The composition and form of issue:
Tablets, film-coated. 1 tablet contains finasteride 5 mg
excipients: lactose MKTS carboximetilkrahmal sodium (type A) corn starch pregelatinization docusate sodium magnesium stearate hypromellose propylene glycol titanium dioxide talc
the strip 10 PCs. in cardboard pack 3 strip.
Description pharmaceutical form:
White round biconvex tablets, film-coated, with a “FIN” on one side and smooth on the other species on a break — white or almost white mass.
Absorption and distribution: after administration of the drug inside the finasteride is rapidly absorbed from the gastrointestinal tract. Bioavailability is about 80% and independent of food intake.
Cmax in plasma achieved through 1-2 h after administration of the drug inside. The plasma protein binding is about 90%.
Metabolism and excretion: finasteride is metabolized by the liver and excreted as metabolites in the urine and feces.
In special cases: T1/2 of drug in patients over 60 years is 6 h. in patients older than 70 years can be extended to 8 h.
Description pharmacological action:
Finasteride is a competitive and specific inhibitor of steroid 5-alpha-reductase — an intracellular enzyme that converts testosterone into the active androgen 5-dihydrotestosterone (DHT). Blocking 5-alpha-reductase, finasteride prevents this conversion, thereby preventing the growth of the prostate tissue and the development of benign hyperplasia. Reduces the concentration of DHT in plasma and in prostate tissue. It binds to androgen receptors.
Reduces the size of prostate and symptoms, associated with adenoma prostate gland.
The drug has no effect on the level of plasma lipids, as well as the content in plasma cortisol, estradiol, prolactin, TSH, thyroxine.
The treatment of benign prostatic hyperplasia with a view to:
- reduce the size of the prostate
- to increase the maximum speed of urine flow and reduce symptoms associated with hyperplasia
- the reduced risk of acute urinary retention and the consequent likelihood of surgery.
- hypersensitivity to finasteride and other ingredients components of the drug
- obstruction of the urinary tract
- the children’s age.
Allergic reactions, gynecomastia, impotence, decreased libido, reduced ejaculate volume (the frequency of side effects does not exceed 3-4% and decreases in the treatment process). In some cases there was an increase in the level of LTG, FSH and testosterone by approximately 10% (however, these parameters remained within the normal range).
Not detected clinically significant interactions with other drugs.
Method of application and dose:
Inside, every day, regardless of meals, and 5 mg of 1 times a day.
The duration of therapy to evaluate its effectiveness should be not less than 6 months. Approximately 50% of patients disappearance of clinical symptoms occurs during the treatment for 12 months.
Currently, the cases of drug overdose were reported.
Before treatment is necessary to exclude diseases which can simulate the benign prostatic hyperplasia (infectious prostatitis, prostate cancer, urethral stricture, hypotonic bladder and changes in the urinary system, emerging in certain diseases of the nervous system).
Be wary appoint patients with impaired liver function.
Periodically in the course of therapy to investigate patients to exclude they have prostate cancer (because when using finasteride, a decrease in prostatic specific antigen by 41 and 48%, respectively for 6 and 12 months from start of therapy).
Women of childbearing age and pregnant women should avoid contact with crushed tablets of the drug because of possible developmental disorders of genital organs in male embryos.