Cholecalciferol (Vitamin D3) - Drug information

Cholecalciferol or Vitamin D3 is used as a dietary supplement in individuals with vitamin D deficiency. It is also used to treat the following medical conditions:

  • Hypoparathyroidism
  • For the prevention of osteoporosis
  • For the treatment of Vitamin D insufficiency & deficiency
  • For the treatment of vitamin D insufficiency or deficiency in patients with chronic kidney disease.

Cholecalciferol (Vitamin D) Dose in Adults

 Note: 1 mcg of cholecalciferol is equivalent to 40 units.

Off-label use in the treatment of Vitamin D insufficiency & deficiency treatment:

The optimal dose and the target serum levels of vitamin D3 are controversial. Most authorities suggest a range of 20 ng/ml to 40 ng/ml to avoid the risk of falls and fractures. Furthermore, for every 100 units/day or 2.5 mcg per day, the serum levels of vitamin D3 is expected to rise by 0.7 - 1 ng/ml after a few weeks


Initial vitamin D dosing based on the baseline serum levels:

  • Serum 25-hydroxyvitamin D levels of  20 to 30 ng/mL:

    • 600 to 800 units orally once daily (repeat testing is not required), or
    • 1,000 to 2,000 units orally once daily (repeat vitamin D levels after 3 months)
  • Serum 25-hydroxyvitamin D levels of 10 to less than 20 ng/mL:

    • 800 to 1,000 units once daily, or
    • 2,000 units once daily (Repeat vitamin D levels after 3 months. If  the target levels are not achieved, administer 50,000 units once a week for 6 to 8 weeks, or
    • 50,000 units orally once weekly (5,000 to 7,000 units once daily alternatively) for 8 weeks (2 months), followed by a reduced maintenance dose to maintain target serum levels of 25-hydroxyvitamin D
  • Symptomatic patients or patients with a serum 25 hydroxyvitamin D levels of less than 10 ng/mL

    • 50,000 units once weekly (5,000 to 7,000 units once daily alternatively) for 6 to 8 weeks to achieve the target serum levels (monitor vitamin D levels after 3 months)
    • The maintenance dose ranges from 600 to 800 units/day to 1000 - 2000 units/day but is highly patient specific.
    • Obese patients may require a higher dose of vitamin D3 and for a longer duration.

Off-label use of Vitamin D deficiency or insufficiency in patients with chronic kidney disease:

  • Patient with chronic kidney disease stage 3 - 5, including patients on hemodialysis and transplant recipients without severe or progressive hyperparathyroidism, should be advised cholecalciferol treatment just like normal patients.
  • Vitamin D analogs or calcitriol should be advised to patients who have a progressively raised serum parathyroid hormone despite the correction of hyperphosphatemia and vitamin D deficiency.

off-label use in the prevention of osteoporosis:

  • Adults 50 years of age or older
    • 800 to 1,000 units/day orally daily.

Off-label use in patients with Hypoparathyroidism:

Cholecalciferol (Vitamin D) Dose in Childrens:

Adequate intake in Infants:

  • 400 units/day orally.

Recommended Daily Allowance In Children and Adolescents :

  • 600 units/day orally

For the prevention of Rickets in Vitamin D deficiency:

  • Fully or partially Breast-fed infants:

    • 400 units/day.
    • Supplementation should be continued until weaning and adequate fortified formula or whole milk has been started.
  • Formula-fed infants on formula milk of with less than 1000 ml of vitamin D.

    • 400 units/day
  • Children and Adolescents without adequate intake:

    • 400 to 600 units/day.

Treatment of Vitamin D deficiency:

Note: Vitamin D supplements must be given simultaneously with calcium and phosphorus supplements. Patients with chronic fat malabsorption, obesity, those on antiepileptics, glucocorticoids, HIV medications, or antifungals may require higher doses of cholecalciferol.

Cholecalciferol dose in Infants:

    • 2,000 units daily for 6 weeks (to achieve a target serum 25 hydroxyvitamin D levels of more than 20 ng/mL)
    • This should be followed by a maintenance dose of 400 to 1,000 units daily.

