CORDARONE TABLET 200 mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

AMIODARONE HCl

Available from:

SANOFI-AVENTIS SINGAPORE PTE. LTD.

ATC code:

C01BD01

Dosage:

200 mg

Pharmaceutical form:

TABLET

Composition:

AMIODARONE HCl 200 mg

Administration route:

ORAL

Prescription type:

Prescription Only

Manufactured by:

SANOFI WINTHROP INDUSTRIE

Authorization status:

ACTIVE

Authorization date:

1998-05-27

Patient Information leaflet

CORDARONE 
AMIODARONE 200MG 
SCORED TABLET 
[SANOFI LOGO] 
COMPOSITION: 
Cordarone 200 contains 200mg of amiodarone hydrochloride. 

PHARMACEUTICAL FORM 
Tablet. 
Round, white tablet with a breakline
on one side, imprinted with 200 and “heart-shaped” symbol on
the 
other. 

CLINICAL PARTICULARS 
THERAPEUTIC INDICATIONS 
Treatment should be initiated and normally monitored only
under hospital or specialist supervision. Oral 
Cordarone is indicated only for the treatment
of severe rhythm disorders not responding to other 
therapies or when other treatments cannot be used. 
Tachyarrhythmias associated with Wolff-Parkinson-White Syndrome. 
Atrial flutter and fibrillation when other drugs cannot be used. 
All types of tachyarrhythmias of paroxysmal nature including:
supraventricular, nodal and ventricular 
tachycardias, ventricular fibrillation: when other drugs cannot be
used. 

POSOLOGY AND METHOD OF ADMINISTRATION 
_ADULTS _
It is particularly important that the minimum effective dose
be used. In all cases the patient's management 
must be judged on the individual response and well being.
The following dosage regimen is generally 
effective. 

_INITIAL STABILISATION _
Treatment should be started with 200mg, three times a day and
may be continued for 1 week. The 
dosage should then be reduced to 200mg, twice daily for a further
week. 

_MAINTENANCE _
The minimum effective dosage should be used according to individual
response. It may range between 
100mg daily to 400mg daily. Cordarone may be given on alternative
days (200mg may be given every 
other day where 100mg are recommended daily); therapeutic windows
have been also recommended (2 
days a week): they are possible due to the prolonged therapeutic
action of Cordarone. 

_GENERAL CONSIDERATIONS _
Initial dosing 
A high dose is needed in order to achieve adequate tissue
levels rapidly. 

Maintenance 
Too high a dose during maintenance
therap

Summary of Product characteristics

Cordarone
Amiodarone 200mg
Scored Tablet
[sanofi logo]
Composition:
Cordarone 200 contains 200mg of amiodarone hydrochloride.
Pharmaceutical Form
Tablet.
Round, white tablet with a breakline on one side, imprinted with 200
and “heart-shaped” symbol on the
other.
Clinical Particulars
Therapeutic Indications
Treatment should be initiated and normally monitored only under
hospital or specialist supervision. Oral
Cordarone is indicated only for the treatment of severe rhythm
disorders not responding to other
therapies or when other treatments cannot be used.
Tachyarrhythmias associated with Wolff-Parkinson-White Syndrome.
Atrial flutter and fibrillation when other drugs cannot be used.
All types of tachyarrhythmias of paroxysmal nature including:
supraventricular, nodal and ventricular
tachycardias, ventricular fibrillation: when other drugs cannot be
used.
Posology and Method of Administration
Adults
It is particularly important that the minimum effective dose be used.
In all cases the patient's management
must be judged on the individual response and well being. The
following dosage regimen is generally
effective.
Initial Stabilisation
Treatment should be started with 200mg, three times a day and may be
continued for 1 week. The
dosage should then be reduced to 200mg, twice daily for a further
week.
Maintenance
The minimum effective dosage should be used according to individual
response. It may range between
100mg daily to 400mg daily. Cordarone may be given on alternative days
(200mg may be given every
other day where 100mg are recommended daily); therapeutic windows have
been also recommended (2
days a week): they are possible due to the prolonged therapeutic
action of Cordarone.
General Considerations
Initial dosing
A high dose is needed in order to achieve adequate tissue levels
rapidly.
Maintenance
Too high a dose during maintenance therapy can cause side effects
which are believed to be related to
high tissue levels of amiodarone and its metabolites.
Amiodarone is strongly protein bound and has an average