Penester
Penester: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Penester
ATX code: G04CB01
Active ingredient: finasteride (finasteride)
Manufacturer: Zentiva k.s (Zentiva, ks) (Czech Republic)
Description and photo update: 2019-20-08
Prices in pharmacies: from 364 rubles.
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Penester is a drug for the treatment of prostate adenoma.
Release form and composition
Penester is available in film-coated tablets: round, convex on both sides, light yellow (10 pieces in blisters, 3 blisters in a cardboard box; 15 pieces in blisters, 2 or 6 blisters in a cardboard box) pack).
1 tablet contains:
- Active ingredient: finasteride - 5 mg;
- Inactive ingredients: lactose monohydrate (77.45 mg), corn starch (40 mg), povidone K30 (3.25 mg), sodium carboxymethyl starch type A (2.6 mg), magnesium stearate (1.3 mg), sodium docusate (0.4 mg);
- Film shell: hypromellose 2910/5 (3.15 mg), macrogol 6000 (0.3 mg), talc (0.3 mg), titanium dioxide (0.2 mg), emulsion of simethicone SE4 (0.03 mg), iron dye yellow oxide (0.02 mg).
Pharmacological properties
Pharmacodynamics
The active ingredient in Penester is finasteride. It is a synthetic 4-azasteroid compound, a specific competitive inhibitor of type II 5α-reductase, an intracellular enzyme that converts testosterone into the active androgen, dihydrotestosterone (DHT).
The enlargement of the prostate gland in benign hyperplasia depends on the conversion of testosterone to DHT in the prostate. Finasteride significantly reduces the level of this hormone in blood plasma and prostate tissue. Suppression of DHT production leads to a decrease in the size of the prostate gland, an increase in the maximum rate of urination and a decrease in the severity of symptoms associated with this disease.
Finasteride has no affinity for androgen receptors.
The PLESS clinical trials involved patients with moderate to severe symptoms of benign prostatic hyperplasia (BPH) and prostate enlargement. It was found that Penester reduces the incidence of acute urinary retention from 7/100 to 3/100 within 4 years and the need for surgical intervention (prostatectomy or transurethral resection of the prostate) from 10/100 to 5/100. At the same time, there was a decrease in the severity of symptoms of the disease (by 2 points on the quasi-AUA symptom scale), a stable increase in the flow rate of urine and a sustained decrease in the volume of the prostate gland by about 20%.
The Medical Therapy Of Prostate Symptoms studies, lasting 4–6 years, enrolled 3,047 men with BPH symptoms. They were randomly divided into 4 groups receiving: I - placebo, II - finasteride at a daily dose of 5 mg, III - doxazosin at a daily dose of 4 or 8 mg, IV - a combination of finasteride at a daily dose of 5 mg and doxazosin at a daily dose of 4 or 8 mg. The results showed a significant reduction in the risk of clinical disease progression, amounting to 34% (p = 0.002) in the finasteride group, 39% (p <0.001) in the doxazosin group and 67% (p <0.001) in the combination therapy group relative to placebo. Progression of BPH in most cases (274 of 351) was manifested by worsening of symptoms by ≥ 4 points on the IPSS (International Prostate Symptom Score) scale. In this case, the risk of worsening symptoms,which were assessed by points, relative to the placebo group decreased by 30% (95% confidence interval - 6-48%) in patients receiving finasteride, by 46% (95% confidence interval - 25-60%) in patients taking doxazosin, by 64 % (95% confidence interval - 48–75%) in those who received combination therapy. The risk of acute urinary retention relative to the placebo group was reduced by 67% (p = 0.011) in the finasteride group, by 31% (p = 0.296) in the doxazosin group, by 79% (p = 0.001) in the combination therapy group. Significant differences from placebo were observed only in patients in the finasteride and combination therapy groups.by 64% (95% confidence interval - 48–75%) in those who received combination therapy. The risk of acute urinary retention relative to the placebo group was reduced by 67% (p = 0.011) in the finasteride group, by 31% (p = 0.296) in the doxazosin group, by 79% (p = 0.001) in the combination therapy group. Significant differences from placebo were observed only in patients in the finasteride and combination therapy groups.by 64% (95% confidence interval - 48–75%) in those who received combination therapy. The risk of acute urinary retention relative to the placebo group was reduced by 67% (p = 0.011) in the finasteride group, by 31% (p = 0.296) in the doxazosin group, by 79% (p = 0.001) in the combination therapy group. Significant differences from placebo were observed only in patients in the finasteride and combination therapy groups.
Pharmacokinetics
The maximum plasma concentration of the drug is reached approximately 2 hours after taking Penester inside. Absorption of finasteride from the gastrointestinal tract is completed 6-8 hours after taking the tablet. The bioavailability of the drug does not depend on food intake, it is about 80% of the intravenous reference dose.
Finasteride is characterized by a high binding to plasma proteins (~ 93%). The apparent volume of distribution is 76 l, plasma clearance is ~ 165 ml / min. With long-term use of Penester, finasteride in small amounts slowly accumulates. With a daily dose of 5 mg, its minimum equilibrium plasma concentration reaches 8–10 ng / ml and remains stable over time.
After 7-10 days of taking the drug, finasteride is found in the cerebrospinal fluid and in small amounts in the semen.
After a single dose of finasteride labeled with 14 C excreted through intestine of 57% of the dose, as metabolites kidney - 39% of the dose. In this study, two metabolites of the active substance of the drug were identified, which, in comparison with finasteride, have a slight inhibitory effect on the enzyme 5α-reductase.
