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

Interactions
PK
Renal impairment
References

Ondansetron

Generic name
Ondansetron
Brand name
ATC Code
A04AA01

Pharmacokinetics in children

The following pharmacokinetic parameters have been observed following intravenous administration (Zofran SPC) (Mondick et al. 2010, Spahr-Schopfer et al. 1995):

Post operatieve nausea and vomiting (PONV):

Age n= t½ (hr) Cl (l/hr/kg) Vd (l/kg)
1-4 months 19 6,7 0,40 3,5
5-24 months 22 2,9 0,58 2,3
3-12 years 21 2,9 0,44 1,65

Chemotherapy induced nausea and vomiting (CINV) :

Age n= t½ (hr) Cl (l/hr/kg) Vd (l/kg)
1-48 months 115 4,9 0,58 3,65
4-18 years 21 2,8 0,60 1,9

 

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

No information is present at this moment.

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Available formulations

No information is present at this moment.

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Dosages

Nausea and vomiting in low emetogenic chemotherapy
  • Oral
  • Intravenous
    • 1 month up to 18 years
      [4] [22] [26] [29] [30]
      • 10 mg/m²/dose, once only. Max single dose: 8 mg/dose.
        • A second dose of 5 mg/m2 can be administerred if needed.
        • 10 mg/m2 is similar to 0,3 mg/kg
Nausea and vomiting in moderate to high emetogenic chemotherapy
  • Intravenous
    • 1 month up to 18 years
      [4] [22] [26] [29] [30]
      • 15 mg/m²/day in 3 doses. Max single dose: 16 mg/dose.
        • 15 mg/m2/day is equivalent to 0,45 mg/kg/day
        • Give 15 minutes before the course of medication.
  • Oral
    • 1 month up to 18 years
      [4] [22] [23] [26] [29] [30]
      • 15 mg/m²/day in 3 doses. Max single dose: 8 mg/dose.
        • 15 mg/m2/day is equivalent to 0,45 mg/kg/day
        • Give 15 minutes before the course of medication.
Nausea and vomiting, post-operative
  • Oral
    • 0 years up to 3 years
      • 1 mg/dose, as required, max. 3x daily with a dosing interval of 4 hours.
    • 3 years up to 11 years
      • 2 mg/dose, as required, max. 3x daily with a dosing interval of 4 hours.
    • 11 years up to 18 years
      • 4 mg/dose, as required, max. 3x daily with a dosing interval of 4 hours.
    • 1 month up to 18 years
      [24] [25] [27] [28] [31] [33]
      • 0.1 mg/kg/dose, as required, max. 3x daily with a dosing interval of 4 hours. Max single dose: 4 mg/dose.

      • Oral administration only if intravenous use is not possible or preferred. 

  • Intravenous
Acute gastroenteritis with vomiting and dehydration

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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 in children

QT extension (Trivedi et al. 2016). 

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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 in children

Paediatric patients receiving ondansetron in combination with hepatotoxic chemotherapeutic agents should be monitored closely for impaired liver function.

Studies in adults show that ondansetron in doses of > 32 mg/dose can cause a dose-dependent extension of the QT interval, potentially leading to cardiac dysrhythmia, including torsades de pointes. Publications by Brenner (2016) Nathan (2011) and McKechnie (2010) describe prolongation of the QT interval leading to heart rhythm abnormalities in children with a heart defect/congenital long QT-interval syndrome. Using ondansetron must be avoided in children with a congenital long QT syndrome. Caution is needed when there are risk factors for prolongation of the QT interval: Hypopotassemia; impaired renal function; diabetes mellitus; combined use with drugs that prolong the QTc-interval or that increase the bloodconcentration; high doses; pre-existing prolonged QTc-interval or long QTc-interval syndrome.  If risk factors are present a ECG should be performed prior to the start of therapy.

A lethal reaction on ondansetron has been described in a case report on a child with comorbid malignant hyperthermia (Gener 2010)

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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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Serotonin (5HT3) antagonists
A04AA02
A04AA05
Other antiemetics
A04AD12

