Rivodaron® 200
tablets
![RivodaronRR 200](javascript:obrazek_big("http://promedcs.cz//en/../img/baleni/600_rivodaron(1).jpg", "en"); "RivodaronRR 200")
- Manufacturer:
- PRO.MED.CS Praha a.s.
- Marketing authorisation holder:
- PRO.MED.CS Praha a.s.
- Composition:
- 1 tablet contains amiodaroni hydrochloridum 200 mg.
- Indication group:
- antiarrhythmic agent
The following information is for health professionals only.
READ CAREFULLY THIS NOTICE!
Characteristics:
Amiodarone ranks among Class III according to Vaughan Williams. It acts as a potassium channels blocker, noncompetitive alpha- and beta-adrenergic inhibitor, feebly blocking also calcium channels. It decelerates the sinoatrial, atrial, and nodal conduction, and does not influence intraventricular conduction. It prolongs the refractary period and decreases the excitability of the myocardium at the atrial, nodal as well as ventricular level.
Indications:
Disorders in atrial rhythm (version of fibrillation or flutter, maintenance of the sinus rhythm after cardioversion), nodal disorders in rhythm - tachycardia, ventricular disorders in rhythm (life-threatening premature contractions of the ventricles, ventricular tachycardias in volleys, prevention of fits of ventricular tachycardia and ventricular fibrillation), disorders in the rhythm associated with Wolff-Parkinson-White syndrome. Amiodarone is indicated particularly in the cases when the above-mentioned disorders in rhythm are accompanied by cardiac diseases (coronary insufficiency, cardiac failure). The preparation is intended for the therapy of adults.
Contraindications:
Sinus bradycardia and sinoatrial blocks. Sick sinus syndrome and A-V blocks of a higher degree, if the patient has not got a pacemaker (risk of sinus arrest). Thyroidal dysfunction. Hypersensitivity to iodine or substances contained in the preparation. Combined therapy with drugs which may cause "torsades de pointes." Lactation. With regard to its iodine content, in pregnancy the preparation is administered only when it is really necessary and for the shortest time possible.
Undesirable effects:
Proarrhythmic effects are infrequent, in dependence on the dose symptomatic bradycardia may occur. Other undesirable effects include nausea, constipation, and other GIT troubles. Amiodarone is deposited into the cornea, inhibits conversion of thyroxin to triiodothyronine (due to the presence of iodine in the molecule), produces photosensitization, peripheral neuropathy, interstitial pneumonitis, headaches, sleep disorders, etc.
Interactions:
Concomitant administration of amiodarone and chinidine, sotalol, intravenously administered erythromycin, or the drugs inducing hypokalemia (diuretics, systemic corticoids, amphotericin B) may produce serious disorders in the rhythm up to the "torsades de pointes" type. Bradycardia and disorders in transfer may take place in combination with beta-blockers, some calcium channel blockers (verapamil, diltiazem) and general anaesthetics. Amiodarone potentiates the effect of oral anticoagulant agents and increases the plasma levels of digoxin, phenytoin and cyclosporin.
Caution:
In the course of treatment, attention may be affected. It is necessary to avoid sunlight during therapy.
Dosage:
The usual initial dose is 600 mg daily divided into 3 partial doses for a period of 8 to 10 days. The dose can be increased up to 1200 mg. The dose for maintenance treatment must be determined according to the individual response. It usually ranges between 100 to 400 mg daily. The preparation should be taken with meals.
Package:
30 or 60 tablets.
Complete information about the preparation is included in the drug information sheet.
Date of the latest revision of the text: March 3, 2004.
The preparation is available on medical prescription only.