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Cetirizine was not mutagenic in the Ames test, and not clastogenic in the human lymphocyte assay, the mouse lymphoma assay, and in vivo micronucleus test in rats. In a fertility and general reproductive performance study in mice, cetirizine did not impair fertility at an oral dose of 64 mg/ kg (approximately 25 times the maximum recommended daily oral dose in adults on a mg/ m 2 basis). Pregnancy Category B: In mice, rats, and rabbits, cetirizine was not teratogenic at oral doses up to 96, 225, and 135 mg/ kg, respectively (approximately 40, 180 and 220 times the maximum recommended daily oral dose in adults on a mg/ m 2 basis). There are no adequate and well-controlled studies in pregnant women. Because animal studies are not always predictive of human response, ZYRTEC should be used in pregnancy only if clearly needed. Nursing Mothers Text Continues Below
In mice, cetirizine caused retarded pup weight gain during lactation at an oral dose in dams of 96 mg/ kg (approximately 40 times the maximum recommended daily oral dose in adults on a mg/ m 2 basis). Studies in beagle dogs indicated that approximately 3% of the dose was excreted in milk. Cetirizine has been reported to be excreted in human breast milk. Because many drugs are excreted in human milk, use of ZYRTEC in nursing mothers is not recommended. Geriatric Use Of the total number of patients in clinical studies of ZYRTEC, 186 patients were 65 years and older, and 39 patients were 75 years and older. No overall differences in safety were observed between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out. With regard to efficacy, clinical studies of ZYRTEC for each approved indication did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently than younger patients. Page: << Prev | 1 | 2 | 3 | 4 | Next >>
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