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

Interactions
PK
Renal impairment
References

Cetirizine

Generic name
Cetirizine
Brand name
ATC Code
R06AE07

Pharmacokinetics in children

The elimination is faster in children than in adults. The elimination half-life in young children (0.5 –2 years) is 3.1 ± 1.8 hours; Tmax is 2.0 ± 1.3 hours, the volume of distribution is 0.44 ± 0.19 l/kg and Cmax is 390 ± 135 ng/ml. The oral clearance in this age group is 2.13 ± 1.15 ml/min/kg. In children aged 2–6 years, the elimination half-life is 5.55 ± 0.98 hours; the clearance is 1.27 ± 0.80 ml/min/kg. The elimination half-life increases in children older than 6 years to approximately 6–7 hours

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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

Symptomatic treatment of allergic rhinitis (including persistent allergic rhinitis), chronic idiopathic urticaria and acute food allergies.
  • Oral
    • 1 year up to 2 years
      [6] [10]
      • 0.5 mg/kg/day in 2 doses. Max: 5 mg/day.
    • 2 years up to 6 years
      [9] [10] [13] [14] [31]
      • 5 mg/day in 1 - 2 doses.

      • In chronic idiopathic urticaria, raising the dose to a maximum of 4 times the daily dose can be considered if there is insufficient effect.

        TAKE CARE when using the liquid formulation in high dosages for the indication urticaria. The liquid formulation contains propylene glycol.

    • 6 years up to 12 years
      [9] [10] [13] [14] [31]
      • 10 mg/day in 1 - 2 doses.

      • In chronic idiopathic urticaria, raising the dose to a maximum of 4 times the daily dose can be considered if there is insufficient effect.

        TAKE CARE when using the liquid formulation in high dosages for the indication urticaria. The liquid formulation contains propylene glycol.

    • 12 years up to 18 years
      [9] [13] [14] [31]
      • 10 mg/day in 1 dose

      • In chronic idiopathic urticaria, raising the dose to a maximum of 4 times the daily dose can be considered if there is insufficient effect.

        TAKE CARE when using the liquid formulation in high dosages for the indication urticaria. The liquid formulation contains propylene glycol.

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Renal impaiment in children > 3 months

When the creatinine clearance is > 50 ml/min/1.73m²:
Dose adjustment is not required

When the creatinine clearance is 10-50 ml/min/1.73m²:
< 12 years: 100% of the normal dose each time, dosage interval 24 hours
≥ 12 years:      50% of the normal dose each time, dosage interval 24 hours

When the creatinine clearance is < 10 ml/min/1.73m²:
general recommendations cannot be given

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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

Headaches, dizziness, dry mouth, pain in the lower abdomen, nausea, pharyngitis, rhinitis, nosebleed, sleepiness, oculogyric crisis (above all in children), agitation, dyskinesia, enuresis and sedation. In young children: diarrhoea, sleepiness, fatigue and rhinitis.
A case has been described in the literature of acute generalized exanthematous pustulosis (AGEP).

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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

The plasma clearance is reduced in patients with renal or hepatic insufficiency. Use in children aged < 2 years is not recommended because of certain excipients in the liquid formulation.

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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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Piperazine derivatives
R06AE03
Other antihistamines for systemic use
R06AX26
R06AX13

