Treatment and control of benign prostatic hyperplasia (BPH) in order to: reduce enlarged prostate gland, improve urinary outflow and alleviate BPH-related symptoms; reduce the risk of acute urinary retention and the need for surgical treatment, including transurethral prostorection and prostatectomy. The product should only be used in patients who have an enlarged prostate gland (volume of the gland over 40 ml).
A specific, competitive inhibitor of the intracellular enzyme, Type II 5-α-reductase. This enzyme converts testosterone to a more potent androgen - dihydrotestosterone (DHT). Proper activity and growth of the prostate gland as well as the course of the proliferative process depend on the conversion of testosterone to DHT. Finasteride has no affinity for the androgen receptor. Decreases in serum DHT by 70% lead to a reduction in prostate volume. After 3 months, the volume of the gland is reduced by approx. 20% and this process is progressing, after 3 years the volume of the gland is reduced by approx. 27%. A significant reduction occurs in the peripheral zone directly surrounding the urethra. The preparation causes a significant reduction in the detrusor muscle tension as a result of reducing the blockage. A significant improvement in the maximum urinary flow rate and alleviation of symptoms is achieved after a few weeks. After oral administration, the maximum concentration in the blood occurs after about 2 hours, and the total absorption after 6-8 hours. The bioavailability is about 80%. Plasma protein binding is approximately 93%. Finasteride is metabolized in the liver. T0,5 in plasma it is on average 6 hours (4-12 h), in men over 70 years - 8 h (6-15 h). Approx. 39% of the administered dose is excreted in the urine in the form of metabolites, approx. 57% - with faeces.
Contraindications:
Hypersensitivity to the components of the preparation. Do not use the drug in women and children. Pregnancy.
Precautions:
Patients with a high volume of urine and / or a significantly limited urinary flow should be carefully observed. The possibility of a surgical procedure should be considered. To date, no clinical benefit has been demonstrated for the use of finasteride in patients with prostate cancer. Before starting treatment with finasteride and then periodically during treatment, it is recommended to perform the testper rectum and other markings for the detection of prostate cancer. For detection of prostate cancer, PSA measurements in serum are also used. Finasteride reduces the serum PSA concentration by approximately 50% in patients with benign prostatic hyperplasia or cancer. For patients treated with finasteride for 6 months or more, the PSA values should be multiplied by 2 to obtain a value comparable to the normal range in untreated men. This relationship provides the sensitivity and specificity of the PSA assay and the possibility of detecting prostate cancer by detecting it. If a free PSA factor is used to diagnose prostate cancer, there is no need to correct the result. Because of the risk of breast cancer in men, patients should be instructed to report all changes to the nipples immediately, such as: papules, pain, gynecomastia or nipple discharge. 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 age should not touch crushed or broken tablets due to the possibility of absorption of finasteride through the skin and the subsequent potential risk to the male fetus. The tablets of the preparation have an envelope that protects against contact with the active substance, provided that the tablets are not broken or crushed. Minor amounts of finasteride were detected in the semen of men taking 5 mg finasteride daily.It is not known whether adverse effects may occur in the fetus if his mother was exposed to the semen of a patient treated with finasteride. If the sexual partner of the patient is or may be pregnant, it is recommended that the patient minimizes the partner's exposure to contact with the semen. It is not known whether finasteride is excreted in human milk.
Side effects:
Common: impotence, decreased sex drive, reduced ejaculate volume. Uncommon: rash, pruritus, urticaria, ejaculation disorders, tenderness of the nipples, enlargement of the nipples. Frequency unknown: palpitations, hypersensitivity reactions (including swelling of the face and tongue), increased liver enzymes, testicular pain. Erectile dysfunction persisting after discontinuation of finasteride treatment and breast cancer in men has been observed after the introduction of the medicine. In most patients, a sudden decrease in PSA is observed during the first months of treatment, then PSA stabilizes at a new level, which is about half of the pre-treatment value.
Dosage:
Orally. Adults: 5 mg once a day, regardless of meals. The tablet should be swallowed whole, it should not be divided or crushed. Although improvement may be evident within a short time, treatment for at least 6 months may be necessary to assess whether a satisfactory clinical response to treatment has been achieved. No dose adjustment is necessary in patients with renal insufficiency (even with a creatinine clearance of 9 ml / min) or in elderly patients. There are no data on patients undergoing hemodialysis and patients with hepatic impairment.
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