Vitamin d3 (cholecalciferol) drug information uptodate

Brand Names: US Aqueous Vitamin D OTC; BProtected Pedia DVite OTC; D35 OTC; DViSol OTC; DVite Pediatric OTC; D350 OTC; Decara OTC; Delta D3 OTC; Dialyvite 5000; Dialyvite Vitamin D 5000 OTC; Dialyvite Vitamin D3 Max OTC; OsteoVit3 OTC; Pronutrients Vitamin D3 OTC; True Vitamin D3 OTC; VitaChew Vitamin D3 OTC; Vitamin D3 Ultra Potency OTC; WeeklyD OTC Brand Names: Canada AGVitamin D; DTabs; EURO D 10000; EUROD; JAMPVitamin D; LuxaD; SANDOZ D 10000; ViDextra Pharmacologic Category Vitamin D Analog Dosing: Adult Note: 1 mcg = 40 units

Official reprint from UpToDate www.uptodate.com © 2024 UpToDate, Inc and/or its affiliates All Rights Reserved.

Brand Names: Canada

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

Vitamin D3 (cholecalciferol): Drug information

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For additional information see "Vitamin D3 (cholecalciferol): Patient drug information" and "Vitamin D3 (cholecalciferol): Pediatric drug information"

For abbreviations, symbols, and age group definitions show table

Osteoporosis prevention (off-label use): Adults ≥50 years of age: Oral: 800 to 1,000

units/day (20 to 25 mcg/day) is recommended, through dietary sources and/or

supplementation if needed (Ref)

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Vitamin D insufficiency/deficiency (off-label use):

Note: The optimal serum 25-hydroxyvitamin D (25[OH]D) level has not been

established; generally, deficiency is defined as 25(OH)D levels <12 ng/mL (<30nmol/L), and insufficiency is defined as 25(OH)D levels 12 to <20 ng/mL (30 to

<50 nmol/L) (Ref) Therefore, some experts suggest a target range of 20 to 40ng/mL (50 to 100 nmol/L) for most patients (Ref) Individualize dose based onpatient-specific factors (eg, presence of malabsorption, liver disease, kidneydisease) and target 25(OH)D level and ensure adequate calcium intake duringtherapy (Ref) The following recommendations are based primarily on expertopinion and clinical experience:

Prevention:

Oral: 600 to 1,000 units (15 to 25 mcg) once daily (Ref)

Treatment:

Initial dosing:

High-dose therapy: May be preferred in patients with a serum

25(OH)D level <12 ng/mL (<30 nmol/L) or who are symptomatic

(eg, bone fracture/pain, muscle weakness), or in patients with

concomitant hypocalcemia (Ref)

Oral: 50,000 units (1,250 mcg) once weekly (or equivalent dose

administered once daily) for 6 to 12 weeks, then recheck25(OH)D level; may repeat high-dose therapy if needed toachieve target 25(OH)D level (Ref)

Low-dose therapy: May be preferred in patients with a serum

25(OH)D level 12 to <20 ng/mL (30 to <50 nmol/L) withoutsymptoms or concomitant hypocalcemia (Ref)

Oral: 800 to 1,000 units (20 to 25 mcg) once daily for ~3 to 4

months; may adjust dose if needed every 3 to 4 monthsbased on 25(OH)D level Some experts suggest modest doseincreases (eg, to 2,000 units [50 mcg] once daily) if serum25(OH)D levels have substantially increased but remain belowtarget or switching to high-dose therapy if serum 25(OH)Dlevels remain substantially below target (Ref)

Maintenance dosing: Oral: Once target 25(OH)D level is achieved, continue

at a maintenance dose of 600 to 2,000 units (15 to 50 mcg) once daily(Ref)

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring

dose/frequency adjustment or avoidance Consult drug interactions database for moreinformation

Dosing: Kidney Impairment: Adult

The renal dosing recommendations are based upon the best available evidence and clinicalexpertise Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A Roberts,PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS

Note: In patients with chronic kidney disease (CKD) G3a to G5D, Kidney Disease: Improving

Global Outcomes guidelines recommend correcting vitamin D deficiency and

insufficiency with treatment strategies recommended for patients without kidney

impairment In patients with CKD G4 to G5 with severe and progressive

hyperparathyroidism despite correction of modifiable factors (eg, hyperphosphatemia,vitamin D deficiency), calcitriol or vitamin D analogs are suggested (Ref)

