Drugs List

Therapeutic Indications

Uses

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.

Contraindications

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

Precautions and Warnings

Glucose-galactose malabsorption syndrome
Lactose intolerance
Pregnancy
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

Pregnancy

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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

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 https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abdominal pain
Anorexia
Chest pain
Confusion
Constipation
Diarrhoea
Discolouration of urine
Dizziness
Dyskinesia
Dyspepsia
Dystonia
Hallucinations
Headache
Hepatotoxicity
Hyperhidrosis
Hypokinesia
Increase in serum ALT/AST
Increased dreaming
Influenza
Nausea
Neuroleptic malignant syndrome
Orthostatic hypotension
Rhabdomyolysis
Severe hepatocellular damage
Sleep disturbances
Somnolence
Syncope
Upper respiratory tract infection
Vomiting
Xerostomia

Presentation

Oral formulations containing tolcapone

Drugs List

Therapeutic Indications

Uses

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.

Dosage

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.

Adults

Elderly

Contraindications

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

Precautions and Warnings

Glucose-galactose malabsorption syndrome
Lactose intolerance
Pregnancy
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

Pregnancy

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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

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 https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abdominal pain
Anorexia
Chest pain
Confusion
Constipation
Diarrhoea
Discolouration of urine
Dizziness
Dyskinesia
Dyspepsia
Dystonia
Hallucinations
Headache
Hepatotoxicity
Hyperhidrosis
Hypokinesia
Increase in serum ALT/AST
Increased dreaming
Influenza
Nausea
Neuroleptic malignant syndrome
Orthostatic hypotension
Rhabdomyolysis
Severe hepatocellular damage
Sleep disturbances
Somnolence
Syncope
Upper respiratory tract infection
Vomiting
Xerostomia

Overdosage

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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

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