Penester tab n / 5mg film about 90 pc

$29.31

Penester tab n / 5mg film about 90 pc

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Description

Composition
Active substance:
1 tablet contains: 5 mg finasteride ;.
Excipients:
Lactose monohydrate, corn starch, povidone K30, sodium carboxymethylstarch (type A), sodium docusate, magnesium stearate; film coating: Hypromellose 2910/5, macrogol 6000, talc, titanium dioxide, simethicone emulsion SE4, iron oxide yellow dye.
Description:
Round, biconvex pale yellow in color, covered with a foil wrapper.
Product form:
Film-coated tablets 5 mg. 10 or 15 tablets in a blister made of PVC / PVDC / A1. 3 blisters (10 tablets) or 2 or 6 blisters (15 tablets) are placed in a cardboard box, together with instructions for use.
Contraindications
Hypersensitivity to any component of the drug. Age up to 18 years; Pregnancy and use of the drug in women of childbearing age (see section “Pregnancy and lactation”.); Patients with a rare hereditary lactose intolerance, lactase deficiency or glucose-galactose malabsorption should not take this medication C caution in patients with a large amount of residual urine and / or a substantially reduced rate of urination; Patients with liver failure; the elderly.
Dosage
5 mg
Indications
BPH treatment and prevention of urological complications in order to: reduce the risk of acute urinary retention; reduce the risk of the need for surgery including transurethral resection (TUR) of the prostate and prostatectomy. Treatment to reduce the size of an enlarged prostate gland, improve urination and reduce the severity of symptoms associated with BPH. In combination with doxazosin to reduce the risk of progression of symptoms associated with BPH.
Interaction with other drugs
Not detected clinically significant interactions with other drugs finasteride. Finasteride, apparently has no significant effect on cytochrome P450 metabolism of drugs and associated with the system. There were no clinically significant interactions when combined with the use of finasteride propranolol, digoxin, glibenclamide, warfarin, theophylline and phenazone. Despite the absence of specific studies of drug interactions in clinical studies finasteride was used together with inhibitors of angiotensin-converting enzyme (ACE) inhibitors, acetaminophen, acetylsalicylic acid, alpha-blockers, beta-blockers, blockers “slow” calcium channel blockers, nitrates in different dosage forms, diuretics, blockers H2 – histamine receptors, inhibitors of HMG-CoA reductase inhibitors, nonsteroidal antiinflammatory drugs (NSAIDs), derivatives of x inolona and benzodiazepines with no clinically significant adverse interactions.
Overdose
Currently, cases of overdose of finasteride has not been reported.
pharmachologic effect
Pharmacological group:
5-alpha reductase inhibitor.
Pharmacodynamics:
Finasteride – synthetic 4-azasteroid compound, a specific inhibitor of 5-alpha reductase type II – intracellular enzyme that converts testosterone into the more active androgen – dihydrotestosterone (DHT). In benign prostatic hyperplasia (BPH) is dependent on its increase the conversion of testosterone to DHT in the prostate. Finasteride is highly effective in reducing DHT concentration in blood and in prostate tissue. Suppression of DHT accompanied by a decrease prostate size, increase the maximum rate of urination and decrease the severity of symptoms associated with benign prostatic hyperplasia. Finasteride has no affinity for the androgen receptor. The drug has no significant effect on the lipid profile (i.e., total cholesterol, low density lipoproteins (LDL), high density lipoproteins (HDL) and triglycerides), and bone mineral density. Finasteride has no effect on the blood levels of cortisol, estradiol, prolactin, thyroid stimulating hormone and thyroxine as compared to placebo. Single administration of finasteride in a dosage of 5 mg leads to a rapid decrease in serum concentrations of DHT to a peak effect after 8 hours. Although finasteride that the concentration in the blood plasma subjected to vibrations for 24 h, the concentration of DHT remains constant. This means that finasteride plasma concentrations are not directly related to the concentration of DHT in the blood plasma. Patients with DHT, which Finasteride 5 mg per day was administered for 4 years, there was a decrease in the concentration of blood DHT of approximately 70%, which was associated with a decrease in prostate volume by approximately 20%. Additionally, approximately 50% decreased the concentration of prostate-specific antigen (PSA), compared with its initial concentration, which implies a reduction of growth of prostate epithelial cells. Reducing the concentration of DHT and reducing the severity of prostatic hyperplasia, accompanied by a decrease in PSA concentration remained in studies of up to 4 years. In these studies, the blood testosterone increased by about 10-20%, while remaining within physiological values. In the application of finasteride for 7-10 days in patients referred for prostatectomy decreased DHT concentration in the prostate tissue by about 80% and an increase in the concentration of testosterone in prostatic tissue 10 times compared to the concentration before treatment. It was found that long-term (over 4 years), the use of finasteride in patients with benign prostatic hyperplasia and moderately expressed or significantly distinct symptoms of the disease reduced the risk of urological complications (surgery: Transurethral resection of the prostate, or prostatectomy, acute urinary retention requiring catheterization) by 51% was accompanied by a marked and persistent reduction in prostate volume, and persistent increase in maximum urinary flow rate and improvement in symptoms (study PLES S). Patients treated with finasteride for 3 months and achieving decrease prostate volume by about 20%, at termination of treatment the volume of the prostate gland returned to the same size after 3 months. Thus, treatment with finasteride reduces prostate size increased, increases the speed and reduces urinary symptoms associated with BPH.
