Rytmonorm Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Propafenone HCl

Indications/Uses

Symptomatic supraventricular tachyarrhythmias warranting treatment (eg, AV junctional tachycardias, supraventricular tachycardias in patients w/ Wolff-Parkinson-White syndrome or paroxysmal atrial fibrillation). Serious symptomatic ventricular tachyarrhythmias if life-threatening or necessitating treatment.

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Dosage/Direction for Use

Initial & maintenance dose: 450-600 mg daily in 2-3 divided doses. May be increased to 900 mg daily.

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Overdosage

View Rytmonorm overdosage for action to be taken in the event of an overdose.

Administration

May be taken with or without food: Swallow whole, do not chew/crush.

Contraindications

Hypersensitivity. Brugada syndrome. Incidence of MI w/in the last 3 mth. Significant structural heart disease eg, uncontrolled CHF where left ventricular output is <35%, cardiogenic shock (unless caused by arrhythmia), severe symptomatic bradycardia, presence of sinus node dysfunction, atrial conduction defects, 2nd degree or greater AV block or bundle branch block or distal block in the absence of an artificial pacemaker, severe hypotension. Electrolyte imbalance (eg, K metabolism disorders). Severe obstructive pulmonary disease. Myasthenia gravis. Concomitant use w/ ritonavir.

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Special Precautions

Propafenone-like other antiarrhythmics may cause proarrhythmic effects ie, may cause new or worsen preexisting arrhythmias. Evaluate patients electrocardiographically & clinically prior to & during therapy. Perform ECG after initiation of therapy to rule out changes suggestive of Brugada syndrome. Check & re-program pacemaker function during therapy. Patients w/ significant structural heart disease; airway obstruction (eg, asthma). May affect the patient's speed of reaction & impair the individual's ability to operate machinery & motor vehicles. Patients w/ renal disease. Pregnancy & lactation. Elderly.

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Use In Pregnancy & Lactation

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Adverse Reactions

Dizziness; cardiac conduction disorders, palpitations. Anxiety, sleep disorders; headache, dysgeusia; blurred vision; sinus bradycardia, bradycardia, tachycardia, atrial flutter; dyspnoea; abdominal pain, vomiting, nausea, diarrhoea, constipation, dry mouth; abnormal hepatic function; chest pain, asthenia, fatigue, pyrexia.

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Drug Interactions

Possible potentiation of drug side effects w/ local anesth (eg, pacemaker implantation, surgery or dental work) & drugs which have an inhibitory effect on the heart rate &/or myocardial contractility (eg, β-blockers, TCAs). May increase plasma/blood levels of drugs metabolized by CYP2D6 (eg, venlafaxine); propranolol, metoprolol, desipramine, cyclosporine, theophylline & digoxin. Increased levels w/ inhibitors of CYP2D6, CYP1A2 & CYP3A4 (eg, ketoconazole, cimetidine, quinidine, erythromycin & grapefruit juice). Potential for increased plasma conc w/ ritonavir. May affect conduction & repolarization w/ amiodarone. Increased risk of CNS side effects w/ IV lidocaine. Phenobarb (chronic use). Reduced antiarrhythmic efficacy w/ rifampicin. May enhance the efficacy of oral anticoagulants (eg, phenprocoumon, warfarin) resulting in an increased prothrombin time. Elevated plasma levels w/ SSRIs (eg, fluoxetine & paroxetine).

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Caution For Usage

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Storage

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Description

View Rytmonorm description for details of the chemical structure and excipients (inactive components).

Action

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MIMS Class

Cardiac Drugs

ATC Classification

C01BC03 - propafenone ; Belongs to class Ic antiarrhythmics.

Regulatory Classification

POM

Presentation/Packing

Form

Rytmonorm FC tab 150 mg

Packing/Price

50's

Rytmonorm

propafenone

Manufacturer:

Abbott

Distributor:

Zuellig Pharma