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 prostate size, increase maximum urinary flow rate and reduce symptoms associated with hyperplasia; reduce risk of acute urinary retention and associated likelihood of surgical intervention).

Active ingredient

Composition

Active substance:

Finasteride 5 mg;

Associates:

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 µg,

magnesium stearate – 1.3 mg;

Shell composition:

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

How to take, the dosage

The drug is administered orally at 5 mg once a day, regardless of meals.

The duration of therapy should be at least 6 months before its effectiveness is evaluated.

About 50% of patients had disappearance of clinical symptoms when treated for 12 months.

Special Instructions

Diseases that may simulate benign prostatic hyperplasia, such as infectious prostatitis, prostate cancer, urethral stricture, hypotonia of the bladder, and a number of urinary changes occurring in some nervous system disorders should be excluded prior to initiating therapy.

Because there is a decrease in prostate-specific antigen with finasteride (by 41% and 48%, respectively, by 6 and 12 months of therapy), patients should be screened periodically during therapy to rule out prostate cancer.

Contraindications

Hypersensitivity, urinary tract obstruction, prostate malignancy.

Side effects

Sexual system: gynecomastia, painful breasts, impotence, decreased libido and reduced ejaculate volume.

Others: allergic reactions.

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