Pharmacokinetics:
Absorption: finasteride maximum concentration in plasma is achieved after about 2 hours after ingestion. Finasteride absorption from the gastrointestinal tract is completed in 6-8 hours after ingestion. Bioavailability of finasteride ingestion of about 80% of an intravenous reference dose and independent of food intake.
Distribution: association with plasma proteins is approximately 93%. Plasma clearance is about 165 ml / min, the volume of – 76 L. During prolonged therapy has been a slow accumulation of small amounts of finasteride. With daily administration of finasteride oral dose of 5 mg its minimum equilibrium concentration in plasma reached 8-10 ng / ml and over time remains stable. In patients treated with finasteride for 7-10 days, the drug was detected in the cerebrospinal fluid. When receiving finasteride in a dosage of 5 mg per day the drug is also found in the seminal fluid. Contents of finasteride in semen was 50-100 times less than the dose of finasteride (5 mg) which had no effect on the concentration of circulating DHT in adult males.
Metabolism: half-life (T1 / 2) of finasteride averages 6 hours
Excretion: in men after a single oral dose of finasteride labeled with 14 C, 39% of the dose is excreted by the kidneys as metabolites (finasteride is practically unchanged excreted by the kidneys); 57% – through the intestine. This study identified two metabolites of finasteride, which have little inhibitory effect on 5-alpha reductase, compared with finasteride. In old age, the rate of elimination of finasteride is somewhat reduced. With age, the half-life (T1 / 2) is increased: in males 18-60 years mean T1 / 2 at 6 hours, and in men over 70 years – 8 hours. These changes have no clinical relevance, and therefore, reduce the dose in elderly men is not required. In patients with chronic renal failure (creatinine clearance (CC) from 9 to 55 ml / min) the distribution of 14C-labeled finasteride when receiving a single dose did not differ from that in healthy volunteers. Communication finasteride plasma protein also did not differ in patients with impaired renal function. In renal insufficiency part metabolites of finasteride, which is normally excreted by the kidneys, outputted via the intestines. This is manifested by an increase amount of finasteride metabolites in feces with a corresponding reduction of their concentration in urine. In patients with renal failure who are on dialysis, the dose of finasteride correction is not required.
Pregnancy and breast-feeding
The use of finasteride is contraindicated during pregnancy and women of childbearing age. Due to the ability of inhibitors of 5-alpha reductase type II inhibit the conversion of testosterone to dihydrotestosterone, the data means including finasteride, when used in pregnant women can cause abnormal development of the external genitalia of the fetus is male. Finasteride is not indicated for use in women. Information about finasteride excretion in breast milk is not. Small amounts of finasteride were found in the semen of patients treated with finasteride 5 mg / day. Although clinical data on the effect of finasteride on the fetus male are not available, women of childbearing age should avoid contact with the semen of men taking finasteride. Women of childbearing age and pregnant women should avoid contact with damaged finasteride tablets, because ability of the drug to inhibit the conversion of testosterone to dihydrotestosterone can cause impaired development of genital organs of male fetus.
Conditions of supply of pharmacies
On prescription.
side effects
The frequency of adverse reactions was determined by the following grading respectively (World Health Organization classification): very frequent – 1/10 more frequent – from more than 1/100 to 1/10 less, infrequent – from more to less than 1/100 to 1/1000, rare – from more to less than 1/10000 1/1000, very rare – from less than 1/10000, including isolated reports; unknown frequency (frequency can not be set, since the information obtained on the basis of the post-marketing experience with the drug).
The most commonly encountered in patients, impotence and decreased libido, although the incidence of these adverse events gradually decreased during treatment.
Disorders of immune system: unknown frequency – hypersensitivity reactions, including angioedema.
Mental disorders: frequent – decreased libido; unknown frequency – depression.
Violations of the heart: unknown frequency – palpitations.
Violations of the liver and biliary tract: unknown frequency, increased activity of “liver” transaminases.
