Treatment of benign prostatic hyperplasia (BPH) to: relieve symptoms; reducing the risk of acute urinary retention; reducing the risk of having a transurethral resection of the prostate (TURP) and / or prostatectomy; reduce enlarged prostate gland, improve urine flow and reduce symptoms associated with prostatic hyperplasia. The preparation is intended only for the treatment of men with enlarged prostate gland.
A specific, competitive inhibitor of the intracellular enzyme, type II testosterone 5-α-reductase. This enzyme converts testosterone to a stronger androgen - dihydrotestosterone (DHT). Finasteride does not show affinity for androgen receptors. The growth of the prostate gland depends on the activities of DHT. The use of finasteride in a dose of 5 mg daily for 4 years in patients with BPH resulted in a decrease in the concentration of DHT in the blood by about 70%, a decrease in the volume of the prostate by approx. 20%. In addition, serum PSA levels decreased by 50%, which is caused by suppression of glandular epithelium. After oral administration, the maximum concentration in the blood occurs after about 2 hours, the absorption is completed after 6-8 hours. The bioavailability is about 80%. Plasma protein binding is approximately 93%. Medium T0,5 in men aged 18-60 it is 6 hours, in men over 70 years - 8 hours. Approx. 39% of the administered dose is excreted in the urine in the form of metabolites, approx. 57% - with faeces. Minor amounts of finasteride were detected in the ejaculate of treated patients.
Contraindications:
Hypersensitivity to finasteride or to any of the excipients. Do not use the drug in women and children. Pregnancy.
Precautions:
In patients with a high volume of residual urine and / or significantly reduced urinary flow, the drug should be used with caution due to the possibility of congestive urinary insufficiency. The clinical benefits of finasteride in patients with prostate cancer have not yet been demonstrated. The test is recommended before starting treatment with finasteride and then periodically during treatmentper rectum and other tests to detect prostate cancer. Prostate cancer is also used in the diagnosis of prostate cancer. In patients with BPH, finasteride causes a decrease in serum PSA by about 50%, even in the presence of prostate cancer. Therefore, a possible reduction in serum PSA should be considered when evaluating PSA results in patients with BPH treated with finasteride; it does not exclude the presence of prostate cancer. In patients treated with finasteride for more than 6 months, it is necessary to double the PSA values compared to normal concentrations in patients not using finasteride. This adjustment of the results allows to maintain the sensitivity and specificity of PSA determination as well as the possibility of detecting prostate cancer. Any sustained increase in PSA levels in patients treated with finasteride requires careful assessment, including consideration of the appropriateness of the preparation. If the value of free PSA is used to diagnose prostate cancer, there is no need to adjust the obtained results. There are no data on the use of the drug in patients with hepatic impairment. The product contains lactose - should not be used in patients with rare hereditary galactose intolerance, Lapp lactase deficiency or malabsorption of glucose-galactose.
Pregnancy and lactation:
The drug is not indicated for use in women. Finasteride is contraindicated in pregnant women and in women of childbearing age. Pregnant women or women of childbearing potential must not touch broken or broken tablets because of the potential for absorption of finasteride and the potential risk to the male fetus. The tablets of the preparation are coated and in case they are not damaged, there is no contact with the active substance. It is not known whether finasteride is excreted in human milk.
Side effects:
Very common: decreased PSA concentration - the majority of patients have a rapid decrease in PSA levels in the first month of treatment, then the concentration stabilizes at a new level, which is about half of the pre-treatment value. Common: impotence, ejaculation disorders (decreased volume of ejaculate), decreased libido. Uncommon: rash, enlargement and tenderness of the mammary glands. Not known: hypersensitivity reactions (including pruritus, urticaria, swelling of the lips and face), testicular pain.
Dosage:
Orally. Adults: the recommended dose is 1 tablet. (5 mg) once a day, regardless of meals. The severity of some symptoms (nocturia, painful or urgent urinary urgency) usually decreases at the beginning of finasteride therapy, but the full effect of the drug causing a reduction in prostate volume and the volume of urine remaining in the bladder occurs after about 6 months of use. There is no need to change the dosage in patients with renal impairment (creatinine clearance reduced to 9 ml / min) and in elderly patients. There is no data on the possible need to change the dosage in patients with hepatic impairment.
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