TRIZEDON MR

Страна: Індонезія

мова: індонезійська

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

Активний інгредієнт:

TRIMETAZIDINE HYDROCHLORIDE

Доступна з:

DARYA-VARIA LABORATORIA TBK - Indonesia

ІПН (Міжнародна Ім'я):

TRIMETAZIDINE HYDROCHLORIDE

Дозування:

35 MG

Фармацевтична форма:

TABLET PELEPASAN LAMBAT

Одиниць в упаковці:

DUS, 2 BLISTER @ 30 TABLET

Виробник:

DARYA-VARIA LABORATORIA TBK - Indonesia

Дата Авторизація:

2016-06-21

Характеристики продукта

TRIZEDON
®
COMPOSITION
Trimetazidine dihydrochloride 35 mg.
Excipients: q.s. for one modified release film-coated tablet.
PHARMACEUTICAL FORM
Modified release film-coated tablet.
THERAPEUTIC INDICATION
Adjunctive
to
established
antiangina.
Should
not
be
used
as
monotherapy.
POSOLOGY AND METHOD OF ADMINISTRATION
Oral route
The dose is one tablet of 35mg of trimetazidine twice daily during
meals.
The benefit of the treatment should be assessed after three months and
trimetazidine should be discontinued if there is no treatment
response.
Special populations
_Patients with renal impairment _
In patients with moderate renal impairment (creatinine clearance [30-
60]
ml/min)
(see
_Special _
_warnings _
_and _
_precautions _
_for _
_use_
and
_Pharmacokinetic properties_), the recommended dose is 1 tablet of
35mg in the morning during breakfast.
_Elderly patients _
Elderly patients may have increased trimetazidine exposure due to age-
related
decrease
in
renal
function
(see
section
_Pharmacokinetic _
_properties_).
In
patients
with
moderate
renal
impairment
(creatinine
clearance [30-60] ml/min), the recommended dose is 1 tablet of 35mg
in the morning during breakfast.
Dose titration in elderly patients should be exercised with caution
(see
_Special warnings and precautions for use_).
_Paediatric population: _
The safety and efficacy of trimetazidine in children aged below 18
years
have not been established. No data are available.
CONTRAINDICATIONS
•
Hypersensitivity to the active substance or to any of the excipients.
•
Parkinson disease, parkinsonian symptoms, tremors, restless leg
syndrome, and other related movement disorders,
•
Severe renal impairment (creatinine clearance < 30 ml/min)
•
Use of this drug in nursing mothers is generally inadvisable.
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
This drug is not a curative treatment for angina attacks, nor is it
indicated as an initial treatment for unstable angina, nor myocardial
infarction, nor in the pre-hospital phase or during the first days of
hospitalisation.