URISPAS® (flavoxate HC1) should be given cautiously in patients with suspected glaucoma.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Mutagenicity studies and long-term studies in animals to determine the carcinogenic potential of URISPAS® (flavoxate HC1) have not been performed.
Teratogenic Effects-Pregnancy Category B.
Reproduction studies have been performed in rats and rabbits at doses up to 34 times the human dose and revealed no evidence of impaired fertility or harm to the fetus due to flavoxate HC1. There are, however, no well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when URISPAS® is administered to a nursing woman.
Safety and effectiveness in children below the age of 12 years have not been established.
Last reviewed on RxList: 6/12/2012
This monograph has been modified to include the generic and brand name in many instances.
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