Drugs List

Therapeutic Indications

Uses

Paroxysmal supra-ventricular tachyarrhythmias
Ventricular arrhythmias

Prophylaxis and treatment of ventricular arrhythmias.
Prophylaxis and treatment of paroxysmal supraventricular tachyarrhythmias when standard therapy has failed or is contraindicated.

Contraindications

Children under 18 years
Brugada syndrome
Bundle branch block where no pacing rescue available
Electrolyte imbalance
Long QT syndrome
Myasthenia gravis
Non paced atrial conduction defects
Non paced second/third degree AV block
Non-arrhythmia induced cardiogenic shock
Non-paced infrahisian block
Non-paced sinus node dysfunction
Severe bradycardia
Severe hypotension
Severe obstructive pulmonary disease
Severe structural cardiac disorder
Torsade de pointes
Uncontrolled congestive cardiac failure with LVEF below 35%
Within 3 months of a myocardial infarction

Precautions and Warnings

Elderly
Family history of long QT syndrome
Predisposition to cardiac failure
Weight below 70kg
Asthma
Atrial fibrillation
Breastfeeding
Cardiac pacemaker
Hepatic impairment
History of torsade de pointes
Obstructive pulmonary disease
Pregnancy
Renal impairment

Consider dosage modification in patients with pacemakers
Advise patient ability to drive or operate machinery may be impaired
Treatment to be initiated and supervised by a specialist
Perform ECG before and during treatment
Consider dose reduction in patients under 70kg
Monitor blood pressure during titration and early maintenance treatment
Monitor serum electrolytes
May convert atrial fibrillation to atrial flutter
Discontinue or reduce dose if QRS is prolonged by more than 20%
Advise patient to avoid grapefruit products

A Brugada syndrome may be unmasked or Brugada like ECG changes may be provoked after exposure to propafenone hydrochloride in previously asymptomatic carriers of the syndrome. An ECG should be performed after initiating therapy with propafenone hydrochloride to rule out Brugada syndrome.

There is a potential for conversion of paroxysmal atrial fibrillation to atrial flutter with accompanying 2:1 or 1:1 conduction block.

Pregnancy and Lactation

Pregnancy

Use propafenone with caution in pregnancy.

Propafenone crosses the placenta, the concentration of propafenone in the umbilical cord has been shown to be approximately 30% of that in maternal blood.

Animal studies in rats and rabbits showed no teratogenic effects, however embryotoxicity occurred when given at doses 10 and 40 times the maximum recommended human doses.

Schaefer (2015) includes propafenone as one of the antiarrhythmic class 1C drugs of choice for the treatment of pregnant women but emphasizes the importance of critically evaluating the indication for use because antiarrhythmic agents themselves may cause arrhythmia.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use propafenone with caution in breastfeeding.

Propafenone is excreted into breast milk. Limited information indicates that maternal doses of propafenone hydrochloride of up to 900mg daily produce low levels in milk and would not be expected to cause any adverse effects in breastfed infants, especially if the infant is older than 2 months.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abdominal distension
Abdominal pain
Agranulocytosis
Anorexia
Anxiety
Arrhythmias
Asthenia
Ataxia
Atrial flutter
Atrioventricular block
Blood dyscrasias
Blurred vision
Bradycardia
Cardiac failure
Changes in hepatic function
Chest pain
Cholestasis
Conduction disturbances
Confusion
Constipation
Convulsions
Decreased appetite
Diarrhoea
Dizziness
Dry mouth
Dysgeusia
Dyspnoea
Elevation of liver enzymes
Erectile dysfunction
Erythema
Exacerbation of pre-existing asthma
Extrapyramidal effects
Fatigue
Flatulence
Gastro-intestinal disturbances
Granulocytopenia
Headache
Hepatitis
Hepatocellular damage
Hypersensitivity reactions
Hypotension
Intraventricular block
Jaundice
Leucopenia
Lupus erythematosus-like syndrome
Nausea
Nightmares
Palpitations
Paraesthesia
Postural hypotension
Pro-arrhythmic effects
Pruritus
Pyrexia
Rash
Reduction in spermatogenesis (in male)
Restlessness
Retching
Sino-atrial block
Sleep disturbances
Syncope
Tachycardia
Thrombocytopenia
Urticaria
Ventricular fibrillation
Ventricular tachycardia
Vertigo
Vomiting
Worsening heart failure

Presentation

Oral formulations of propafenone hydrochloride.

Drugs List

Therapeutic Indications

Uses

Paroxysmal supra-ventricular tachyarrhythmias
Ventricular arrhythmias

Prophylaxis and treatment of ventricular arrhythmias.
Prophylaxis and treatment of paroxysmal supraventricular tachyarrhythmias when standard therapy has failed or is contraindicated.

