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*Urinary incontinence (UI) in men facts Medically Edited by: Melissa Conrad Stöppler, MD
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Information for Patients
See PATIENT INFORMATION section.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Mutagenicity studies and long-term studies in animals to determine the carcinogenic potential of Urispas (flavoxate HCl) 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 HCl. 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.
Nursing Mothers
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 (flavoxate hcl) is administered to a nursing woman.
Pediatric Use
Safety and effectiveness in children below the age of 12 years have not been established.
Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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