Altered kidney function: No dosage adjustment necessary for any degree of kidney

dysfunction (primarily excreted in feces) (Ref)

Hemodialysis, intermittent (thrice weekly): Unlikely to be significantly dialyzed (large V ):

No supplemental dose or dosage adjustment necessary (Ref)

Peritoneal dialysis: Unlikely to be significantly dialyzed (large V ): No dosage adjustment

necessary (Ref)

CRRT: No dosage adjustment necessary (Ref)

PIRRT (eg, sustained, low-efficiency diafiltration): No dosage adjustment necessary (Ref)

Dosing: Hepatic Impairment: Adult

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

Dosing: Older Adult

Refer to adult dosing

d

d

(For additional information see "Vitamin D3 (cholecalciferol): Pediatric drug information")

Note: 1 mcg = 40 units.

Vitamin D deficiency, prevention (eg, Rickets prevention): (Ref):

Breastfed infants (fully or partially): Oral: 400 units (10 mcg) daily beginning in thefirst few days of life; continue supplementation unless infant is transitioned tofull formula intake

Children and Adolescents without adequate intake: Oral: 600 units (15 mcg) daily

Note: Children with increased risk of vitamin D deficiency (chronic fat

malabsorption, maintained on chronic antiseizure medications) may requirehigher doses; use laboratory testing [25(OH)D, PTH, bone mineral status] toevaluate

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Vitamin D deficiency (severe, symptomatic), treatment: Note: Treatment should

also include calcium 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 (Ref); monitor vitamin D status closely

Infants: Oral: 2,000 units (50 mcg) 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 (10 to

25 mcg) daily Note: For patients at high risk of fractures a serum 25(OH)D

level >30 ng/mL has been suggested (Ref)

Children and Adolescents: Oral: 2,000 units (50 mcg) 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 (15 to 25 mcg) daily Note: For patients at high risk of

fractures a serum 25(OH)D level >30 ng/mL has been suggested (Ref)

Vitamin D deficiency in cystic fibrosis, prevention and treatment:

CF guidelines (Ref):

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

Vitamin D deficiency in cystic fibrosis, prevention and treatment 

Infants: Oral: 400 to 500 units (10 to 12.5 mcg) once daily.

Children ≤10 years: Oral: 800 to 1,000 units (20 to 25 mcg) once daily

Children >10 years and Adolescents: Oral: 800 to 2,000 units (20 to 50mcg) once daily

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

Infants: Oral: 800 to 1,000 units (20 to 25 mcg) once daily

Children ≤10 years: Oral: 1,600 to 3,000 units (40 to 75 mcg) once daily

Children >10 years and Adolescents: Oral: 1,600 to 6,000 units (40 to 150mcg) once daily

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

Infants: Oral: Increase up to a maximum 2,000 units (50 mcg) once daily

Children ≤10 years: Oral: Increase to a maximum of 4,000 units (100 mcg)once daily

Children >10 years and Adolescents: Oral: Increase to a maximum of10,000 units (250 mcg) once daily

Alternate dosing (Ref):

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

Infants: Oral: 8,000 units (200 mcg) once weekly.

Children and Adolescents: Oral: 800 units (20 mcg) once daily

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

Infants and Children <5 years: Oral: 12,000 units (300 mcg) once weekly

for 12 weeks

Children ≥5 years and Adolescents: Oral: 50,000 units (1,250 mcg) once

weekly for 12 weeks.

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

Infants and Children <5 years: Oral: 12,000 units (300 mcg) twice weekly

for 12 weeks

Children ≥5 years and Adolescents: Oral: 50,000 units (1,250 mcg) 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 (Ref):

Serum 25(OH)D level 16 to 30 ng/mL: Infants, Children, and Adolescents: Oral:

2,000 units (50 mcg) daily for 3 months or 50,000 units (1,250 mcg) everymonth for 3 months

Serum 25(OH)D level 5 to 15 ng/mL: Infants, Children, and Adolescents: Oral: 4,000units (100 mcg) daily for 12 weeks or 50,000 units (1,250 mcg) every otherweek for 12 weeks

