Cholecalciferol (Lexi-Drugs)

Pronunciation

(kole e kal SI fer ole)

Brand Names: US

Aqueous Vitamin D [OTC]; Bio-D-Mulsion Forte [OTC] [DSC]; Bio-D-Mulsion [OTC] [DSC]; BProtected Pedia D-Vite [OTC]; D-3-5 [OTC]; D-Vi-Sol [OTC]; D-Vita [OTC] [DSC]; D3 Vitamin [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]; Vitamin D3 Ultra Potency [OTC]

Brand Names: Canada

D-Tabs; EURO D 10000; EURO-D; JAMP-Vitamin D; Luxa-D; ViDextra

Pharmacologic Category

Vitamin D Analog

Dosing: Adult

Note: 1 mcg = 40 units

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 [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). In patients with normal absorption, for every 100 units/day of cholecalciferol, the serum 25(OH)D level is expected to increase by ~0.7 to 1 ng/mL after a few weeks (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 cholecalciferol): 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 [Camacho 2016]; NOF [Cosman 2014]).

Serum 25(OH)D <10 ng/mL or in patients with deficiency symptoms: Initial: Therapeutic dosing (ie, high-dose cholecalciferol): 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 [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 [Camacho 2016]; NOF [Cosman 2014]).

Special populations (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 [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 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 cholecalciferol (or ergocalciferol) 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 cholecalciferol (or ergocalciferol) (KDOQI commentary [Uhlig 2010]).

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

Hypoparathyroidism (off-label use): Note: Active vitamin D preparations (ie, alfacalcidolcalcitriol) in conjunction with calcium supplementation are recommended therapy. Addition of cholecalciferol (or ergocalciferol) 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

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

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

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: 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: Oral: 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 cholecalciferol (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 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 deficiency in cystic fibrosis, prevention and treatment: Oral:

CF guidelines (Tangricha [CF Foundation] 2012):

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

Infants: Oral: 400 to 500 units/day

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

Children >10 years and Adolescents: Oral: 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: Oral: 800 to 1,000 units/day

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

Children >10 years and Adolescents: Oral: 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 increase):

Infants: Increase up to a maximum 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: Oral: 8,000 units/week

Children and Adolescents: Oral: 800 units/day

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

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

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

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

Vitamin D insufficiency or deficiency associated with CKD (stages 2 to 5, 5D), treatment; serum 25 hydroxyvitamin D [25(OH)D] level ≤30 ng/mL (KDOQI 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/month 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

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:

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, cholecalciferol 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: As a vitamin D dietary supplement

Use: Off-Label: Adult

  HypoparathyroidismLevel of Evidence [G]

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. Based on the Endocrine Society guidelines for the Management of Hypoparathyroidism, active vitamin D preparations (ie, alfacalcidolcalcitriol) in conjunction with calcium supplementation is the standard therapy for hypoparathyroidism. Addition of native vitamin D (eg, cholecalciferol or ergocalciferol) may be considered for supplemental therapy.

  Osteoporosis (prevention)Level 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 to prevent 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 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 CKD stages G3 to G5 and dialysis or transplant patients, should be corrected using treatment strategies recommended for the general population, which includes repletion with cholecalciferol (or ergocalciferol) 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 instead of cholecalciferol (or ergocalciferol) Ref.

Level of Evidence Definitions
  Level of Evidence Scale
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

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

Cystic Fibrosis:

Cystic Fibrosis Foundation, Screening, Diagnosis, Management and Treatment of Vitamin D Deficiency in Cystic Fibrosis2012

Hypoparathyroidism:

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

Nutrition:

American Academy of Pediatrics, Optimizing Bone Health in Children and Adolescents2014

Lawson Wilkins Pediatric Endocrine Society, Vitamin D Deficiency in Children and Its Management: Review of Current Knowledge and Recommendations2008

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: Oral

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

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):

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); do not freeze. 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?)

• Have patient report immediately to prescriber signs of high calcium (weakness, confusion, fatigue, 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.

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

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 cholecalciferol 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:

• 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.

