Long-term treatment of benign prostatic hyperplasia in order to reduce the volume of the enlarged prostate gland, to relieve the symptoms of painful or difficult urination. The preparation should be used in patients with prostatic hyperplasia.
A specific, competitive inhibitor of the intracellular enzyme, Type II 5-α-reductase. This enzyme converts testosterone to a stronger androgen - dihydrotestosterone (DHT). Finasteride acts mainly on type II isoenzyme, thereby reducing serum DHT concentrations by approximately 70% after a single 5 mg dose. Decrease in serum DHT concentration leads to a decrease in prostate volume. After 3 months, the volume of the prostate gland is reduced by approx. 20% and this process is progressing, reaching approx. 27% after 3 years. A significant reduction occurs in the peripheral zone directly surrounding the urethra. The preparation causes a significant reduction in the bladder muscle detrusor tension as a result of reducing the blockage. Significant improvement in the maximum rate of urine flow and alleviation of symptoms is achieved after a few weeks of treatment. After oral administration, the maximum concentration in the blood occurs after about 2 hours. The bioavailability is about 80%. Plasma protein binding is approximately 90%. Finasteride is metabolized in the liver. T0,5 it is 4.7-7.1 h, in men over 70 it is prolonged. Approx. 39% of the administered dose is excreted in the urine as metabolites, approx. 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 large amounts of residual urine and / or a significantly limited urinary flow should be carefully observed. The possibility of a surgical procedure should be considered. For patients treated with Finasteride, consultations with the urologist should be considered. Caution is advised in patients with impaired liver function due to the possibility of increased plasma levels of finasteride. 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 for the detection of prostate cancer. For detection of prostate cancer, PSA measurements in serum are also used. 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. If a free PSA ratio is used to diagnose prostate cancer, it is not necessary to take into account the fact of treatment with finasteride. 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 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 semen, eg by using a condom. It is not known whether finasteride is excreted in human milk.
Side effects:
Very often: impotence. Common: reduction of sex drive, rash, breast tenderness, breast enlargement, ejaculation disorders, decreased ejaculate volume. Uncommon: testicular pain. Rare: hypersensitivity reactions (including swelling of the lips and face), pruritus, urticaria. Very rare: secretion from the mammary gland, breast nodules. Not known: depression, palpitations, increased liver enzymes, erectile dysfunction (persisting after discontinuation of finasteride), infertility in men and / or decreased semen 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:
Oral: usually 5 mg once a day regardless of meals. 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. In patients with varying degrees of renal insufficiency (creatinine clearance up to 9 ml / min) and in patients over 70 years, no dose adjustment is necessary. There are no data available in patients with hepatic impairment.
(C)
