when appropriate.

Nursing Physical Assessment/Monitoring

Provide patient appropriate nutritional counseling. Monitor calcium and phosphate levels.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule, Oral:

Drisdol: 50,000 units [contains brilliant blue fcf (fd&c blue #1), soybean oil, tartrazine (fd&c yellow #5)]

Generic: 50,000 units

Solution, Oral:

Calcidol: 8000 units/mL (60 mL) [contains propylene glycol]

Calciferol: 8000 units/mL (60 mL) [contains propylene glycol]

Drisdol: 8000 units/mL (60 mL [DSC]) [contains propylene glycol]

Generic: 8000 units/mL (60 mL)

Tablet, Oral:

Generic: 400 units, 2000 units

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule, Oral:

Osto-D2: 50,000 units [DSC]

Generic: 50,000 units

Anatomic Therapeutic Chemical (ATC) Classification
  • A11CC01
Generic Available (US)

Yes

Pricing: US

Capsules (Drisdol Oral)

50000 unit (per each): $3.49

Capsules (Ergocalciferol Oral)

50000 unit (per each): $0.72

Solution (Calcidol Oral)

8000 units/mL (per mL): $1.66

Solution (Calciferol Oral)

8000 units/mL (per mL): $3.44

Solution (Ergocalciferol Oral)

8000 units/mL (per mL): $0.59 – $1.67

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer’s AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Mechanism of Action

Ergocalciferol (vitamin D2) is a provitamin. The active metabolite, 1,25-dihydroxyvitamin D (calcitriol), stimulates calcium and phosphate absorption from the small intestine, promotes secretion of calcium from bone to blood; promotes renal tubule phosphate resorption.

Pharmacodynamics/Kinetics

Onset of action: 10 to 24 hours; Maximum effect: ~1 month following daily doses

Absorption: Absorbed in the small intestine; fat soluble; requires bile (IOM 2011)

Metabolism: Inactive until hydroxylated hepatically to 25-hydroxyvitamin D [25(OH)D; calcifediol] then renally to the active metabolite 1,25-dihydroxyvitamin D (calcitriol)

Half-life, circulating: 25(OH)D: 2 to 3 weeks; 1,25-dihydroxyvitamin D ~4 hours

Excretion: Feces (IOM 2011)

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

Key adverse event(s) related to dental treatment: Metallic taste and xerostomia (normal salivary flow resumes upon discontinuation).

Effects on Bleeding

No information available to require special precautions

Index Terms

Activated Ergosterol; D2; Viosterol; Vitamin D2

References

ACOG Committee on Obstetric Practice. ACOG Committee Opinion No. 495: Vitamin D: Screening and supplementation during pregnancy. Obstet Gynecol. 2011;118(1):197-198. doi: 10.1097/AOG.0b013e318227f06b.[PubMed 21691184]

Brandi ML, Bilezikian JP, Shoback D, et al. Management of hypoparathyroidism: summary statement and guidelines. J Clin Endocrinol Metab. 2016;101(6):2273-2283. doi: 10.1210/jc.2015-3907.[PubMed 26943719]

Camacho PM, Petak SM, Binkley N, et al. American Association of Clinical Endocrinologists and American College of Endocrinology clinical practice guidelines for the diagnosis and treatment of postmenopausal osteoporosis–2016: executive summary [published correction appears in Endocr Pract. 2017;23(3):383]. Endocr Pract. 2016;22(9):1111-1118. doi: 10.4158/EP161435.ESGL.[PubMed 27643923]

Carpenter TO, Imel EA, Holm IA, Jan de Beur SM, Insogna KL. A clinician’s guide to X-linked hypophosphatemia [published correction appears in J Bone Miner Res. 2015;30(2):394]. J Bone Miner Res. 2011;26(7):1381-1388. doi: 10.1002/jbmr.340.[PubMed 21538511]

Cosman F, de Beur SJ, LeBoff MS, et al; National Osteoporosis Foundation. Clinician’s guide to prevention and treatment of osteoporosis [published correction appears in Osteoporos Int. 2015;26(7):2045-2047]. Osteoporos Int. 2014;25(10):2359-2381. doi: 10.1007/s00198-014-2794-2.[PubMed 25182228]

Dawson-Hughes B. Vitamin D deficiency in adults: Definition, clinical manifestations, and treatment. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed October 1, 2018.[PubMed 25182228]

Drisdol (ergocalciferol) [prescribing information]. Bridgewater, NJ: Sanofi-Aventis; July 2018.

FDA consumer update. Infant overdose risk with liquid vitamin D. June 15, 2010. Available at https://www.fda.gov/forconsumers/consumerupdates/ucm214343.htm. Accessed March 11, 2019.