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References

  1. Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
  2. GlaxoSmithKline BV, SPC Zofran (RVG 14291) 09-04-2019, www.geneesmiddeleninformatiebank.nl
  3. Carter B. et al, Antiemetic treatment for acute gastroenteritis in children: an updated Cochrane systematic review with meta-analysis and mixed treatment comparison in a Bayesian framework, BMJ Open, 2012, Jul 19;2(4)
  4. Van de Wetering, MD., Werkboek Supportive Care, www.skion.nl, 2017
  5. Alhashimi D, et al, Antiemetics for reducing vomiting related to acute gastroenteritis in children and adolescents, Cochrane Database Syst Rev, 2009, Apr 15;(2), CD005506
  6. Roslund G, et al, The role of oral ondansetron in children with vomiting as a result of acute gastritis/gastroenteritis who have failed oral rehydration therapy: a randomized controlled trial., Ann Emerg Med, 2008, Jul;52(1), 22-29
  7. Lincke, CR, Ondansetron tegen braken bij acute gastro-enteritis, Farmacother Kind, 2010, 1, 12-8
  8. Szajewska H, et al, Meta-analysis: ondansetron for vomiting in acute gastroenteritis in children., Aliment Pharmacol Ther., 2007, Feb 15;25(4), 393-400
  9. Stork CM, et al, Emergency department treatment of viral gastritis using intravenous ondansetron or dexamethasone in children., Acad Emerg Med, 2006, Oct;13(10), 1027-33
  10. Freedman SB, et al, Oral ondansetron for gastroenteritis in a pediatric emergency department, N Engl J Med, 2006, Apr 20;354(16), 1698-705
  11. Reeves JJ, et al, Ondansetron decreases vomiting associated with acute gastroenteritis: a randomized, controlled trial, Pediatrics, 2002, Apr;109(4), e62
  12. Ramsook C, et al, A randomized clinical trial comparing oral ondansetron with placebo in children with vomiting from acute gastroenteritis, Ann Emerg Med, 2002, Apr;39(4), 397-403
  13. DeCamp LR, et al, Use of antiemetic agents in acute gastroenteritis: a systematic review and meta-analysis, Arch Pediatr Adolesc Med, 2008, Sep;162(9), 858-65
  14. Nathan AT, et al, Implications of anesthesia in children with long QT syndrome, Anesth Analg, 2011 , May;112(5):, 1163-8
  15. McKechnie K et al, Ventricular tachycardia after ondansetron administration in a child with undiagnosed long QT syndrome, Can J Anaesth, 2010, May;57(5), 453-7
  16. Fedorowicz Z et al., Antiemetics for reducing vomiting related to acute gastroenteritis in children and adolescents, Cochrane Database Syst Rev, 2011, Sep 7;(9), CD005506
  17. Gener B et al, Administration of ondansetron is associated with lethal outcome, Pediatrics, 2010, Jun;125(6), e1514-7
  18. GlaxoSmithKline BV. , Product Information Zofran (IV, tablets), dec 2013, http://us.gsk.com/products/assets/us_zofran_tablets.pdf <br/>http://us.gsk.com/products/assets/us_zofran.pdf
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  20. Brenner SM et al., Fatal Cardiac Arrest in 2 Children: Possible Role of Ondansetron, Pediatr Emerg Care., 2016, Nov;32(11), 779-784
  21. Trivedi S et al., Effect of Ondansetron on QT Interval in Patients Cared for in the PICU., Pediatr Crit Care Med., 2016, Jul;17(7), e317-23
  22. Dupuis, L. L.,et al., Guideline for the prevention of acute nausea and vomiting due to antineoplastic medication in pediatric cancer patients., Pediatr Blood Cancer, 2013, 60(7), 1073-82
  23. Patel, P., et al, Guideline for the prevention of acute chemotherapy-induced nausea and vomiting in pediatric cancer patients: A focused update, Pediatr Blood Cancer, 2017, 64(10)
  24. Bowhay, A. R., et al , A randomized controlled trial of the antiemetic effect of three doses of ondansetron after strabismus surgery in children., Paediatr Anaesth , 2001, 11(2), 215-21
  25. Lawhorn, C. D., et al. , Ondansetron dose response curve in high-risk pediatric patients., J Clin Anesth, 1997, 9 (8), 637-42
  26. Kovacs, G., et al., Palonosetron compared with ondansetron in pediatric cancer patients: multicycle analysis of a randomized Phase III study., Future Oncol, 2017, 13(19), 1685-98
  27. Shen, Y. D., et al., Dexamethasone, ondansetron, and their combination and postoperative nausea and vomiting in children undergoing strabismus surgery: a meta-analysis of randomized controlled trials., Paediatr Anaesth, 2014, 24(5), 490-8
  28. Splinter, W. M., et al, Prophylactic antiemetics in children undergoing tonsillectomy: high-dose vs low-dose ondansetron, Paediatr Anaesth, 1997, 7(2), 125-9
  29. Jain, S., et al , A randomized, open-label non-inferiority study to compare palonosetron and ondansetron for prevention of acute chemotherapy-induced vomiting in children with cancer receiving moderate or high emetogenic chemotherapy, Support Care Cancer, 2018, 26(9), 3091-3097
  30. Tan, J., et al. , Palonosetron is nonsuperior to ondansetron in acute phase but provides superior antiemetic control in delayed phase for pediatric patients administered highly emetogenic chemotherapy., Pediatr Blood Cancer, 2018, 65 (2)
  31. Watcha, M. F., et al , The dose-response relationship of ondansetron in preventing postoperative emesis in pediatric patients undergoing ambulatory surgery., Anesthesiolog, 1995, y85 (1), 47-52
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  33. Sadhasivam, S., et al, Prophylactic ondansetron in prevention of postoperative nausea and vomiting following pediatric strabismus surgery: a dose-response study, Anesthesiology, 2000, 92(4), 1035-42
  34. Spahr-Schopfer, I. A., et al 1995. "." 58 (3):316-2, Pharmacokinetics of intravenous ondansetron in healthy children undergoing ear, nose, and throat surgery, Clin Pharmacol Ther, 1995, 58(3), 316-21
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  36. Novartis Pharma GmbH, SmPC, Zofran® 4/8 mg Filmtabletten (22008.00.01), 04/18
  37. Novartis Pharma GmbH, SmPC, Zofran® 4/8 mg Zydis Lingual Schmelztabletten (41349.00.00), 04/18
  38. Novartis Pharma GmbH, SmPC, Zofran Lösung 4 mg/5 ml Lösung zum Einnehmen (37196.00.00), 04/18
  39. Novartis Pharma GmbH, SmPC, Zofran i.v. 4/8 mg Injektionslösung (22008.00.00), 04/18
  40. STADAPHARM GmbH, SmPC, Cellondan lingual 4/8 mg Schmelztabletten (59771.00.00), 07/17
  41. STADAPHARM GmbH, SmPC, Cellondan 4/8 mg Filmtabletten (58383.01.01), 07/17
  42. STADAPHARM GmbH, SmPC, Cellondan 4/8 mg Injektionslösung (59451.00.00), 08/17
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  46. Fugetto F et al., Single-dose of ondansetron for vomiting in children and adolescents with acute gastroenteritis-an updated systematic review and meta-analysis, Eur J Pediatr., 2020, Jul;179(7), 1007-1016

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Changes

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