Colfen Special Precautions

Activities Requiring Mental Alertness: In clinical trials, the occurrence of somnolence has been reported in some patients taking cetirizine; due caution should therefore be exercised when driving car or operating potentially dangerous machinery. Concurrent use of cetirizine with alcohol or other CNS depressants should be avoided because additional reductions in alertness and additional impairment of CNS performance may occur.
Carcinogenesis, Mutagenesis, and Impairment of Fertility: In a 2 years carcinogenicity study in rats, cetirizine was not carcinogenic at dietary doses up to 20 mg/kg. In a 2 years carcinogenicity study in mice, cetirizine caused an increased incidence of benign liver tumors in males at a dietary dose of 16 mg/kg. No increase in the incidence of liver tumors was observed in mice at a dietary dose of 4 mg/kg. The clinical significance of these findings during long-term use of cetirizine is not known. 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.
Pediatric Under 2 Years Old: The safety and effectiveness of cetirizine in pediatric patients under the age of 2 years have not yet been established.
Pregnancy and Lactation: Safe uses of cetirizine during pregnancy and lactation have not been established, therefore it is not recommended.
Effects on ability to drive and use machine: Objective measurements of driving ability, sleep latency and assembly line performance have not demonstrated any clinically relevant effects at the recommended dose of 10 mg. However, patients who experience somnolence should refrain from driving, engaging in potentially hazardous activities or operating machinery. Patients intending to drive, engaging in potentially hazardous activities or operating machinery should not exceed the recommended dose and should take their response to the medicinal product into account.