Serum 25(OH)D level <5 ng/mL: Infants, Children, and Adolescents: Oral: 8,000

units (200 mcg) daily for 4 weeks then 4,000 units (100 mcg) daily for 2 months

for total therapy of 3 months or 50,000 units (1,250 mcg) weekly for 4 weeks

followed by 50,000 units (1,250 mcg) 2 times/month for a total therapy of 3months

Maintenance dose [once repletion accomplished; serum 25(OH)D level >30 ng/mL]:Infants, Children, and Adolescents: Oral: 200 to 1,000 units (5 to 25 mcg) daily

Vitamin D insufficiency or deficiency associated with CKD, treatment; serum 25

Nutritional rickets, treatment: Limited data available (Ref): Administer in

combination with calcium supplementation:

Daily therapy (preferred):

Infants: Oral: 2,000 units (50 mcg) daily for ≥3 months, followed bymaintenance dose of 400 units (10 mcg) daily

Children: Oral: 3,000 to 6,000 units (75 to 150 mcg) daily for ≥3 months,followed by maintenance dose of 600 units (15 mcg) daily

Adolescents: Oral: 6,000 units (150 mcg) daily for ≥3 months, followed bymaintenance dose of 600 units (15 mcg) daily

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring

dose/frequency adjustment or avoidance Consult drug interactions database for moreinformation

Dosing: Kidney 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 notnecessary

Dosing: Hepatic Impairment: Pediatric

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

Adverse Reactions

No adverse reactions listed in the manufacturer's labeling

Contraindications

US labeling: 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

Canadian labeling: Hypersensitivity to vitamin D, vitamin D analogues and derivatives, or anycomponent of the formulation, hypercalcemia and/or hypercalciuria, nephrolithiasis,

severe kidney impairment, malabsorption syndrome, abnormal sensitivity to toxic effects

of vitamin D, sarcoidosis, or hypervitaminosis D Note: Contraindications may vary by

product; also refer to manufacturer's labeling

Children: Oral: 150,000 units (3,750 mcg) once, or in divided doses over severaldays; after 3 months, initiate maintenance dose of 600 units (15 mcg)daily

Adolescents: Oral: 300,000 units (7,500 mcg) once, or in divided doses overseveral days; after 3 months, initiate maintenance dose of 600 units (15mcg) daily

• 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 isdiscontinued

Disease related concerns:

• Hyperphosphatemia: Normal serum phosphorous concentrations must be maintained

in patients treated for hyperphosphatemia to prevent metastatic calcification

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 reportedfollowing exposure to pharmaceutical products containing polysorbate 80 in certainindividuals (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 arepotentially toxic and have been associated hyperosmolality, lactic acidosis, seizuresand respiratory depression; use caution (AAP 1997; Zar 2007) See manufacturer'slabeling

Warnings: Additional Pediatric Considerations

Some dosage forms may contain propylene glycol; in neonates large amounts of propyleneglycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associatedwith 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)

Decara: 250 mcg (10000 unit) [DSC] [contains fd&c yellow #6(sunset yellow)alumin lake,gelatin (bovine), quinoline (d&c yellow #10) aluminum lake]

Decara: 625 mcg (25000 unit) [contains soybean oil]

Dialyvite Vitamin D 5000: 125 mcg (5000 unit)

Pronutrients Vitamin D3: 25 mcg (1000 unit) [contains soybean oil]

True Vitamin D3: 10 mcg (400 unit), 1250 mcg (50000 unit), 250 mcg (10000 unit), 125 mcg(5000 unit), 25 mcg (1000 unit)

Weekly-D: 1250 mcg (50000 unit) [contains fd&c red #40 (allura red ac dye)]

Generic: 1250 mcg (50000 unit), 250 mcg (10000 unit), 50 mcg (2000 unit)

Capsule, Oral [preservative free]:

D-3-5: 125 mcg (5000 unit) [dairy free, dye free, egg free, gluten free, no artificial color(s),nut free, soy free, sugar free, wheat free, yeast free]

D3-50: 1250 mcg (50000 unit) [dairy free, egg free, fish derivative free, gluten free, koshercertified, no artificial color(s), nut free, soy free, sugar free, wheat free, yeast free]Generic: 10,000 units, 125 mcg (5000 unit), 25 mcg (1000 unit), 50 mcg (2000 unit)

