LODOZ

Nazione: Indonesia

Lingua: indonesiano

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

Principio attivo:

BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDE

Commercializzato da:

MERCK TBK - Indonesia

INN (Nome Internazionale):

BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDE

Dosaggio:

5 MG /6.25 MG

Forma farmaceutica:

TABLET SALUT SELAPUT

Confezione:

DUS, 3 BLISTER @ 10 TABLET SALUT SELAPUT

Prodotto da:

MERCK TBK - Indonesia

Data dell'autorizzazione:

2021-03-28

Scheda tecnica

Page 1 of 10
LODOZ
BISOPROLOL FUMARATE/HYDROCHLOROTHIAZIDE
Selective beta
1
adrenoceptor blocker + Diuretic
1.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lodoz 2.5 mg/6.25 mg, film-coated tablet:
Bisoprolol fumarate 2.5 mg
Hydrochlorothiazide 6.25 mg
Lodoz 5 mg/6.25 mg, film-coated tablet:
Bisoprolol fumarate 5 mg
Hydrochlorothiazide 6.25 mg
2.
PHARMACEUTICAL FORM
Film-coated tablet
3.
CLINICAL PARTICULARS
3.1 INDICATIONS
Treatment of hypertension.
3.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
For individual therapy Lodoz is available in the strengths:
Lodoz 2.5 mg/6.25 mg, film-coated tablets.
Lodoz 5 mg/6.25 mg, film-coated tablets.
The usual starting dose is one Bisoprolol 2.5 mg/Hydrochlorothiazide
6.25 mg tablet once
daily.
If the antihypertensive effect of this dosage is inadequate, the dose
will be increased to one
Bisoprolol
5 mg/Hydrochlorothiazide
6.25 mg
tablet
once
daily
and,
if
response
is
still
inadequate, to one Bisoprolol 10 mg/Hydrochlorothiazide 6.25 mg tablet
once daily.
If
discontinuation
is
necessary,
gradual
discontinuation
of
Bisoprolol
treatment
is
recommended, since abrupt withdrawal of Bisoprolol may lead to an
acute deterioration of the
patient's condition, in particular in patients with ischaemic heart
disease.
_Patient with renal or hepatic impairment _
No dose adjustment is necessary in patients with mild-to-moderate
hepatic impairment or
mild-to-moderate renal impairment (creatinine clearance
>
30 mL/min).
_Elderly _
No dose adjustment is normally required.
_Paediatric population _
Experience
with
Lodoz
in
paediatric
patients
is
limited,
therefore
its
use
cannot
be
recommended in this population.
METHOD OF ADMINISTRATION
Lodoz should be taken in the morning with or without food. The
film-coated tablets should be
swallowed with some liquid and not be chewed.
3.3 CONTRAINDICATIONS
Lodoz must not be used in patients with:
DISETUJUI OLEH BPOM : 23/02/2021
ID : EREG100149VR12100018
EREG100149VR12100019
Page 2 of 10
•
hypersensitive to Bisoprolol, Hydrochlorothiazide, other Thiazides