CONCOR

País: Indonesia

Idioma: indonesio

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

Ingredientes activos:

BISOPROLOL FUMARATE

Disponible desde:

MERCK TBK - Indonesia

Designación común internacional (DCI):

BISOPROLOL FUMARATE

Dosis:

5 MG

formulario farmacéutico:

TABLET SALUT SELAPUT

Unidades en paquete:

DUS, 10 BLISTER @ 10 TABLET SALUT SELAPUT

Fabricado por:

MERCK TBK - Indonesia

Fecha de autorización:

2018-12-31

Ficha técnica

_Page 1 of 10 _
CONCOR®
BISOPROLOL FUMARATE
SELECTIVE BETA BLOCKING AGENTS
1.
QUALITATIVE AND QUANTITATIVE COMPOSITION
CONCOR 1.25 MG
Each film-coated tablet contains 1.25 mg Bisoprolol fumarate.
CONCOR 2.5 MG
Each film-coated tablet contains 2.5 mg Bisoprolol fumarate.
CONCOR 5 MG
Each film-coated tablet contains 5 mg Bisoprolol fumarate.
CONCOR 10 MG
Each film-coated tablet contains 10 mg Bisoprolol fumarate.
2.
PHARMACEUTICAL FORM
Film-coated tablet.
3.
CLINICAL PARTICULARS
3.1 INDICATIONS
CONCOR 1.25 MG, CONCOR 2.5 MG, CONCOR 5 MG, AND CONCOR 10 MG
Treatment of stable chronic heart failure with reduced systolic left
ventricular function in addition to ACE
inhibitors, and diuretics, and optionally cardiac glycosides.
CONCOR 5 MG AND CONCOR 10 MG
- Treatment of hypertension
- Treatment of coronary heart disease (angina pectoris)
3.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_TREATMENT OF HYPERTENSION OR ANGINA PECTORIS _
Adults: For both indications the dosage is 5 mg Bisoprolol fumarate
once daily. If necessary, the dose may
be increased to 10 mg Bisoprolol fumarate once daily.
The maximum recommended dose is 20 mg once daily.
In all cases the dosage is adjusted individually, in particular
according to the pulse rate and therapeutic
success.
_TREATMENT OF STABLE CHRONIC HEART FAILURE _
The patients should have stable chronic heart failure without acute
failure during the past six weeks and a
mainly unchanged basic therapy during the past two weeks. They should
be treated at optimal dose with
an optimal dose with an ACE inhibitor (or other vasodilator in case of
intolerance to ACE inhibitors) and a
diuretic, and optionally cardiac glycosides, prior to the
administration of Bisoprolol.
Titration phase
The treatment of stable chronic heart failure with bisoprolol is
initiated according to the following titration
scheme, individual adaptation may be necessary depending on how well
the patient tolerates each dose,
i.e. the dose is to be increased only, if the previous dose is well
tolerated.
DISETUJUI OLEH BP