Monograph Details
|
|
Central Nervous System
> Parkinsonism
|
|
TASMAR |
| Manufacturer |
|
Valeant Pharmaceuticals, Inc |
| Legal Classification |
|
Rx
|
| Pharmacological Class |
|
COMT inhibitor. |
| Generic Name |
|
Tolcapone 100mg, 200mg; tabs. |
| Indications |
|
Adjunct to carbidopa/levodopa in idiopathic Parkinson's disease patients who have symptom fluctuations and for whom other adjunctive therapies are inappropriate or inadequate. |
| Children |
|
Not applicable. |
| Adults |
|
100mg three times daily; may cautiously increase to 200mg three times daily. Discontinue if no substantial benefit after 3 weeks. |
| Contraindications |
|
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. Concomitant non-selective MAOIs (eg, phenelzine, isocarboxazid, tranylcypromine): not recommended. |
| Precautions |
|
Obtain informed written consent. Severe dyskinesia or dystonia. Before starting and when increasing dose: do transaminases at baseline, then every 2–4 weeks for 6 months, then periodically if clinically relevant. Monitor for liver disease (eg, jaundice, fatigue, anorexia). Discontinue if signs or symptoms of liver disease develop or if serum transaminases >2xULN. Orthostatic hypotension/syncope. Diarrhea (follow-up if persistent). Reduce levodopa dose if dyskinesias appear or worsen. Severe renal impairment (CrCl <25mL/min). Monitor patient closely when withdrawing therapy. Pregnancy (Cat.C). Nursing mothers. |
| Interactions |
|
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. |
| Adverse Reactions |
|
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), fulminant liver failure and death, rhabdomyolysis, hematuria, others. |
| How Supplied |
|
Tabs—90 |
| Additional Resources |
|
• Related Prescribing Note |
|
|
|
|