Violations of the skin and subcutaneous tissue disorders: rare – rash; unknown frequency – urticaria, pruritus.
Violations by the genitals and mammary glands: frequent – impotence, infrequent – abnormal ejaculation, enlargement and tenderness of the breast; unknown frequency – testicular pain, erectile dysfunction, male infertility and / or decrease in quality of semen.
The connection between long-term intake of finasteride and the occurrence of breast neoplasia in men has not been established at this time.
laboratory findings
Patients taking finasteride may decrease the concentration prostat- specific antigen (PSA).
Other differences in the levels of standard laboratory parameters between the groups of patients treated with finasteride and placebo was not observed.
special instructions
Effect on the content of PSA and diagnosis of prostate cancer
To date, no proven clinical benefit PENESTER® drug application in patients with prostate cancer. In controlled clinical trials in patients with BPH, and an increased concentration of PSA PSA content was monitored and the results of prostate biopsy studies. It has been found that the use of finasteride, apparently, does not change the frequency of detection of cancer of the prostate and no effect on the frequency of its occurrence in patients treated with finasteride or placebo. Before beginning treatment and periodically during therapy with PENESTER® recommended rectal examination and use other methods of cancer diagnosis prostate. PSA in the blood plasma was also used to detect prostate cancer. In general, the initial concentration of PSA is above 10 ng / ml to the need of further examination and biopsy of the patient. In determining the concentration of PSA in the range 4-10 ng / ml is necessary to further examination of the patient. PSA concentration in men with prostate cancer and without the disease may coincide to a great extent, so in men with BPH normal PSA values ​​do not allow to eliminate prostate cancer, regardless of drug treatment PENESTER®. The initial concentration of PSA less than 4 ng / ml, does not exclude prostate cancer. PENESTER® causes a decrease in serum PSA concentration of approximately 50% in patients with BPH, even in the presence of prostate cancer. This fact must be taken into account when assessing the content of PSA in patients with BPH treated with drug PENESTER® as lower PSA does not rule out concomitant prostate cancer. This reduction is possible to anticipate in any range of values ​​of concentration of PSA, though it may vary in individual patients. Analysis of PSA values ​​in more than 3000 patients in a 4-year double placebo-controlled, blind, PLESS study confirmed that taking finasteride for 6 months or more PSA values ​​must be doubled to match them with the normal values ​​of the indicator in patients not receiving drug treatment. This adjustment preserves the sensitivity and specificity of PSA testing and the ability to detect prostate cancer. Any continuing increase in PSA levels for patients receiving treatment with finasteride, requires careful examination to determine the cause, which may be in non-compliance mode receiving PENESTER® preparation. PENESTER® not significantly reduces the percentage of free PSA (fPSA ratio of the total). This indicator remains constant even under the influence of the drug. If the percentage of free PSA is used, correction values ​​of the given parameter is optional for diagnosing prostate cancer.
Influence on laboratory parameters
PSA content.
PSA concentration in the blood plasma correlates with the patient’s age and prostate volume and prostate volume, in turn, depends on the age of the patient. In determining the concentration of PSA should be noted that this figure is reduced in patients taking PENESTER®. In most patients, a rapid decrease in PSA content is observed in the first months of therapy, after which it takes place to stabilize at a new level, which is usually about half the value measured prior to initiating therapy. In this regard, patients taking PENESTER® for 6 months or more, it is necessary to double the value of PSA for its comparison with normal males without taking PENESTER®.
EFFECTS ON THE ABILITY OF VEHICLES AND MECHANISMS
On the adverse effects of the drug on the ability to drive and operate machinery has not been reported.
Storage conditions
It does not require any special storage conditions.
Keep out of the reach of children!.
Dosing and Administration
Inside, 1 to 5 mg once a day, regardless of the meal. Duration of therapy to assess its effectiveness should be at least 6 months. PENESTER® can be used as monotherapy and in combination with doxazosin.
Hepatic impairment: there are no sufficient data on the use of the drug in patients with hepatic insufficiency.
Renal insufficiency: patients with different stages of renal insufficiency (. In reducing CK and 9 ml / min) dose adjustment is required, because specific studies have not shown any changes pharmacokinetic profile finasteride
Elderly patients: no dose adjustment is required although pharmacokinetic studies indicate that the excretion of finasteride in patients older than 70 years is somewhat reduced.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist

Additional information

Weight0.100 kg
Manufacturer

SANOFI RUSSIA

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