The half-life (T 1/2) of the drug is 6 hours on average.
The rate of elimination of finasteride is somewhat reduced in elderly patients and, as a consequence, the T 1/2 period increases to 8 hours. These changes are not of clinical significance, therefore, dose adjustment is not required in older men.
In chronic renal failure (creatinine clearance 9–55 ml / min), the degree of distribution of 14 C- labeled finasteride after a single dose of Penester did not differ from that in healthy volunteers. The binding of the substance to plasma proteins in impaired renal function also did not differ. Part of the metabolites of finasteride, which is normally excreted by the kidneys, in patients with renal insufficiency is excreted through the intestines, which is manifested by a decrease in the number of metabolites of the substance in the urine and an increase in their number in the feces. Men with renal failure who do not require hemodialysis do not need to adjust the dose of Penester.
Indications for use
According to the instructions, Penester is a drug intended for the treatment of benign prostatic hyperplasia.
The use of finasteride is recommended if necessary:
- Reduction of the size of the prostate gland;
- Increase in the maximum rate of urine outflow;
- Removal or reduction of symptoms caused by hyperplasia;
- Reducing the risk of acute urinary retention and the likelihood of surgery.
Contraindications
Absolute:
- Childhood;
- Obstruction of the urinary tract;
- Prostate cancer;
- Hypersensitivity to any component of Penester.
Use the drug with caution for violations of liver function.
Instructions for use of Penester: method and dosage
Penester should be taken orally. Food intake does not affect the effectiveness of the drug.
Adult patients are prescribed 1 tablet 1 time per day.
The duration of therapy is determined individually, but should be at least 6 months. In about 50% of cases, clinical symptoms disappeared within 12 months of treatment.
Side effects
- On the part of the reproductive system: decrease in ejaculate volume, breast tenderness, gynecomastia, decreased libido, impotence;
- Others: allergic reactions;
- Laboratory indicators: a slight (within the normal range) increase in the concentration of luteinizing and follicle-stimulating hormone.
The frequency of adverse reactions does not exceed 4% and usually decreases during treatment.
Overdose
There are known cases of a single dose of finasteride in doses up to 400 mg, as well as multiple administration of the drug in daily doses of up to 80 mg for 3 months. No adverse reactions were observed in patients.
Special treatment for an overdose of finasteride is not required.
special instructions
Before the appointment of Penester, the patient must undergo a complete examination in order to exclude the presence of other diseases that could lead to the development of benign prostatic hyperplasia, such as bladder hypotension, prostatitis of an infectious origin, urethral stricture, prostate cancer and a number of other changes in the urinary system. arising in some diseases of the nervous system.
Finasteride helps to reduce the prostate-specific antigen (by 41% and 48% by 6 and 12 months from the start of therapy, respectively), therefore, patients should be examined periodically during treatment to exclude prostate cancer in them.
Pregnant women and women of childbearing age should avoid contact with crushed Penester tablets, since finasteride is able to suppress the conversion of testosterone to dihydrotestosterone, as a result of which a violation of the development of the genital organs in a male fetus is possible. In this case, the tablets are film-coated, therefore, if their integrity is not compromised, contact with the active substance is excluded.
Influence on the ability to drive vehicles and complex mechanisms
There were no reports of a negative effect of Penester on the patient's cognitive, mental and motor functions.
Application during pregnancy and lactation
Penester is not intended for use in women.
Due to the ability of finasteride to suppress the conversion of testosterone to dihydrotestosterone, Penester, if ingested by a woman during pregnancy, can cause abnormalities in the development of the external genital organs in a male fetus. Pregnant women and women of reproductive age are advised to avoid contact with damaged tablets.
Finasteride was found in small amounts in the seminal fluid of men who received the drug in a daily dose of 5 mg. There are no clinical data on its effect on male fetuses. However, women whose partners take Penester are advised to use reliable contraception and avoid contact with semen as a safety precaution.
Pediatric use
Penester is not used in pediatric practice.
With impaired renal function
In case of impaired renal function, correction of the dosage regimen of the drug is not required.
For violations of liver function
Patients with hepatic impairment should be careful while using Penester.
Use in the elderly
In old age, Penester should be used with caution.
Drug interactions
No clinically significant interaction of Penester with other drugs was found.
Analogs
Penester's analogues are: Zerlon, Alfinal, Proscar, Urofin, Finast, Finasterid-OBL, Finasterid-Teva, Proterid, Finpros.
Terms and conditions of storage
Keep out of the reach of children. No special storage conditions are required.
The shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Penester
In general, the reviews about Penester are positive. Patients note the effectiveness of the drug against symptoms of benign prostatic hyperplasia, but most complain about the development of side effects, the most common of which is the dilution of the ejaculate and a decrease in its volume.
Price for Penester in pharmacies
Approximate price of Penester (coated tablets, 5 mg) per package 30 pcs. amounts to 462-538 rubles; per package 90 pcs. - 1199-1320 rubles.
Penester: prices in online pharmacies
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Drug name Price Pharmacy |
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Penester 5 mg film-coated tablets 30 pcs. 364 RUB Buy |
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Penester tablets p.o. 5mg 30 pcs. 436 r Buy |
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Penester 5 mg film-coated tablets 90 pcs. 1129 RUB Buy |
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Penester tablets p.o. 5mg 90 pcs. 1146 RUB Buy |
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