Dosage

Treatment with propafenone hydrochloride should be initiated under hospital conditions under the supervision of a physician experienced in the treatment of arrhythmias.

Dose increases should not be attempted until the patient has been receiving treatment for three to four days.

A reduction in dose should be considered for patients weighing less than 70kg.

Cardiological surveillance, including ECG monitoring and blood pressure control, should be used to determine individual maintenance doses.

Adults

Elderly

Patients with Renal Impairment

Patients with Hepatic Impairment

Additional Dosage Information

Contraindications

Children under 18 years
Brugada syndrome
Bundle branch block where no pacing rescue available
Electrolyte imbalance
Long QT syndrome
Myasthenia gravis
Non paced atrial conduction defects
Non paced second/third degree AV block
Non-arrhythmia induced cardiogenic shock
Non-paced infrahisian block
Non-paced sinus node dysfunction
Severe bradycardia
Severe hypotension
Severe obstructive pulmonary disease
Severe structural cardiac disorder
Torsade de pointes
Uncontrolled congestive cardiac failure with LVEF below 35%
Within 3 months of a myocardial infarction

Precautions and Warnings

Elderly
Family history of long QT syndrome
Predisposition to cardiac failure
Weight below 70kg
Asthma
Atrial fibrillation
Breastfeeding
Cardiac pacemaker
Hepatic impairment
History of torsade de pointes
Obstructive pulmonary disease
Pregnancy
Renal impairment

Consider dosage modification in patients with pacemakers
Advise patient ability to drive or operate machinery may be impaired
Treatment to be initiated and supervised by a specialist
Perform ECG before and during treatment
Consider dose reduction in patients under 70kg
Monitor blood pressure during titration and early maintenance treatment
Monitor serum electrolytes
May convert atrial fibrillation to atrial flutter
Discontinue or reduce dose if QRS is prolonged by more than 20%
Advise patient to avoid grapefruit products

A Brugada syndrome may be unmasked or Brugada like ECG changes may be provoked after exposure to propafenone hydrochloride in previously asymptomatic carriers of the syndrome. An ECG should be performed after initiating therapy with propafenone hydrochloride to rule out Brugada syndrome.

There is a potential for conversion of paroxysmal atrial fibrillation to atrial flutter with accompanying 2:1 or 1:1 conduction block.

Pregnancy and Lactation

Pregnancy

Use propafenone with caution in pregnancy.

Propafenone crosses the placenta, the concentration of propafenone in the umbilical cord has been shown to be approximately 30% of that in maternal blood.

Animal studies in rats and rabbits showed no teratogenic effects, however embryotoxicity occurred when given at doses 10 and 40 times the maximum recommended human doses.

Schaefer (2015) includes propafenone as one of the antiarrhythmic class 1C drugs of choice for the treatment of pregnant women but emphasizes the importance of critically evaluating the indication for use because antiarrhythmic agents themselves may cause arrhythmia.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use propafenone with caution in breastfeeding.

Propafenone is excreted into breast milk. Limited information indicates that maternal doses of propafenone hydrochloride of up to 900mg daily produce low levels in milk and would not be expected to cause any adverse effects in breastfed infants, especially if the infant is older than 2 months.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abdominal distension
Abdominal pain
Agranulocytosis
Anorexia
Anxiety
Arrhythmias
Asthenia
Ataxia
Atrial flutter
Atrioventricular block
Blood dyscrasias
Blurred vision
Bradycardia
Cardiac failure
Changes in hepatic function
Chest pain
Cholestasis
Conduction disturbances
Confusion
Constipation
Convulsions
Decreased appetite
Diarrhoea
Dizziness
Dry mouth
Dysgeusia
Dyspnoea
Elevation of liver enzymes
Erectile dysfunction
Erythema
Exacerbation of pre-existing asthma
Extrapyramidal effects
Fatigue
Flatulence
Gastro-intestinal disturbances
Granulocytopenia
Headache
Hepatitis
Hepatocellular damage
Hypersensitivity reactions
Hypotension
Intraventricular block
Jaundice
Leucopenia
Lupus erythematosus-like syndrome
Nausea
Nightmares
Palpitations
Paraesthesia
Postural hypotension
Pro-arrhythmic effects
Pruritus
Pyrexia
Rash
Reduction in spermatogenesis (in male)
Restlessness
Retching
Sino-atrial block
Sleep disturbances
Syncope
Tachycardia
Thrombocytopenia
Urticaria
Ventricular fibrillation
Ventricular tachycardia
Vertigo
Vomiting
Worsening heart failure

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: April 2018.

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 23 April 2018.

Summary of Product Characteristics: Arythmol 150mg tablets. Mylan Products Limited. Revised June 2017.

Summary of Product Characteristics: Arythmol 300mg tablets. Mylan Products Limited. Revised June 2017.

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Propafenone. Last revised: 10 March 2015.
Last accessed: 23 March 2018.