Cholecalciferol dose in children and Adolescents:

  • 2,000 units daily for 6 to 8 weeks to achieve a target serum 25 hydroxyvitamin D levels of more than 20 ng/mL
  • This should be followed by a  maintenance dose of 600 to 1,000 units per day.

Prevention and treatment of Vitamin D deficiency in cystic fibrosis:

  • Serum vitamin D levels of 30 ng/ml or more:
    • Infants:

      • 400 to 500 units/day
    • Children less than10 years of age:

      • 800 to 1,000 units/day
    • Children older than 10 years of age and Adolescents:

      • 800 to 2,000 units/day
  • Serum Vitamin D levels of 20 - 30 ng/ml:
    • Infants:

      • 800 to 1,000 units/day
    • Children less than 10 years of age:

      • 1,600 to 3,000 units/day
    • Children older than 10 years and Adolescents:

      • 1,600 to 6,000 units/day
  • Serum Vitamin D levels of less than 20 ng/ml:
    • Infants:

      • Increase up to a maximum dose of 2,000 units/day
    • Children less than 10 years of age:

      • Increase to a maximum dose of 4,000 units/day
    • Children older than 10 years and Adolescents:

      • Increase to a maximum dose of 10,000 units/day

Alternate dosing:

  • Serum Vitamin D levels of less than 30 ng/mL
    • Infants:

      • 8,000 units/week
    • Children and Adolescents:

      • 800 units/day

Medium-dose regimen:

  • Serum vitamin D levels remain less than 30 ng/mL while on therapy and compliant:
    • Infants and Children less than 5 years of age:

      • 12,000 units/week for 12 weeks
    • Children older than 5 years and Adolescents:

      • 50,000 units/week for 12 weeks

High-dose regimen:

  • Serum Vitamin D levels remain less than 30 ng/mL despite compliant to the medium dose regimen:
    • Infants and Children less than 5 years of age:

      •  12,000 units twice weekly for 12 weeks
    • Children older than 5 years and Adolescents:

      • 50,000 units twice weekly for 12 weeks

Vitamin D deficiency in patients with CKD stage 2 - 5, and patients on hemodialysis:

  • Serum vitamin D levels of 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 vitamin D levels of 5 to 15 ng/mL:

    • Infants, Children, and Adolescents:
      • 4,000 units/day for 12 weeks or 50,000 units on the alternate week for 12 weeks
  • Serum vitamin D levels of less than 5 ng/mL:

    • Infants, Children, and Adolescents:
      • 8,000 units/day for 4 weeks then 4,000 units/day for 2 months for a total of 3 months or
      • 50,000 units/week for 4 weeks followed by 50,000 units twice a month for a total therapy of 3 months
  • The maintenance dose after repletion is 200 - 1000 units per day.

Treatment of Vitamin D in Nutritional rickets ( Vitamin D should be replaced with calcium):

Daily therapy is preferred:

  • Infants:

    •  2,000 units daily for 3 months or more, followed by a maintenance dose of 400 units daily
  • Children:

    • 3,000 to 6,000 units daily for 3 months or more, followed by a maintenance dose of 600 units daily
  • Adolescents:

    • 6,000 units daily for 3 months or more, followed by a maintenance dose of 600 units daily

Single-dose therapy:

  • Infants 3 months or older:

    • 50,000 units once
    • Initiate a maintenance dose of 400 units daily after 3 months.
  • Children:

    • 150,000 units once
    • Initiate a maintenance dose of 600 units daily after three months
  • Adolescents:

    • 300,000 units once
    • Initiate a maintenance dose of 600 units daily after 3 months

Pregnancy Risk Factor A (in usual dosage ranges)

  • Cholecalciferol can cross the placenta, but there have been no adverse effects in neonates when levels are within the acceptable range.
  • Vitamin D status should be checked by pregnant women at high risk for vitamin D deficiency.
  • It is vital for the growth of the fetus. Vitamin D deficient patients require a high dosage, i.e. A high dose of vitamin D, i.e. 1000 to 2000 units/day is recommended for patients with vitamin D deficiency. 
  • Avoid supratherapeutic doses or doses greater than the RDA.