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

The cholecalciferol metabolite, 25(OH)D, crosses the placenta; maternal serum concentrations correlate with fetal concentrations at birth (Misra 2008; Wagner 2008).

Adequate maternal vitamin D is required for fetal growth and development (Misra 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 1,000 to 2,000 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; IOM 2011).

Breast-Feeding Considerations

Cholecalciferol is present in breast milk (Oberhelman 2013).

Following administration of vitamin D as cholecalciferol, concentrations of cholecalciferol and 25(OH)D increase in the maternal serum and may correlate with breast milk concentrations (Oberhelman 2013).

Vitamin D is present in breast milk following normal maternal exposure via sunlight and diet (Wagner 2008). Vitamin D in breast milk is primarily vitamin D3 (cholecalciferol) and 25(OH)D3 (við Streym 2016). The amount of endogenous vitamin D in breast milk is insufficient to provide an exclusively breastfed child the recommended intake of vitamin D (Misra 2008). In addition, premature infants, infants born to vitamin D deficient mothers, dark-skinned children, children living at high latitudes, and exclusively breastfed infants and children may be at increased risk for vitamin D deficiency. Therefore, vitamin D supplementation is recommended in all infants who are partially or exclusively breast fed (IOM 2011; Misra 2008; Wagner 2008).

Maternal vitamin D requirements are the same for breastfeeding and nonbreastfeeding females (IOM 2011). Although administration of cholecalciferol in doses larger than the maternal RDA may increase 25(OH)D in breast milk, the actual maternal dose needed to provide the infant with an adequate amount of vitamin D is still under study (Wagner 2008)

Briggs’ Drugs in Pregnancy & Lactation
Adverse Reactions

No adverse reactions listed in the manufacturer’s labeling.

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 and symptoms of vitamin D toxicity (eg hypercalcemia, hypercalcuria, confusion, psychosis, tremor, calcification of soft tissues, 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), alkaline phosphatase may be required depending on severity of 25(OH)D deficiency and/or concomitant clinical conditions (eg, chronic kidney disease, hypoparathyroidism) (Dawson-Hughes 2018; Endocrine Society [Brandi 2016]; KDIGO 2017).

Infants, Children, and Adolescents:

Vitamin D deficiency: 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).

Increased risk of vitamin D deficiency (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/L) (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

Obtain serum 25(OH)D, calcium, phosphorus, parathyroid hormone, and alkaline phosphatase as clinically needed. Assess for signs of vitamin D toxicity.

Nursing Physical Assessment/Monitoring

Check ordered labs and report any abnormalities. Monitor for and educate patient to report any signs of vitamin D toxicity (eg, confusion, psychosis, tremor, nausea, weakness, tissue calcification).

Dosage Forms: US

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

Capsule, Oral:

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

Decara: 10,000 units [contains fd&c yellow #10 aluminum lake, fd&c yellow #6 aluminum lake, gelatin (bovine)]

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 [dairy free, dye free, egg free, gluten free, no artificial color(s), nut free, soy free, sugar free, wheat free, yeast free]

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

Generic: 1000 units, 2000 units, 5000 units, 10,000 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 [DSC]) [contains sesame oil]

Bio-D-Mulsion Forte: 2000 units/0.03 mL (30 mL [DSC]) [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 [DSC]) [alcohol free, gluten free, lactose free, sugar free; contains polysorbate 80, propylene glycol, sodium benzoate; fruit flavor]

D3 Vitamin: 400 units/mL (50 mL) [contains polysorbate 80, sodium benzoate]

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]

Vitamin D3 Ultra Potency: 50,000 units

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

Dosage Forms: Canada

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

Capsule, Oral:

Generic: 2000 units, 5000 units, 10,000 units, 25,000 units, 50,000 units

Tablet, Oral:

Generic: 10,000 units

Anatomic Therapeutic Chemical (ATC) Classification
  • A11CC05
Generic Available (US)

Yes

Pricing: US

Capsules (D3-50 Oral)

50000 unit (per each): $0.18

Capsules (Decara Oral)

10000 unit (per each): $0.80

25000 unit (per each): $1.91

50000 unit (per each): $1.17

Capsules (Dialyvite Vitamin D 5000 Oral)

