Treatment and control of symptomatic benign prostatic hyperplasia (BPH) in men with enlarged prostate gland in order to: induce regression of the enlarged prostate gland, improve urine flow and alleviate symptoms associated with BPH; reduce the risk of acute urinary retention and the need for surgery, including transurethral resection of the prostate (TURP) and prostatectomy. The preparation is intended for administration only in patients with enlarged prostate (volume of the prostate approximately 40 ml).
A specific, competitive inhibitor of the intracellular enzyme, Type II 5-α-reductase. This enzyme converts testosterone to a stronger androgen - dihydrotestosterone (DHT). The correct function and growth of prostate tissue depends 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 prostate gland is reduced by approx. 20% and this process is progressing, reaching approx. 27% after 3 years. A noticeable reduction occurs in the peri-renal area directly surrounding the urethra. The preparation causes a significant reduction in bladder detrusor muscle tension as a result of the reduction of urinary tract obstruction. 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 absorption occurs within 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 finasteride or to any of the excipients. Do not use the drug in women and children.
Precautions:
Patients with a high volume of residual urine and / or significantly reduced urinary flow should be carefully monitored to prevent complications in the form of obstructive uropathy. Patients receiving finasteride should be consulted with a urologist. There are no data on the use of finasteride in patients with hepatic impairment. Special care should be taken in patients with impaired hepatic function. To date, no clinical benefit has been demonstrated in the treatment of patients with prostate cancer with finasteride. A palpation examination should be performed before starting treatment with finasteride and periodically during treatmentper rectum and, if necessary, determination of serum prostate antigen (PSA) levels to exclude prostate cancer. In patients with BPH, finasteride causes a reduction in serum PSA by about 50%, even for prostate cancer. This should be taken into account when assessing the PSA values in the serum of patients with BPH treated with Finasteride, as this does not exclude the simultaneous occurrence of prostate cancer. This concentration reduction can be expected regardless of the PSA value, although there may be inter-individual differences. For patients treated with finasteride for 6 months or more, the PSA values should be multiplied by two to compare them with the normal range in men not treated with finasteride. Such a correction allows the preservation of the sensitivity and specificity of the PSA test as well as the detection of prostate cancer. Any sustained increase in PSA in patients treated with finasteride should be carefully evaluated taking into account the patient's non-compliance with finasteride therapy. The percentage of free PSA (ratio of free to total PSA) is not significantly reduced by finasteride. If the percentage of free PSA is used as an aid to the detection of prostate cancer, there is no need to correct its value.Due to the risk of breast cancer, the patient should be advised to immediately contact a doctor if there are changes in the breast, such as: tumors, pain, gynecomastia, discharge from the nipple. The preparation contains lactose - should not be used in patients with rare hereditary galactose intolerance, lactase deficiency (Lapp type) or malabsorption of glucose-galactose.
Pregnancy and lactation:
Finasteride is contraindicated in women. Finasteride can cause external genital malformations in male fetuses. Pregnant women and women who may become pregnant should not touch the broken or split tablets because of the possibility of penetration of finasteride through the skin, which poses a potential risk to male fetuses. Fmasteride has been seen in the semen of men taking finasteride 5 mg daily. It is not known whether this may have an adverse effect on the male fetus if the pregnant woman is exposed to the semen of the patient being treated with finasteride. If the sexual partner of the patient is or may be pregnant, the patient is advised to minimize exposure to the semen. It is not known if finasteiide is excreted in human milk.
Side effects:
Common: decreased ejaculate volume, impotence, decreased libido. Uncommon: ejaculation disorders, breast enlargement and tenderness, skin rash. Rare: testicular pain, pruritus, urticaria, hypersensitivity reactions such as swelling of the lips and face. Very rare (including isolated cases): discharge from the breast, breast nodules (requiring surgical removal in some patients). Not known: palpitations, increased liver enzymes. In addition, cases of breast cancer in men have been reported. When assessing the results of laboratory PSA tests, it should be remembered that generally, in patients treated with finasteride, PSA levels are reduced. In the majority of such patients, a rapid reduction in PSA concentration is observed in the first months of treatment. After this period, the PSA concentration stabilizes at a new level. Values after treatment are approximately half that of pre-treatment values. Therefore, in typical patients taking finasteride for 6 months or more, the PSA values should be multiplied by 2 to be able to compare them with the normal range in untreated men.
Dosage:
Orally. The recommended dose is 1 tabl. (5 mg) daily. Even if the patient has a clinical improvement after a short period of treatment with finasteride, the treatment should be used for at least 6 months to properly evaluate the effectiveness. No adjusted doses are required in patients with varying degrees of renal impairment (creatinine clearance reduced to only 9 ml / min). Finasteride has not been tested in patients undergoing hemodialysis. Elderly, dose adjustment is not necessary. Table. should be swallowed whole, do not divide or crush tablets; take regardless of meals.
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