Propafenone Hydrochloride

Registered South African indications:

• Ventricular tachyarrhythmias

Contraindications

• Hypersensitivity to to the active ingredient or any of its excipients
• Brugada syndrome
• Significant structural heart disease such as patients with an incident of myocardial infarction within the last 3 months
• Uncontrolled congestive cardiac failure where left ventricular output is less than 35%
• Cardiogenic shock (unless arrhythmia-induced)
• Severe symptomatic bradycardia
• Manifest electrolyte imbalance (e.g., potassium metabolism disorders)
• Unless patients are adequately paced propafenone hydrochloride should not be used in the presence of:
  - Sinus node dysfunction
  - Atrial conduction defects
  - Second degree or greater AV block
  - Bundle branch block or distal block
• Severe obstructive pulmonary disease
• Severe hypotension
• Propafenone hydrochloride may worsen myasthenia gravis
• Coadministration with ritonavir

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Elderly
• Pacemakers
• Atrial fibrillation
• May affect ability to drive and operate machinery

Forms avail. in SA and covered in this monograph: tab

Arrhythmias - ventricular, supraventricular 
Re-entry tachycardias

• Oral (tab): Initial: 150mg, 8hrly OR 300mg, 12hrly; Titrate at 3 day intervals; Max: 300mg, 8hrly

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Tablets to be swallowed whole with liquid after meals

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Reduction in total daily dose is recommended for patients under 70kg

Not established for use in children

Pregnancy

• Caution; Not Recommended
• There are no adequate and well-controlled studies in pregnant women
• Propafenone should be used during pregnancy only if the potential benefit justifies the potential risk to the foetus
• Propafenone is known to pass the placental barrier in humans. The concentration of propafenone in the umbilical cord has been reported to be about 30% of that in the maternal blood

Breastfeeding

• Caution, not recommended
• Excretion of propafenone in human breast milk has not been studied
• Limited data suggest that propafenone may be excreted in human breast milk. Propafenone should be used with caution in nursing mothers

Renal Impairment

• Caution; no dose adjustment recommended

Hepatic Impairment

• Caution; no dose adjustment recommended

Elderly

• Caution; no dose adjustment recommended

Porphyria Information

• Probably porphyrinogenic (PRP)

Drugs in Sport

• Permitted - No warning

Central Nervous System Disorders

• Dizziness
• Headache
• Dysgeusia
• Anxiety
• Sleep disorders
• Vertigo
• Fatigue
• Nightmares
• Syncope
• Ataxia
• Parasthesia
• Confusion
• Convulsion
• Extrapyramidal symptoms
• Restlessness

Cardiovascular Disorders

• Cardiac conduction disorders
• Palpitations
• Sinus bradycardia
• Tachycardia
• Atrial flutter
• Ventricular tachycardia
• Arrhythmia
• Hypotension
• Ventricular fibrillation
• Cardiac failure
• Hypotension
• Orthostatic hypotension
• Chest pain

Respiratory Disorders

• Dyspnoea

Gastrointestinal Disorders

• Abdominal pain
• Nausea and vomiting
• Diarrhoea
• Constipation
• Dry mouth
• Abdominal distension
• Flatulence
• Retching
• Gastrointestinal disturbance

Hepatobiliary Disorders

• Hepatic function abnormal
• Hepatocellular injury
• Cholestasis
• Hepatitis
• Jaundice

Genitourinary Disorders

• Erectile dysfunction
• Decreased sperm count

Endocrine and Metabolic Disorders

• Decreased appetite

Musculoskeletal Disorders

• Lupus-like syndrome

Skin and Subcutaneous Tissue Disorders

• Urticaria
• Pruritus
• Rash
• Erythema

Immune, Blood and Lymphatic System Disorders 

• Thrombocytopenia
• Agranulocytosis 
• Leukopenia
• Granulocytopenia
• Hypersensitivity

Sensory Disorders

• Vision blurred
• Vertigo

Others

• Pyrexia

• Ritonavir
• Local anaesthetics
• Beta blockers
• Tricyclic antidepressants
• Propranolol
• Metoprolol
• Desipramine
• Ciclosporin
• Theophylline
• Digoxin
• Selective serotonin reuptake inhibitors
• Warfarin
• Venlafaxine
• CYP450 inhibitors
• Amiodarone
• Phenobarbital
• Rifampicin

• ECG
• Blood pressure
• Pulse

• Owing to the bitter taste and surface anesthetic action of propafenone, the film-coated tablets and sugar-coated tablets should be swallowed whole (without chewing) with liquid

Propafenone has a stabilising action on myocardial membranes, reduces the fast inward current carried by sodium ions with a reduction in depolarisation rate and prolongs the impulse conduction time in the atrium, AV node and primarily, in the His-Purkinje system.

Impulse conduction through accessory pathways, is either inhibited, by prolongation of the refractory period or blockade of the conduction pathway, both in anterograde but mostly retrograde direction. At the same time, spontaneous excitability is reduced by an increase of the myocardial stimulus threshold while electrical excitability of the myocardium is decreased by an increase of the ventricular fibrillation threshold.

Anti-arrhythmic effects: Slowing of upstroke velocity of the action potential, decrease of excitability, homogenisation of conduction rates, suppression of ectopic automaticity, lowered myocardial disposition to fibrillation.

Tablet 150mg

• Rythmol (Abbott) originator

Tablet 300mg

• Rythmol (Abbott) originator