5000 unit (per each): $0.12

Capsules (Pronutrients Vitamin D3 Oral)

1000 unit (per each): $0.07

Liquid (BProtected Pedia D-Vite Oral)

400 units/mL (per mL): $0.17

Liquid (D-Vi-Sol Oral)

400 units/mL (per mL): $0.17

Tablets (Dialyvite Vitamin D3 Max Oral)

50000 unit (per each): $1.08

Tablets (Vitamin D Oral)

1000 unit (per each): $0.03

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

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)

Pharmacodynamics/Kinetics

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) (IOM 2011)

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

D3

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]

Ahlfors CE. Benzyl alcohol, kernicterus, and unbound bilirubin. J Pediatr. 2001;139(2):317-319.[PubMed 11487763]

Alade SL, Brown RE, Paquet A. Polysorbate 80 and E-Ferol toxicity. Pediatrics. 1986;77(4):593-597.[PubMed 3960626]

American Academy of Pediatrics Committee on Drugs. “Inactive” ingredients in pharmaceutical products: update (subject review). Pediatrics. 1997;99(2):268-278.[PubMed 9024461]

Bio-D-Mulsion (cholecalciferol) [prescribing information]. Rosenberg, TX: Biotics Research; July 2013.

Bio-D-Mulsion Forte (cholecalciferol) [prescribing information]. Rosenberg, TX: Biotics Research; July 2013.

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]

Centers for Disease Control (CDC). Neonatal deaths associated with use of benzyl alcohol—United States. MMWR Morb Mortal Wkly Rep. 1982;31(22):290-291.[PubMed 6810084]

Centers for Disease Control (CDC). Unusual syndrome with fatalities among premature infants: association with a new intravenous vitamin E product. MMWR Morb Mortal Wkly Rep. 1984;33(14):198-199.[PubMed 6423951]

Cosman F, de Beur SJ, LeBoff MS, et al; National Osteoporosis Foundation. Clinician’s guide to prevention and treatment of osteoporosis. Osteoporos Int. 2014;25(10):2359-2381.[PubMed 25182228]

D1000 Capsules (cholecalciferol) [prescribing information]. Miami Lakes, FL: Mason Vitamins; 2015.

D2000 Capsules (cholecalciferol) [prescribing information]. Miami Lakes, FL: Mason Vitamins; 2015.

D5000 Capsules (cholecalciferol) [prescribing information]. Miami Lakes, FL: Mason Vitamins; 2015.

D400 Chewable Tablets (cholecalciferol) [prescribing information]. Miami Lakes, FL: Mason Vitamins; 2015.

D1000 Chewable Tablets (cholecalciferol) [prescribing information]. Miami Lakes, FL: Mason Vitamins; 2015.

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.

Decara 25,000 IU Capsules (cholecalciferol) [prescribing information]. Baton Rouge, LA; Medecor Pharma LLC; February 2014.

Decara 50,000 IU Capsules (cholecalciferol) [prescribing information]. Baton Rouge, LA: Medecor Pharma LLC; February 2014.

D-Vi-Sol (cholecalciferol) [prescribing information]. Evansville, IN: Mead Johnson Nutritionals; November 2014.

Folsom LJ, DiMeglio LA. Recommendations released on prevention, management of rickets. AAP News. Published February 10, 2017. Available at http://www.aappublications.org/news/2017/02/10/Rickets021017.

Golden NH, Abrams SA; Committee on Nutrition. Optimizing bone health in children and adolescents. Pediatrics. 2014;134(4):e1229-1243.[PubMed 25266429]

Hall WB, Sparks AA, Aris RM. Vitamin d deficiency in cystic fibrosis. Int J Endocrinol. 2010;2010:218691.[PubMed 20148079 ]

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

Isaksson M, Jansson L. Contact allergy to Tween 80 in an inhalation suspension. Contact Dermatitis. 2002;47(5):312-313.[PubMed 12534540]

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 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.[PubMed 19231749]

Ketteler M, Block GA, Evenepoel P, et al. Diagnosis, evaluation, prevention, and treatment of chronic kidney disease-mineral and bone disorder: synopsis of the Kidney Disease: Improving Global Outcomes 2017 clinical practice guideline update. Ann Intern Med. 2018;168(6):422-430. doi: 10.7326/M17-2640.[PubMed 29459980]

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.

