Cholecalciferol (vitamin D)

Generic name
Cholecalciferol (vitamin D)
Brand name
ATC Code
A11CC05
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Cholecalciferol (vitamin D)

Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

No information

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Prophylaxis vitamin D deficiency, treatment of vitamin D deficiency (25(OH)D levels ≥30 nmol/l) (DUTCH INDICATION DUE TO AVAILABILITY OF FORMULATIONS)
  • Oral
    • Premature infants Gestational age < 37 weeks and < 1250 g
      [2] [5] [6]
      • 600 IU/day in 1 dose

      • The vitamin D dose is an addition to the amount of vitamin D intake with formula in order to meet the total daily requirement.

    • Premature infants Gestational age < 37 weeks and ≥ 1250 g
      [2] [5] [6]
      • 400 IU/day in 1 dose

      • The vitamin D dose is an addition to the amount of vitamin D intake with formula in order to meet the total daily requirement.

    • Term neonate
      [2] [5] [6] [20] [24]
      • 400 IU/day in 1 dose In children with dark coloured skin: 800 IE/day.
    • 1 month up to 4 years
      [2] [5] [6] [20] [24]
      • 400 IU/day in 1 dose In children with dark coloured skin: 800 IE/day.
    • 4 years up to 18 years
      [19]
      • 400 - 600 IU/day in 1 dose in children that have an increased risk for vitamin D deficiency. For children with dark coloured skin: 800 IE/day.
Supplementation in cystic fibrosis
  • Oral
    • 1 month up to 2 years
      [3] [18] [23]
      • Initial dose: 400 IU/day in 1 dose
      • Maintenance dose: Adjust dose if needed based on bloodlevel to 400 - 1.000 IU/day in 1 dose
    • 2 years up to 4 years
      [18] [23]
      • Initial dose: 400 IU/day in 1 dose
      • Maintenance dose: Adjust dose if needed based on bloodlevels to 400 - 2.000 IU/day in 1 dose
    • 4 years up to 10 years
      [18] [23]
      • Initial dose: 600 IU/day in 1 dose
      • Maintenance dose: Adjust dose if needed based on bloodlevels to  600 - 2.000 IU/day in 1 dose
    • 10 years up to 18 years
      [18] [23]
      • Initial dose: 600 IU/day in 1 dose
      • Maintenance dose: Adjust dose if needed based on bloodlevels to 600 - 4.000 IU/day in 1 dose
Treatment of vitamin D deficiency (25(OH)D spiegel <30 nmol/l)(DUTCH INDICATION DUE TO AVAILABILITY OF FORMULATIONS)
  • Oral
    • Premature neonates Gestational age < 37 weeks and < 1250 g
      [6]
      • 600 IU/day in 1 dose

      • The vitamin D dose is an addition to the amount of vitamin D intake with formula in order to meet the total daily requirement.

    • Preterm neonates Gestational age < 37 weeks and ≥ 1250 g
      [6]
      • 400 IU/day in 1 dose

      • The vitamin D dose is an addition to the amount of vitamin D intake with formula in order to meet the total daily requirement.

    • Term neonates 0 months up to 3 months
      [4] [6] [7] [20] [21] [26]
      • Initial dose: 2.000 IU/day in 1 dose for 3 months.
      • Maintenance dose: 400 IU/day in 1 dose In children with dark coloured skin: 800 IE/day..

      • Ensure adequate calcium intake (at least 500 mg / day) in the diet or give calcium supplementation.

    • 3 months up to 1 year
      [20] [21] [22] [25] [26]
      • Initial dose: 2.000 IU/day in 1 dose For 3 months.

        .
      • Maintenance dose: 400 IU/day in 1 dose In children with dark coloured skin: 800 IE/day.
        • Ensure adequate calcium intake (at least 500 mg / day) in the diet or give calcium supplementation.
        • As an alternative to a daily initial dose, a single high dose (50,000 IU/dose) may be considered in individual cases. Then, after 3 months, check whether the 25(OH)D level has normalized and, if so, continue with the maintenance dose. 
    • 1 year up to 12 years
      [20] [25]
      • Initial dose: 3.000 - 6.000 IU/day in 1 dose For 3 months.

        .
      • Maintenance dose: 600 IU/day in 1 dose In children with dark coloured skin: 800 IE/day.
        • Ensure adequate calcium intake (at least 500 mg / day) in the diet or give calcium supplementation.
        • As an alternative to a daily initial dose, a single high dose (150.000 IU/dose) may be considered in individual cases. Then, after 3 months, check whether the 25(OH)D level has normalized and, if so, continue with the maintenance dose. 

         

    • 12 years up to 18 years
      [20]
      • Initial dose: 6.000 IU/day in 1 dose For 3 months.

        .
      • Maintenance dose: 600 IU/day in 1 dose In children with dark coloured skin: 800 IE/day.
        • Ensure adequate calcium intake (at least 500 mg / day) in the diet or give calcium supplementation.
        • As an alternative to a daily initial dose, a single high dose (300.000 IU/dose) may be considered in individual cases. Then, after 3 months, check whether the 25(OH)D level has normalized and, if so, continue with the maintenance dose. 

Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

Gastro-intestinal symptoms (Holmlund-Suila 2012).

