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Cholecalciferol

Pronunciation

Pronunciation

(kole e kal SI fer ole)

Index Terms

  • D3

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Oral:

D-3-5: 5000 units

D3-50: 50,000 units [dairy free, egg free, fish derivatives, gluten free, kosher certified, no artificial color(s), nut free, soy free, sugar free, wheat free, yeast free]

Decara: 25,000 units [contains soybean oil]

Decara: 50,000 units [contains fd&c yellow #10 (quinoline yellow), fd&c yellow #6 (sunset yellow), soybean oil]

Dialyvite Vitamin D 5000: 5000 units

Pronutrients Vitamin D3: 1000 units [contains soybean oil]

Generic: 10,000 units, 50,000 units

Capsule, Oral [preservative free]:

D-3-5: 5000 units [dye free]

D3-50: 50,000 units [dye free, sugar free, yeast free]

Generic: 2000 units, 5000 units

Liquid, Oral:

Aqueous Vitamin D: 400 units/mL (50 mL) [gluten free, lactose free, sugar free; contains methylparaben, polysorbate 80]

Bio-D-Mulsion: 400 units/0.03 mL (30 mL) [contains sesame oil]

Bio-D-Mulsion Forte: 2000 units/0.03 mL (30 mL) [contains sesame oil]

BProtected Pedia D-Vite: 400 units/mL (50 mL) [alcohol free, sugar free; contains polysorbate 80, propylene glycol, sodium benzoate; cherry flavor]

D-Vi-Sol: 400 units/mL (50 mL) [gluten free, lactose free, sugar free; contains polysorbate 80]

D-Vita: 400 units/mL (50 mL) [alcohol free, gluten free, lactose free, sugar free; contains polysorbate 80, propylene glycol, sodium benzoate; fruit flavor]

Generic: 400 units/mL (50 mL, 52.5 mL)

Liquid, Oral [preservative free]:

Generic: 5000 units/mL (52.5 mL)

Tablet, Oral:

Delta D3: 400 units [gelatin free, gluten free, lactose free, no artificial color(s), no artificial flavor(s), starch free, sugar free, yeast free]

Dialyvite Vitamin D3 Max: 50,000 units [scored]

Vitamin D3 Super Strength: 2000 units [gluten free]

Generic: 400 units, 1000 units, 2000 units, 3000 units, 5000 units

Tablet, Oral [preservative free]:

Generic: 400 units, 1000 units, 2000 units, 5000 units

Tablet Chewable, Oral:

Generic: 400 units

Brand Names: U.S.

  • Aqueous Vitamin D [OTC]
  • Bio-D-Mulsion Forte [OTC]
  • Bio-D-Mulsion [OTC]
  • BProtected Pedia D-Vite [OTC]
  • D-3-5 [OTC]
  • D-Vi-Sol [OTC]
  • D-Vita [OTC]
  • D3-50 [OTC]
  • Decara [OTC]
  • Delta D3 [OTC]
  • Dialyvite Vitamin D 5000 [OTC]
  • Dialyvite Vitamin D3 Max [OTC]
  • Pronutrients Vitamin D3 [OTC]
  • Vitamin D3 Super Strength [OTC]

Pharmacologic Category

  • Vitamin D Analog

Pharmacology

Cholecalciferol (vitamin D3) 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 (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) (IOM 2011)

Excretion

Feces (IOM 2011)

Half-Life Elimination

Circulating: 25(OH)D: 2 to 3 weeks; 1,25-dihydroxyvitamin D: ~4 hours (Holick 2011)

Use: Labeled Indications

Dietary supplement: As a vitamin D dietary supplement

Vitamin D deficiency: Prevention and treatment of vitamin D deficiency

Use: Unlabeled

Osteoporosis prevention

Contraindications

OTC labeling: Replesta products only: When used for self-medication, do not use if you have hypercalcemia, primary hyperparathyroidism, sarcoidosis, hypervitaminosis D, Williams syndrome, or are pregnant.

