Treatment of benign prostatic hyperplasia, used to relieve symptoms associated with prostatic hyperplasia, reduce the risk of acute urinary retention and reduce the risk of having surgery, including transurethral resection of the prostate gland and prostatectomy.
Composition:
1 tabl powl. contains 5 mg finasteride.
Action:
Synthetic 4-azasteroid compound, belonging to the group of specific Type II 5-α-reductase inhibitors - intracellular enzyme metabolizing testosterone to the stronger androgen - dihydrotestosterone (DHT). Finasteride has no affinity for the androgen receptor. It reduces the concentration of DHT in the blood circulating and present in the prostate tissue. Decrease in DHT concentration leads to a decrease in the volume of the gland, an increase in coil flow, and a reduction in subjective symptoms. Finasteride reaches its maximum concentration in the blood within 2 h after oral administration, is absorbed 6-8 h, bioavailability is about 80%. Approximately 93% of the drug is bound to plasma proteins. The drug is metabolized in the liver. T0,5 it is on average 6-8 h. 39% of the administered dose is excreted in urine, 57% - unchanged with faeces. In older age, after 70 years, elimination of the drug is reduced, but it does not require modification of the dosage.
Contraindications:
Hypersensitivity to the components of the preparation. Pregnant women or childbearing age, children.
Precautions:
Patients with a high volume of residual urine and / or a significantly limited urinary flow should be carefully monitored for obstructive uropathy. Before the treatment is started and periodically during it, a prostate test is recommendedper rectum and other tests to detect prostate cancer. In patients treated with Finasteride, the concentration of prostate specific antigen (PSA) in serum is approximately 50% lower than before treatment, which should be taken into account in the diagnosis of cancer of the gland. The increase in PSA levels in a patient treated with finasteride should be carefully analyzed. Clinical breast cancer cases have been reported in clinical trials and post-marketing experience. Patients should be advised to immediately report any changes in breast tissue such as nodules, pain, enlargement of the mammary glands or leakage of the nipple. The tablets contain lactose monohydrate. It should not be used in patients with rare hereditary problems of galactose intolerance, lactase deficiency (Lapp type) or malabsorption of glucose-galactose.
Pregnancy and lactation:
The drug should not be used in women. Pregnant women or women of childbearing age should not touch crushed or broken tablets due to the possibility of percutaneous absorption of the drug and the associated risk of malformations in the fetus. Avoid contact with semen due to the presence of the preparation in it.
Side effects:
Common: decreased libido, impotence, decreased volume of ejaculate. Uncommon: rash, ejaculation disorders, tenderness of the mammary glands, enlargement of the mammary glands. In addition: hypersensitivity reactions such as angioneurotic edema (including swelling of lips, tongue, throat and face), depression, persistence of decreased libido after discontinuation of treatment, palpitations, increased liver enzymes, pruritus, urticaria, testicular pain, erectile dysfunction after discontinuation of treatment, ejaculation disorders persisting after discontinuation of treatment, male infertility and / or poor sperm quality. After the discontinuation of the finster, normalization or improvement of semen quality was reported. There have been reports of breast cancer in men. In a 7-year placebo-controlled study, a slightly lower incidence of prostate cancer but a higher grade of malignancy in the group receiving the preparation was indicated. When assessing PSA results, a reduction in PSA should be considered in patients using the product.
Dosage:
Orally. Adults: usually 5 mg once a day regardless of meals. The preparation should be used for at least 6 months.There is no need to reduce the dose in patients with renal insufficiency, hepatic insufficiency and in elderly patients.
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