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General: Central Nervous System (CNS) Effects: Somnolence, fatigue and asthenia reported. Caution required when performing hazardous activities requiring mental alertness or physical coordination (eg, operating machinery, driving a motor vehicle).
Specific Populations: Hepatic Impairment: Pharmacokinetics not evaluated, but clearance unlikely to be decreased. Dosage adjustment not necessary.
Renal Impairment: Decreased clearance, resulting in increased risk of adverse effects. Dosage adjustment necessary based on degree of renal impairment (see Dosage & Administration).
Use in pregnancy: No clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development. Caution should be exercised when prescribing to pregnant or lactating women.
Use in lactation: Expected to distribute into milk (as cetirizine is distributed into milk). Use not recommended.
Use in children: Safety and efficacy not established in children <6 years. Efficacy of 2.5 mg dally dosage for management of allergic rhinitis or chronic idiopathic urticaria in children 6-11 years is based on extrapolation of demonstrated efficacy of 5 mg daily dosage in children ≥12 years and on pharmacokinetic comparisons in adults and children. Efficacy of 5 mg dally dosage for management of chronic idiopathic urticaria in children ≥12 years is based on extrapolation of demonstrated efficacy in adults.
Use in the elderly: Insufficient experience in patients ≥65 years to determine whether geriatric patients respond differently than younger adults. Select dosage with caution because of age-related decreases in hepatic, renal and/or cardiac function, and concomitant disease and drug therapy. (See Dosage & Administration.) Periodic monitoring of renal function may be useful.
