CARLEPONE

Country: Индонезија

Језик: Индонежански

Извор: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Доступно од:

SOHO INDUSTRI PHARMASI - Indonesia -

Дозирање:

200 MG /200 MG /54 MG

Фармацеутски облик:

TABLET SALUT SELAPUT

Састав:

LEVODOPA, ENTACAPONE, CARBIDOPA MONOHYDRATE

Јединице у пакету:

DUS, 3 BLISTER @ 10 TABLET SALUT SELAPUT

Класа:

Obat

Произведен од:

MACLEODS PHARMACEUTICALS LIMITED - India

Статус ауторизације:

Berlakus/d 20-07-2028

Датум одобрења:

2023-07-20

Карактеристике производа

CARLEPONE
CARBIDOPA/LEVODOPA/ENTACAPONE
FILM COATED TABLETS 18.75/75/200MG. 25/100/200MG, 31.25/125/200MG DAN
50/200/200MG
SUMMARY OF PRODUCTS CHARACTERISTIC
1.
NAME OF THE MEDICINAL PRODUCT
CARLEPONE
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablets contains:
•
Carbidopa + Levodopa + Entacapone tablet 18.75/75/200mg
•
Carbidopa + Levodopa + Entacapone tablet 25/100/200mg
•
Carbidopa + Levodopa + Entacapone tablet 31.25/125/200mg
•
Carbidopa + Levodopa + Entacapone tablet 50/200/200mg
FOR EXCIPIENTS SEE POINT 6.1
3.
PHARMACEUTICAL FORM
Film coated tablets
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Carbidopa + Levodopa + Entacapone tablet is indicated for the
treatment of
adult patients with Parkinson's disease and end-of-dose motor
fluctuations
not stabilised on levodopa/dopa decarboxylase (DDC) inhibitor
treatment.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The
optimum
daily
dosage
must
be
determined
by
careful
titration
of
levodopa in each patient. The daily dose should preferably be
optimised
using
one
of
the
four
available
tablet
strengths
(18.75/75/200mg,
25/100/200mg,
31.25/125/200mg
or
50/200/200mg
carbidopa/
levodopa/entacapone).
Patients should be instructed to take only one Carbidopa + Levodopa +
Entacapone tablet per dose administration. Patients receiving less
than 70-
100 mg carbidopa a day are more likely to experience nausea and
vomiting.
While the experience with total daily dosage greater than 200 mg
carbidopa
is limited, the maximum recommended daily dose of entacapone is 2000
mg
and therefore the maximum Carbidopa + Levodopa + Entacapone dose, for
the
Carbidopa
+
Levodopa
+
Entacapone
strengths
of
18.75/75/200mg,
25/100/200mg, 31.25/125/200mg is 10 tablets per day. Ten (10) tablets
of
Carbidopa + Levodopa + Entacapone tablet 150/37.5/200 mg equal 375 mg
of carbidopa a day. Therefore, using maximum recommended daily dose of
375 mg of carbidopa, the maximum daily dose of Carbidopa + Levodopa +
Entacapone tablet 50/200/200 mg is 7 tablets per day.
The
maximum
tot