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An antineoplastic hormonal drug. It inhibits type II 5-alpha reductase, which converts testosterone into the more active 5-alpha-dihydrotestosterone, reduces its concentration in the blood and prostate tissue within 24 hours after oral administration. Inhibits the stimulating effect of testosterone on tumor development. Suppression of the formation of dihydrotestosterone is accompanied by a decrease in the volume of the prostate gland, an increase in the maximum flow rate of urine and a decrease in symptoms of urinary tract obstruction. With constant administration, a statistically significant effect is recorded after 3 months (decrease in the volume of the gland), 4 months (increase in the maximum flow rate of urine) and 7 months (decrease in general symptoms and symptoms of urinary tract obstruction).
Absorption in the gastrointestinal tract is completed 6-8 hours after administration. It is well absorbed and penetrates into tissues and biofluids, and is found in ejaculate (at a concentration of 5 μg). Bioavailability - 80%, does not depend on food intake. TCmax - 2 h, Cmax - 8-10 ng / ml. Connection with plasma proteins - 93%. Penetrates the BBB (after 7-10 days of treatment, it is found in small amounts in the CSF) Systemic clearance - 165 ml / min, volume of distribution - 76 liters. Slightly cumulates with prolonged use. T1 / 2 in men 18-60 years old - 6 hours, in men over 70 years old - 8 hours. It is excreted in the form of metabolites by the kidneys (39%) and through the intestines (57%). In chronic renal failure, part of metabolites 9, which are normally excreted in the urine) are excreted in the feces.
Benign prostatic hyperplasia (to reduce the size of the prostate gland, increase the maximum flow rate of urine, reduce the risk of acute urinary retention).
Inside, regardless of food intake, 5 mg once a day, both in monotherapy and in combination with doxazosin.
Hypersensitivity to finasteride; age under 18; pregnancy and the use of finasteride in women of childbearing age (see "Use during pregnancy and lactation").
Restrictions on use
Patients with a large volume of residual urine and / or a significantly reduced urinary rate; liver failure; elderly age.
Application during pregnancy and lactation
The use of finasteride is contraindicated during pregnancy and women of childbearing age. Due to the ability of type II 5-alpha reductase inhibitors to suppress the conversion of testosterone to DHT, the data of drugs, incl. finasteride, when used in pregnant women, can cause anomalies in the development of the external genital organs in a male fetus.
Finasteride is not indicated for use in women.
There are no data on the excretion of finasteride in breast milk.
Small amounts of finasteride were found in the semen of patients receiving finasteride 5 mg / day. Although there are no clinical data on the effect of finasteride on a male fetus, women of childbearing age should avoid contact with the seminal fluid of men taking finasteride. Women of childbearing age and pregnant women should avoid contact with damaged finasteride tablets. its ability to inhibit the conversion of testosterone to DHT can cause reproductive disorders in male fetuses.
Clinically significant interactions with other drugs have not been identified.
Finasteride is metabolized mainly with the participation of the isoenzyme CYP3A4 of the cytochrome P450 system, without significantly affecting the function of this system. Although the risk of the effect of finasteride on the pharmacokinetics of other drugs is assessed as low, there is a possibility that inhibitors or inducers of the CYP3A4 isoenzyme will affect the plasma concentration of finasteride. However, given the available safety data, it seems unlikely that an increase in the concentration of finasteride associated with the concomitant use of such inhibitors will be of clinical significance. There was no clinically significant interaction with the combined use of finasteride with propranolol, digoxin, glibenclamide, warfarin, theophylline and phenazone.
Symptoms: patients received finasteride once in doses up to 400 mg, and with repeated use - in doses up to 80 mg / day for 3 months, while no adverse reactions were observed.
Treatment: Finasteride overdose does not require special treatment.
Precautions for Finasteride
In order to avoid obstructive complications, it is necessary to closely monitor patients with a large volume of residual urine and / or significantly difficulty urinating. Consideration should be given to the possibility of the need for surgical intervention.
Effect on PSA content and diagnosis of prostate cancer
The clinical benefits of using finasteride in patients with prostate cancer have not yet been proven. In controlled clinical trials in patients with BPH and elevated plasma PSA concentrations, PSA levels and the results of prostate biopsy studies were monitored. It was found that the use of finasteride, apparently, does not change the incidence of prostate cancer and does not affect the frequency of its occurrence in patients taking finasteride or placebo. Before starting treatment and periodically during therapy with finasteride, it is recommended to conduct a rectal examination and use other methods for diagnosing prostate cancer. Plasma PSA is also used to detect prostate cancer. In general, an initial PSA concentration above 10 ng / ml indicates the need for further examination of the patient and a biopsy. When determining the PSA concentration in the range of 4-10 ng / ml, further examination of the patient is necessary. In men with BPH, normal PSA values do not rule out prostate cancer, regardless of treatment with finasteride. An initial PSA concentration below 4 ng / ml also does not exclude prostate cancer.
