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

Interactions
PK
Renal impairment
References

Calcitriol

Generic name
Calcitriol
Brand name
ATC Code
A11CC04

Pharmacokinetics in children

The elimination half-life of calcitriol is prolonged (4-5 times) in children compared to adults (Jones et al.)

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

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Available formulations

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Dosages

Secondary hyperparathyroidism; renal failure; pre-dialysis
  • Oral
    • 1 month up to 18 years
      • Starting dose: 0.01 - 0.02 microg./kg/day in 1 - 2 doses. Max: 0.25 microg./day.
        • Corresponding to 10-20 ng/kg/day, max 250 ng/day
        • Alternative: 0.035 microg/kg/day (= 35 ng/kg/day) in 1-2 doses three times a week.
        • Titrate dose based on effect and biochemical parameters. Dose may be increased every 2-4 weeks. Closely monitor serum calcium, phosphate, PTH, alkaline phosphatase and creatinine.
    • 1 month up to 18 years
      [6] [7] [16] [18] [19] [20] [22] [23] [24]
      • Starting dose: 0.01 - 0.02 microg./kg/day in 1 - 2 doses. Max: 0.25 microg./day.
        • Corresponding to 10-20 ng/kg/day, max 250 ng/day
        • Alternative: 0.035 microg/kg/day (= 35 ng/kg/day) in 1-2 doses three times a week.
        • Titrate dose based on effect and biochemical parameters. Dose may be increased every 2-4 weeks. Closely monitor serum calcium, phosphate, PTH, alkaline phosphatase and creatinine.
  • Intravenous
    • 9 years up to 18 years
      • Starting dose: 0.5 - 2 microg./dose 3 times a week.

      • Titrate dose based on effect and biochemical parameters. Dose may be increased every 2-4 weeks. Closely monitor serum calcium, phosphate, PTH, alkaline phosphatase and creatinine.

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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.

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

Side effects

No information is present at this moment.

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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

No information available on specific warnings and precautions in children.

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Interactions

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

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Vitamin A, plain
A11CA01
Vitamin D and analogues
A11CC03
A11CC05

