GLUCOVANCE

Country: Ինդոնեզիա

language: ինդոնեզերեն

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

active_ingredient:

METFORMIN HYDROCHLORIDE, GLIBENCLAMIDE

MAH:

MERCK TBK - Indonesia

INN:

METFORMIN HYDROCHLORIDE, GLIBENCLAMIDE

dosage:

500 MG /2.5 MG

pharmaceutical_form:

TABLET SALUT SELAPUT

units_in_package:

DUS, 10 BLISTER @ 10 TABLET SALUT SELAPUT

manufactured_by:

MERCK TBK - Indonesia

authorization_date:

2021-09-09

SPC

GLUCOVANCE
®
METFORMIN HYDROCHLORIDE -
GLIBENCLAMIDE
COMBINATIONS OF ORAL BLOOD GLUCOSE LOWERING DRUGS
1.
QUALITATIVE AND QUANTITATIVE COMPOSITION
GLUCOVANCE
 250 MG/1.25 MG: each film-coated tablet contains Metformin
hydrochloride 250 mg with
Glibenclamide 1.25 mg.
GLUCOVANCE
 500 MG/2.5 MG: each film-coated tablet contains Metformin
hydrochloride 500 mg with
Glibenclamide 2.5 mg.
GLUCOVANCE
 500 MG/5 MG: each film-coated tablet contains Metformin hydrochloride
500 mg with
Glibenclamide 5 mg.
GLUCOVANCE
 1000 MG/5 MG: each film-coated tablet contains Metformin
hydrochloride 1000 mg with
Glibenclamide 5 mg.
2.
PHARMACEUTICAL FORM
Film-coated tablet.
3.
CLINICAL PARTICULARS
3.1 INDICATIONS
GLUCOVANCE
 250 MG/1.25 MG, GLUCOVANCE
 500 MG/2.5 MG
Glucovance is indicated as initial therapy, as an adjunct to diet and
exercise, to improve glycemic control
in patients with type 2 diabetes with HbA1c above 8% whose
hyperglycemia cannot be satisfactorily
managed with diet and exercise alone.
GLUCOVANCE
 250 MG/1.25 MG, GLUCOVANCE
 500 MG/2.5 MG, GLUCOVANCE
 500 MG/5 MG,
GLUCOVANCE
 1000 MG/5 MG
Glucovance is indicated as second-line therapy when diet, exercise,
and initial treatment with a
Sulfonylurea or Metformin do not result in adequate glycemic control
in patients with type 2 diabetes
with HbA1c above 8%.
3.2 POSOLOGY AND METHOD OF ADMINISTRATION
GENERAL CONSIDERATIONS
Dosage of Glucovance must be individualized on the basis of both
effectiveness and tolerance while
not exceeding the maximum recommended daily dose of 2000 mg
Metformin/20 mg Glibenclamide.
Glucovance should be given with meals and should be initiated at a low
dose, with gradual dose
escalation as described below, in order to avoid hypoglycemia (largely
due to Glibenclamide), to reduce
GI side effects (largely due to Metformin), and to permit
determination of the minimum effective dose
for adequate control of blood glucose for the individual patient.
With initial treatment and during dose titration, appropriate blood
glucos