COMTAN TABLET 200MG

Negara: Malaysia

Bahasa: Inggris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

ENTACAPONE

Tersedia dari:

ORION PHARMA (MY) SDN. BHD.

INN (Nama Internasional):

ENTACAPONE

Unit dalam paket:

100 Tablets; 30 Tablets

Diproduksi oleh:

ORION CORP

Karakteristik produk

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