Zyrtec

[Certirizine]

Warnings & Precautions
PRECAUTIONS

Activities Requiring Mental Alertness

In clinical trials, the occurrence of somnolence has been reported in some patients taking ZYRTEC; due caution should therefore be exercised when driving a car or operating potentially dangerous machinery. Concurrent use of ZYRTEC with alcohol or other CNS depressants should be avoided because additional reductions in alertness and additional impairment of CNS performance may occur.

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Drug-Drug Interactions

No clinically significant drug interactions have been found with theophylline at a low dose, azithromycin, pseudoephedrine, ketoconazole, or erythromycin. There was a small decrease in the clearance of cetirizine caused by a 400-mg dose of theophylline; it is possible that larger theophylline doses could have a greater effect.

Carcinogenesis, Mutagenesis and Impairment of Fertility

In a 2-year carcinogenicity study in rats, cetirizine was not carcinogenic at dietary doses up to 20 mg/ kg (approximately 15 times the maximum recommended daily oral dose in adults on a mg/ m 2 basis, or approximately 7 times the maximum recommended daily oral dose in infants on a mg/ m 2 basis). In a 2-year carcinogenicity study in mice, cetirizine caused an increased incidence of benign liver tumors in males at a dietary dose of 16 mg/ kg (approximately 6 times the maximum recommended daily oral dose in adults on a mg/ m 2 basis, or approximately 3 times the maximum recommended daily oral dose in infants on a mg/ m 2 basis). No increase in the incidence of liver tumors was observed in mice at a dietary dose of 4 mg/ kg (approximately 2 times the maximum recommended daily oral dose in adults on a mg/ m 2 basis, or approximately equivalent to the maximum recommended daily oral dose in infants on a mg/ m 2 basis). The clinical significance of these findings during long-term use of ZYRTEC is not known.

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