Generic Name and Formulations:
Tolcapone 100mg; tabs.
Valeant Pharmaceuticals, Inc
Indications for TASMAR:
Adjunct to carbidopa/levodopa in idiopathic Parkinson's disease patients who have symptom fluctuations and for whom other adjunctive therapies are inappropriate or inadequate.
100mg three times daily; may cautiously increase to 200mg three times daily. Discontinue if no substantial benefit after 3 weeks.
Liver disease (clinical evidence or serum transaminases 2xULN). Previous tolcapone-associated hepatocellular injury. History of non-traumatic rhabdomyolysis or fever and confusion possibly related to medication.
Risk of potentially fatal, acute fulminant liver failure.
Obtain informed written consent. Risk of liver injury. Before starting and when increasing dose: do transaminases at baseline, then every 2–4 weeks for 6 months, then periodically if clinically relevant. Discontinue if signs/symptoms of liver disease (eg, jaundice, fatigue, anorexia) develop or if serum transaminases >2xULN. Reduce levodopa dose if dyskinesias appear or worsen. Orthostatic hypotension/syncope. Diarrhea (follow-up if persistent). Severe renal impairment (CrCl <25mL/min). Monitor for compulsive behaviors; consider reduce dose or discontinuation. Do periodic skin exam. Monitor patient closely when withdrawing therapy. Pregnancy (Cat.C). Nursing mothers.
Concomitant non-selective MAOIs (eg, phenelzine, isocarboxazid, tranylcypromine): not recommended. Reduce concomitant levodopa dose. CNS depression potentiated with alcohol, other CNS depressants. May potentiate other drugs metabolized by COMT (eg, methyldopa, dobutamine, isoproterenol); monitor and reduce dose as needed. Monitor warfarin.
Dyskinesias, nausea, sleep disorders, dystonia, excessive dreaming, anorexia, muscle cramps, orthostatic complaints, somnolence, diarrhea, confusion, dizziness, headache, hallucinations, vomiting, constipation, fatigue, upper respiratory or urinary tract infection, falling, increased sweating, syncope, xerostomia, urine discoloration (yellow); liver injury (may be fatal), rhabdomyolysis, hematuria, compulsive behavior, others.