RYTHMOL 150 mg
RYTHMOL 300 mg
SCHEDULING STATUS :
(and dosage form):
RYTHMOL 150 mg
RYTHMOL 300 mg
Film coated tablets
One film coated tablet of RYTHMOL 150 mg contains 150 mg of propafenone hydrochloride; one film coated tablet of RYTHMOL 300 mg contains 300 mg of propafenone hydrochloride.
6.2 Cardiac Depressants.
RYTHMOL is an antiarrhythmic agent with a membrane-stabilising effect on the cardiac muscle cell. It prolongs conduction time and refractory period in the atria, AV node and ventricles dose-dependently. Negative dromotropic and negative inotropic effects occur.
After onset of effect (approximately 30 minutes) RYTHMOL achieves its maximum effect after 2 to 3 hours. The duration of effect is approximately 8 hours.
Treatment of clinically significant refractory ventricular tachy-arrhythmias, where alternative therapy has failed.
Heart failure, cardiogenic shock (except for shock induced by arrhythmia), bradycardia, pre-existing high degree sinoatrial, atrioventricular and intraventricular disorders of impulse conduction, sick sinus syndrome and AV block. Disorders of electrolyte balance, severe obstructive pulmonary disease and marked hypotension. Particular caution should be exercised with patients suffering from asthma, spastic bronchitis with emphysema.
The safety of RYTHMOL in pregnant women or lactating women as well as in children has not been established.
DOSAGE AND DIRECTIONS FOR USE:
Treatment should be initiated by a cardiologist.
The dosage is as follows.
The individual maintenance dose should be determined under cardiological surveillance including ECG monitoring and repeated blood pressure control (dose adjustment phase). If the QRS phase is prolonged by more than 20% or the QTc interval is lengthened, the dose should be reduced or discontinued until the ECG returns to normal. The initial and maintenance treatment is a daily dose of 450 to 600 mg (1 tablet of RYTHMOL 150 mg 3 times daily or up to 1 tablet of RYTHMOL 300 mg twice daily). Occasionally an increase of the daily dose to 900 mg may be necessary (1 tablet of RYTHMOL 300 mg or 2 tablets of RYTHMOL 150 mg 3 times per day). This daily dose should be exceeded only in exceptional circumstances and under strict cardiological control.
These data apply to patients with a body mass of about 70 kg. The daily doses are to be reduced accordingly for patients with a lower body mass.
In the elderly or in patients with marked previous myocardial damage the dose of RYTHMOL should be increased only slowly and gradually during the initial phase of treatment.
Tablets should be swallowed whole together with some liquid after meals.
SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Gastrointestinal disturbances, e.g. anorexia, sensation of repletion, nausea, and bitter taste may occur, as well as blurred vision, vertigo, fatigue and headache.
Orthostatic hypotension may occur in the elderly. These symptoms disappear after reduction of the dose or discontinuation of the drug.
Bronchospasm may occur in patients suffering from asthma, bronchitis or bronchitis with emphysema of the lungs. Congestive cardiac failure may especially occur in patients with impaired myocardial contractility. Bradycardia, SA or AV block may occur (antidote: atropine or beta-stimulants). A variety of neuropsychiatric disorders may occur, ranging from vague fatigue and malaise, sleeplessness, vivid dreams and nightmares, to overt psychosis. Sexual impotence may occur.
Cholestasis may occur under RYTHMOL therapy. It indicates individual hypersensitivity reactions of the hyperergic allergic type. This symptom is not dose-related and is usually reversible after discontinuation of RYTHMOL.
Ventricular tachycardia, ventricular fibrillation and extrasystoles may occur.
In impaired liver and/or renal function there may be drug accumulation after therapeutic doses.
If blurred vision, dizziness, fatigue or circulatory disorders with a fall in blood pressure occur, the patient's reaction time may be impaired when operating machinery or motor vehicles.
Local anaesthetics and other antiarrhythmic medicines with negative inotropic and chronotropic effects may potentiate the effects of RYTHMOL.
Rises in the digoxin plasma level with simultaneous administration of RYTHMOL may occur. Patients may require a lower digoxin dose. Digoxin plasma levels must be monitored.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Overdosage may produce severe hypotension. Bradycardia, SA or AV block may occur (antidote: atropine or beta-stimulants).
RYTHMOL may impair impulse conduction in the His-Purkinje system (antidote: electrotherapy) and myocardial contractility.
Bronchospasm and heart failure may be produced.
RYTHMOL 150 mg: Off-white, round, biconvex film coated tablet.
RYTHMOL 300 mg: Off-white, round, biconvex film coated tablet with single score-line.
RYTHMOL 150 mg: Blister packs of 100 film coated tablets.
RYTHMOL 300 mg: Blister packs of 100 film coated tablets.
Store at room temperature (below 25°C).
Keep out of reach of children.
RYTHMOL 150 mg: R/6.2/149
RYTHMOL 300 mg: R/6.2/150
NAME AND BUSINESS ADDRESS OF APPLICANT:
South Africa (Pty) Ltd.
P.O. Box 3030, Halfway House 1685.
DATE OF PUBLICATION OF THIS PACKAGE INSERT:
31 July 1990. Knoll logo
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