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

Risk factors for a vitamin D deficiency are insufficient sun exposure (in the Netherlands from October to April, city and indoor living, clothing, sunscreen), insufficient production of vitamin D in the skin (dark skin, old age, chronic illness), high volume of distribution at obesity, pregnancy, celiac disease, bariatric surgery, impaired renal function and some drugs (including anti-epileptics, tuberculostatics) (Aguirre Castaneda 2012, Öhlund 2017, Rajakumar 2016). Symptoms of vitamin D deficiency can also occur in premature babies, infants who are exclusively breastfed for more than six months without receiving calcium-containing food and children who are strictly vegetarian. [SmPC Dekristolmin 12/2018]

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

VITAMIN A AND D, INCL. COMBINATIONS OF THE TWO

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Vitamin A, plain
A11CA01

References

  1. Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
  2. Gezondheidsraad, Evaluatie van de voedingsnormen voor vitamine D, Den Haag, 2012, pu­bli­ca­tienr. 2012/15
  3. Kneepkens CMF et al, Werkboek Kindergastro-Enterologie, VU Uitgeverij, 2002, 2e druk
  4. Noordam C et al, Werkboek Kinderendocrinologie, digitale publicatie op www.nvk.nl (alleen leden), 2010
  5. Het voedingscentrum, Rapportage consultatieronde vitamine D- suppletieadviezen, www.voedingscentrum.nl, Mei 2011, http://www.voedingscentrum.nl/Assets/Uploads/Documents/Voedingscentrum/Professionals/Rapport%20consultatieronde%20vitamine%20D%20DEF.pdf
  6. Lafeber H. et al, NVK Werkboek enterale en parenterale voeding van pasgeborenen, VU Uitgeverij, 2012
  7. Laboratories SMB S.A., SmPC D-Cura 2400 IE (RVG 112993) 11-03-2015, www.geneesmiddeleninformatiebank.nl
  8. Merck, SmPC Vigantoletten 500 IE, 1.000 IE (6154298.00.00/ 6154298.01.00), 02/ 2017
  9. mibe, SmPC Dekristol® 20 000 I.E. (3000309.00.00), 09/2015
  10. Hexal, SmPC Vitamin D-Sandoz® 500 / 1000 I.E. Tabletten (91571.00.00 / 91571.00.00), 03/2017
  11. Pädia, SmPC DeVit® Tropfen 2400 I.E. (94267.00.00), 07/2015
  12. mibe, SmPC Dekristol 400IE Tabletten (3000424.00.00), 09/2015
  13. Merck, SmPC Vigantol Öl 20.000 IE/ml Lösung (6154275.00.01), 12/2015
  14. Rajakumar R et al. , Effect of Vitamin D3 Supplementation in Black and in White Children: A Randomized, Placebo-Controlled Trial., J Clin Endocrinol Metab. , 2015, Aug;100(8), 3183-92
  15. Öhlund I et al. , Increased vitamin D intake differentiated according to skin color is needed to meet requirements in young Swedish children during winter: a double-blind randomized clinical trial, Am J Clin Nutr, 2017, Jul;106(1), 105-112
  16. Aguirre Castaneda R et al, Response to Vitamin D3 Supplementation in Obese and Nonobese Caucasian Adolescents, Horm Res Paediatr, 2012, 78(4), 226-31
  17. Holmlund-Suila E., High-dose vitamin d intervention in infants--effects on vitamin d status, calcium homeostasis, and bone strength, J Clin Endocrinol Metab, 2012, 97(11), 4139-47
  18. Turck, D et al, ESPEN-ESPGHAN-ECFS guidelines on nutrition care for infants, children, and adults with cystic fibrosis, Clin NUtr, 2016, 35(3), 557-77
  19. Ross, A. C et al, The 2011 report on dietary reference intakes for calcium and vitamin D from the Institute of Medicine: what clinicians need to know, J Clin Endocrinol Metab, 2011, 96 (1), 53-8
  20. Munns, C. F. et al, Global Consensus Recommendations on Prevention and Management of Nutritional Rickets, J Clin Endocrinol Metab, 2016, 101 (2), 394-415
  21. Kruse, K. , Pathophysiology of calcium metabolism in children with vitamin D-deficiency rickets, J Pediatr, 1995, 126 (5 Pt 1), 736-41
  22. Gordon, C. M. et al, Treatment of hypovitaminosis D in infants and toddlers, J Clin Endocrinol Metab, 2008, 93 (7), 2716-21
  23. Gijsbers, C.F.M. et al , Werkboek Kindermaag-darm-leverziekten. Derde druk, VU Uitgeverij www.nvk.nl, 2014
  24. Gallo, S.. et al , Effect of different dosages of oral vitamin D supplementation on vitamin D status in healthy, breastfed infants: a randomized trial., JAMA, 309(17), 1785-92
  25. Emel, T. et al , Therapy strategies in vitamin D deficiency with or without rickets: efficiency of low-dose stoss therapy, J Pediatr Endocrinol Metab, 2012, 25 (1-2), 107-10
  26. Cesur, Y. et al, Comparison of low and high dose of vitamin D treatment in nutritional vitamin D deficiency rickets., J Pediatr Endocrinol Metab, 2003, 16(8), 1105-9

Changes

Therapeutic Drug Monitoring


Overdose