CORDARONE 200MG

Country: Մալայզիա

language: անգլերեն

source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

active_ingredient:

AMIODARONE HYDROCHLORIDE

MAH:

SANOFI-AVENTIS (MALAYSIA) SDN. BHD.

INN:

AMIODARONE HYDROCHLORIDE

units_in_package:

30Tablet Tablets

manufactured_by:

SANOFI WINTHROP INDUSTRIE

SPC

1
ANNEX I
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contain
Amiodarone (INN) hydrochloride
........................................... 200mg
PHARMACEUTICAL FORM
White, round tablets, scored and enegraved with a “heart-shaped”
symbol and “200” on one
face.
CLINICAL PARTICULARS
Therapeutic indications
Cordarone is indicated only for the treatment of severe rhythm
disorders, not responding to
other therapy or when other treatments cannot be used:
- atrial rhythm disorders (conversion of fibrillation or flutter, and
maintenance of sinus rhythm
following conversion)
- nodal rhythm disorders
- ventricular rhythm disorders (life threatening ventricular premature
contractions, non-
sustained ventricular tachycardia, prevention of ventricular
tachycardia or ventricular
fibrillation episodes.
-rhythm disorders, associated with Wolf-Parkinson-White syndrome
In view of its pharmaceutical properties, amiodarone is indicated in
the above rhythm
disorders especially when they are associated with an underlying heart
disease (coronary
insufficiency, heart failure).
Posology and method of administration
Initial treatment
The usual dosage regimen is 3 tablets daily for 8 to 10 days.
In some cases, higher doses have been used for initial treatment (4 to
5 tablets daily), always
for short periods and under electrocardiographic monitoring.
Maintenance treatment
The minimum effective dose, which varies depending on the patient,
should be determined,
and ranges from half a tablet daily (1 tablet every 2 days) to 2
tablets daily.
Pediatric population
The safety and efficacy of amiodarone in children have not been
established. See Sections
pharmacodynamics properties and pharmacokinetics properties for
currently available data.
Method of administration
Oral route.
This product is to be used only by a registered medical practitioner
with experience in cardiology
2
Contraindications
This medicinal product is contraindicated in the following cases:

sinus bradycardia and sinoatrial block in patients without a
pacemaker;