Cetirizine and Levocetirizine Use in Children

Marcia L. Buck, Pharm.D., FCCP, FPPAG


Pediatr Pharm. 2010;16(6) 

In This Article

Clinical Trials


The efficacy of cetirizine has been established in several studies. In 2000, Simons and colleagues conducted a prospective, randomized, placebo-controlled, double-blind, cross-over single-dose study to evaluate the onset and duration of action of cetirizine and loratadine.[6] Fifteen children (mean age 9 years) underwent testing. Cetirizine, at a dose of 10 mg, suppressed the wheal and flare reaction from 0.25 to 24 hours after dose administration. A 10 mg dose of loratadine produced suppression of response from 0.75 to 24 hours. The authors concluded that both agents were effective antihistamines for children.

The efficacy of both drugs was also recently evaluated in a randomized, double-blind, placebo-controlled trial in children 6 to 12 years of age.[7] Eighty children with moderate to severe perennial allergic rhinitis were enrolled and randomized to receive either cetirizine (10 mg), levocetirizine (5 mg), or placebo daily at bedtime for 12 weeks. Nasal symptoms consisting of rhinorrhea, congestion, itching, and sneezing, in addition to non-nasal symptoms consisting of eye itching or burning, tearing, eye redness, or itching of the ears or palate were recorded each day by the patient or a parent. The eight symptoms were combined to make a total symptom score (TSS). Patients were evaluated at 4, 8, and 12 weeks. Families also completed quality of life questionnaires. All patients underwent nasal peak expiratory flow rate (nPERF) assessments and laboratory testing for eosinophil counts and IgE levels. Nasal smears were also examined for eosinophils.

Both cetirizine and levocetirizine produced significantly greater improvements in TSS than placebo. Cetirizine appeared to be more efficacious than levocetirizine with statistically significant differences in scores at weeks 8 and 12. Questionnaire results were significantly better in the treatment groups compared to placebo, but there was no difference between the two antihistamines. Both cetirizine and levocetirizine improved nPERF values compared to placebo, with cetirizine producing a greater effect. The eosinophil proportion in nasal smears decreased in the cetirizine group, but not in the other groups. The authors concluded that both drugs were effective in improving symptoms in children with allergic rhinitis, but that cetirizine appeared to be more efficacious.[7]

Similar benefit in allergic symptoms was observed in two prospective randomized, double-blind, placebo-controlled trial of cetirizine in children.[8,9] de Blic and colleagues used a four item symptom score (T4SS), which includes sneezing, rhinorrhea, nasal and ocular pruritus, to evaluate the efficacy of 5 mg levocetirizine given daily versus placebo in 177 children between 6 and 12 years of age.[8] The authors found significant improvement in T4SS in the treatment group, with a difference in adjusted means of 1.29 (95% CI, 0.66–1.92). Potter and colleagues, publishing as the Pediatric Levocetirizine Study Group, found similar results in their study of 306 children between 6 and 12 years of age.[9] Patients received either 5 mg levocetirizine once daily or placebo for 4 weeks. T4SS, 50% response rate, quality of life questionnaire scores, and the investigators' global evaluations of improvement were significantly better in the treatment group.


An 18-month prospective, randomized, double-blind study established the long-term safety of cetirizine in children.[10] The Early Treatment of the Atopic Child (ETAC) study randomized 817 children (1–2 years of age) to either 0.25 mg/kg cetirizine or placebo given twice daily. The most frequent reactions were insomnia, somnolence, and fatigue. There were no significant differences in the rate of these adverse effects between the groups. No adverse effects on growth, behavioral, or developmental assessments were reported, and there were no abnormalities noted on laboratory tests or electrocardiograms.

The safety of long-term levocetirizine use in young children was also studied by the Early Prevention of Asthma in Atopic Children (EPAAC) Study Group in 2007.[11] This prospective, randomized, double-blind placebo-controlled trial enrolled 510 atopic children between 12 and 24 months of age. Patients were randomized to receive either 0.125 mg/kg levocetirizine or placebo twice daily for 18 months. The frequency of serious adverse effects was similar between the two study arms (12.2% in the levocetirizine group and 14.5% in the controls). The incidence of medication-attributed adverse effects was also similar between groups (5.1% in the levocetirizine group and 6.3% in the controls). Two percent of the levocetirizine patients withdrew from the study because of adverse effects compared to 1.2% of the children in the placebo group. The most frequently reported adverse effects were related to upper respiratory tract infections, transient gastrointestinal symptoms, or worsening of allergic disease. There were no differences between the groups in height, weight, attainment of developmental milestones, or laboratory tests. The authors concluded that long-term administration of levocetirizine was associated with a mild adverse effect profile in young children.


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