Vitamin D use during  breastfeeding

Cholecalciferol (Vitamin D) Dose in Kidney Disease:

No dose adjustment has been recommended by the manufacturer in patients with renal disease.

Cholecalciferol (Vitamin D) Dose in Liver Disease:

No dose adjustment has been recommended by the manufacturer in patients with liver disease.

Side effects:

Side effects have not been listed in the manufacturer's labeling

Contraindication to Vitamin D include:

  • Hypercalcemia
  • Primary hyperparathyroidism
  • Sarcoidosis
  • Hypervitaminosis D
  • Williams syndrome
  • Severe allergic reactions

Warnings & Precautions

  • Excessive intakesVitamin D can cause toxicity. Vitamin D toxicity can be manifested as:
    • nausea,
    • vomiting,
    • Anorexia
    • Constipation
    • Dehydration
    • Fatigue
    • irritability,
    • Confused
    • Weakness
    • weight loss.
    • Vitamin D toxicity can last for up to two months after treatment is stopped.
  • Hyperphosphatemia:
    • To prevent metastatic calcification, serum phosphate levels must be maintained before starting therapy.
  • Obesity:
  • Renal impairment:
    • Patients with impaired renal function may need the activated vitamin D form.

Vitamin D3 (cholecalciferol): Drug Interaction

Risk Factor C (Monitor therapy)

Calcium Salts

May enhance the adverse/toxic effect of Vitamin D Analogs.

Cardiac Glycosides

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

Danazol

May enhance the hypercalcemic effect of Vitamin D Analogs.

Thiazide and Thiazide-Like Diuretics

May enhance the hypercalcemic effect of Vitamin D Analogs.

Risk Factor D (Consider therapy modification)

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.

Erdafitinib

Serum Phosphate Level-Altering Agents may diminish the therapeutic effect of Erdafitinib. Management: Avoid coadministration of serum phosphate level-altering agents with erdafitinib before initial dose increase period based on serum phosphate levels (Days 14 to 21).

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.

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 Factor X (Avoid combination)

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.

Multivitamins/Fluoride (with ADE)

May enhance the adverse/toxic effect of Vitamin D Analogs.

Multivitamins/Minerals (with ADEK, Folate, Iron)

May enhance the adverse/toxic effect of Vitamin D Analogs.

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.

Vitamin D Analogs

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

Monitoring Parameters:

Patients on long term or high doses of vitamin D should be monitored for features of toxicity.

These include:

  • Hypercalcemia
  • Hypercalcuria
  • Confusion
  • Psychosis
  • Tremor
  • Calcification of soft tissues
  • Nausea
  • Weakness

Periodic monitoring of cholecalciferol levels may be advised to patients on high doses of vitamin D. Other parameters that require monitoring include:

  • Serum calcium levels
  • Phosphate levels
  • Parathyroid hormone levels
  • Alkaline phosphatase levels
  • Magnesium levels
  • X-rays in pediatric patients

How to Administer Cholecalciferol (Vitamin D)?

  • Administer vitamin D with the largest meal of the day. In children, do not use a teaspoon for measuring vitamin D levels, use a correct measuring device like a syringe or a dropper instead.
  • Do not swallow the wafer whole.
  • Maybe Chewed or crushed before swallowing.

Mechanism of action of Vitamin D3

  • Vitamin D3 (Cholecalciferol) is a provitamin. Its active metabolite, calcitriol, or 1,25-dihydroxy vitamin Vitamin D, acts through the following mechanisms.
  • Stimulates small intestine calcium and phosphate absorption
  • Calcium from bones to blood is increased by this enzyme.
  • Encourages renal tubule and phosphate absorption

It isabsorbedIn the small intestine. It is a fat-soluble vitamin that requires bile to absorb.

