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Entacapone oral

Updated 2 Feb 2023 | Other dopaminergic drugs


Tablets containing entacapone

Drugs List

  • COMTESS 200mg tablets
  • entacapone 200mg tablets
  • Therapeutic Indications


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

    Indicated as an adjunct to standard preparations of levodopa/benserazide or levodopa/carbidopa for use in patients with Parkinson's disease and end-of-dose motor fluctuations, who cannot be stabilised on those combinations.



    One 200 mg tablet taken with each levodopa/dopa decarboxylase inhibitor dose, up to a maximum of 200 mg ten times daily (total 2 g entacapone).

    To reduce undesirable side effects, the dose of anti-parkinson drugs may need to be adjusted when entacapone is initiated.

    Entacapone enhances the effect of levodopa. To reduce levodopa - related dopaminergic side effects, it may be necessary to adjust the levodopa dosage reducing it by about 10 to 30% within the first few days to first weeks of initiating entacapone. This may be achieved by extending the dosing intervals and/or reducing the amount of levodopa per dose according to the clinical condition of the patient.

    If entacapone is discontinued, adjustment of dosing of other anti-parkinson drugs will be required.


    (See Dosage; Adult)

    Patients with Renal Impairment

    For patients receiving dialysis therapy a longer dosing interval may be considered.


    Children under 18 years
    Hepatic impairment
    History of neuroleptic malignant syndrome
    History of non-traumatic rhabdomyolysis

    Precautions and Warnings

    Ischaemic heart disease
    Renal dialysis

    Consider increasing dose interval for dialysis patients
    Advise ability to drive/operate machinery may be affected by side effects
    Advise patient that sudden onset sleep episodes may affect ability to drive
    Some products contain arachis (peanut) oil, soya or soya derivative
    Take at a different time from iron supplement
    Monitor patient's weight
    Monitor patients for impulse control disorders
    Monitor weight loss if side effect of diarrhoea occurs and is tolerated
    Review treatment if impulse control disorders symptoms occur
    Advise patient that postural hypotension may occur
    Lower dose of levodopa initially to reduce dopaminergic side effects
    Avoid abrupt withdrawal: May cause signs of neuroleptic malignant syndrome
    Advise patient urine may be coloured reddish brown
    Advise patient/carer about symptoms of impulse control disorders

    Isolated cases of Neuroleptic Malignant Syndrome have been reported, especially following abrupt reduction or discontinuation of entacapone and other dopaminergic medications. When necessary, withdrawal of entacapone and other dopaminergic treatment should proceed slowly, and if signs and/or symptoms occur despite a slow withdrawal, an increase in levodopa dosage may be necessary.

    The doses of other antiparkinsonian medications may need to be adjusted when entacapone treatment is initiated.

    Entacapone increases the bioavailability of levodopa from standard levodopa/benserazide combinations slightly (5 to 10%) more than from standard levodopa/carbidopa ones. Therefore on initiation of entacapone, patients taking a levodopa/benserazide combination may need a larger reduction in the levodopa dose.

    For patients who experience progressive anorexia, asthenia and weight decrease within a relatively short period of time, a general medical evaluation including liver function should be considered.

    Pregnancy and Lactation


    Entacapone is contraindicated in pregnancy.

    Animal studies have shown entacapone was teratogenic in rats at plasma levels of entacapone close to those observed in humans. Although no teratogenic effect was seen in rabbits (Briggs, 2011).

    There is no experience in pregnant women. Schafer (2007) concludes that the inadvertent use of entacapone is not grounds for termination of pregnancy or for invasive diagnostic procedures. A detailed ultrasonography may be considered.

    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 to 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 ( ).


    Entacapone is contraindicated in breastfeeding.

    At the time of writing no reports describing the use of entacapone during human breastfeeding have been located. The molecular weight (about 305) is low enough that excretion into milk should be expected, but the relatively short elimination half-life should limit the amount in milk (Briggs, 2011).

    In animal studies entacapone was excreted in milk. The safety of entacapone in infants is unknown.

    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
    Altered liver function tests
    Angina pectoris
    Cholestatic hepatitis
    Darkening of urine
    Discolouration of hair
    Discolouration of nails (temporary)
    Discolouration of urine
    Dream abnormalities
    Dry mouth
    Erythematous rash
    Increased libido
    Increased sweating
    Maculopapular rash
    Myocardial infarction
    Neuroleptic malignant syndrome
    Orthostatic hypotension
    Pathological gambling
    Skin discolouration
    Sudden sleep onset episodes
    Weight loss
    Worsening of Parkinson's disease


    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: March 2014

    Reference Sources

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

    Joint Formulary Committee. British National Formulary. 66th ed. London: BMJ Group and Pharmaceutical Press; 2013. Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press [Accessed on [March 12, 2014]].

    Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.

    Summary of Product Characteristics: Comtess 200mg film-coated tablets. Orion Pharma (UK) Ltd. Revised August 2013.

    Summary of Product Characteristics: Entacapone 200mg film-coated tablets. Wockhardt UK Ltd. Revised February 2013.

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