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Somnolence, fatigue and asthenia are associated with levocetirizine treatment. Patients should exercise caution when performing hazardous activities requiring mental alertness and physical coordination (e.g., driving, operating machinery).
Concurrent use of levocetirizine with alcohol or other central nervous system (CNS) depressants should be avoided. (See Interactions.)
Renal Impairment: Levocetirizine is mainly excreted by the kidneys and the risk of adverse effects may be greater in patients with impaired renal function. Levocetirizine is not recommended in children 6 months to 11 years old with renal impairment (see Dosage & Administration/Contraindications).
Use in Pregnancy: Pregnancy Category B. No adequate and well-controlled studies in pregnant women are available for levocetirizine. Levocetirizine should only be used during pregnancy when clearly needed.
Use in Lactation: The use of levocetirizine is not recommended in breastfeeding women as it is possibly distributed into milk (cetirizine is distributed into milk).
Use in children: Dose should be carefully selected in children. Take only as prescribed. Do not exceed the recommended dosage. (See Pharmacology: Pharmacokinetics: Pharmacokinetics in Children under Actions.)
Use in the elderly: Clinical experience with levocetirizine has not identified differences in responses between the elderly and younger patients. However, dose should be carefully selected for elderly patients, usually starting at the lowest dose due to greater frequency of decreased hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.