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

Dosing: Adult

Dietary Reference Intake for Vitamin D: Oral:

Adults 19 to 70 years: RDA: 600 units/day (IOM 2011)

Female: Pregnancy/Lactating: RDA: 600 units/day (IOM 2011)

Adults >70 years: RDA: 800 units/day (IOM 2011)

Vitamin D deficiency prevention: Oral: 1,500 to 2,000 units daily to maintain serum 25(OH)D levels >30 ng/mL (Holick 2011)

Vitamin D deficiency treatment: Oral: 6,000 units daily or 50,000 units once weekly for 8 weeks to achieve serum 25(OH)D level >30 ng/mL, followed by maintenance dose of 1,500 to 2,000 units daily (Holick 2011).

Special populations (obese patients, patients on medications known to affect vitamin D metabolism, patients with malabsorption syndromes): 6,000 to 10,000 units daily to achieve a 25(OH)D level >30 ng/mL; then maintenance dose of 3,000 to 6,000 units daily (Holick 2011).

Osteoporosis prevention (off-label): Adults ≥50 years: Oral: 800 to 1,000 units/day (NOF guidelines 2014)

Dosing: Geriatric

≤70 years: Refer to adult dosing.

>70 years: RDA: 800 units/day (IOM, 2011)

Dosing: Pediatric

Dietary Reference Intake for Vitamin D: Oral:

Infants, Children, and Adolescents:

0 to 12 months: Adequate intake: 400 units/day (IOM 2011)

1 to 18 years: RDA: 600 units/day (IOM 2011)

Prevention of vitamin D deficiency: (Greer 2000; Wagner 2008): Oral:

Breast-fed infants (fully or partially): 400 units/day beginning in the first few days of life. Continue supplementation until infant is weaned to ≥1,000 mL/day or 1 quart/day of vitamin D-fortified formula or whole milk (whole milk should not be used until after 12 months of age)

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

Children ingesting <1,000 mL of vitamin D-fortified milk: 400 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

Adolescents without adequate intake: 400 units/day

Treatment of vitamin D deficiency: Oral: Note: In addition to calcium and phosphorus supplementation (Holick 2011; Golden 2014):

Infants: 2,000 units daily or 50,000 units once weekly 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 (Golden 2014); some organizations suggest a serum 25(OH)D level >30 ng/mL should be used for all patients (Holick 2011).

Children and Adolescents: 2,000 units daily or 50,000 units once weekly for 6 to 8 weeks to achieve 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 (Golden 2014); some organizations suggest a serum 25(OH)D level >30 ng/mL should be used for all patients (Holick 2011).

Children with increased risk of vitamin D deficiency (chronic fat malabsorption, maintained on chronic antiseizure medications, glucocorticoids, HIV medications and antifungals such as ketoconazole, obesity): Higher doses (2 to 3 times higher) may be required; doses of at least 6,000 to 10,000 units daily have been suggested (Holick 2011).

Note: If poor compliance, single high-dose administration (100,000 to 600,000 units over 1 to 5 days) followed by maintenance dosing; intermittently repeating (usually every 3 months) may be needed if poor compliance continues with maintenance dosing (Misra 2008).

Treatment of vitamin D insufficiency or deficiency associated with CKD (stages 2 to 5, 5D); serum 25 hydroxyvitamin D [25(OH)D] level ≤30 ng/mL (KDOQI Guidelines 2009): Oral: Infants, Children, and Adolescents:

Serum 25(OH)D level 16 to 30 ng/mL: 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: 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: 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/month for a total therapy of 3 months

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

Prevention and treatment of vitamin D Deficiency in cystic fibrosis: Oral:

CF guidelines (Tangricha [CF Foundation] 2012):

Recommended daily intake to maintain serum 25(OH)D level ≥30 ng/mL:

Infants: 400 to 500 units/day

Children ≤10 years: 800 to 1,000 units/day

Children >10 years and Adolescents: 800 to 2,000 units/day

Dosing adjustment for serum 25(OH)D level between 20 to 30 ng/mL and patient adherence established (Step 1 increase):

Infants: 800 to 1,000 units/day

Children ≤10 years: 1,600 to 3,000 units/day

Children >10 years and Adolescents: 1,600 to 6,000 units/day

Dosing adjustment for serum 25(OH)D level <20 ng/mL or persistently between 20 to 30 ng/mL and patient adherence established (Step 2):

