urinary tract obstruction
Finasteride (Propecia) Contraindications and Precautions
Finasteride is not indicated for use in females. Finasteride is pregnancy risk category X and is therefore absolutely contraindicated during pregnancy. Finasteride and other 5-alpha-reductase inhibitors, by inhibiting the conversion of testosterone to DHT, have the ability to cause abnormalities in the external genitalia of the male fetus. Pregnant women or females trying to conceive should not handle crushed or broken finasteride tablets. The distribution of finasteride into human semen has been assessed and appears to be well below the threshold concentration associated with fetal anomalies in animals.
Finasteride is not indicated for use in females. It is not known whether finasteride is excreted in human milk. Therefore, the effects of finasteride on infants during breast-feeding cannot be determined.
Finasteride is contraindicated for use in children. Safety and effectiveness have not been established in this age group.
Clinical efficacy studies of finasteride for hair loss did not include subjects aged 65 and over. Based on the pharmacokinetics of finasteride 5 mg, no dosage adjustment is necessary in the elderly. However, the efficacy of finasteride for hair loss in the elderly has not been established.
Finasteride should be used with caution in patients with hepatic disease, since finasteride is metabolized extensively in the liver. Data are lacking regarding the incidence of adverse effects or drug accumulation in patients with hepatic impairment.
Finasteride reduces total serum prostate specific antigen (PSA). It is recommended that a new baseline PSA concentration be established for interpretation of serial PSAs in men taking finasteride. This new baseline PSA should be used to assess potentially cancer-related changes in PSA. Further, lower urinary tract symptoms of BPH can be indicative of other urological diseases, including prostate cancer. Patients should be assessed to rule out other urological diseases prior to treatment with finasteride. Patients with a large residual urinary volume and/or severely diminished urinary flow may not be good candidates for 5-alpha-reductase inhibitor therapy and should be carefully monitored for urinary tract obstruction.
Men treated with finasteride should not donate blood while taking finasteride. The purpose of this is to prevent administration of finasteride to a pregnant female transfusion recipient.
[ Last revised: 3/16/2004 4:18:00 PM ]
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