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Cordarone
amiodarone

This product is to be used only by a registered medical practitioner with experience in cardiology

COMPOSITION
Per tab
Amiodarone (INN) hydrochloride ......... 200mg

CLINICAL PARTICULARS
Cordarone is indicated only for the treatment of severe rhythm disorders, not responding to therapy or when other treatments cannot be used:
Atrial rhythm disorders (conversion of fibrillation of flutter, and maintenance of sinus rhythm following conversion)

Nodal rhythm disorders
Ventricular rhythm disorders (life-threatening ventricular premature contractions, ventricular tachycardia salves, prevention of ventricular tachycardia attacks or ventricular fibrillation episodes)
Rhythm disorders associated with Wolff-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).


PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties

Class III Antiarrhythmic
ATC Code: C01BD01 (C: cardiovascular system)


Anti-arrhythmic properties:
Prolongation of phase 3 of the action potential of cardiac fiber essentially resulting from a reduction in the potassium channel (Vaughan Williams class III);
Bradycardiac effect due to reduction of sinus automatism. This effect is not antagonized by atropine;
Non-competitive alpha- and beta anti-adrenergic antagonist properties;
Slowing down of sino-atrial, atrial and nodal conduction, which is more marked the higher the rhythm;

No modification in intraventricular conduction;

Increase in refractory period and reduction in myocardial excitability at the atrial, nodal and ventricular stage;
Slowing in conduction and prolongation of refractory periods in accessory atrioventricular pathways;


Other properties:
Reduction in oxygen consumption due to moderate decrease in peripheral resistance and reduction in heart rate;
Increase of coronary output due to a direct effect on myocardial arteries smooth muscle
Maintenance of cardiac output due to a decrease in aortic pressure and peripheral resistance

A meta-analysis of thirteen controlled, randomized, prospective studies including 6553 patients with recent myocardial infarction (78%) or chronic heart failure (22%) was conducted.


The average follow-up period for the patients ranged from 0.4 to 2.5 years. The daily maintenance dosage was, on average, between 200 and 400mg.


This meta-analysis demonstrated a significant reduction in favour of amiodarone by 13% for total mortality (CL95% 0.78 - 0.99; P = 0.030) and by 29% for rhythm-related mortality (CL95% 0.59 - 0.85; p = 00003).


However, these results must be interpreted cautiously, taking into account the heterogeneity of the studies included (heterogeneity related mainly to the population selected, the duration of followup, the methodology used and the results of the studies).

 

The percentage of treatment withdrawals was higher in the amiodarone group (41%) than in the placebo group (27%).

 

Seven percent of the patients taking amiodarone presented hypothyroidism, versus 1% in the placebo group. Hyperthyroidism was diagnosed in 1.4% of patients taking amiodarone, versus 0.5% in the placebo group.


Interstitial pneumopathy occurred in 1.6% of patients taking amiodarone, versus 0.5% in the placebo group.


Pharmacokinetic properties
Amiodarone is a compound which is slowly absorbed and has a high tissue affinity.


Its bioavailability following oral administration varies between individuals from 30 to 80% (mean value, 50%). Following a single dose, peak plasma levels are reached in 3 to 7 hours. Therapeutic activity is usually achieved within one week (a few days to two weeks). Amiodarone has a long half-life with great inter-individual variations (20 to 100 days). During the first days of treatment, the compound accumulates in most tissues in the body, and particularly in adipose tissue. Excretion starts after a few days and output/input equilibrium is reached after one or several months, depending on subjects.


These characteristics justify the use of loading doses intended to ensure the rapid tissue impregnation necessary for therapeutic activity.


A certain proportion of the iodine breaks away from the compound and is found in an iodide form in the urine; this corresponds to 6mg/24 hours at a daily dose of 200mg of amiodarone. The remainder of the compound, and thus the majority of the iodine, is eliminated in the faeces following passage through the liver.

 

The negligible urinary excretion enables the use of this compound at standard doses in renal failure patients.

 

Following treatment discontinuation, elimination of the product continues for several months. The persistence of residual activity over 10 days to one month should be taken into account.


Posology and Method of Administration
Initial treatment
The usual dosage regimen is 3 tablets per day, for 8 to 10 days. In some cases, the initial treatment has used higher doses (4 to 5 tablets per day), always for short periods and under electrocardiographic monitoring.


Maintenance treatment
Seek the minimum effective dose, which varies depending on the patient, ranging from 1/2 tablet per day (1 tablet every 2 days) to 2 tablets every day.


Contraindications
This medicine is contraindicated in the following situations:
Sinus bradycardia and sino-atrial heart blocks not corrected by a pacemaker; Sinus disease not corrected by a pacemaker (risk of sinus arrest); High-degree conduction disorders not corrected by a pacemaker;
Hyperthyroidism due to its possible exacerbation by amiodarone;

Known hypersensitivity to iodine or to amiodarone
The last 6 months of pregnancy;
Breast-feeding;
Combination with medicines that can induce torsades de pointes:
-  Class la antiarrhythmics (quinidine, hydroquinidine, disopyramide, etc.),
-  Class III antiarrhythmics (sotalol, dofetilide, ibutilide, etc.),

-  Sultopride
-  Other medicines, such as bepridil, cisapride, diphemanil, erythromycin IV, mizolastine, sparfloxacin, etc. (see Interactions with other medicinal products and other forms of interaction),

This medicine IS NOT GENERALLY RECOMMENDED in combination with:
injectable diltiazem
Halofantrine, pentamidine, moxifloxacine,
Certain neuroleptics (thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, amisulpride, tiapride, primozide, haloperidol, droperidol),
And with beta-blockers other than sotalol and Esmolol (see Interactions with other medicinal products and other forms of interaction).

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