Country: মাল্যাশিয়া
ভাষা: ইংরেজি
সূত্র: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ENTACAPONE
ORION PHARMA (MY) SDN. BHD.
ENTACAPONE
100 Tablets; 30 Tablets
ORION CORP
156657-1 COMTAN® Catechol-O-methyl transferase inhibitor COMPOSITION AND PHARMACEUTICAL FORM Tablet containing 200 mg entacapone. For a full list of excipients, see section EXCIPIENTS. Brownish-orange, oval, biconvex film-coated tablet with Comtan® engraved on one side. INDICATIONS Entacapone is 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 stabilized on those combinations. DOSAGE AND ADMINISTRATION 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. POSOLOGY One 200 mg tablet is taken with each levodopa/ dopa decarboxylase inhibitor dose. 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. Entacapone increases the bioavailability of levodopa from standard levodopa/benserazide preparations slightly more (5 to 10%) than from standard levodopa/carbidopa preparations. Hence, patients who are taking standard levodopa/benserazide preparations may need a larger reduction of their levodopa dose when entacapone is initiated. 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. Renal impairment does not affect the pharmacokinetics of entacapone and ther সম্পূর্ণ নথি পড়ুন