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Tolcapone oral

Updated 2 Feb 2023 | Other dopaminergic drugs


Oral formulations containing tolcapone

Drugs List

  • TASMAR 100mg film coated tablets
  • tolcapone 100mg tablets
  • Therapeutic Indications


    Parkinson's disease - adjunct to levodopa + dopa-decarboxylase inhibitor

    Parkinson's disease and end-of-dose motor fluctuations in combination with levodopa/benserazide or levodopa/carbidopa.

    Due to the risk of rare but potentially fatal acute liver injury, tolcapone is only indicated for use in patients with levodopa-responsive idiopathic Parkinson's disease and motor fluctuations, who failed to respond to, or are intolerant of other COMT inhibitors.


    Liver function should be monitored before initiating treatment. If liver function tests are abnormal or there are signs of hepatic impairment, tolcapone should not be prescribed.

    Tolcapone should be used only as an adjunct to levodopa/benserazide or levodopa/carbidopa therapy.


    100 mg three times daily.

    Only in exceptional cases should the dose be increased to 200 mg three times daily.

    The maximum dose of 600 mg daily should not be exceeded.

    If clinical benefit is not observed within 3 weeks of treatment, tolcapone therapy should be discontinued.


    (See Dosage; Adult)


    Children under 18 years
    Predisposition to malignant hyperthermia
    Hepatic impairment
    History of neuroleptic malignant syndrome
    History of non-traumatic rhabdomyolysis
    Severe dyskinesia

    Precautions and Warnings

    Glucose-galactose malabsorption syndrome
    Lactose intolerance
    Renal impairment - creatinine clearance below 30 ml/minute

    Starting/stopping this product may need dose adjustment of other medication
    Advise patient ability to drive or operate machinery may be impaired
    Treatment to be initiated and supervised by a specialist
    Contains lactose
    Monitor hepatic function before treatment and regularly during treatment
    Monitor patients for impulse control disorders
    Advise patient/carer to contact GP immediately if signs of liver disorder
    Discontinue if hepatic function deteriorates
    Discontinue if patient develops neuroleptic malignant syndrome
    Discontinue if there is no evidence of clinical benefit within 3 weeks
    Discontinue if transaminase levels exceed the normal
    May discolour urine yellow or brown

    Due to the risk of rare but potentially fatal acute liver injury, tolcapone is only indicated for use in patients with levodopa-responsive idiopathic Parkinson's disease and motor fluctuations, who failed to respond to, or are intolerant of other COMT inhibitors.

    Hepatic function should be monitored before commencing treatment, and every 2 weeks for the first year, and every 4 weeks for the next 6 months and at 8 weekly intervals thereafter. Hepatic function should be monitored before any increases in dose are made.

    Pregnancy and Lactation


    Use with extreme caution in pregnancy.

    In rats and rabbits, embryo-foetal toxicity was observed after tolcapone administration. The potential for humans is not known.

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( ) or if this is unavailable at the backup site ( ).


    Contraindicated in lactation.

    Tolcapone has been shown to be excreted into maternal milk in animal studies.

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at

    Side Effects

    Abdominal pain
    Chest pain
    Discolouration of urine
    Increase in serum ALT/AST
    Increased dreaming
    Neuroleptic malignant syndrome
    Orthostatic hypotension
    Severe hepatocellular damage
    Sleep disturbances
    Upper respiratory tract infection


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: June 2013

    Reference Sources

    British National Formulary, 65th Edition (March - September 2013) Pharmaceutical Press, London.

    Summary of Product Characteristics: Tasmar 100mg Tablets. Meda Pharmaceuticals. Revised March 2013

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