Finasteride causes a decrease in serum PSA concentration of approximately 50% in patients with BPH, even with prostate cancer. This fact must be taken into account when assessing the PSA content in patients with BPH treated with finasteride, because a decrease in PSA concentration does not exclude the presence of concomitant prostate cancer. This decrease is expected over any range of PSA concentrations, although it may differ from patient to patient. Analysis of PSA values in more than 3,000 patients in a 4-year, double-blind, placebo-controlled study PLESS confirmed that PSA values should be doubled in patients who took finasteride for 6 months or more to compare them with normal values of this indicator in untreated patients ... This correction preserves the sensitivity and specificity of the PSA assay and the ability to detect prostate cancer. Any persistent increase in PSA concentration in patients receiving finasteride treatment requires careful examination to determine the cause, which may be non-adherence to the drug regimen.
Finasteride does not significantly reduce the percentage of free PSA (the ratio of free PSA to total). This indicator remains constant even under the influence of taking finasteride. If the percentage of free PSA is used to diagnose prostate cancer, correction of the values of this indicator is not necessary.
Breast cancer in men
During clinical studies, as well as during the post-marketing period, cases of breast cancer have been observed in men taking finasteride. Doctors should instruct their patients to promptly report any changes in breast tissue, such as lumps, pain, gynecomastia, or nipple discharge.
Special groups of patients
Liver failure. There are insufficient clinical data on the use of finasteride in patients with hepatic insufficiency.
Renal failure In patients with various stages of renal failure (with a decrease in Cl creatinine to 9 ml / min), dose adjustment is not required, since special studies have not demonstrated any changes in the pharmacokinetic profile of finasteride.
Elderly age. No dose adjustment is required, although pharmacokinetic studies indicate that the elimination of finasteride in patients over 70 years of age is somewhat reduced.
Influence on the ability to drive vehicles and mechanisms. The adverse effects of finasteride on the ability to drive vehicles and operate machinery have not been reported.
Side effects of the substance Finasteride
Adverse reactions to finasteride are divided into systemic organ classes in accordance with theclassification MedDRA. The frequency of adverse reactions was determined according to the following gradation (WHO classification): very often (≥1 / 10); often (≥1 / 100, <1/10); infrequently (≥1 / 1000, <1/100); rarely (≥1 / 10000, <1/1000); very rare (<1/10000), including isolated messages; the frequency is unknown (the frequency cannot be established, since the information was obtained on the basis of post-marketing experience with the use of finasteride).
Most often, patients experienced impotence and decreased libido, although the incidence of these side effects gradually decreased during treatment.
From the immune system: frequency is unknown - hypersensitivity reactions, incl. angioedema (including edema of the lips, face and larynx).
From the side of the psyche: often - decreased libido; frequency is unknown - depression, decreased libido, which persists after discontinuation of therapy.
From the side of the heart: frequency unknown - palpitations.
From the liver and biliary tract: the frequency is unknown - an increase in the activity of hepatic transaminases.
On the part of the skin and subcutaneous tissues: infrequently - rash; frequency unknown - urticaria, pruritus.
On the part of the genitals and mammary glands: often - erectile dysfunction; infrequently - violation of ejaculation, enlargement and tenderness of the mammary glands; frequency unknown - testicular pain, erectile dysfunction persisting after discontinuation of therapy, male infertility and / or decreased semen quality.
Thestudy MTOPS compared finasteride 5 mg / day (n = 768), doxazosin 4 or 8 mg / day (n = 756), combination therapy with finasteride 5 mg / day and doxazosin 4 or 8 mg / day (n = 786) and placebo (n = 737). According to the results of this study, the safety and tolerability profile of the combination therapy generally coincided with the profile of its individual components. The incidence of ejaculatory disorders in patients receiving combination therapy was comparable to the sum of the incidence of this adverse event in the presence of two types of monotherapy.
A 7-year, placebo-controlled study was conducted in 18882 healthy men. Puncture biopsy data of the prostate gland available for analysis were obtained for 9060 subjects, while prostate cancer was detected in 803 men (18.4%) who received finasteride at a dose of 5 mg, and in 1147 men (24.4%). receiving a placebo. According to the results of puncture biopsy, prostate cancer with a Gleason score of 7-10 was diagnosed in 280 men (6.4%) from the group receiving finasteride at a dose of 5 mg, while in the placebo group cancer with such a degree of differentiation was diagnosed in 237 patients (5.1%). The results of an additional analysis indicated that the increase in the prevalence of poorly differentiated prostate cancer observed in the group receiving finasteride at a dose of 5 mg can be explained by a bias in assessing the results associated with the effect of therapy with finasteride 5 mg on prostate volume. Of the total prostate cancer cases diagnosed in this study, approximately 98% of the cases at the time of diagnosis were classified as localized cancer (clinical stage T1 or T2). The clinical significance of the data on the tumor process with the degree of differentiation of 7-10 points on the Gleason scale is unknown.