TheHalf-life of 25 hydroxyvitaminD in circulationIt takes 2 to 3 weeks, while 1,25-dihydroxy vitamin B takes around 4 hours.

Excretion is primarily via feces.     

International brands of Cholecalciferol:

  • D-Tabs
  • EURO D 10000
  • EURO-D
  • JAMP-Vitamin D
  • Luxa-D
  • ViDextra
  • Aqueous Vitamin D
  • Bio-D-Mulsion Forte
  • Bio-D-Mulsion
  • BProtected
  • Pedia D-Vite
  • D-3-5
  • D-Vi-Sol
  • D-Vita
  • D3 Vitamin
  • D3-50
  • Delta D3
  • Dialyvite Vitamin D 5000
  • Dialyvite Vitamin D3 Max
  • Vitamin D3 Super Strength
  • Vitamin D3 Ultra Potency
  • Adalben
  • Arachitol
  • Aviticol
  • Baby D Drops
  • D Drops
  • D-Cure
  • D3
  • Capsules
  • D3 Drops
  • D3 Drops Forte
  • D4U
  • Deetipat
  • Dekristol 400
  • Deltius
  • Desunin
  • Devaron
  • Devitre
  • Divisun
  • Duvit D3
  • Fultium-D3
  • Iper D3
  • Laevovit
  • Laevovit D3
  • Ostelavit
  • Plivit D3
  • Teorol
  • Thorens
  • Tridelta
  • Uvedose
  • Vi-De 3
  • Vigantol
  • Vitamin D3
  • Vitamin D3 Fresenius
  • Vitamin D3 Streuli
  • Vitamine
  • D3 BON
  • Vitaminum D3
  • Vitamon D3

Cholecalciferol (Vitamin D) in Pakistan:

Cholecalciferol [Inj 5 mg]

D-TRES SAMI PHARMACEUTICALS (PVT) LTD.
MIURA GETZ PHARMA PAKISTAN (PVT) LTD.

 

Cholecalciferol [Inj 5 mg/ml]

AM-D3 MUNAWAR PHARMA (PVT) LTD.
CALCIFEROL GLOBAL PHARMACEUTICALS
CARA-IN-D CARAWAY PHARMACEUTICALS
CLOCRYS POLYFINE CHEMPHARMA (PVT) LTD.
D4U GENIX PHARMA (PVT) LTD
DALIX FORAY PHARMACEUTICALS
DELTA-D3 WNS FIELD PHARMACEUTICALS
DX 3 MACTER INTERNATIONAL (PVT) LTD.
ED-3 ENGLISH PHARMACEUTICALS INDUSTRIES
FERO-D MEDISURE LABORATORIES PAKISTAN (PVT.) LTD.
FYCALCI FYNK PHARMACEUTICALS
G-CAL GLITZ PHARMA
GET-D GETZ PHARMA PAKISTAN (PVT) LTD.
GROW-D MASS PHARMA (PRIVATE) LIMITED
HILTO MATRIX PHARMA
INDROP-D NEUTRO PHARMA (PVT) LTD.
INVITAL-D KAIZEN PHARMACEUTICALS PVT LTD.
KINVIT-D3 CARAWAY PHARMACEUTICALS
MEDIROL-D MEDLEY PHARMACEUTICALS
SUNNY D3 SCOTMANN PHARMACEUTICALS
VD-3 ENGLISH PHARMACEUTICALS INDUSTRIES
VITAL D MACTER INTERNATIONAL (PVT) LTD.

 

Cholecalciferol [Drops 40 IU]

D4U GENIX PHARMA (PVT) LTD

 

Cholecalciferol [Tabs 200 IU]

CAVLID PLUS GENOME PHARMACEUTICALS (PVT) LTD

 

Cholecalciferol [Tabs 1000 IU]

SUNNY D3 SCOTMANN PHARMACEUTICALS

 

Cholecalciferol [Caps 5000 IU]

D-ZAK SCHAZOO ZAKA

 

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