Treatment of benign prostatic hyperplasia (PBH) in men to: reduce enlarged prostate gland, improve urinary flow and regress symptoms associated with benign prostatic hyperplasia; reduce the risk of acute urinary retention and reduce the risk of having surgery, including transurethral resection of the prostate (TURP) and prostatectomy.
Composition:
1 tabl powl. contains 5 mg finasteride. The drug contains lactose.
Action:
A specific type II 5-α-reductase inhibitor. Inhibiting 5-α-reductase activity stops the conversion of testosterone to a hormone with a stronger androgenic effect - dihydrotestosterone (DHT), which stimulates benign prostatic hyperplasia (BPH). Finasteride reduces DHT levels in both the circulating and prostatic tissues. It does not show affinity for androgen receptors. Cmax occurs within approx. 2 h after administration, bioavailability is about 80% (food does not affect bioavailability). Finasteride is approximately 93% bound to plasma proteins. It is metabolized in the liver. T0,5 is 6 hours, in men> 70 years it is extended to 8 hours (however, there is no need to modify the doses depending on the age). 39% of the administered dose is excreted in the urine in the form of metabolites (urine is not excreted unchanged drug), 57% - with faeces.
Contraindications:
Hypersensitivity to the components of the preparation. The drug should not be used in women and children. Pregnancy.
Precautions:
Patients with a large amount of residual urine and / or a significantly limited urinary flow should be carefully monitored to avoid complications caused by urinary tract obstruction. The possibility of surgery should be considered. The clinical benefit of 5 mg finasteride in patients with prostate cancer has not yet been demonstrated. Before starting treatment with finasteride and then periodically during treatment, it is recommended to perform the testper rectum and other markings to detect prostate cancer. For the detection of prostate cancer, PSA measurements in the blood are also used. The values of PSA in men with prostate cancer can coincide significantly with the values found in men without this cancer. Therefore, in men with BPH, PSA levels within the normal range do not exclude prostate cancer, regardless of treatment with finasteride. Baseline PSA concentration <4 ng / ml does not exclude prostate cancer. Finasteride reduces the level of PSA in the blood by about 50% in patients with benign growth, even for prostate 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. Any case of persistent elevated PSA levels in patients treated with finasteride should be carefully evaluated. The ratio of free PSA (ratio of free PSA to total) is not significantly reduced by finasteride. When the free PSA factor is used to detect prostate cancer, there is no need to adjust this factor. Due to the risk of breast cancer in men, patients should immediately report all changes within the nipples, such as: nodules, pain, gynecomastia or discharge from the nipples. Due to the lactose content, the drug 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 broken 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 the contact of a pregnant woman with the semen of a patient treated with finasteride may have a detrimental effect on the male fetus. Therefore, when the sexual partner of the patient is or may be pregnant, the patient should minimize the partner's exposure to contact with the semen.
Side effects:
Common: decreased libido, impotence, decreased ejaculate volume. Uncommon: rash, ejaculation disorders, breast tenderness, breast enlargement. Not known: hypersensitivity reactions (including lip and face edema), depression, palpitations, increased hepatic enzymes, pruritus, urticaria, testicular pain, erectile dysfunction and ejaculation (which may persist after discontinuation of treatment), male infertility and (or ) reduction in sperm quality (after discontinuation of the drug, a return to normal values was observed). In clinical trials and post-marketing experience, breast cancer has been reported in men. In patients treated with Finasteride, PSA levels are usually reduced.
Dosage:
Orally. Adults: 5 mg once a day. In order to assess whether a favorable response to treatment has been achieved, it may be necessary to continue it for at least 6 months, although a reduction in symptoms may be noticeable in the early period. Reduction of the risk of acute urinary retention occurs within 4 months of treatment.Special groups of patients. No dose adjustment is required in patients with varying degrees of renal insufficiency (even with a creatinine clearance of 9 ml / min) and in elderly patients. There is no data on the possible need to change the dosage in patients with hepatic impairment.Way of giving. The drug can be taken regardless of meals.
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