Folsom LJ, DiMeglio LA. Recommendations released on prevention, management of rickets. AAP Newshttp://www.aappublications.org/news/2017/02/10/Rickets021017. Published February 10, 2017. Accessed October 19, 2018.

Golden NH, Abrams SA; Committee on Nutrition. Optimizing bone health in children and adolescents. Pediatrics. 2014;134(4):e1229-e1243. doi: 10.1542/peds.2014-2173.[PubMed 25266429]

Institute of Medicine (IOM). Dietary Reference Intakes for Calcium and Vitamin D. Washington, DC: The National Academies Press; 2011.

Khan QJ, Fabian CJ. How I treat vitamin d deficiency. J Oncol Pract. 2010;6(2):97-101. doi: 10.1200/JOP.091087.[PubMed 20592785]

KDOQI clinical practice guidelines for bone metabolism and disease in chronic kidney disease. Guideline 7. Prevention and treatment of vitamin D insufficiency and vitamin D deficiency in CKD patients. http://kidneyfoundation.cachefly.net/professionals/KDOQI/guidelines_bone/guide7.htm. Published 2003. Accessed October 31, 2018.

KDOQI Work Group. KDOQI clinical practice guideline for nutrition in children with CKD: 2008 update. Executive summary. Am J Kidney Dis. 2009;53(3)(suppl 2):S11-S104. doi: 10.1053/j.ajkd.2008.11.017.[PubMed 19231749]

Kidney Disease: Improving Global Outcomes (KDIGO) CKD-MBD Work Group. KDIGO clinical practice guideline for the diagnosis, evaluation, prevention, and treatment of chronic kidney disease-mineral and bone disorder (CKD-MBD). Kidney Int Suppl. 2009;76(113):S1-S130. doi: 10.1038/ki.2009.188.[PubMed 19644521]

Kidney Disease: Improving Global Outcomes (KDIGO). KDIGO 2017 clinical practice guideline update for the diagnosis, evaluation, prevention, and treatment of chronic kidney disease–mineral and bone disorder (CKD-MBD). Kidney Int Suppl. 2017;7(1):1-59. https://kdigo.org/wp-content/uploads/2017/02/2017-KDIGO-CKD-MBD-GL-Update.pdf. Accessed October 25, 2018.

McKeever L. Vitamins and Trace Elements. In: Mueller CM, ed. A.S.P.E.N. Adult Nutrition Support Core Curriculum. 3rd edition. Silver Spring, MD: American Society for Parenteral and Enteral Nutrition; 2017:146. http://www.nutritioncare.org/

Misra M, Pacaud D, Petryk A, et al, “Vitamin D Deficiency in Children and Its Management: Review of Current Knowledge and Recommendations,” Pediatrics, 2008, 122(2):398-417.[PubMed 18676559]

Munns CF, Shaw N, Kiely M, et al. Global consensus recommendations on prevention and management of nutritional rickets. J Clin Endocrinol Metab. 2016;101(2):394-415. doi: 10.1210/jc.2015-2175.[PubMed 26745253]

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Riggs BL, Melton LJ. The Prevention and Treatment of Osteoporosis. N Engl J Med. 1992;327(9):620-627.[PubMed 1640955]

Sanders KM, Stuart AL, Williamson EJ, et al. Annual high-dose oral vitamin D and falls and fractures in older women: a randomized controlled trial [published correction appears in JAMA. 2010;303(23):2357]. JAMA. 2010;303(18):1815-1822. doi: 10.1001/jama.2010.594.[PubMed 20460620]

Smith LM, Gallagher JC, Suiter C. Medium doses of daily vitamin D decrease falls and higher doses of daily vitamin D3 increase falls: A randomized clinical trial. J Steroid Biochem Mol Biol. 2017;173:317-322. doi: 10.1016/j.jsbmb.2017.03.015.[PubMed 28323044]

Tripkovic L, Lambert H, Hart K, et al. Comparison of vitamin D2 and vitamin D3 supplementation in raising serum 25-hydroxyvitamin D status: a systematic review and meta-analysis. Am J Clin Nutr. 2012;95(6):1357-1364. doi:10.3945/ajcn.111.031070.[PubMed 22552031]

Uhlig K, Berns JS, Kestenbaum B, et al. KDOQI US commentary on the 2009 KDIGO clinical practice guideline for the diagnosis, evaluation, and treatment of CKD-mineral and bone disorder (CKD-MBD). Am J Kidney Dis. 2010;55(5):773-799. doi: 10.1053/j.ajkd.2010.02.340.[PubMed 22552031]

