INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo RYTHMOL INJECTION

SCHEDULING STATUS:
S4

PROPRIETARY NAME
(and dosage form):

RYTHMOL INJECTION

COMPOSITION:
Each 20 mL ampoule contains
propafenone hydrochloride 70 mg

PHARMACOLOGICAL CLASSIFICATION:
A 6.2 Cardiac depressants.

PHARMACOLOGICAL ACTION:
RYTHMOL is an anti-arrhythmic 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 chronotropic and negative inotropic effects occur.
Onset of effect occurs during or shortly after completion of the injection.
Maximum effect is achieved a few minutes after injection and the effect lasts for up to 1 hour.

INDICATIONS:
RYTHMOL injection is used acutely to convert refractory supraventricular arrhythmias including supraventricular tachycardia and atrial fibrillation/flutter.

CONTRA-INDICATIONS:
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, chronic obstructive bronchitis and emphysema. Propafenone may aggravate myasthenia gravis and should be avoided in patients with this condition.
The safety of propafenone in pregnant or lactating women as well as safety and efficacy in children have not been established.

DOSAGE AND DIRECTIONS FOR USE:
Treatment should be initiated by a cardiologist, in a hospital under controlled conditions (ECG monitor, resuscitation pacemaker etc.).
The single intravenous dosage is 2 mg/kg body mass in Dextrose 5% in Water infused over 10 minutes. The patient must be kept under continuous cardiological observation with ECG and blood pressure monitoring. If the QRS interval is prolonged by more than 20% or the QTc interval is lengthened, the injection should be discontinued immediately.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects
Gastrointestinal disturbances, e.g. anorexia, sensation of repletion, nausea and vomiting and bitter taste may occur, as well as blurred vision, vertigo, fatigue and headache.
Orthostatic hypotension may occur in the elderly.
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.
Cholestastasis may occur under propafenone therapy. It indicates individual hypersensitivity reactions of the hyperergic allergic type. This symptom is not dose-related and is usually reversible after discontinuation of propafenone.
Ventricular tachycardia, ventricular fibrillation and extrasystoles may occur.
In impaired liver and/or renal function there may be drug accumulation after therapeutic doses.
Convulsions, blood dyscrasias and lupus erythematosus have been reported.
Precautions
Electrolyte disturbances should be corrected before initiating propafenone treatment. It should be used with caution in patients with hepatic impairment.
Interactions
Local anaesthetics and other anti-arrythmic medicines with negative inotropic and chronotropic effects may potentiate the effects of propafenone.
Rises in the digoxin plasma level with simultaneous administration of propafenone may occur. Patients may require a lower digoxin dose.
Digoxin plasma levels may be monitored. The concentration in the plasma may increase during concurrent administration of cimetidine.
Propafenone can enhance the effects of warfarin and propafenone activity may be diminished by rifampicin. Quinidine can raise plasma-propafenone concentrations.

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 g        antidote: electrotherapy) and myocardial contractility.
Bronchospasm and heart failure may be produced.

IDENTIFICATION:
Clear, colourless solution in colourless ampoules.

PRESENTATION:
Packs containing 5 ampoules.

STORAGE INSTRUCTIONS:
Store between 15°C and 25°C. Do not store below 15°C.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
R/6.2/151

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Knoll Pharmaceuticals South Africa (Pty) Ltd.
Cor George Road and 16th Street
Midrand
1685

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
11 November 1996

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