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Pronunciation
(er goe kal SIF e role)
Generic Available (U.S.)
Yes: Capsule (softgel), tablet
Index Terms
U.S. Brand Names
Canadian Brand Names
Pharmacologic Category
Use: Labeled Indications
Treatment of refractory rickets, hypophosphatemia, hypoparathyroidism; dietary supplement
Use: Unlabeled/Investigational
Prevention and treatment of vitamin D deficiency in patients with chronic kidney disease (CKD)
Pregnancy Risk Factor
C (manufacturer); A/C (dose exceeding RDA recommendation; per expert analysis)
Pregnancy Considerations
Abnormalities have been observed in animal studies with maternal doses causing hypervitaminosis D. Doses larger than the RDA should be avoided during pregnancy.
Lactation
Enters breast milk/use caution
Breast-Feeding Considerations
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. Therefore, vitamin D supplementation is recommended in all infants who are partially or exclusively breast fed. Hypercalcemia has been noted in a breast-feeding infant following maternal use of large doses of ergocalciferol; high doses should be avoided in lactating women.
Contraindications
Hypersensitivity to ergocalciferol or any component of the formulation; hypercalcemia; malabsorption syndrome; hypervitaminosis D or abnormal sensitivity to the toxic effects of vitamin D
Warnings/Precautions
Disease-related concerns:
• Cardiovascular disease: Use with caution in patients with cardiovascular disease.
• Renal impairment: Use with caution in patients with renal impairment or diseases that may impair vitamin D metabolism.
• Rickets: The range between therapeutic and toxic doses is narrow in vitamin D-resistant rickets; adjust dose based on clinical response to avoid toxicity.
Dosage form specific issues:
• Tartrazine: Products may contain tartrazine, which may cause allergic reactions in certain individuals.
Other warnings/precautions:
• Appropriate use: Adequate calcium supplementation is required; calcium and phosphorous levels must be monitored during therapy.
• Toxicity: Effects of vitamin D can last ≥2 months after therapy is discontinued.
Adverse Reactions
Frequency not defined: Endocrine & metabolic: Hypervitaminosis D (signs and symptoms include hypercalcemia, resulting in headache, nausea, vomiting, lethargy, confusion, sluggishness, abdominal pain, bone pain, polyuria, polydipsia, weakness, cardiac arrhythmias [eg, QT shortening, sinus tachycardia], soft tissue calcification, calciuria, and nephrocalcinosis)
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 (e.g., 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
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
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 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
Storage
Store at room temperature of 15°C to 30°C (59°F to 86°F). Protect from light.
Mechanism of Action
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: Peak effect:~1 month following daily doses
Absorption: Readily; requires bile
Metabolism: Inactive until hydroxylated hepatically and renally to calcifediol and then to calcitriol (most active form)
Dosage
Oral: Note: 1 mcg = 40 int. units
Dietary Intake Reference ([DIR] 1997): Note: DIR is currently being reviewed (March 2009):
Infants and Children: 5 mcg (200 int units)/day
Adults:
18-50 years: 5 mcg/day (200 int. units/day)
51-70 years: 10 mcg/day (400 int. units/day)
Elderly >70 years: 15 mcg/day (600 int. units/day)
Adequate intake:
Infants and Children (Wagner, 2008): 10 mcg/day (400 int. units/day)
Breast-fed (fully or partially) Infants: 10 mcg/day (400 int. units/day) beginning in the first few days of life; continue supplementation until infant is weaned to ≥1 L/day or 1 quart/day of vitamin D-fortified formula or whole milk (after 12 months of age)
Nonbreast-fed Infants, Older Children ingesting <1000 mL of vitamin D-fortified formula or milk: 10 mcg/day (400 int. units/day)
Adolescents without adequate intake: 10 mcg/day (400 int. units/day)
