Penester, 5 mg 30 pcs.

Penester is a drug for the treatment of benign prostatic hyperplasia. Finasteride is a synthetic 4-azasteroid compound. It is a competitive and specific inhibitor of steroid 5-alpha reductase, an intracellular enzyme which converts testosterone to the active androgen 5-dihydrotestosterone.

The growth of prostate tissue and development of benign hyperplasia are caused by conversion of testosterone to dihydrotestosterone in prostate cells. Under the influence of the drug there is a significant decrease of dihydrotestosterone concentration both in the blood plasma and in the glandular tissue. Finasteride does not bind to androgen receptors.

The use of the drug results in decreasing size of the prostate gland and reduces severity of symptoms associated with prostatic hyperplasia.

The drug has no effect on plasma lipid concentrations and plasma levels of cortisol, estradiol, prolactin, thyrotropic hormone, and thyroxin.

Pharmacokinetics

Intake and distribution

After oral administration finasteride is rapidly absorbed from the GI tract. Bioavailability is about 80% and is not dependent on food intake. Cmax in plasma is reached 1-2 hours after oral administration. Binding to plasma proteins 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

The T1/2 in patients over 60 years is 6 h, in patients over 70 years may lengthen to 8 h.

Indications

Benign prostatic hyperplasia (to reduce the size of the prostate gland, increase the maximum flow rate of urine and reduce symptoms associated with hyperplasia; reduce the risk of acute urinary retention and the associated likelihood of surgical intervention).

Pharmacological effect

Penester is a drug for the treatment of benign prostatic hyperplasia. Finasteride is a synthetic 4-azasteroid compound. It is a competitive and specific inhibitor of steroid 5-alpha reductase, an intracellular enzyme that converts testosterone into the active androgen 5-dihydrotestosterone.

The growth of prostate tissue and the development of benign hyperplasia are caused by the conversion of testosterone to dihydrotestosterone in prostate cells. Under the influence of the drug, a significant decrease in the concentration of dihydrosterone occurs both in the blood plasma and in the gland tissue. Finasteride does not bind to androgen receptors.

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

The drug does not affect the concentration of plasma lipids, as well as the content of cortisol, estradiol, prolactin, thyroid-stimulating hormone, and thyroxine in the blood plasma.

Pharmacokinetics

Suction and distribution

After oral administration, finasteride is rapidly absorbed from the gastrointestinal tract. Bioavailability is about 80% and is independent of food intake. Cmax in blood plasma is achieved 1-2 hours after taking the drug orally. Plasma protein binding is about 90%.

Metabolism and excretion

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

Pharmacokinetics in special clinical situations

T1/2 in patients over 60 years of age is 6 hours, in patients over 70 years of age it can extend to 8 hours.

Special instructions

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

Since when using finasteride, a decrease in prostate-specific antigen is observed (by 41% and 48%, respectively, by 6 and 12 months from the start of therapy), patients must be examined periodically during therapy to exclude prostate cancer.

Active ingredient

Finasteride

Composition

Active ingredient:

finasteride 5 mg;

Excipients:

lactose monohydrate – 77.45 mg,

corn starch – 40 mg,

povidone K30 – 3.25 mg,

sodium carboxymethyl starch (type A) – 2.6 mg,

sodium docusate – 400 mcg,

magnesium stearate – 1.3 mg;

Shell composition:

hypromellose 2910/5 – 3.15 mg, macrogol 6000 – 300 mcg, talc – 300 mcg, titanium dioxide – 200 mcg, simethicone emulsion SE4 – 30 mcg, iron dye yellow oxide – 20 mcg

Contraindications

Hypersensitivity, urinary tract obstruction, prostate cancer.

Side Effects

From the reproductive system: gynecomastia, breast tenderness, impotence, decreased libido and decreased ejaculate volume.

Other: allergic reactions.

Storage conditions

In a dry place, protected from light, at a temperature not exceeding 25 °C

Shelf life

2 years

Manufacturer

Zentiva k.s., Czech Republic