Lucente P, Iorizzo M, Pazzaglia M. Contact sensitivity to Tween 80 in a child. Contact Dermatitis. 2000;43(3):172.[PubMed 10985636]

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]

National Kidney Foundation. KDOQI clinical practice guidelines for bone metabolism and disease in children with chronic kidney disease. Am J Kidney Dis. 2005;46(4 Suppl 1):S1-S121.

National Kidney Foundation. KDOQI clinical practice guidelines for bone metabolism and disease in chronic kidney disease. Am J Kidney Dis. 2003;42(4 Suppl 3):S1-S201.[PubMed 14520607]

Oberhelman SS, Meekins ME, Fischer PR, et al. Maternal vitamin D supplementation to improve the vitamin D status of breast-fed infants: a randomized controlled trial. Mayo Clin Proc. 2013;88(12):1378-1387.[PubMed 24290111]

Pedia D-Vite Drops (cholecalciferol) [prescribing information]. Tampa, FL: Bayshore Pharmaceuticals; 2015.

Replesta (cholecalciferol) [prescribing information]. St. Louis, MO: Everidis Health Sciences; 2015.

Replesta Children’s (cholecalciferol) [prescribing information]. St. Louis, MO: Everidis Health Sciences; 2015.

Replesta NX (cholecalciferol) [prescribing information]. St. Louis, MO: Everidis Health Sciences; 2015.

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]

Shelley WB, Talanin N, Shelley ED. Polysorbate 80 hypersensitivity. Lancet. 1995;345(8980):1312-1313.[PubMed 7746084]

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]

Thera-D Sport (cholecalciferol) [prescribing information]. Rockville, MD: Theralogix; received September 3, 2015.

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]

við Streym S, Højskov CS, Møller UK, et al. Vitamin D content in human breast milk: a 9-mo follow-up study. Am J Clin Nutr. 2016;103(1):107-114.[PubMed 26675779]

Wagner CL, Greer FR; American Academy of Pediatrics Section on Breastfeeding; American Academy of Pediatrics Committee on Nutrition. Prevention of rickets and vitamin D deficiency in infants, children, and adolescents. Pediatrics. 2008;122(5):1142-1152.[PubMed 18977996]

Zar T, Graeber C, Perazella MA. Recognition, treatment, and prevention of propylene glycol toxicity. Semin Dial. 2007;20(3):217-219.[PubMed 17555487]

Brand Names: International

Adalben (ES); Arachitol (IN); Aviticol (GB); Baby D Drops (SG); D Drops (SG); D-Cure (BE, LU); D3 Capsules (AU); D3 Drops (AU); D3 Drops Forte (AU); D4U (LK); Deetipat (FI); Dekristol 400 (DE); Dekristolmin (AT); Deltius (ES); Desunin (GB, IE); Devaron (NL); Devitre (SE); Divisun (NO); Duvit D3 (IT); Fultium-D3 (GB); Iper D3 (IT); Laevovit (HU); Laevovit D3 (AT); Ostelavit (PL); Plivit D3 (HR); Teorol (ID); Thorens (IE); Tridelta (IT); Uvedose (FR, LU); Vi-De 3 (CH); Vigantol (CZ, HU, LU, PL, PT); Vigantoletten (LU, PL); Vitamin D3 (HU); Vitamin D3 Fresenius (HU); Vitamin D3 Streuli (CH); Vitamine D3 BON (FR); Vitaminum D3 (PL); Vitamon D3 (BE)

Cholecalciferol (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

(kole e kal SI fer ole)

Brand Names: US

Aqueous Vitamin D [OTC]; Bio-D-Mulsion Forte [OTC] [DSC]; Bio-D-Mulsion [OTC] [DSC]; BProtected Pedia D-Vite [OTC]; D-3-5 [OTC]; D-Vi-Sol [OTC]; D-Vita [OTC] [DSC]; D3 Vitamin [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]; Vitamin D3 Ultra Potency [OTC]

