PENESTER

Active material: Finasteride
When ATH: G04CB01
CCF: Drug for the treatment of benign prostatic hyperplasia. Ингибитор 5a-редуктазы
ICD-10 codes (testimony): N40
When CSF: 28.01.01.01
Manufacturer: ZENTIVA a.s. (Czech Republic)

Pharmaceutical form, composition and packaging

Pills, coated light yellow, lenticular.

Excipients: lactose monohydrate, corn starch, povidone 30, sodium carboxymethyl starch, sodium docusate, magnesium stearate, gipromelloza 2910/5, macrogol 6000, talc, Titanium dioxide, dimethicone emulsion SE2, iron oxide yellow.

10 PC. – blisters (3) – packs cardboard.
15 PC. – blisters (2) – packs cardboard.

Pharmacological action

Drug for the treatment of benign prostatic hyperplasia. Finasteride – 4-synthetic compound azasteroid. It is a competitive and specific inhibitor of steroid 5-alpha reductase – intracellular enzyme, which converts testosterone to 5-active androgen DHT. Tissue growth and development of prostate benign hyperplasia due to the conversion of testosterone to dihydrotestosterone in the prostate cells. Under the influence of the drug decreases significantly digidrosterona concentration in blood plasma, and in prostate tissue. Finasteride does not bind to androgen receptors.

As a result of the drug decreases the size of the prostate, decreases symptoms, associated with prostatic hyperplasia.

The drug has no effect on the plasma lipid concentration, and the content in plasma cortisol, Estradiol, prolactin, thyroid stimulating hormone, tiroksina.

Pharmacokinetics

Absorption and distribution

After oral finasteride is rapidly absorbed from the gastrointestinal tract. Bioavailability is about 80% and independent of food intake. C_max plasma levels achieved after 1-2 hours after oral administration. Plasma protein binding is about 90%.

Metabolism and excretion

Finasteride is metabolized in the liver and excreted as metabolites in the urine and feces.

Pharmacokinetics in special clinical situations

T_1/2 in patients over 60 s is 6 no, in patients over 70 years can be extended to 8 no.

Testimony

- Benign prostatic hyperplasia (to reduce the size of the prostate, increasing the maximum speed of the flow of urine and reduce symptoms, associated with hyperplasia, reduce the risk of acute urinary retention and the associated probability of surgery).

Dosage regimen

The drug is prescribed inside of 5 mg 1 time / day, regardless of the meal.

Duration of therapy to assess its effectiveness should be at least 6 Months.

Approximately 50% patients with disappearance of clinical symptoms occurred during the treatment 12 Months.

Side effect

On the part of the reproductive system: gynecomastia, breast tenderness, impotence, reduced libido and decrease in ejaculate volume.

Other: allergic reactions.

The incidence of side effects than 3-4% and decreases during treatment. In some cases, there is an increased concentration of luteinizing and follicle-stimulating hormone and testosterone (approximately 10%), however, these parameters remained within normal limits.

Contraindications

- Prostate cancer;

- Obstruction of the urinary tract;

- Children's age;

- Hypersensitivity to finasteride and other ingredients.

FROM caution It should appoint a drug in the human liver.

Pregnancy and lactation

Women of childbearing age and pregnant Avoid contact with the crushed tablets of the drug Penester, tk. the ability of the drug to inhibit the conversion of testosterone to DHT can cause impaired development of the genital organs of male fetus. Penestera tablets film-coated, so, if they are not pulverized or powdered their integrity is not broken, contact with the active material removed.

Cautions

Before treatment is necessary to eliminate the disease, which may simulate benign prostatic hyperplasia, such as infectious prostatitis, prostate cancer, urethral stricture, hypotension, urinary bladder and a number of changes in the urinary system, occur in some diseases of the nervous system.

Since the use of finasteride, a decrease in prostate-specific antigen (on 41% and 48% according to 6 and 12 Months of therapy), periodically during therapy is necessary to conduct a survey of patients to avoid their prostate cancer.

Overdose

Currently, cases of drug overdose were reported Penester.

Drug Interactions

There were no clinically significant drug interactions Penester with other drugs.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

No special storage conditions. Shelf life – 3 year.