GLUCOBAY 50

Negara: Indonesia

Bahasa: Bahasa Indonesia

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

Karakteristik produk Karakteristik produk (SPC)
01-01-2021

Bahan aktif:

ACARBOSE

Tersedia dari:

BAYER INDONESIA - Indonesia

INN (Nama Internasional):

ACARBOSE

Dosis:

50 MG

Bentuk farmasi:

TABLET

Unit dalam paket:

DUS, 5 BLISTER @ 10 TABLET

Diproduksi oleh:

BAYER INDONESIA - Indonesia

Tanggal Otorisasi:

2019-02-28

Karakteristik produk

                                Acarbose/Pruning 100 mg
1
GLUCOBAY
®

-GLUCOSIDASE INHIBITOR TABLETS
Important information, please read carefully!
1 tablet of Glucobay
®
50 contains 50 mg acarbose
Additional therapy in association with diet in patients with diabetes
mellitus.
Impaired glucose tolerance (IGT)*, in combination with diet and
exercise.
* defined 2 hour post-glucose load plasma concentration (2HPG) between
7.8 and 11.0 mmol/L (140-200mg/dl) and fasting
values between 6.1-6.9 and 7.0 mmol/L (100-125 mg/dL).
DOSAGE REGIMEN
The dosage must be adjusted by the doctor to suit each patient,
because efficacy and tolerability vary from one
individual to another.
Unless otherwise prescribed, the recommended dosage is as follows:
Initially
3 x 1 tablet of 50 mg Glucobay/day or
Subsequently
3 x 2 tablets of 50 mg Glucobay/day
up to max dose 600 mg / daily (divided into 3 doses)
The dose may be increased after 4 - 8 weeks, and if patients show an
inadequate clinical response in the later
course of the treatment. If distressing complaints develop in spite of
strict adherence to the diet the dose should
not be increased further, and if necessary should be somewhat reduced.
The average dose is 300 mg
Glucobay/day (corresponding to 3 x 2 tablets of Glucobay 50/day).
ELDERLY (ABOVE 65 YEARS): No alteration of dosage or dosing frequency
is recommended with regard to the age of
the patients.
CHILDREN: See contraindications and special warning & precautions for
use.
RENAL IMPAIRMENT: see contraindications.
NATURE AND DURATION OF USE
Glucobay tablets are effective only if swallowed whole with a little
liquid directly before the meal or be chewed
with the first few mouthfuls of the meal.
No limit to the length of time for which Glucobay can be used is
envisaged.
The limitation on dosage is due to the secondary effects of
carbohydrate mal-absorption, in particular distention,
flatulence and loose stools. Some adaptation to these effects occurs
in the first few weeks of use. The optimal
therapeutic dose is established by minimizing whilst reducing
post
                                
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