Entacapone should only be used in combination with levodopa/benserazide or levodopa/carbidopa. The prescribing information for these levodopa preparations is applicable to their concomitant use with entacapone.
Parkinson's disease; Adjunct: Adult: Usual dosage: 200 mg orally with each dose of levodopa and carbidopa; reductions in daily levodopa dose or extension of levodopa dosing intervals may be necessary to optimize patient's response.
The maximum recommended dose is 200 mg ten times daily, i.e. 2,000 mg of entacapone.
Entacapone enhances the effects of levodopa. Hence, to reduce levodopa-related dopaminergic adverse reactions, e.g. dyskinesias, nausea, vomiting and hallucinations, it is often necessary to adjust levodopa dosage within the first days to first weeks after initiating entacapone treatment. The daily dose of levodopa should be reduced by about 10 to 30% by extending the dosing intervals and/or by reducing the amount of levodopa per dose, according to the clinical condition of the patient.
Pediatric Dosing: Normal Dosage: General Dosage Information: Safety and efficacy have not been established in pediatric patients.
Renal Impairment: There are no dosage adjustments provided in the manufacturer's labeling; however, renal function was not found to significantly affect the pharmacokinetics of entacapone.
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