Treatment and control of benign prostatic hyperplasia (BPH) in order to: reduce enlarged prostate gland, improve urine flow and alleviate BPH-related symptoms; reduce the incidence of acute urinary retention and the need for surgical treatment, including transurethral resection of the prostate gland (TURP) and prostatectomy.
A specific, competitive inhibitor of the intracellular enzyme, Type II 5-α-reductase. This enzyme converts testosterone to a stronger androgen - dihydrotestosterone (DHT). A rapid reduction in serum DHT by 70% leads to a reduction in prostate volume. After 3 months, the volume of the prostate 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 clear reduction occurs in the peri-ligation zone directly surrounding the urethra. The preparation causes a significant reduction in the detrusor muscle tension as a result of reducing the obstruction of urine outflow. Significant improvement in the maximum rate of urine flow and alleviation of symptoms is achieved after a few weeks of treatment. After oral administration of Cmaxin the blood occurs after approx. 2 h. Bioavailability is about 80%. Plasma protein binding is approximately 93%. Finasteride is metabolized in the liver. 39% of the administered dose is excreted in the urine in the form of metabolites, 57% in the faeces.
Contraindications:
Hypersensitivity to the active substance or to any of the excipients. The drug should not be used in women and children. Pregnancy.
Precautions:
Patients with large amounts of residual urine and / or a significantly limited urinary flow should be carefully monitored. The possibility of a surgical procedure 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 detection of prostate cancer, PSA measurements in serum 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 values in the normal range do not exclude prostate cancer, regardless of treatment with finasteride 5 mg. Baseline PSA concentration <4 ng / ml does not exclude prostate cancer. Finasteride reduces serum PSA concentrations by up to 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 5 mg should be carefully evaluated, including discontinuation of treatment. The ratio of free PSA (ratio of free PSA to total) is not significantly reduced by finasteride 5 mg. 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. 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 those who are likely to become pregnant 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. It is not known whether finasteride is excreted in human milk.
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 liver enzymes, pruritus, urticaria, testicular pain, erectile dysfunction (persisting after discontinuation of finasteride), male infertility and / or decreased sperm quality (after discontinuation of the drug, a return to normal values or an improvement in sperm quality was observed). In clinical trials and post-marketing experience breast cancer has been observed in men. In patients treated with Finasteride, PSA levels are usually reduced. In the majority of patients, a rapid reduction in PSA is observed in the first months of treatment, after which the values stabilize at a new level, which is about half of the pre-treatment value.
Dosage:
Orally. Adults: usually 5 mg once a day. Although alleviation of symptoms may occur in a short time, treatment may be necessary for at least 6 months to ensure the effectiveness of treatment.Special groups of patients. In patients with renal insufficiency of varying degrees of severity (even with a creatinine clearance of 9 ml / min) and in patients over 70 years, no dosage adjustment is necessary. There are no data on use in patients with hepatic impairment. There have been no studies with finasteride in hemodialyzed patients.Way of giving. The tablets should be taken with or without food, swallowed whole and must not be divided or crushed.
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