Brand Names: Canada

D-Vi-Sol

What is this drug used for?
  • It is used to treat or prevent vitamin D deficiency.
What do I need to tell my doctor BEFORE I take this drug?
  • If you have an allergy to cholecalciferol 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: Malabsorption syndrome, overactive parathyroid gland, sarcoidosis, too much vitamin D or calcium in your body, or Williams 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?
  • All products:
  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid other sources of vitamin D.
  • Follow the diet and workout 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.
  • Wafer:
  • Do not give the wafer to a child younger than 6 years of age.
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.
  • Signs of high calcium levels like weakness, confusion, feeling tired, headache, upset stomach and throwing up, constipation, or bone pain.
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:
  • To gain the most benefit, do not miss doses.
  • Wafer:
  • Take this drug with the largest meal of the day.
  • Chew or crush well. Do not swallow it whole.
  • This drug is not taken every day. Be sure you know how to take it. Talk with your doctor if you have questions.
  • All other products:
  • Some drugs may need to be taken with food or on an empty stomach. For some drugs it does not matter. Check with your pharmacist about how to take this drug.
  • Tablets and capsules:
  • Some strengths of this drug are not taken every day. Be sure you know how to take this drug. Talk with your doctor if you have questions.
  • Chewable tablet:
  • Chew well before swallowing.
  • Liquid (drops):
  • Measure liquid doses carefully. Use the measuring device that comes with this drug.
  • Shake well before use.
  • You may put this drug right in the mouth or you may mix it with formula, fruit juice, cereal or other food, water or juice. Take the whole dose.
  • Under the tongue (sublingual) spray:
  • Shake well before use.
  • Spray into the mouth under the tongue.
  • Oral-disintegrating tablet:
  • Dissolve slowly in your mouth.
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. Do not freeze.
  • 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.
Cholecalciferol (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

(kole e kal SI fer ole)

Brand Names: US

Aqueous Vitamin D [OTC]; Bio-D-Mulsion Forte [OTC] [DSC]; Bio-D-Mulsion [OTC] [DSC]; BProtected Pedia D-Vite [OTC]; D-3-5 [OTC]; D-Vi-Sol [OTC]; D-Vita [OTC] [DSC]; D3 Vitamin [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]; Vitamin D3 Ultra Potency [OTC]

Brand Names: Canada

D-Vi-Sol

What is this drug used for?
  • It is used to treat or prevent vitamin D deficiency.
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: Malabsorption syndrome, overactive parathyroid gland, sarcoidosis, too much vitamin D or calcium in the body, or Williams 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?
  • All products:
  • 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.
  • Avoid other sources of vitamin D.
  • Have your child follow the diet and workout 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.
  • Wafer:
  • Do not give the wafer to a child younger than 6 years of age.
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.
  • Signs of high calcium levels like weakness, confusion, feeling tired, headache, upset stomach and throwing up, constipation, or bone pain.
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:
  • To gain the most benefit, do not miss giving your child doses.
  • Wafer:
  • Give this drug with the largest meal of the day.
  • Have your child chew or crush well. Do not let your child swallow it whole.
  • This drug is not given every day. Be sure you know how to give it. Talk with the doctor if you have questions.
  • All other products:
  • Some drugs may need to be given with food or on an empty stomach. For some drugs, it does not matter. Check with your pharmacist about how to give this drug to your child.
  • Tablets and capsules:
  • Some strengths of this drug are not given every day. Be sure you know how to give this drug. Talk with your child’s doctor if you have questions.
  • Chewable tablet:
  • Have your child chew well before swallowing.
  • Liquid (drops):
  • Measure liquid doses carefully. Use the measuring device that comes with this drug.
  • Shake well before use.
  • You may put this drug right in your child’s mouth or you may mix it with formula, fruit juice, cereal or other food, water or juice. Be sure to give the whole dose.
  • Under the tongue (sublingual) spray:
  • Shake well before use.
  • Spray into the mouth under the tongue.
  • Oral-disintegrating tablet:
  • Dissolve slowly in your child’s mouth.
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. Do not freeze.
  • 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.