What is the use of Cetirizine (antihistamine) in pediatric patients?

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Last updated: May 20, 2025View editorial policy

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From the Guidelines

Cetirizine is a safe and effective treatment option for children with allergies, particularly those aged 6 months and older, due to its well-tolerated and good safety profile 1. When considering the use of cetirizine in children, it is essential to weigh the benefits against the potential risks. The evidence suggests that second-generation antihistamines like cetirizine have a favorable safety profile in young children 1. Some key points to consider when prescribing cetirizine to children include:

  • The recommended dose for children aged 6-12 months is 2.5 mg once daily, while those aged 12 months to 5 years can receive 2.5 mg once daily, increasing to 2.5 mg twice daily if needed 1.
  • For children aged 6-11 years, the dose is 5-10 mg once daily, and adolescents 12 years and older can take the adult dose of 10 mg once daily.
  • Cetirizine is preferred over older antihistamines like diphenhydramine due to its lower risk of drowsiness, making it suitable for daytime use without significantly affecting school performance 1.
  • The medication typically starts working within an hour and lasts for 24 hours, with common side effects being mild and including slight drowsiness, dry mouth, or headache.
  • For children with kidney problems, dose adjustments may be necessary, and it is crucial to measure liquid formulations accurately using the provided dosing device. In contrast to first-generation antihistamines and decongestants, which have been associated with significant safety concerns in young children, cetirizine has been shown to be well-tolerated and effective in this population 1.

From the FDA Drug Label

6 yrs & older Antihistamine ALLERGY Indoor & Outdoor Allergies 24 Hour Relief of: •Sneezing •Runny Nose •Itchy, Watery Eyes •Itchy Throat or Nose

Cetirizine is approved for use in children 6 years and older.

  • The recommended age for cetirizine use is 6 years and older 2, 2.
  • No information is provided for use in children under 6 years old.

From the Research

Cetirizine Use in Children

  • Cetirizine is a second-generation antihistamine that has been used in children for the treatment of allergic rhinitis and chronic spontaneous urticaria 3.
  • The use of cetirizine in children is licensed in Europe for children older than 2 years old and in the USA for children older than 6 months old 3.
  • Cetirizine has been shown to be effective in reducing histamine-induced skin reactions in adults, with a significant reduction in wheal and flare diameters and a decrease in the LDF index 4.

Safety of Cetirizine in Children

  • Second-generation antihistamines, including cetirizine, are less likely to produce sedation compared to first-generation antihistamines 5.
  • Cetirizine has been shown to impair performance and cognition in several studies, although to a much lesser degree than older antihistamines 5.
  • The safety of cetirizine in children has been demonstrated in several studies, with no significant changes in vital signs, laboratory parameters, or ECG parameters observed 6, 7.

Comparison with Other Antihistamines

  • Levocetirizine has been shown to be a suitable treatment option for allergic rhinitis and chronic urticaria in children aged 6 months to 12 years, with a better safety profile compared to first-generation antihistamines 6.
  • Fexofenadine has been shown to be nonsedating, even at high doses, and has an excellent safety record in pediatric patients 5.
  • Loratadine has also been shown to be safe and effective in children, with no significant impairment of performance or cognition observed 5.

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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