Tasmar

TOLCAPONE

Manufacturer: Bausch Health US LLC

Score: 147.0

Quick Summary

Tasmar (TOLCAPONE) is a selective and reversible inhibitor of catechol-O-methyltransferase (COMT) used as an adjunct to levodopa/carbidopa in the treatment of Parkinson's disease. The drug has been shown to increase the bioavailability of levodopa, allowing for more sustained plasma levels and greater effects on the signs and symptoms of Parkinson's disease. However, Tasmar carries a boxed warning for potentially fatal, acute fulminant liver failure and should be used with caution in patients with liver disease or those who have experienced liver injury. The initial dose is 100 mg three times daily, and the recommended daily dose is also 100 mg tid. Special considerations are necessary for patients with impaired hepatic or renal function, as well as for pregnant or nursing women, and pediatric or geriatric patients.

Key Clinical Findings and Indications

Tasmar is used as an adjunct to levodopa/carbidopa in the treatment of Parkinson's disease
The drug increases the bioavailability of levodopa, allowing for more sustained plasma levels
Tasmar has been shown to be effective in reducing 'Off' time and improving motor function in patients with Parkinson's disease

Important Safety Information

Warning

Potentially fatal, acute fulminant liver failure

Contraindications

Patients with liver disease
Patients who have experienced liver injury
Patients with a history of nontraumatic rhabdomyolysis or hyperpyrexia and confusion

Adverse Reactions

Dyskinesia
Nausea
Diarrhea
Anorexia
Sleep disorder
Vomiting
Urine discoloration
Somnolence
Hallucination
Dystonia
Sweating

Dosing Recommendations

General Guidance

Dose reduction may be necessary in patients with impaired hepatic or renal function

Parkinson's disease

Adult Dose

100 mg tid

Pediatric Dose

Not established

Special Population Considerations

Pregnancy

Tasmar should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus
Animal studies have shown that tolcapone is excreted into maternal rat milk

Nursing Mothers

Caution should be exercised when tolcapone is administered to a nursing woman
It is not known whether tolcapone is excreted in human milk

Pediatric Use

There is no identified potential use of tolcapone in pediatric patients
The safety and efficacy of Tasmar in pediatric patients have not been established

Geriatric Use

Parkinson's disease is primarily an affliction of the elderly
Patients greater than 75 years of age may be more likely to develop hallucinations than patients less than 75 years of age