Cetirizine Use in Infants Under 6 Months

FDA Approval and Age Restrictions

The American Academy of Allergy, Asthma, and Immunology guidelines note that OTC cough and cold preparations recommend consulting a physician for dosing below age 2 years for decongestants and below age 6 years for antihistamines, in patients with allergic symptoms 1

Between 1969-2006, there were 69 fatalities associated with antihistamines in children under 6 years, with 41 deaths occurring in children under 2 years, due to drug overdose and toxicity 1
The FDA's Nonprescription Drugs and Pediatric Advisory Committees recommended in 2007 that OTC medications used to treat cough and cold no longer be used for children below 6 years of age due to safety concerns, in the context of managing allergic symptoms 1

Most second-generation antihistamines have approval only starting at age 2 years, with some extending down to 6 months in controlled studies—but not below 6 months, according to the American Academy of Allergy, Asthma, and Immunology 2

Intranasal corticosteroids are the most effective medication class for controlling symptoms of allergic rhinitis in children under 2 years, including all four major symptoms: sneezing, itching, rhinorrhea, and nasal congestion, as recommended by the American Academy of Allergy, Asthma, and Immunology 1, 2
Isotonic and hypertonic saline solutions can provide modest benefit for reducing symptoms in patients with allergic rhinitis, with minimal side effects, low cost, and generally good patient acceptance, according to the American Academy of Allergy, Asthma, and Immunology 2

The British guidelines recommend avoiding all antihistamines in pregnancy, especially during the first trimester, and note that dosing and age restrictions for individual products vary in younger children, requiring consultation of relevant data sheets before prescribing, in the context of managing allergic symptoms 3

At 6 months of age and older, cetirizine can be administered at 0.25 mg/kg twice daily, based on controlled safety studies, as recommended by the American Academy of Pediatrics 2
For children aged 2-5 years, cetirizine can be dosed at 2.5 mg once or twice daily with FDA approval, according to the American Academy of Pediatrics 2

The British guidelines state that dosing and age restrictions vary significantly in children under 6 years, and the one-month difference between 5 and 6 months is clinically meaningful enough to require consulting product labeling before prescribing, with specific consideration for renal impairment requiring dose reduction in moderate cases and avoidance in severe cases 4

The British guidelines also note that if the infant has renal impairment, cetirizine requires dose reduction in moderate renal impairment and should be avoided in severe renal impairment, though this becomes relevant only when the infant reaches appropriate age for use 4