Expiration date: 11/2024
The composition and form of issue:
Tablets, film-coated. 1 tablet contains: finasteride 5 mg
excipients: magnesium stearate talc sodium starch of glycolate (type A) pregelatinization MCC starch lactose monohydrate
the composition of the shell: titanium dioxide macrogol 6000 hydroxypropyl cellulose hydroxypropyl methylcellulose, lactose monohydrate
blistere in 14 PCs. in cardboard pack 1 or 2 packs.
Description pharmaceutical form:
Tablets, film-coated, white or almost white, rounded triangle shaped, slightly biconvex, almost odorless, engraved with "RG" on one side.
After intake of rapidly absorbed from the gastrointestinal tract. Bioavailability is about 80% and independent of food intake. After a single oral Cmax in plasma achieved in 1-2 hours Linking blood plasma is about 90%. Metabolized by the liver and excreted as metabolites by the kidneys (approximately 40%) and through the intestine (about 60%). T1/2 of the drug is about 6 h in patients older than 70 years can be extended to 8 h.
Description pharmacological action:
Synthetic 4-azasteroid connection, a competitive and specific inhibitor of 5-alpha-reductase inhibitors — intracellular enzyme, which converts testosterone into the active androgen 5-dihydrotestosterone. The growth of the prostate tissue and the development of BPH due to the conversion of testosterone to dihydrotestosterone in the prostate cells. The drug is a significant reduction in the concentration of DHT in both plasma and prostate tissue. Finasteride does not bind to androgen receptors. Inhibits the stimulatory effect of dihydrotestosterone on the development of BPH, resulting in a decrease in the severity of symptoms associated with BPH.
Has no effect on lipid levels and plasma levels of cortisol, estradiol, prolactin, TSH, thyroxine.
The treatment of benign prostatic hyperplasia to reduce the size of the prostate to increase the maximum speed of urine flow and reduce symptoms associated with hyperplasia reduce the risk of acute urinary retention and the consequent likelihood of surgery.
Hypersensitivity to finasteride or other components of the drug.
In some cases, gynecomastia, impotence, decreased libido, reduced ejaculate volume (the frequency of these side-effects does not exceed 3-4% and decreases in the treatment process). In some cases there was an increase level of LH, FSH and testosterone by approximately 10%, however, these parameters remained within the normal values.
Possible allergic reactions (angioedema of the lips, skin rash).
Method of application and dose:
Inside, 5 mg 1 time per day, regardless of meals. The duration of therapy to evaluate its effectiveness should be not less than 6 months. Approximately 50% of patients disappearance of the clinical symptoms occurred only in treatment of within 12 months.
Pregnant women should avoid contact with crushed or loss of the integrity of the finasteride tablets, because the ability of the drug to inhibit the transformation of testosterone into dihydrotestosterone can cause impaired development of the genital organs of the fetus.
Before therapy is necessary to exclude diseases that have symptoms similar to symptoms of BPH such as prostate cancer, infection prostatitis, stricture urethra, hypotonicity bladder and a number of changes in the urinary system, emerging in certain diseases of the nervous system.
With care prescribe the drug to patients with impaired liver function.
Because when using finasteride, a decrease in prostate specific antigen periodically during therapy to investigate patients to exclude them from prostate cancer.