Rivodaron 200

Basic information

Composition

Amiodaroni hydrochloridum 200 mg in 1 tablet

Pharmacotherapeutic group

Antiarrhythmic agent (ATC code: C01BD01)

Therapeutic 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 other cardiac diseases (coronary insufficiency, cardiac failure). The preparation is intended for the therapy of adults.

Pharmacological properties

Amiodarone belongs to Vaughan Williams Class III. 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 refractory period and decreases the excitability of the myocardium at the atrial, nodal as well as ventricular level.

Pharmaceutical form

Tablets

More information

Posology and method of administration

The usual initial dose is 600 mg daily divided into 3 partial doses for a period of 8 to 10 days. The dose may be increased up to 1,200 mg. The dose for maintenance treatment must be determined according to the individual response. It usually ranges between 100 to 400 mg daily. Tablets may be swallowed regardless of food.

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 product. Combined therapy with drugs which may cause “torsades de pointes.” Lactation. With regard to its iodine content, in pregnancy the preparation should be administered only if strictly necessary and for the shortest time possible.

Interactions

Concomitant administration of amiodarone and chinidin, sotalol, intravenously administered erythromycin, or the drugs inducing hypokalemia (diuretics, systemic corticoids, amphotericin B) may develop 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 plasmatic levels of digoxin, phenytoin and cyclosporine.

Undesirable effects

Proarrhythmic effects are infrequent, in dependence on the dose symptomatic bradycardia may occur. Amiodarone is deposited into the cornea, inhibits conversion of thyroxin to triiodothyronine (due to the presence of iodine in the molecule), produces photosensitisation, peripheral neuropathy, interstitial pneumonitis, headaches, sleep disorders, nausea, constipation and other gastrointestinal difficulties.

Special warnings and precautions for use

It is necessary to avoid sunlight during therapy.

For more detailed product information, see the Summary of Product Characteristics.

Availability

The medicinal product is available on prescription only and is partly covered by health insurance.

Contents of container

30 or 60 tablets of 200 mg each

Package available in the Czech Republic

30 or 60 tablets of 200 mg each

SPC and PIL

Manufacturer and marketing authorisation holder

PRO.MED.CS Praha a.s., Telčská 377/1, Michle, 140 00 Prague 4, Czech Republic

Date of revision of the text

3 August 2020

Product images