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Home Contact Us Full Prescribing Information for Zelapar Full Prescribing Information for Tasmar, including Boxed Warning

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Welcome to the Valeant Pharmaceuticals Customer Support Site for Zelapar and Tasmar. This website is designed to give you the ability to order complimentary literature and download sample request forms for Zelapar and Tasmar. We would also like to remind you that Valeant Pharmaceuticals has a new, easy to use product support service. For further information, please contact our product support team at 1-800-505-4423.

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Important Safety Information

TASMAR (tolcapone) is indicated as an adjunct to levodopa and carbidopa for the treatment of the signs and symptoms of idiopathic Parkinson's disease.

TASMAR SHOULD NOT BE USED BY PATIENTS UNTIL THERE HAS BEEN A COMPLETE DISCUSSION OF THE RISKS AND PATIENT HAS PROVIDED WRITTEN ACKNOWLEDGMENT THAT THE RISKS HAVE BEEN EXPLAINED (SEE PATIENT ACKNOWLEDGMENT OF RISKS SECTION).

WARNING: Due to the risk of potentially fatal, acute fulminant liver failure, TASMAR should ordinarily be used in patients with Parkinson's disease on levodopa/carbidopa who have symptom fluctuations and are not responding satisfactorily to or who are not appropriate candidates for other adjunctive therapies (see INDICATIONS and DOSAGE AND ADMINISTRATION).

TASMAR should not be initiated in patients with clinical evidence of liver disease or SGPT/ALT or SGOT/AST values > 2X ULN and should be discontinued if substantial clinical benefit is not seen within 3 weeks.

Patients with severe dyskinesia or dystonia should be treated with caution (see PRECAUTIONS: Rhabdomyolysis).

Laboratory monitoring is recommended (see PRECAUTIONS: Laboratory Tests for the recommended schedule).

Liver monitoring may not prevent liver failure; however, early detection and immediate drug withdrawal are believed to enhance the likelihood of recovery. Patients should be advised to self-monitor for signs of liver disease. Discontinue TASMAR if hepatic enzymes exceed 2 times (2X) ULN or patient exhibits signs of liver failure.

TASMAR is contraindicated in patients with liver disease and in patients who were withdrawn from TASMAR because of evidence of TASMAR-induced hepatocellular injury or who have demonstrated hypersensitivity to the drug or its ingredients. TASMAR is also contraindicated in patients with a history of non-traumatic rhabdomyolysis or hyperpyrexia and confusion possibly related to medication
In clinical trials, adverse events reported at a frequency of >10% when TASMAR was administered in combination with levodopa/carbidopa were dyskinesia, nausea, sleep disorder, dystonia, anorexia, diarrhea, somnolence, excessive dreaming, muscle cramps, orthostatic complaints, dizziness, headache, and confusion
The majority of these effects are dopaminergic and may be reduced by decreasing the dose of levodopa; however, some may persist despite levodopa dosage adjustment
Diarrhea was the adverse event that most commonly led to discontinuation
Patients with severe renal impairment or severe dyskinesia or dystonia should be treated with caution
The following notable dopaminergic effects occurred but infrequently led to the discontinuation of TASMAR therapy: symptomatic hypotension (approximately 0.7% of patients withdrew); hallucinations (1.0% to 1.4%); dyskinesia (0.3% to 1.0%)
Cases of severe rhabdomyolysis have been reported; it is impossible to determine what role, if any, TASMAR played in the pathogenesis. Rare cases of hyperpyrexia and confusion have been reported similar to those reported in association with dose reduction or abrupt withdrawal of other dopaminergic drugs. It is difficult to determine what role TASMAR may have played. The postmarketing cases involved concomitant administration of several medications affecting brain monoaminergic and anticholinergic systems
TASMAR should not be given in conjunction with nonselective MAO inhibitors such as phenelzine and tranylcypromine. TASMAR can be given concomitantly with a selective MAO-B inhibitor (eg, selegiline)
Patients should be advised not to drive a car or operate complex machinery until they have gained sufficient experience on TASMAR to know how it affects them

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Important Safety Information

Zelapar® is indicated as an adjunct therapy for Parkinson's disease patients being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to this therapy. Zelapar® is contraindicated in patients with a known hypersensitivity to any formulation of selegiline or any of the inactive ingredients of Zelapar. Zelapar is also contraindicated for use with meperidine and should not be administered with the analgesic agents tramadol, methadone, and propoxyphene. Zelapar should not be used with the antitussive agent dextromethorphan and should not be administered along with other selegiline products/MAO inhibitors, including selective MAO-B inhibitors.

Daily doses of Zelapar should not exceed 2.5 mg/day because of the risks associated with nonselective inhibition of MAO.

In general, the combination of Zelapar and tricyclic antidepressants, as well as Zelapar and serotonin reuptake inhibitors, should be avoided.

In clinical trials, the incidence of adverse orthostatic hypotension was higher in geriatric patients than in nongeriatric patients. Zelapar may potentiate the dopaminergic side effects of levodopa and may cause or worsen preexisting dyskinesia. Decreasing the dose of levodopa may improve this side effect.

Zelapar should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus

The most commonly observed adverse events reported during clinical trials were dizziness, nausea, pain, headache, insomnia, rhinitis, dyskinesia, back pain, skin disorders, stomatitis, and dyspepsia. In addition, 5.2% of patients discontinued Zelapar therapy due to adverse events (versus 1% with placebo).

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