NATEXAM

Negara: Indonesia

Bahasa: Bahasa Indonesia

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

Bahan aktif:

AMLODIPINE BESILATE; INDAPAMIDE

Tersedia dari:

DARYA-VARIA LABORATORIA TBK - Indonesia

INN (Nama Internasional):

AMLODIPINE BESILATE; INDAPAMIDE

Dosis:

1,5/10 MG

Bentuk farmasi:

TABLET

Unit dalam paket:

DUS, 6 BLISTER @ 5 TABLET PELEPASAN LAMBAT

Diproduksi oleh:

DARYA-VARIA LABORATORIA TBK - Indonesia

Tanggal Otorisasi:

2018-01-03

Karakteristik produk

NAME OF THE MEDICINAL PRODUCT
Natexam 1.5 mg / 5 mg modified-release tablets
Natexam 1.5 mg / 10 mg modified-release tablets
QUALITATIVE AND QUANTITATIVE COMPOSITION
One tablet contains 1.5 mg indapamide and 6.935
mg
amlodipine
besilate
equivalent
to
5
mg
amlodipine.
One tablet contains 1.5 mg indapamide and 13.87
mg
amlodipine
besilate
equivalent
to
10
mg
amlodipine.
Excipient
with
known
effect:
104.5
mg
lactose
monohydrate.
PHARMACEUTICAL FORM
Modified-release tablet.
White,
round,
film-coated,
bilayered,
modified-
release
tablet
of
9
mm
diameter
engraved
with
on one face.
Pink, round, film-coated, bilayered, modified-release
tablet of 9 mm diameter engraved with
on one
face.
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
Natexam
is
indicated
as
substitution
therapy
for
treatment
of
essential
hypertension
in
patients
already controlled with indapamide and amlodipine
given concurrently at the same dose level.
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
One tablet per day as single dose, preferably to be
taken in the morning, to be swallowed whole with
water and not chewed.
The
fixed
dose
combination
is
not
suitable
for
initiation therapy.
If a change of the posology is required, titration
should be done with the individual components.
Special populations
_Paediatric population _
The safety and efficacy of Natexam in children and
adolescents have not been established._ _
No data are available.
_Patients _
_with _
_renal _
_impairment _
_(see _
_sections _
_Contraindications _
_and _
_Special _
_warnings _
_and _
_precautions for use): _
In
severe
renal
impairment
(creatinine
clearance
below 30 ml/min), treatment is contraindicated.
In patients with mild to moderate renal impairment,
no dose adjustment is needed.
_Older _
_people _
_(see _
_section _
_Special _
_warnings _
_and _
_precautions for use and Pharmacokinetic properties): _
Older people can be treated with Natexam according
to renal function.
_Patients _
_with _
_hepatic _
_impairment _
_(see _
_sections _
_Contraindications _
_and _
_Special _
_warnin