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Brand Names: International

Adekon (MX); Aderowest (MX); AFI-D2 forte (NO); Aquasol AD (MX); Axed (MX); Biocatines D2 (ES); Calciferol (CZ); Calciferol BD (TH); D-forte (FI); DePURA (BR); Devitol (AT, FI); Endo-D (IT); Ergosterina Irradiata (IT); Farmobion D2 (IT); Infadin (CZ); Jekovit (FI); One-Alpha (AE, BB, BF, BJ, BM, BS, BZ, CI, CY, ET, GH, GM, GN, GY, IL, IQ, IR, JM, JO, KE, KW, LB, LR, LY, MA, ML, MR, MU, MW, NE, NG, NL, OM, PR, QA, SA, SC, SD, SL, SN, SR, SY, TN, TT, TZ, UG, YE, ZA, ZM, ZW); Ostelin (AU, IT); Pharmaton Complex (MX); Raquiferol (AR); Raquiferol BC (PY); Raquiferol D2 (PE); Sterogyl (BE, LU); Sterogyl-15 (FR); Uvesterol D (FR); Vigantol (ES); Vigantolo (IT); Vitamina D2 Salf (IT); Vitaminol (GR)

Ergocalciferol (Patient Education – Adult Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(er goe kal SIF e role)

Brand Names: US

Calcidol [OTC]; Calciferol [OTC]; Drisdol; Drisdol [OTC] [DSC]

Brand Names: Canada

D-Forte; Erdol

What is this drug used for?
  • It is used to treat poor parathyroid function.
  • It is used to treat or prevent low phosphate levels.
  • It is used to treat rickets.
  • It may be given to you for other reasons. Talk with the doctor.
What do I need to tell my doctor BEFORE I take this drug?
  • If you have an allergy to ergocalciferol or any other part of this drug.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have any of these health problems: High calcium levels, high vitamin D levels, or malabsorption syndrome.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take this drug?
  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  • If you are allergic to tartrazine, talk with your doctor. Some products have tartrazine.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Too much vitamin D in the body may cause problems. Do not take more of this drug than what your doctor told you to take. Be sure you know the signs of too much vitamin D in the body. If you have questions, talk with your doctor.
  • If you are taking other sources of vitamin D, talk with your doctor.
  • Follow the diet plan that your doctor told you about.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this drug while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.
What are some side effects that I need to call my doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best taken?
  • Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
  • All products:
  • Take with or without food. Take with food if it causes an upset stomach.
  • To gain the most benefit, do not miss doses.
  • Keep taking this drug as you have been told by your doctor or other health care provider, even if you feel well.
  • Liquid:
  • Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, ask the pharmacist for a device to measure this drug.
What do I do if I miss a dose?
  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
How do I store and/or throw out this drug?
  • Store at room temperature.
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Ergocalciferol (Patient Education – Pediatric Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(er goe kal SIF e role)

Brand Names: US

Calcidol [OTC]; Calciferol [OTC]; Drisdol; Drisdol [OTC] [DSC]

Brand Names: Canada

D-Forte; Erdol

What is this drug used for?
  • It is used to treat poor parathyroid function.
  • It is used to treat or prevent low phosphate levels.
  • It is used to treat rickets.
  • It may be given to your child for other reasons. Talk with the doctor.
What do I need to tell the doctor BEFORE my child takes this drug?
  • If your child has an allergy to this drug or any part of this drug.
  • If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If your child has any of these health problems: High calcium levels, high vitamin D levels, or malabsorption syndrome.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
What are some things I need to know or do while my child takes this drug?
  • Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
  • If your child is allergic to tartrazine, talk with your child’s doctor. Some products have tartrazine.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Too much vitamin D in the body may cause problems. Do not give your child more of this drug than what your child’s doctor told you to give. Be sure you know the signs of too much vitamin D in the body. If you have questions, talk with your child’s doctor.
  • If your child is taking other sources of vitamin D, talk with the doctor.
  • Have your child follow the diet plan your child’s doctor told you about.
  • If your child is pregnant or breast-feeding a baby:
  • Talk with the doctor if your child is pregnant, becomes pregnant, or is breast-feeding a baby. You will need to talk about the benefits and risks to your child and the baby.
What are some side effects that I need to call my child’s doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if your child has any side effects that bother your child or do not go away.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best given?
  • Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
  • All products:
  • Give this drug with or without food. Give with food if it causes an upset stomach.
  • To gain the most benefit, do not miss giving your child doses.
  • Keep giving this drug to your child as you have been told by your child’s doctor or other health care provider, even if your child feels well.
  • Liquid:
  • Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, ask the pharmacist for a device to measure this drug.
What do I do if my child misses a dose?
  • Give a missed dose as soon as you think about it.
  • If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
  • Do not give 2 doses at the same time or extra doses.
How do I store and/or throw out this drug?
  • Store at room temperature.
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
  • Do not share your child’s drug with others and do not give anyone else’s drug to your child.
  • Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
  • Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.