Firide Special Precautions

Use with caution in patients with hepatic dysfunction; Finasteride is extensively metabolized in the liver.
1 mg: Oral Finasteride therapy has been associated with reductions (from 0.7 to 0.5 ng/ml) in serum prostate specific antigen (PSA) at 12^th month in men 18-41 years of age receiving the drug at a dosage of 1 mg daily for male pattern hair loss. When oral Finasteride 1 mg daily is used for treatment of male pattern hair loss in older men who also have BPH, PSA reductions of approximately 50% have been demonstrated. Such reductions should be consideration when interpreting serum PSA value in men receiving Finasteride.
5 mg: Patients with large residual urinary volume and/or severity diminished urinary flow should be carefully monitored for obstructive uropathy. These patients may not be candidates for Finasteride therapy.
Effect on PSA and prostate cancer detection: Finasteride did not appear to alter the rate of prostate cancer detection in BPH. Other urological diseases (including prostate cancer) should be ruled out before initiating therapy with Finasteride (in BPH management) and periodically thereafter. Digital rectal examination as well as other evaluations for prostate cancer are recommended. Serum Prostate Specific Antigen (PSA) is also used for prostate cancer detection. For BPH, a minimum of 6 months of treatment may be necessary to determine whether an individual will respond to Finasteride.
Use of Finasteride in BPH decreases PSA concentrations by approximately 50% even when cancer is present. To interpret serial PSAs, a new PSA baseline should be established ≥6 months after treatment initiation and PSA monitored periodically thereafter. A reduction in baseline PSA concentration by approximately 50% within 6 months of therapy is indicative of efficacy. In typical patients treated with Finasteride ≥6 months, PSA values should be doubled for comparison with normal ranges in untreated men.
Finasteride does not interfere with free PSA levels. If percent free PSA (the ratio of free to total PSA) is used as an aid in the detection of prostate cancer, no adjustment to its value is necessary. The percent free PSA remains constant.
Use in Pregnancy: Finasteride is contraindicated in women who are or may become pregnant. Pregnant women are advised to avoid contact with crushed or broken tablets. Active ingredient of crushed or broken tablets can be absorbed through the skin and the subsequent potential risk of abnormalities in the external genitalia of a male fetus.