Alphascar Special Precautions

General: Patients with large residual urine and/or severely diminished urinary flow should be carefully monitored for obstruction uropathy.
Consultation of a urologist should be considered in patients treated with finasteride.
Obstruction due to trilobular growth pattern of the prostate should be excluded before starting treatment with finasteride.
To avoid obstructive complications, it is important that patients with large residual urine and/or heavily decreased urinary flow are carefully controlled.
The possibility of surgery should be an option.
Erectile dysfunction, male infertility and decreased libido: Erectile dysfunction (ED) that continued after discontinuation of treatment, reported rarely in men taking finasteride for the treatment of BPH. Most men were older and were taking concomitant medications and/or had co-morbid conditions with a known association to ED. The independent role of Alphascar in these events is unknown.
Male infertility and/or poor seminal quality have been reported rarely in men taking finasteride for the treatment of BPH. The independent role of Alphascar in these events is unknown. Normalization or improvement of seminal quality has been reported after discontinuation of finasteride.
Decreased libido that continued after discontinuation of treatment.
Effects on prostate-specific antigen (PSA) and prostate cancer detection: No clinical benefit has yet been demonstrated in patients with prostate cancer treated with finasteride. Patients with BPH and elevated PSA were monitored in controlled clinical studies with serial PSAs and prostate biopsies. In these BPH studies, finasteride did not appear to alter the rate of prostate cancer detection and the overall incidence of prostate cancer was not significantly different in patients treated with finasteride or placebo.
Digital rectal examination, as well as other evaluations for prostate cancer, should be performed on patients with BPH prior to initiating therapy with finasteride and periodically thereafter. Serum PSA is also used for prostate cancer detection. Generally, a baseline PSA >10 ng/mL (Hybritech) prompts further evaluation and consideration of biopsy; for PSA levels between 4 and 10 ng/mL, further evaluation is advisable. There is considerable overlap in PSA levels among men with and without prostate cancer. Therefore, in men with BPH, PSA values within the normal reference range do not rule out prostate cancer regardless of treatment with finasteride. A baseline PSA <4 ng/mL does not exclude prostate cancer.
Finasteride causes a decrease in serum PSA concentrations by approximately 50% in patients with BPH, even in the presence of prostate cancer. This decrease in serum PSA levels in patients with BPH treated with finasteride should be considered when evaluating PSA data and does not rule out concomitant prostate cancer. This decrease is predictable over the entire range of PSA values, although it may vary in individual patients. In patients treated with finasteride for six months or more, PSA values should be doubled for comparison with normal ranges in untreated men. This adjustment preserves the sensitivity and specificity of the PSA assay and maintains its ability to detect prostate cancer.
Any sustained increase in PSA levels of patients treated with finasteride should be carefully evaluated, including consideration of non-compliance to therapy with finasteride.
Percent free PSA (free to total PSA ratio) is not significantly decreased by finasteride and remains constant even under the influence of finasteride. When percent free PSA is used as an aid in the detection of prostate cancer, no adjustment to its value is necessary.
Prostate cancer: Use of the product may increase the risk of high-grade prostate cancer. The product is not approved for the prevention of prostate cancer.
Drug/laboratory test interactions: Effect on levels of PSA: Serum PSA concentration is correlated with patient age and prostatic volume, and prostatic volume is correlated with patient age. When PSA laboratory determinations are evaluated, consideration should be given to the fact that PSA levels decrease in patients treated with finasteride. In most patients, a rapid decrease in PSA is seen within the first months of therapy, after which time PSA levels stabilize to a new baseline. The post-treatment baseline approximates half of the pre-treatment value. Therefore, in typical patients treated with finasteride for six months or more, PSA values should be doubled for comparison to normal ranges in untreated men.
Percent free PSA (free to total PSA ratio) is not significantly decreased by finasteride. The ratio of free to total PSA remains constant even under the influence of finasteride. When percent free PSA is used as an aid in the detection of prostate cancer, no adjustment to its value is necessary.
Breast cancer in men: Breast cancer has been reported in men taking finasteride 5 mg during clinical trials. Post-marketing cases of male breast cancer have been reported with the use of finasteride. Physicians should instruct their patients to promptly report any changes in their breast tissue such as lumps, pain, gynaecomastia or nipple discharge.
Mood alterations and depression: Mood alterations including depressed mood, depression and, less frequently, suicidal ideation have been reported in patients treated with finasteride 5 mg. Patients should be monitored for psychiatric symptoms and if these occur, the patient should be advised to seek medical advice.
Lactose: The tablet contains lactose monohydrate. Patients with any of the following genetic deficiencies should not take this medicine: galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.
Hepatic insufficiency: The effect of hepatic insufficiency on the pharmacokinetics of finasteride has not been studied.
Effects on ability to drive and use machines: There are no data to suggest that finasteride affects the ability to drive or use machines.
Use in Pregnancy: Women who are pregnant or may become pregnant should not handle crushed or broken finasteride tablets because of the possibility of absorption of finasteride and the subsequent potential risk to a male foetus. Finasteride tablets have a film-coating which prevents contact with the active ingredient provided that the tablets have not been broken or crushed.
Use in Children: Finasteride is not indicated for use in children. Safety and effectiveness in children have not been established.