SIFROL ER

Negara: Indonesia

Bahasa: Bahasa Indonesia

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

Bahan aktif:

PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE

Tersedia dari:

BOEHRINGER INGELHEIM INDONESIA - Indonesia

INN (Nama Internasional):

PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE

Dosis:

0,75 Mg

Bentuk farmasi:

TABLET PELEPASAN LAMBAT

Unit dalam paket:

DUS, 3 ALUBLISTER @ 10 TABLET PELEPASAN LAMBAT

Diproduksi oleh:

ROTTENDORF PHARMA GMBH - Federal Republic of Germany

Tanggal Otorisasi:

2021-08-04

Karakteristik produk

PT. Boehringer Ingelheim Indonesia
Medical and Regulatory Affairs
SIFROL ER, Rottendorf
SIFROL
®
PRAMIPEXOLE
COMPOSITION
1 EXTENDED-RELEASE TABLET CONTAINS 0.375, 0.75 MG
(S)-2-AMINO-4,5,6,7-TETRAHYDRO-6-PROPYLAMINO-BENZOTHIAZOLE
DIHYDROCHLORIDE MONOHYDRATE EQUIVALENT
TO 0.26, 0.52 MG PRAMIPEXOLE BASE.
Excipients**: hypromellose 2208, maize starch, carbomer 941, colloidal
anhydrous silica, magnesium stearate
INDICATION/USAGE
SIFROL
®
tablets and Extended-release tablets are indicated for the treatment
of the signs and symptoms of
idiopathic Parkinson’s disease when the effect of levodopa wears off
or becomes inconsistent and fluctuations
of the therapeutic effect occur (end of dose “on off”
fluctuations). It may be used alone (without levodopa) or
in combination with levodopa.
SIFROL
®
tablets are indicated for the symptomatic treatment of idiopathic
Restless Legs Syndrome.
DOSAGE AND ADMINISTRATION
_(All dose information refers to pramipexole salt form) _
PARKINSON ’S DISEASE
Dosage
Initial treatment
As shown below dosages should be increased gradually from a starting
dose of 0.375 mg per day and then
increased every 5 - 7 days. Providing patients do not experience
intolerable side effects, the dosage should be
titrated to achieve a maximal therapeutic effect.
ASCENDING-DOSE SCHEDULE OF SIFROL
®
_week _
_total daily _
_dose (mg) _
_tablets (mg) _
_Extended-release _
_tablets (mg) _
1
0.375
3 x 0.125
_0.375 _
2
0.75
3 x 0.25
_0.75 _
3
1.50
3 x 0.5
_1.50 _
If a further dose increase is necessary the daily dose should be
increased by 0.75 mg at weekly intervals up to
a maximum dose of 4.5 mg per day.
Patients already taking SIFROL
®
tablets may be switched to SIFROL
®
prolonged-release tablets overnight, at
the same daily dose.
Maintenance treatment:
The individual dose should be in the range of 0.375 mg to a maximum of
4.5 mg per day. During dose escalation
in pivotal studies both in early and advanced disease efficacy was
observed starting at a daily dose of 1.5 mg.
This does not preclude that in in