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Indications And Usage Tolcapone Tablets, Usp Is Indicated As An Adjunct To Levodopa And Carbidopa For The Treatment Of The Signs And Symptoms Of Idiopathic Parkinson's Disease. Because Of The Risk Of Potentially Fatal, Acute Fulminant Liver Failure, Tolcapone Tablets, Usp Should Ordinarily Be Used In Patients With Parkinson's Disease On L-Dopa/carbidopa Who Are Experiencing Symptom Fluctuations And Are Not Responding Satisfactorily To Or Are Not Appropriate Candidates For Other Adjunctive Therapies. Because Of The Risk Of Liver Injury And Because Tolcapone Tablets, Usp, When It Is Effective, Provides An Observable Symptomatic Benefit, The Patient Who Fails To Show Substantial Clinical Benefit Within 3 Weeks Of Initiation Of Treatment, Should Be Withdrawn From Tolcapone Tablets, Usp. The Effectiveness Of Tolcapone Tablets, Usp Was Demonstrated In Randomized Controlled Trials In Patients Receiving Concomitant Levodopa Therapy With Carbidopa Or Another Aromatic Amino Acid Decarboxylase Inhibitor Who Experienced End Of Dose Wearing-Off Phenomena As Well As In Patients Who Did Not Experience Such Phenomena (See Clinical Pharmacology : Clinical Studies ).
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