Children with increased risk of vitamin D deficiency (chronic fat malabsorption, maintained on chronic antiseizure medications): Higher doses may be required; use laboratory testing (25 [OH]D, PTH, bone mineral status) to evaluate
Osteoporosis prevention and treatment: Adults ≥50 years: 10 mcg/day (800-1000 int. units/day)
Vitamin D deficiency/insufficiency in patients with CKD stages 3-4 (K/DOQI guidelines): Note: Dose is based on 25-hydroxyvitamin D serum level (25[OH]D):
Children (treatment duration should be a total of 3 months):
Serum 25(OH)D <5 ng/mL:
8000 int. units/day for 4 weeks, then 4000 int. units/day for 2 months or
50,000 int. units/week for 4 weeks, then 50,000 int. units twice a month for 2 months
Serum 25(OH)D 5-15 ng/mL:
4000 int units/day or
50,000 int units every other week
Serum 25(OH)D 16-30 ng/mL:
2000 int. units/day or
50,000 int. units every 4 weeks
Adults (treatment duration should be a total of 6 months):
Serum 25(OH)D <5 ng/mL:
50,000 int. units/week for 12 weeks, then 50,000 int. units/month
Serum 25(OH)D 5-15 ng/mL:
50,000 int. units/week for 4 weeks, then 50,000 int. units/month
Serum 25(OH)D 16-30 ng/mL:
50,000 int. units/month
Hypoparathyroidism:
Children: 1.25-5 mg/day (50,000-200,000 int. units) and calcium supplements
Adults: 625 mcg to 5 mg/day (25,000-200,000 int. units) and calcium supplements
Nutritional rickets and osteomalacia:
Children and Adults (with normal absorption): 25-125 mcg/day (1000-5000 int. units)
Children with malabsorption: 250-625 mcg/day (10,000-25,000 int. units)
Adults with malabsorption: 250-7500 mcg (10,000-300,000 int. units)
Vitamin D
-dependent
rickets:
Children: 75-125 mcg/day (3000-5000 int. units); maximum: 1500 mcg/day
Adults: 250 mcg to 1.5 mg/day (10,000-60,000 int. units)
Vitamin D
-resistant
rickets: Children and Adults: 12,000-500,000 int. units/day
Familial hypophosphatemia:
Children: 40,000-80,000 int. units plus phosphate supplements; dose may be reduced once growth is complete
Adults: 10,000-60,000 int. units plus phosphate supplements
Monitoring Parameters
Serum calcium, creatinine, BUN, and phosphorus every 1-2 weeks; x-ray bones monthly until stabilized; signs and symptoms of vitamin D intoxication
Children at increased risk of vitamin D deficiency (chronic fat malabsorption, chronic antiseizure medication use) require serum 25(OH)D, PTH, and bone mineral status to evaluate. If vitamin D supplement required, then 25(OH)D levels should be repeated at 3-month intervals until normal. PTH and bone mineral status should be monitored every 6 months until normal.
Vitamin D deficiency/insufficiency in patients with CKD stages 3-4: Measure serum 25(OH)D levels after 3 months of treatment in children or after 6 months in adults. Discontinue ergocalciferol (or any vitamin D supplements) if the corrected total serum calcium level is >10.2 mg/dL.
Reference Range
Serum calcium times phosphorus should not exceed 70 mg2/dL2 to avoid ectopic calcification
Adults: Vitamin D deficiency: Serum 25(OH)D <50 nmol/L (20 ng/mL); Vitamin D insufficiency: 25 (OH)D 50-80 nmol/L
Children: Serum 25 (OH)D concentrations defining vitamin D deficiency have not been determined in infants and children; use adult parameters to evaluate
CKD K/DOQI guidelines definition of stages; chronic disease is kidney damage or GFR <60 mL/minute/1.73 m2 for ≥3 months:
Stage 2: GFR 60-89 mL/minute/1.73 m2 (kidney damage with mild decrease GFR)
Stage 3: GFR 30-59 mL/minute/1.73 m2 (moderate decrease GFR)
Stage 4: GFR 15-29 mL/minute/1.73 m2 (severe decrease GFR)
Stage 5: GFR <15 mL/minute/1.73 m2 or dialysis (kidney failure)
Dietary Considerations
Vitamin D is found in fish, fortified milk, fortified cereal, and infant formulas; it is also produced by exposure to sunlight. Multivitamin supplements containing vitamin D may be required for breast fed infants, those ingesting <1000 ml/day of vitamin D-fortified formula or milk, adolescents who do not obtain 400 int. units/day through vitamin D-fortified milk (100 int units/8 ounce serving), and children at increased risk of vitamin D deficiency.