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References

  1. Correspondentie Roche Nederland BV, Rocaltrol druppels/aanpassing dosering, 1993
  2. Roche Nederland BV, SPC Rocaltrol (RVG 08285), www.cbg-meb.nl, Geraadpleegd 20 april 2011, http://db.cbg-meb.nl/IB-teksten/h08285.pdf
  3. Roche Pharma (Zwitserland), Fachinformation des Arzneimittel Rocaltrol, http://www.kompendium.ch/Monographie.aspx?Id=cf5e4837-c34d-4da8-8aba-2854b6325a28&lang=de&MonType=fi
  4. Noordam C et al, Werkboek Kinderendocrinologie, 2010, digitale publicatie op www.nvk.nl (alleen leden)
  5. NVDV, Multidisciplinaire evidencebased richtlijn Psoriasis, 2017
  6. Klaus G, et al., Is intermittent oral calcitriol safe and effective in renal secondary hyperparathyroidism?, Lancet., 1991, 337(8744), 800-1
  7. Roche Laboratories Inc., FDA Product information Leaflet Rocaltrol capsule (0.5 and 0.25 ug) FDA. Last update: Oct 1996, Available from: https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/018044a_s018_s019_s024.pdf
  8. Chan JC, et al., Hypercalcemia in children with disorders of calcium and phosphate metabolism during long-term treatment with 1,25-dihydroxyvitamin-D3., Pediatrics, 1983, 72(2), 225-33
  9. Harrell RM, et al., Healing of bone disease in X-linked hypophosphatemic rickets/osteomalacia. Induction and maintenance with phosphorus and calcitriol., J Clin Invest, 1985, 75(6), 1858-68
  10. Alikasifoglu A, et al, Long-term effect of conventional phosphate and calcitriol treatment on metabolic recovery and catch-up growth in children with PHEX mutation, J Pediatr Endocrinol Metab., 2021, 34(12), 1573-84
  11. Jones CL, et al., Comparisons between oral and intraperitoneal 1,25-dihydroxyvitamin D3 therapy in children treated with peritoneal dialysis., Clin Nephrol., 1994, 42(1), 44-9
  12. Edouard T, et al., Short- and long-term outcome of patients with pseudo-vitamin D deficiency rickets treated with calcitriol., J Clin Endocrinol Metab., 2011, 96(1), 82-9
  13. Kruse K,et al., Calcium metabolism and growth during early treatment of children with X-linked hypophosphataemic rickets., Eur J Pediatr., 1998, 157(11), 894-900
  14. Chesney RW, et al., Long-term influence of calcitriol (1,25-dihydroxyvitamin D) and supplemental phosphate in X-linked hypophosphatemic rickets., Pediatrics, 1983, 71(4), 559-67
  15. Block JE, et al, Familial hypophosphatemic rickets: bone mass measurements in children following therapy with calcitriol and supplemental phosphate., Calcif Tissue Int., 1989, 44(2), 86-92
  16. Roche Laboratories Inc., SmPC Rocaltrol oral solution (1ug/ml) FDA. Last update: Nov 1998, Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/21068lbl.pdf].
  17. Verge CF, et al, Effects of therapy in X-linked hypophosphatemic rickets., N Engl J Med., 1991, 325(26), 1843-8.
  18. Wesseling-Perry K, et al., Calcitriol and doxercalciferol are equivalent in controlling bone turnover, suppressing parathyroid hormone, and increasing fibroblast growth factor-23 in secondary hyperparathyroidism., Kidney Int., 2011, 79(1), 112-9.
  19. Ardissino G,et al., Calcitriol pulse therapy is not more effective than daily calcitriol therapy in controlling secondary hyperparathyroidism in children with chronic renal failure. European Study Group on Vitamin D in Children with Renal Failure., Pediatr Nephrol., 2000, 14(7), 664-8.
  20. Salusky IB, et al., Intermittent calcitriol therapy in secondary hyperparathyroidism: a comparison between oral and intraperitoneal administration., Kidney Int., 1998, 54(3), 907-14
  21. Alon US, et al., Calcimimetics as an adjuvant treatment for familial hypophosphatemic rickets., Clin J Am Soc Nephrol., 2008, 3(3), 658-64
  22. Kuizon BD, et al., Diminished linear growth during intermittent calcitriol therapy in children undergoing CCPD., Kidney Int., 1998, 53(1), 205-11
  23. Salusky IB, et al, "High-dose" calcitriol for control of renal osteodystrophy in children on CAPD., Kidney Int., 1987, 32(1), 89-95
  24. Bettinelli A, et al., Effects of 1,25-dihydroxyvitamin-D3 treatment on mineral balance in children with end stage renal disease undergoing chronic hemofiltration., Pediatr Res., 1986, 20(1), 5-8
  25. Seeherunvong W, et al., Paricalcitol versus calcitriol treatment for hyperparathyroidism in pediatric hemodialysis patients., Pediatr Nephrol, 2006, Oct;21(10), 1434-9
  26. Baskin E, et al., Beneficial role of intravenous calcitriol on bone mineral density in children with severe secondary hyperparathyroidism, Int Urol Nephrol, 2004, 36(1), 113-8
  27. Greenbaum LA, et al, Intravenous calcitriol for treatment of hyperparathyroidism in children on hemodialysis. , Pediatr Nephrol, 2005, May;20(5):, 622-30
  28. mibe GmbH Arzneimittel, SmPC Decostriol Injektionslösung (59174.00.00), 12-2019
  29. Greenbaum LA, et al, Intravenous calcitriol for treatment of hyperparathyroidism in children on hemodialysis., Pediatr Nephrol, 2005, May;20(5):, 622-30
  30. Salusky IB, et al., Intermittent calcitriol therapy in secondary hyperparathyroidism: a comparison between oral and intraperitoneal administration., Kidney Int., 1998, 54(3), 907-14

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