Release form, composition and packing
Tablets, coated blue color film; in the form of an apple, with the engraving “of MSD 72 ‘on one side and” PROSCAR “- on the other.
Excipients: lactose monohydrate, pregelatinized starch (corn), sodium salt of carboxymethyl ether of starch, iron oxide yellow, docusate sodium, microcrystalline cellulose, magnesium stearate.
Composition of coating film: methylhydroxypropylcellulose, hydroxypropylcellulose, titanium dioxide, talc, indigo carmine aluminum lake.
14 pcs. – Blisters (1) – boxes cardboard.
14 pcs. – Blisters (2) – boxes cardboard.
Treatment of benign prostatic hyperplasia in order to:
– Prevention of urological complications (reduced risk of acute urinary retention) and to reduce the need for surgical procedures (including transurethral resection of the prostate and prostatectomy);
– Reducing the size of an enlarged prostate gland, improve urine flow and decrease the severity of symptoms associated with benign prostatic hyperplasia.
Therapy of Proscar is indicated in patients with an enlarged prostate.
- Ask urologist
- Buy drugs
- View establishments
– Hypersensitivity to the drug.
Proscar is not indicated for use in women and children.
With caution is prescribed to patients with large residual urine volume and / or significantly reduced urine current (should be carefully monitored for obstructive uropathy).
The recommended dose is 5 mg (1 tab.) 1 times / day regardless of the meal.
Proscar may be used alone or in combination with doxazosin .
For patients with renal failure of varying severity (with a decrease in QC to 9 ml / min) is not required for individual selection of doses, as pharmacokinetic studies did not reveal any changes in the distribution of finasteride in these patients.
For older patients is also no need for dose selection, although the pharmacokinetic studies indicate that the removal of finasteride in patients older than 70 years, several reduced.
The study PLESS safety assessment was performed in 1524 patients treated with Proscar 5 mg / day and 1516 patients receiving placebo for 4 years. At 4.9% (74) of the patients treated were canceled due to side effects attributed to Proscar, compared with 3.3% (50) of patients receiving placebo. At the same time 3.7% (57) patients treated with Proscar, and 2.1% (32) of patients treated with placebo, the treatment was canceled due to sexual dysfunction, which was the most frequently observed side effect.
In the first year of treatment of impotence, decreased libido, and ejaculation disorder were more common in patients treated with Proscar compared with placebo. When using Proscar for 2-4 year study the incidence of the above side-effects in patients taking Proscar, did not differ from that of patients receiving placebo.
From the reproductive system: tenderness of the testicles, impotence, decreased libido, ejaculation disorders, reduction of volume of ejaculate.
From endocrine system: an increase in pain and breast tenderness.
Allergic reactions: rash, pruritus, urticaria, angioneurotic edema of the lips and face.
With prolonged use of Proscar no increase in the frequency and severity of side effects, and the number of cases of sexual dysfunction associated with taking the drug is reduced during prolonged therapy.
safety and tolerability profile in the combined treatment with finasteride 5 mg / day and doxazosin 4 or 8 mg / day with a comparable safety and tolerability of each of said drugs in isolation.
The 7-year placebo-controlled study (which was included in 18,882 healthy men) on the results of the biopsy (in 9060 men), cancer of the prostate was diagnosed in 18.4% of patients treated with Proscar and 24.4% of patients receiving placebo. In 280 men (6.4%) in the Proscar and 237 men (5.1%) in the placebo group based on the results of the biopsy was diagnosed with prostate cancer, estimated at 7-10 Gleason. Approximately 98% of all cases of cancer tumor was intracapsular (stage T1 or T2).
From the laboratory parameters: reduction of prostate-specific antigen.
Proscar Patients received a single dose of 400 mg and in multiple doses up to 80 mg / day for 3 months, with no adverse effects were detected.
Recommendations for specific treatment Proscar no overdose.
There were no clinically significant interaction with other medications Proscar.
Apparently, Proscar has no appreciable effect on the activity of isoenzymes of cytochrome P 450 and the pharmacokinetics of drugs whose metabolism data isozymes are involved. The combined use of Proscar with propranolol, digoxin, glyburide, warfarin, theophylline, with ACE inhibitors, acetaminophen, acetylsalicylic acid, alpha-blockers, beta-blockers, calcium channel blockers , nitrates, diuretics, blockers of histamine H 2 receptor antagonists, inhibitors of GMG KoA-reductase inhibitors, NSAIDs, quinolones and benzodiazepines were found clinically significant manifestations of drug interactions.
The effect on the level of prostate-specific antigen and diagnosis of prostate cancer
So far, not shown positive clinical effect of Proscar patients with prostate cancer. Patients with BPH and elevated PSA level in controlled clinical trials (with a few definitions of PSA and biopsy of the prostate gland) Proscar therapy had no effect on the incidence of prostate cancer. The overall incidence of prostate cancer was not significantly different in patients treated with Proscar or placebo.
Before treatment Proscar and periodically during treatment with rectal examination should be performed, as well as the study of other methods to determine the presence of prostate cancer. Determination of Serum PSA is also used for prostate cancer. In general, when the initial level above 10 ng PSA / ml requires a wider examination of the patient, including, if necessary, the purpose of biopsy. When the level of PSA in the 4-10 ng / mL is recommended to further examination of the patient. There is considerable overlap in PSA levels in prostate cancer patients, and patients who do not have the disease. Consequently, BPH in men with normal PSA value does not allow to exclude prostate cancer, regardless of treatment Proscar. Initial PSA levels below 4 ng / ml did not exclude the presence of prostate cancer.
Proscar causes a decrease in serum PSA of approximately 50% in patients with BPH even in the presence of prostate cancer. In this connection it should be borne in mind that the reduction in PSA levels in patients with BPH treated with Proscar not exclude concomitant prostate cancer.
It is shown that in patients treated with Proscar for 6 months or more, PSA values should be doubled for comparison with their normal values of this indicator in patients who are not receiving treatment. This adjustment preserves the sensitivity and specificity of PSA analysis and the ability to detect prostate cancer.
Any sustained increase in PSA levels of patients treated with finasteride, requires a thorough examination to determine the cause, which may be in non-compliance with the use of Proscar.
Proscar does not significantly reduce the percentage of free PSA (ratio of free PSA to total). This indicator remains constant even under the influence of Proscar. If the percentage of free PSA is used, correction values of this index is not required for the diagnosis of prostate cancer.
Effects on laboratory parameters
The concentration of PSA in serum is correlated with patient age and prostate volume and prostate volume, in turn, depends on the age of the patient. In determining the PSA level should be noted that this figure is reduced in patients taking Proscar. In most patients, a rapid decrease in PSA is observed in the first months of therapy, after which it takes place to stabilize at a new level, which is usually half the value measured prior to initiating therapy. In this regard, patients taking Proscar for 6 months or more, it is necessary to double the value of PSA for its comparison with normal males without taking Proscar.
Pregnancy and lactation
Women of childbearing age and pregnant women should avoid contact with crushed or loss of integrity of the drug Proscar tablets because of the possibility of penetration of finasteride in the body of the pregnant woman and the subsequent risk for the development of the male fetus.
Due to the ability of inhibitors of 5-alpha-reductase type II inhibit the conversion of testosterone to dihydrotestosterone, these drugs, including finasteride, may cause abnormalities of prenatal form of the external genitalia in male fetus.
Proscar coated tablets, and this prevents contact with finasteride provided that the tablets are not milled and have not lost integrity.