Supplemental calcium and/or phosphorous may be required depending on the indication for therapy. Alternately, a low phosphate diet and/or the use of a nonaluminum-binding agent may be required.
Patient Education
Your prescriber may recommend a special diet. You may experience nausea, vomiting, or metallic taste. Report weakness, unresolved nausea or vomiting, or CNS irritability.
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.
Dental Health: Effects on Dental Treatment
Key adverse event(s) related to dental treatment: Metallic taste and xerostomia (normal salivary flow resumes upon discontinuation).
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
No information available to require special precautions
Mental Health: Effects on Mental Status
May cause irritability or drowsiness; may rarely cause psychosis
Mental Health: Effects on Psychiatric Treatment
None reported
Nursing: Physical Assessment/Monitoring
Provide patient appropriate nutritional counseling.
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule, oral: 50,000 int. units
Drisdol®: 50,000 int. units [contains soybean oil, tartrazine; 1.25 mg]
Capsule, softgel, oral: 50,000 int. units, 50,000 units [1.25 mg]
Solution, oral [drops]: 8000 int. units/mL (60 mL)
Calciferol™: 8000 int. units/mL (60 mL) [contains propylene glycol; 200 mcg/mL]
Drisdol®: 8000 int. units/mL (60 mL) [contains propylene glycol; 200 mcg/mL, OTC]
Tablet, oral: 400 int. units
Pricing: U.S. (www.drugstore.com)
Capsules (Drisdol)
50000 unit (50): $118.78
Capsules (Vitamin D (Ergocalciferol))
50000 unit (100): $152.99
Solution (Calciferol)
8000 units/mL (60): $161.00
References
Cardella CJ, Birkin BL, and Rapoport A, “Role of Dialysis in the Treatment of Severe Hypercalcemia: Report of Two Cases Successfully Treated With Hemodialysis and Review of the Literature,” Clin Nephrol, 1979, 12(6):285-90.
“Dietary Reference Intakes for Calcium, Phosphorus, Magnesium, Vitamin D, and Fluoride. Standing Committee on the Scientific Evaluation of Dietary Reference Intakes, Food and Nutrition Board, Institute of Medicine,” National Academy of Sciences, Washington, DC: National Academy Press, 1997:250-287.
“K/DOQI Clinical Practice Guidelines for Bone Metabolism and Disease in Children With Chronic Kidney Disease.” Available at http://www.kidney.org/professionals/KDOQI/guidelines_pedbone/index.htm
“K/DOQI 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.” Available at http://www.kidney.org/professionals/KDOQI/guidelines_bone/Guide7.htm
Letsou AP and Price LS, “Health Aging and Nutrition: An Overview,” Clin Geriatr Med, 1987, 3(2):253-60.
Myrianthopoulos M, “Dietary Treatment of Hyperlipidemia in the Elderly,” Clin Geriatr Med, 1987, 3(2):343-59.
National Osteoporosis Foundation, Clinician's Guide to Prevention and Treatment of Osteoporosis, Washington, DC: National Osteoporosis Foundation; 2008. Available at http://www.nof.org/professionals/NOF_Clinicians_Guide.pdf
Pettifor JM, Bikle DD, Cavaleros M, et al, “Serum Levels of Free 1,25-Dihydroxyvitamin D in Vitamin D Toxicity,” Ann Intern Med, 1995, 122(7):511-3.
Riggs BL and Melton LJ, “The Prevention and Treatment of Osteoporosis,” N Engl J Med, 1992, 327(9):620-7.
Thomas MK, Lloyd-Jones, DM, Thadhani RI, et al, “Hypovitaminosis D in Medical Inpatients,” N Engl J Med, 1998, 338(12):777-83.
Wagner CL, Greer FR, and the Section on Breastfeeding and Committee on Nutrition, “Prevention of Rickets and Vitamin D Deficiency in Infants, Children, and Adolescents,” Pediatrics, 2008, 122(5):1142-52.
International Brand Names
Lexi-Comp.com
Last full review/revision May 2011
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