
Active ingredient: Tolcapone
Antiparquisionian
Due to the risk of potentially fatal acute fulminant liver failure, tolcapone normally be used in patients with Parkinson's disease with levodopa / carbidopa who are experiencing symptom fluctuations and are not responding satisfactorily or are not candidates for other adjunctive treatments.
Due to the risk of liver injury and because tolcapone, when effective, provides symptomatic benefit observed, the patient does not show a substantial clinical benefit within 3 weeks of treatment, you should retirarel tolcapone.
TheTolcapone treatment has not to be started if the patient exhibits clinical evidence of liver disease or two SGPT / ALT or SGOT / AST values greater than the upper limit of normal. Patients with severe dyskinesia or dystonia should be treated with caution.
Patients who develop signs of hepatocellular injury and to take tolcapone and remove them for any reason drugs may be at increased risk of liver damage when reintroducing tolcapone. Consequently, these patients should not normally be considered for treatment a second time.
Cases of severe hepatocellular injury, including fulminant hepatic failure resulting in death have been reported in use after leaving the pharmaceutical market. In May 2005, 3 fatal cases of fulminant hepatic failure have been reported more than 40,000 patient-years of use worldwide. This incidence may be 10 times to 100 times the background incidence in the general population. The reporting of cases may lead to a significant underestimation of the increased risk associated with the use of tolcapone. All 3 cases were reported in the first six months of starting treatment with tolcapone. Laboratory analysis of data control in more than 3,400 patients treated with tolcapone in clinical trials indicated that increased SGPT / ALT or SGOT / AST, when present, generally occurred within the first 6 months of treatment with tolcapone.
It is advisable to control the administration of tolcapone with an increased risk of liver injury. It is recommended to monitor patients for evidence of liver damage emerging. Patients should be advised of the need for controls for both the classic signs of liver disease (eg, clay-colored, jaundice) and nonspecific (eg, fatigue, loss of appetite, lethargy).
Before starting treatment with tolcapone, the physician should perform appropriate tests for the presence of liver disease. In patients identified as appropriate candidates for treatment with tolcapone, glutamic-pyruvic transaminase (SGPT / ALT) and glutamic-oxaloacetic transaminase (SGOT / AST) were determined at baseline and periodically (every 2 to 4 weeks) the first 6 months of treatment. After the first six months, periodic monitoring is recommended at intervals deemed clinically relevant. Although most increases the likelihood of frequent monitoring of early detection, the precise timing for surveillance is a matter of clinical trial. Increasing the dose of 200 mg three times a day, monitoring of liver enzymes should be performed before increasing the dose is then performed every 2 to 4 weeks for the next 6 months of treatment. After six months, periodic monitoring is recommended at intervals deemed clinically relevant.
HOW TO USE: This medication is recommended for use in Parkinson's medicine (eg, levodopa / carbidopa). The drug is taken by mouth as directed, usually three times a day with or without food. Follow all instructions as this other drug and dose adjustments may be necessary during treatment. Do not stop using this medication suddenly, or decrease the dose without consulting your doctor. Serious side effects can result. Benefits should be detectable within 3 weeks. Please consult your doctor.
Tasmar 100 mg 100 cpr 130,00 € |