There is evidence that patients treated with PROSCAR ® in a dose of 400 mg once daily, and in a dose of 80 mg a day for 3 months, there was no appearance of any symptoms of overdose.
Specific recommendations overdose treatment halotestin drug ® no.
INTERACTION WITH OTHER DRUGS
No clinically significant interactions of the drug ® with other drugs have been identified.
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 application preparation ® with propranolol, digoxin, glibenclamide, warfarin, theophylline and phenazone.
Although no special studies of drug interactions in clinical studies PROSCAR ® was used together with inhibitors angiotenzinprevragtsayuschego enzyme, paracetamol, acetylsalicylic acid, alpha-blockers, beta-blockers, blockers “slow” calcium channel blockers, nitrates in various dosage forms, diuretics, blockers of H 2 histamine receptors, lipid-lowering drugs reductase inhibitors, nonsteroidal antiinflammatory drugs (NSAIDs), quinolone derivatives and benzodiazepines without any clinically significant adverse interactions.
Cautions Effects on maintenance and diagnosis of prostate cancer is still no proven clinical benefits of the drug use of ® in patients with prostate cancer. In controlled clinical trials in patients with BPH and elevated halotestinconcentrations were monitored PSA content and results of prostate biopsy studies. It has been found that the use of PROSCAR preparation ® , apparently, does not change the frequency of prostate cancer and has no effect on the frequency of its occurrence in patients treated with ® or placebo.
Before treatment and periodically during therapy® recommended rectal research and use other methods of diagnosis of cancer of the prostate. Determination of Serum PSA is also used for prostate cancer. In general, the initial concentration of above Jung / ml indicates the need for further examination of the patient and a biopsy. In determining the concentration of PSA in the 4-10 ng / ml is necessary to further examination of the patient. The concentration of in men with prostate cancer and without this disease may coincide to a great extent, so BPH in men with normal levels of do not allow to exclude prostate cancer, regardless of treatment with PROSCAR ® .
The initial concentration of less than 4 ng / ml, does not exclude prostate cancer. ® causes a decrease in serum 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 PROSCAR ® , as the decline in PSA does not rule out concomitant prostate cancer. This reduction is possible to predict with any range of PSA values, although it may vary in individual patients. Analysis of PSA values in more than 3000 patients in the 4-year, double-blind, placebo-controlled studyhalotestinconfirmed that taking PROSCAR ® , for 6 months or more, PSA values should be doubled for comparing them with normal values of this indicator in patients not receiving drug treatment. This adjustment preserves the sensitivity and specificity of PSA analysis and the ability to detect prostate cancer. Any continued increase in PSA levels of patients treated with finasteride, requires a thorough examination to determine the cause, which may be in non-compliance receiving PROSCAR drug ® . PROSCAR ® does not significantly reduce the the percentage of free PSA (free to total PSA ratio). This indicator remains constant even under the influence of the drug receiving PROSCAR ® . If the percentage of free PSA is used, correction values of this index is not required for the diagnosis of prostate cancer.
Effect on laboratory parameters content. Concentration in plasma is correlated with patient age and prostate volume, and the volume of the prostate gland, 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 treated with PROSCAR ® . In most patients, a rapid decrease in content is observed in the first months of therapy, after which it takes place to stabilize at a new level, which is typically about half of the value measured prior to initiating therapy. In this regard, patients taking ® for 6 months or longer and, should double the value of for its comparison with normal males without taking ® .
Contact with finasteride halotestin is associated with the risk of teratogenicity for the male fetus
Pregnant women and women of childbearing age should avoid contact with crushed or loss of integrity of tablets PROSCAR drug ® because of the possibility of absorption of finasteride, due to the high risk of teratogenic effects for the male fetus (see. section “Pregnancy and lactation”). Tablets PROSCAR ® film coating that prevents contact with the active substances, provided that the tablets are not milled and have not lost integrity.