COMTAN TABLET 200 mg

Land: Singapore

Språk: engelska

Källa: HSA (Health Sciences Authority)

Aktiva substanser:

ENTACAPONE

Tillgänglig från:

ORION PHARMA (SG) PTE. LTD.

ATC-kod:

N04BX02

Dos:

200 mg

Läkemedelsform:

TABLET, FILM COATED

Sammansättning:

ENTACAPONE 200 mg

Administreringssätt:

ORAL

Receptbelagda typ:

Prescription Only

Tillverkad av:

Orion Corporation, Orion Pharma

Bemyndigande status:

ACTIVE

Tillstånd datum:

1999-11-29

Bipacksedel

156654-1
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 th

Produktens egenskaper

156654-2
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 th