Infants: Increase up to a maximum of 2,000 units/day

Children ≤10 years: Increase to a maximum of 4,000 units/day

Children >10 years and Adolescents: Increase to a maximum of 10,000 units/day

Alternate dosing (Hall 2010):

Initial dose: Serum 25(OH)D level ≤30 ng/mL

Infants: 8,000 units/week

Children and Adolescents: 800 units/day

Medium-dose regimen: Serum 25(OH)D level remains ≤30 ng/mL and patient compliance established

Infants and Children <5 years: 12,000 units/week for 12 weeks

Children ≥5 years and Adolescents: 50,000 units/week for 12 weeks

High-dose regimen: Repeat 25(OH)D level remains ≤30 ng/mL and patient compliance established

Infants and Children <5 years: 12,000 units twice weekly for 12 weeks

Children ≥5 years and Adolescents: 50,000 units twice weekly for 12 weeks

Dosing: Renal Impairment

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

Dosing: Hepatic Impairment

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

Administration

Wafers: Chew or crush before swallowing; do not swallow wafer whole; administer with the largest meal of the day.

Infant drops: Administer with syringe directly into mouth (tip against the inside of cheek) or mix with formula, juice, cereal, or other food and use within 1 hour. Liquid vitamin D preparations have the potential for dosing errors when administered to infants. The FDA recommends using a calibrated dropper that delivers no more than 400 units per dose for products intended for infants.

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).

Storage

Store at 15°C to 30°C (59°F to 86°F); do not freeze. Protect from light.

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. 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. Consider therapy modification

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

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

Danazol: May enhance the hypercalcemic effect of Vitamin D Analogs. 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. Consider therapy modification

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

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

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

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

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)

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:

• Hepatic impairment: May be at greater risk of vitamin D toxicity.

• Renal impairment: May be at greater risk of vitamin D toxicity.

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:

• Benzyl alcohol and derivatives: Some dosage forms may contain sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension and cardiovascular collapse (AAP 1997; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol derivative with caution in neonates. See manufacturer’s labeling.

• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer’s labeling.

• Propylene glycol: Some dosage forms may contain propylene glycol; large amounts are potentially toxic and have been associated hyperosmolality, lactic acidosis, seizures and respiratory depression; use caution (AAP 1997; Zar 2007). See manufacturer’s labeling.

Other warnings/precautions:

• 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 (Holick 2011).

Monitoring Parameters

Signs and symptoms of vitamin D intoxication.

Serum 25(OH)D should be monitored in patients at risk for vitamin D deficiency; Serum 1,25-dihydroxyvitamin D may be used in conditions such as acquired or inherited vitamin D disorders (eg, chronic kidney disease, vitamin D resistant rickets) or phosphate metabolism (Holick 2011).

When treating vitamin D deficiency in children, monitor 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).

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. (Wagner 2008).

Vitamin D deficiency/insufficiency in patients with CKD stages 3 to 4: Measure serum 25(OH)D levels after 3 months of treatment in children or after 6 months in adults. Measure corrected total calcium and phosphorous after 1 month and then at least every 3 months in children and at least every 3 months in adults. Discontinue ergocalciferol (or any vitamin D supplements) if the corrected total serum calcium level is >10.2 mg/dL (K/DOQI 2003; K/DOQI 2005).

Serum 25(OH)D in patients on long term anticonvulsant medications, antifungals, cholestyramine, glucocorticoids, or medications to treat HIV; the catabolism of the metabolite 25(OH)D may be increased (Holick 2011).

Pregnancy Considerations

The cholecalciferol metabolite, 25(OH)D, crosses the placenta; maternal serum concentrations correlate with fetal concentrations at birth (Misra 2008; Wagner 2008). Vitamin D requirements are the same in pregnant and nonpregnant females (IOM 2011).

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 1,000 to 2,000 units/day until more safety data is available (ACOG 2011; Holick 2011). In women not at risk for deficiency, doses larger than the RDA should be avoided during pregnancy (ACOG 2011).

Patient Education

• 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?)

• Have patient report immediately to prescriber signs of high calcium (weakness, confusion, feeling tired, headache, nausea and vomiting, constipation, or bone pain) (HCAHPS).

• 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 healthcare 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.

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