Liquid, Oral:

Aqueous Vitamin D: 10 mcg/mL (400 unit/mL) (50 mL) [gluten free, lactose free, sugar

free; contains corn oil, methylparaben, polysorbate 80]

BProtected Pedia D-Vite: 10 mcg/mL (400 unit/mL) (50 mL) [alcohol free, sugar free;

contains polysorbate 80, propylene glycol, sodium benzoate; cherry flavor]

D-Vi-Sol: 10 mcg/mL (400 unit/mL) (50 mL) [gluten free, lactose free, sugar free; containspolysorbate 80]

D-Vite Pediatric: 10 mcg/mL (400 unit/mL) (50 mL) [alcohol free, gluten free, lactose free,

no artificial color(s), sugar free; contains disodium edta, polysorbate 80, propyleneglycol, saccharin sodium, sodium benzoate]

Dialyvite Vitamin D3 Max: 1250 mcg (50000 unit) [scored]

True Vitamin D3: 10 mcg (400 unit), 25 mcg (1000 unit), 125 mcg (5000 unit), 250 mcg

(10000 unit), 1250 mcg (50000 unit)

Vitamin D3 Ultra Potency: 1250 mcg (50000 unit)

Generic: 10 mcg (400 unit), 125 mcg (5000 unit), 20 mcg (800 unit), 25 mcg (1000 unit),

250 mcg (10000 unit), 50 mcg (2000 unit), 75 mcg (3000 unit)

Tablet, Oral [preservative free]:

Generic: 5000 units, 10 mcg (400 unit), 25 mcg (1000 unit), 50 mcg (2000 unit)

Tablet Chewable, Oral:

VitaChew Vitamin D3: 25 mcg (1000 unit) [dairy free, gluten free, no artificial color(s), noartificial flavor(s), nut free, soy free; contains coconut oil (copra/cocos nucifera oil)]Generic: 10 mcg (400 unit)

Tablet Chewable, Oral [preservative free]:

1.25 MG(50000 UT) (per each): $0.21

Capsules (Decara Oral)

1.25 MG(50000 UT) (per each): $1.19

625 MCG(25000 UT) (per each): $1.91

Capsules (Dialyvite Vitamin D 5000 Oral)

125 MCG(5000 UT (per each): $0.13

Capsules (Pronutrients Vitamin D3 Oral)

25 MCG(1000 UT) (per each): $0.07

Capsules (Weekly-D Oral)

1.25 MG(50000 UT) (per each): $1.10

Liquid (BProtected Pedia D-Vite Oral)

Tablets (Dialyvite Vitamin D3 Max Oral)

1.25 MG(50000 UT) (per each): $1.08

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 isavailable and uses the low and high price reported by the manufacturers to determine therange The pricing data should be used for benchmarking purposes only, and as such shouldnot 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 updatedmonthly

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consultspecific product labeling

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)

Use: Labeled Indications

Dietary supplement: As a vitamin D dietary supplement

Use: Off-Label: Adult

Osteoporosis, prevention; Vitamin D insufficiency/deficiency

Medication Safety Issues

Cholecalciferol may be confused with alfacalcidol, ergocalciferol

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(For additional information: Launch drug interactions program)

Metabolism/Transport Effects

None known

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group

interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed) For a

complete list of drug interactions by individual drug name and detailed management

recommendations, use the drug interactions program by clicking on the “Launch drug

interactions program” link above

Bile Acid Sequestrants: May decrease the serum concentration of Vitamin D Analogs Morespecifically, 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 severalhours 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

Erdafitinib: Serum Phosphate Level-Altering Agents may diminish the therapeutic effect ofErdafitinib Management: Avoid coadministration of serum phosphate level-altering

The Institute for Safe Medication Practices (ISMP) includes this medication amongits list of drugs (pediatric liquid medications requiring measurement) whichhave a heightened risk of causing significant patient harm when used in error(High-Alert Medications in Community/Ambulatory Care Settings)

Liquid vitamin D preparations have the potential for dosing errors when

administered to infants Droppers should be clearly marked to easily provide

400 units For products intended for infants, the FDA recommends thataccompanying droppers deliver no more than 400 units per dose