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References

  1. AVOXA, ABDA-Datenbank Wirkstoffdossier Cetirizin, 04/2011
  2. ALIUD, SmPC Cetirizin AL 1 mg/ml Sirup (62388.00.00), 04/2014
  3. ALIUD, SmPC Cetirizin AL direkt (68336.00.00), 09/2017
  4. Curran MP, et al., Cetirizine: a review of its use in allergic disorders., Drugs., 2004, 64, 523-61
  5. Diepgen TL, et al., Early Treatment of the Atopic Child Study Group. Long-term treatment with cetirizine of infants with atopic dermatitis: a multi-country, double-blind, randomized, placebo-controlled trial (the ETAC trial) over 18 months, . Pediatr Allergy Immunol, 2002, 13, 278-86
  6. Fraunfelder FW, et al., Oculogyric crisis in patients taking cetirizine, Am J Ophthalmol, 2004, 137, 355-7
  7. Ng KH, et al, Central nervous system side effects of first- and second-generation antihistamines in school children with perennial allergic rhinitis: a randomized, double-blind, placebo-controlled comparative study, Pediatrics., 2004, 113, 116-21
  8. Pitsiu M, et al, Retrospective population pharmacokinetic analysis of cetirizine in children aged 6 months to 12 years, Br J Clin Pharmacol., 2004, 57, 402-11
  9. Simons FE, et al, Safety of cetirizine in infants 6 to 11 months of age: a randomized, double-blind, placebo-controlled study, J Allergy Clin Immunol., 2003, 111, 1244-8
  10. Stevenson J, et al, ETAC Study Group. Long-term evaluation of the impact of the h1-receptor antagonist cetirizine on the behavioral, cognitive, and psychomotor development of very young children with atopic dermatitis, Pediatr Res., 2002, 52, 251-7
  11. Esen I, et al, Cetirizine-induced dystonic reaction in a 6-year-old boy, Pediatr Emerg Care, 2008 , Sep;24 (9), 627-8
  12. Park JH, et al, Comparison of cetirizine and diphenhydramine in the treatment of acute food-induced allergic reactions, J Allergy Clin Immunol, 2011 , Nov;128(5), 1127-8
  13. Phan H, et al, Treatment of allergic rhinitis in infants and children, Drugs , 2009, 69, 2541-76
  14. Rajput A, et al, Cetirizine-induced dystonic movements, Neurology, 2006, Jan 10;66(1), 143-4
  15. Badawi AH et al, Cetirizine-induced acute generalized exanthematous pustulosis: a serious reaction to a commonly used drug. , Dermatol Online J, 2014, May 16;20(5), 22613
  16. Nederlandse Vereniging voor Dermatologie en Venereologie, Richtlijn Chronische spontane urticaria 03-12-2015, www.ndvd.nl
  17. Zuberbier T, et al, The EAACI/GA(2) LEN/EDF/WAO Guideline for the definition, classification, diagnosis, and management of urticaria: the 2013 revision and update, Allergy, 2014 , Jul;69(7), 868-87
  18. Italiano D et al., Iatrogenic nocturnal eneuresis – an overlooked side effect of anti histamines?, J Postgrad Med., 2015, Apr-Jun;61(2), 110-1
  19. ALIUD, SmPC Cetirizin AL 10 mg Filmtabletten (52621.00.00), 07/2014
  20. ALIUD, SmPC Cetirizin AL direkt 10 mg Lutschtablette (68336.00.00), 03/2018
  21. Hexal, SmPC Cetirizin bei Allergien 10mg Filmtabletten (49400.00.00), 01/2014
  22. AVOXA, ABDA-Datenbank Interaktionen: Cetirizin, accessed 2018-08-28
  23. UpToDate®, Pediatric Drug Information: Cetirizin Version 52.0, accessed 08/2018
  24. Heumann, SmPC Cetirizin Heumann 10 mg Filmtabletten (47308.00.00), 05/2014
  25. ratiopharm, SmPC Cetirizin-ratiopharm® Saft Lösung zum Einnehmen (49928.00.00), 11/2017
  26. Hexal, SmPC Cetirizin HEXAL® Tropfen bei Allergien (49401.00.01), 01/2014
  27. UCB Pharma GmbH, SmPC Zyrtec® 10 mg Filmtabletten (14836.00.00), 06/2017
  28. AbZ-Pharma, SmPC Cetirizin AbZ 10 mg Filmtabletten (71508.00.00), 04/2014
  29. betapharm Arzneimittel , SmPC Cetirizin beta® Tropfen (51088.00.00), 05/2015
  30. Aristo Pharma , SmPC Cetirizin Aristo Allergiesaft 1 mg/ml Lösung zum Einnehmen (98375.00.00), 11/2017
  31. UCB Pharma B.V, SmPC Zyrtec drank 1mg/ml (RVG 14635) 10-06-2022, www.geneesmiddeleninformatiebank.nl

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Changes

Changes