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Miodarone Tablets (Amiodarone HCL 200mg)
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Miodarone Tablets (Amiodarone HCL 200mg)

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Composition:

Miodarone 200mg Tablet: Each tablet contains Amiodarone hydrochloride B.P. 200mg.
Clinical particulars

Therapeutic indications:

Miodarone 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-theatening ventricular premature contractions, ventricular tachycardia salves, prevention of ventricular tachycardia attacks 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.)

Dosage and Administration:

Initial stabilization: Usual dosage is 600mg daily and may be continued for 8 to 10 days.

Maintenance:

The minimum effective dosage should be used; according to individual response. It may range between 100mg daily to 400mg daily. Miodarone may be given on alternate day (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 Miodarone.

Contra-Indications:

  • Sinus bardycardia and sino-atrial heart blocks.
  • Sick sinus syndrome, except used in conjunction with a pacemaker (risk of sinus arrest).
  • High grade conduction disorders, except when used in conjunction with a pacemaker.
  • Thyroid dysfunction.
  • Known hypersensitivity to iodine.
  • Combined therapy with drugs which may induce Torsades de Pointes.
  • Pregnancy, unless exceptional circumstances (see "pregnancy"),
  • Lactation (see "Lactation")

Special Warnings and Precautions:

Special Warnings: In the elderly, heart rate may be more markedly decreased. Miodarone induces ECG changes: QT prolongation (in relation with prolonged repolarization) with the possible development of U-waves; these changes are evidence of its pharmacological action and do not reflect toxicity. Precautions: Undesirable effects are related in most cases with drug overloading; therefore careful attention should be paid in determining the minimum effective maintenance in order to avoid or to minimize undesirable effects. Patients should be instructed to avoid sun exposure or to use protective measures during therapy. In patients with personal or family history of thyroid disorders, caution should be exercised when administering Miodarone if it is necessary; the minimum effective dosage should be used and careful clinical and biological monitoring should be undertaken.

Drug Interactions:

Combined therapy with drugs that may induce Torsades de pointes is contraindicated:
  • antiarrhythmic agents including bepridil, Class 1a - quinidine type-agents, Sotalol.
  • Non-antiarrhythmic agents including Vincamine, Sultopride, Erythromycin IV, Pentamidine in case of parenteral administration as there is an increased risk of potentially lethal torsades de pointes. Combined therapy with the following drugs is not recommended:
  • Beta-blockers and certain calcium channel inhibitors (verapamil, diltiazem) as disturbances of automaticity (excessive bradycardia) and conduction may occur.
  • Stimulating laxative agents as their use may cause hypokalemia and therefore increase the risk of Torsades de pointes' type of laxative agents should be used.

Overdosage:

Little information is available regarding acute overdosage with amiodarone. Sinus bardycardia of spontaneously resolving attacks of ventiricular tachycardia may occur. Most often the patient does not demonstrate clinical sign. Nevertheless, due to the pharmacokinetics of amiodarone, the patient should be monitored long enough, particularly with regard to cardiac status. Neither amiodarone nor its metabolites can be dialyzed .

Pharmacological properties Anti-arrhythmic Properties:
  • Prolongation of phase 3 of the cardiac fiber action potential resulting mainly in a decrease in potassium current (class III from Vaughan William's classification); this prolongation is not related to heart rate.
  • Reduced sinus automaticity leading to bradycardia unresponsive to atropine administration.
  • Non-competitive alpha- and beta-adrenergic inhibition.
  • Slowing in sino-atrial and nodal conduction, that is all the more marked since the rhythm is rapid.
  • No change in intra-ventricular conduction.
  • Increase in refractory period and decrease of myocardial excitability at the atrial, nodal and ventricular levels.
  • Slowing in conduction and prolongation of refractory periods in accessory atrio-ventricular pathways.
  • Moderate drop in peripheral resistance and decrease in heart rate leading to a reduction of oxygen intake.
  • Non competitive alpha-and beta-adrenergic antagonism properties.
  • 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.

Others:

No significant negative inotropic effect.
Pharmacokinetic Properties:
Amiodarone has a slow transit and a high affinity to tissues. Oral bioavailability has varied between 30 and 80% along with individual Patients (mean value around 50%). Following single administration, peak plasma concentrations are reached after 3 to 7 hours. Therapeutic effects are usually obtained after one week (from a few days to two weeks), according to the loading dose.
Amiodarone has a long half-life including considerable inter-patient variability (from 20 to 100 days). During the first days of therapy, the drug accumulates in almost all tissues, especially the adipose tissue. Elimination occurs after a few days and steady state plasma concentration is reached between 1 to several months depending on each individual patient.
Due to the above characteristics, loading doses should be used in order to rapidly obtain the impregnation of tissues that is necessary to have a therapeutic effect. Iodine is partly removed from the molecule and is found in urine as iodure, this corresponds to 6mg/24 hours when 200mg of amiodarone is given daily. The remaining part of a molecule, thus including most of iodine, is eliminated in the feces following hepatic excretion.
The negligible renal excretion allows the administration of usual doses in patients with renal failure.
Following treatment discontinuation, the elimination continues over several months. The persistence of a residual effect over 10 days to one month should be taken into account.

Special precautions for storage:

Protect from moisture, freezing, excessive heat and sunlight.

Presentations:

Miodarone 200mg Tablets: Blister Pack containing 30 Tablets.