Penester (Finasteride) tablets 5mg 30 tablets, 5mg 90 tablets,

Release form and composition: 

Tablets, film-coated light yellow in color, lenticular.

1 tablet contains: finasteride 5 mg

Excipients: lactose monohydrate, corn starch, povidone 30, carboximetilkrahmal sodium, sodium docusate, magnesium stearate, hypromellose 2910/5, macrogol 6000, talc, titanium dioxide, Dimethicone emulsion SE2, iron oxide yellow.

10 PCs. – blisters (3) – packs cardboard.

15 PCs. – blisters (2) – packs of cardboard.

Pharmacological action:

Drug for treatment of benign prostatic hyperplasia. Finasteride – synthetic 4-azasteroid connection. Is a competitive and specific inhibitor of steroid 5-alpha reductase inhibitors – intracellular enzyme, which converts testosterone to the active androgen 5-dihydrotestosterone. The growth of the prostate tissue and the development of benign hyperplasia due to the conversion of testosterone to dihydrotestosterone in the prostate cells. The drug is a significant reduction in the concentration of digidrosteron as in plasma and in prostate tissue. Finasteride does not bind to androgen receptors.

The result of the drug reduces prostate size, decreases symptoms associated with benign prostatic hyperplasia.

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

Pharmacokinetics:

Absorption and distribution

After intake of 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 in the liver and excreted as metabolites in the urine and feces.

Pharmacokinetics in special clinical cases

T1/2 in patients over 60 years is 6 hours, in patients older than 70 years can be extended to 8 h.

Indications:

— benign prostatic hyperplasia (to reduce prostate size, increase in maximum urine flow and reduce symptoms associated with hyperplasia, reduce the risk of acute urinary retention and the consequent likelihood of surgical intervention).

Dosing regimen:

The drug is administered orally, of 5 mg 1 time/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 in the treatment for 12 months.

Side effects:

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

Other: allergic reactions.

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 concentration of luteinizing and follicle-stimulating hormone and testosterone (approximately 10%), however, these parameters remained within the normal values.

Contraindications:

— prostate cancer

— obstruction of the urinary tract

— children’s age

— hypersensitivity to finasteride and other ingredients components of the drug.

With caution should designate product in violation of liver function.

Pregnancy and lactation:

Women of childbearing age and pregnant women should avoid contact with crushed tablets of the drug Penester, because the ability of the drug to inhibit the transformation of testosterone into dihydrotestosterone can cause impaired development of the genital organs in male fetus. Tablet Penester film-coated, so if they are not pulverized or broken their integrity, contact with the active material removed.

Special instructions:

Before treatment is necessary to exclude diseases that can simulate the benign prostatic hyperplasia, such as infectious prostatitis, prostate cancer, stricture of the urethra, hypotension bladder and a number of changes in the urinary system, emerging in certain diseases of the nervous system.

Because when you apply finasteride decrease prostate-specific antigen (on 41% and 48% respectively for 6 and 12 months from start of therapy), periodically during therapy to investigate patients to exclude them from prostate cancer.

Overdose:

Currently, the cases of drug overdose Penester was not reported.

Drug interactions:

Not detected clinically significant drug interactions Penester with other drugs.

Terms and conditions of storage:

Does not require special storage conditions. Shelf life – 3 years.