Atepros Special Precautions

The long term (> 10 years) beneficial and adverse effects of finasteride have not been established.
The use of finasteride for the control of prostatic hyperplasia in asymptomatic patients has not been studied.
General: Finasteride has been detected in the semen and has been shown to cause abnormalities of the external genitalia in male offspring. Therefore, the exposure of the female sexual partner to the finasteride-treated patient's semen should be avoided or finasteride-treated patients discontinue therapy when the partner is or may become pregnant. (See Use in Pregnancy & Lactation.)
Effects on Prostate-Specific Antigen (PSA) and the Use of PSA in Prostate Cancer Detection: Finasteride may interfere with the interpretation of PSA determinations. PSA may be elevated in patients with BPH, prostate cancer or other prostatic disease.
Although finasteride causes a decrease in PSA even in patients with prostate cancer, this should not be interpreted as efficacy of finasteride on prostate cancer.
In most patients, a rapid decrease in PSA is observed within the first months of therapy, after which time PSA levels stabilize to a new baseline. The post-treatment baseline is approximately half of the pre-treatment value. Therefore, PSA values should be doubled for comparison in patients treated with finasteride for six month or more compared to normal ranges in untreated men.
Carefully evaluate (consider patient compliance to therapy) when sustained increases in serum PSA concentrations is observed during finasteride therapy.
Increased Risk of High-Grade Prostate Cancer: 5α-reductase inhibitors such as finasteride may increase the risk of development of high-grade prostate cancer. An increased risk of prostate cancer (Gleason score 8-10) was observed in men (> 55 years old) with normal digital rectal examination and baseline PSA levels of <3 ng/mL who took finasteride 5 mg/day (finasteride 1.8% vs placebo 1.1%) in the 7-year Prostate Cancer Prevention Trial (PCPT). This was similar to the results from the REduction by DUtasteride of prostate Cancer Events (REDUCE) trial (4-year placebo-controlled) using another 5α-reductase inhibitor, dutasteride (1% dutasteride vs 0.5% placebo). Whether the effect of 5α-reductase inhibitors to reduce prostate volume, or study-related factors had an influence in the results of these studies is not known.
Evaluation for Other Urological Conditions: Before starting finasteride therapy, perform appropriate patient evaluation to identify conditions which might mimic BPH such as infection, prostate cancer, stricture disease, hypotonic bladder, or other neurogenic disorders. Other screening tests for prostate cancer, including digital rectal examination should also be performed before starting finasteride therapy and periodically thereafter.
Carefully monitor patients with large residual urinary volume and/or diminished urinary flow for obstructive uropathy. Finasteride may not be the appropriate therapy for these patients. The possibility of surgery should be an option.
Effect on Semen Characteristics: Patients should be informed on the possibility of having a reduced volume of ejaculate during finasteride treatment. Although this does not appear to interfere with normal sexual function, impotence and decreased libido have been observed in patients treated with finasteride.
Breast Cancer in Men: During clinical trials and post-marketing studies, breast cancer was reported in men taking finasteride 5 mg. Patients should promptly inform their attending physician of any changes in their breasts (e.g., lumps, pain, nipple discharge) since breast changes including breast enlargement (gynecomastia), tenderness and neoplasms have been reported.
Sexual Function: Increased duration of treatment with finasteride did not result in increased sexual adverse experiences. New reports of drug-related sexual adverse experiences decreased with duration of treatment.
Laboratory Test Findings: Finasteride has been shown to have no effect on circulating levels of cortisol, estradiol, prolactin, thyroid stimulating hormone, or thyroxine in patients with BPH. There was no clinically significant effect observed on the plasma lipid profile (i.e., total cholesterol, low density lipoproteins, high density lipoproteins, and triglycerides) or bone mineral density. Luteinizing hormone (LH) and follicle-stimulating hormone (FSH) was shown to increase by about 10% in finasteride-treated patients but levels remained within the normal range. Treatment with finasteride, however, did not alter the response of LH and FSH to gonadotropin-releasing hormone which indicates that the hypothalamic-pituitary-testicular axis was not affected.
PSA levels are decreased in patients treated with finasteride and therefore, consideration should be given when PSA laboratory determinations are evaluated.
There is no difference observed in standard laboratory parameters in patients treated with placebo or finasteride. Percent free PSA (free total PSA ratio) is not significantly decreased by finasteride. The ratio of free to total PSA remains constant even under the influence of finasteride and therefore no adjustment to its value is necessary when free PSA is used as an aid to the detection of prostate cancer.
Ability to Use and/or Drive Machinery: There is no data that finasteride affects the ability to drive and/or use machinery.
Hepatic Insufficiency: Since finasteride is extensively metabolized in the liver, exercise caution in administering finasteride in patients with liver function abnormalities.
Renal Insufficiency: No dosage adjustment is necessary in patients with renal insufficiency.
Use in Children: Finasteride is not indicated for use in pediatric patients. The safety and efficacy of finasteride has not been established in this age group.
Use in the Elderly: Dosage adjustment is not necessary in elderly patients.