MADOPAR

Land: Indonesië

Taal: Indonesisch

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

Werkstoffen:

LEVODOPA, BENSERAZIDE HYDROCHLORIDE

Beschikbaar vanaf:

MENARINI INDRIA LABORATORIES - Indonesia

INN (Algemene Internationale Benaming):

LEVODOPA, BENSERAZIDE HYDROCHLORIDE

Dosering:

100.00 MG /28.5 MG

farmaceutische vorm:

TABLET DISPERSIBLE

Eenheden in pakket:

DUS, 1 BOTOL @ 30 TABLET DISPERSIBLE

Geproduceerd door:

DELPHARM MILANO S.R.L - Italy

Autorisatie datum:

2021-12-23

Productkenmerken

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Information for Health Professionals
Madopar
®
Levodopa + Benserazide
1. DESCRIPTION
1.1 Therapeutic/Pharmacologic Class of Drug
ATC code: N04BA
Madopar is a combination of levodopa and benserazide for the treatment
of Parkinson’s disease.
1.2 Type of Dosage Form
Dispersible form:
Madopar single-scored dispersible tablets as Madopar ‘125’
1.3 Route of Administration
Oral administration.
1.4 Sterile/Radioactive Composition
No text.
1.5 Qualitative and Quantitative Composition
Madopar is a combination of levodopa and the decarboxylase inhibitor
benserazide (as hydrochloride) in
a ratio of 4:1. The following strength is available: Madopar ‘125’
= levodopa 100 mg + benserazide 25
mg
2. CLINICAL
PARTICULARS
2.1 Therapeutic Indications
Parkinson’s disease, symptomatic parkinsonism post-encephalitic,
except drug-induced parkinsonism
syndromes.
2.2 Dosage and Administration
The optimum daily dosage of Madopar should be determined for and
adapted to each individual patient.
The following scheme may be taken as a guide.
a.
Initial Therapy:
The initial dosage recommended is ½ tablet of Madopar 125 mg 3 to 4
times daily. The daily dosage
should then be increased by 1 tablet of Madopar 125 mg at weekly
intervals until the individual
therapeutic dosage is reached. If the patient can be examined
regularly, the dosage may be increased more
rapidly, e.g. the daily dosage can be increased by 1 tablet Madopar
125 mg twice a week. Thus, the
effective dosage may be reached in 4 days. The effective dosage is
generally between 4 and 8 tablets of
Madopar 125 mg daily, divided into 3 or 4 doses; it is rarely
necessary to administer > 10 tablets of
Madopar 125 mg daily.
DISETUJUI OLEH BPOM : 07/06/2021
ID : EREG100364VR12000532
Draft_Madopar_PI_MAT_CDS7.0_EN_v1
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Example: Madopar 125 mg tablet intake
Morning
Noon
at 4 pm
Night
Total per
Day
1
st
Week
1
1
-
1
3
2
nd
Week
1
1
1
1
4
3
rd
Week
2
1
1
1
5
4
th
and 5
th
Weeks
2
2
1
1
6
If there is no satisfactory improvement