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ENTACAPONE HEC is a brand name for Entacapone. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Entacapone is indicated as an adjunct to standard preparations of levodopa/benserazide or levodopa/carbidopa for use in adult patients with Parkinson’s disease and end-of-dose motor fluctuations, who cannot be stabilised on the levodopa combinations.
Verbatim from this product's MHRA label. Tap a section to expand.
Entacapone should only be used in combination with levodopa/benserazide or levodopa/carbidopa. The prescribing information for the levodopa preparations is applicable to their concomitant use with entacapone. Posology One 200 mg tablet is taken with each levodopa/dopa decarboxylase inhibitor dose.
The maximum recommended entacapone dose is 200 mg ten times daily (2000 mg). Entacapone enhances the effects of levodopa. Hence, to reduce levodopa- related dopaminergic adverse reactions such as dyskinesias, nausea, vomiting and hallucinations, it is often necessary to adjust the levodopa dose within days or weeks of initiating entacapone treatment.
The daily dose of levodopa should be reduced by 10-30% either by reducing the amount of levodopa in each dose or by extending the dosing intervals, according to the clinical condition of the patient. If entacapone treatment is discontinued, it is necessary to adjust the dosing of other antiparkinsonian treatments, especially levodopa, to achieve a sufficient level of control of the parkinsonian symptoms.
Entacapone increases the bioavailability of levodopa from standard levodopa/benserazide preparations by 5-10% more than from standard levodopa/carbidopa preparations. Hence, patients who are taking standard levodopa/benserazide preparations may need a larger reduction of levodopa dose when entacapone is initiated.
Patients with renal impairment:
Renal insufficiency does not affect the pharmacokinetics of entacapone and there is no need for dose adjustment. 2).
Patients with hepatic impairment:
See section
a. Summary of the safety profile The most frequent adverse reactions caused by entacapone relate to the increased dopaminergic activity and occur most commonly at the beginning of treatment. Reduction of the levodopa dose decreases the severity and frequency of these reactions.
The other major class of adverse reactions is gastrointestinal including nausea, vomiting, abdominal pain, constipation and diarrhoea. Urine may be discoloured reddish-brown by entacapone but this is a harmless phenomenon. Usually the adverse reactions caused by entacapone are mild to moderate.
7%). 2%) were reported significantly more often with entacapone than with placebo in pooled data from clinical studies involving 406 patients taking the medicinal product and 296 patients taking placebo. Some of the adverse reactions, such as dyskinesia, nausea and abdominal pain, may be more common with the higher doses (1,400 to 2,000mg per day) than with lower doses of entacapone.
b. Tabulated list of adverse reactions The adverse reactions listed in Table 1 have been accumulated from both clinical studies and post-marketing surveillance. Table 1. g. ) Skin and subcutaneous tissue disorders Rare: Erythematous or maculopapular rash Very rare: Urticaria Not known: Skin, hair, beard and nail discolorations Renal and urinary disorders Very common: Urine discoloration General disorders and administration site conditions Common: Fatigue, increased sweating, fall Very rare: Weight decrease * Adverse reactions are ranked under headings of frequency, the most frequent first, using the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data, since no valid estimate can be derived from clinical trials or epidemiological studies).
54%, respectively) are derived from an analysis of 13 double-blind entacapone studies involving 2082 patients with end-of-dose motor fluctuations. c. Description of selected adverse reactions Entacapone in association with levodopa has been associated with isolated cases of excessive daytime somnolence and sudden sleep onset episodes.
Rhabdomyolysis secondary to severe dyskinesias or neuroleptic malignant syndrome (NMS) has been observed rarely in patients with Parkinson’s disease. NMS, including rhabdomyolysis and hyperthermia, is characterised by motor symptoms (rigidity, myoclonus, tremor), mental status changes (agitation, confusion, coma), hyperthermia, autonomic dysfunction (tachycardia, labile blood pressure) and elevated serum creatine phosphokinase.
In individual cases, only some of these symptoms and/or findings may be evident. Neither NMS nor rhabdomyolysis has been reported following controlled trials involving entacapone treatment in which entacapone has been discontinued abruptly.
Since its introduction into the market, isolated cases of NMS have been reported, especially following abrupt reduction or discontinuation of entacapone and other concomitant dopaminergic medicinal products. When considered necessary, withdrawal of entacapone and other dopaminergic treatment should proceed slowly and, if signs and/or symptoms occur despite a slow withdrawal of entacapone, an increase in levodopa dosage may be necessary.
Entacapone therapy should be administered cautiously to patients with ischemic heart disease. Because of its mechanism of action, entacapone may interfere with the metabolism of medicinal products containing a catechol group and potentiate their action.
5). Entacapone is always given as an adjunct to levodopa treatment. Hence, the precautions valid for levodopa treatment are also applicable to entacapone treatment. Entacapone increases the bioavailability of levodopa from standard levodopa/benserazide preparations 5-10% more than from standard levodopa/carbidopa preparations.
8). To reduce levodopa- related dopaminergic adverse reactions it is often necessary to reduce the daily dose of levodopa by 10-30% either by reducing the amount of levodopa in each dose or by extending the dosing intervals, according to the clinical condition of the patient.
3.
Older people:
No dosage adjustment of entacapone is required for elderly patients.
Paediatric population:
The safety and efficacy of entacapone in children aged less than 18 years have not been established. No data are available. Method of administration Entacapone is administered orally and simultaneously with each levodopa/carbidopa or levodopa/benserazide dose.
2). 1. Hepatic impairment. Phaeochromocytoma. Concomitant use of entacapone and non-selective monoamine oxidase (MAO-A and MAO-B) inhibitors such as phenelzine and tranylcypromine. 5). Previous history of neuroleptic malignant syndrome (NMS) and/or non- traumatic rhabdomyolysis.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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4). Isolated cases of NMS have been reported following the abrupt reduction or discontinuation of entacapone and other dopaminergic treatments. Isolated cases of rhabdomyolysis have been reported. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
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8). Entacapone may aggravate levodopa-induced orthostatic hypotension and should, therefore, be given cautiously to patients who are taking other medicinal products which may cause orthostatic hypotension. In clinical studies, undesirable dopaminergic effects such as dyskinesia were more common in patients who received entacapone and dopamine agonists such as bromocriptine, selegiline or amantadine than in those who received placebo in this combination.
The doses of other antiparkinsonian medicinal products may need to be adjusted when entacapone treatment is initiated. 7). For patients experiencing diarrhoea, the monitoring of bodyweight is recommended in order to avoid possible excessive weight loss.
Prolonged or persistent diarrhoea during entacapone treatment may be a sign of colitis. In the event of prolonged or persistent diarrhoea, the drug should be discontinued and appropriate medical therapy and investigations considered.
Impulse control disorders Patients should be regularly monitored for the development of impulse control disorders. Patients and carers should be made aware that behavioural symptoms such as pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments such as entacapone in association with levodopa.
A review of treatment is recommended if such symptoms develop. A general medical evaluation, including liver function tests, should be considered for patients who experience progressive anorexia, asthenia and weight loss within a relatively short period.