Pharmacokinetics in children

The bioavailability varies strongly (12–50%), food reduces the first-pass-effect and increases the bioavailability. Metabolization: in the liver by CYP2D6 to give active 5-hydroxypropafenone.

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Renal impaiment in children > 3 months

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

Nausea, abdominal pain, tiredness, blurred vision, taste disturbances. Pro-arrhythmic effects such as bradycardia and conduction disorders can occur both in the form of new arrhythmias and in the form of deterioration of existing arrhythmias; these can lead to a reduced cardiac function and even cardiac arrest. The risk of pro-arrhythmic effects is significantly greater in patients with structural heart disease and/or poor left ventricular function.

Abundant oral secretion and respiratory stress can occur with oral administration. This is most probably caused by the bitter taste and can be prevented with taste correction

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

Propafenone should be administered while hemodynamic parameters are being monitored. In case of reduced hepatic or renal function the dose should be adapted due to accumulation. Just like with other antiarrhythmic drugs there is a risk of arrhythmogenic effects, which can worsen the ventricular arrhythmia

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

• CARDIOVASCULAR SYSTEM
• CARDIAC THERAPY

ANTIARRHYTHMICS, CLASS I AND III

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

References

1. Guccione P, et al., Oral propafenone therapy for children with arrhythmias: efficacy and adverse effects in midterm follow-up., Am Heart J, 1991, 122, 1022-7
2. Ito S, et al., Intravenous and oral propafenone for treatment of tachycardia in infants and children: pharmacokinetics and clinical response., J Clin Pharmacol, 1998, 38, 496-501
3. Janousek J, et al., Safety of oral propafenone in the treatment of arrhythmias in infants and children (European retrospective multicenter study). Working Group on Pediatric Arrhythmias and Electrophysiology of the Association of European Pediatric Cardiologists., Am J Cardiol, 1998, 81, 1121-4
4. Kishore AG, et al., Guidelines for the use of propafenone in treating supraventricular arrhythmias., Drugs, 1995, 50, 250-62
5. Paul T, et al., New antiarrhythmic drugs in pediatric use: propafenone., Pediatr Cardiol, 1994, 15, 190-7
6. Reimer A, et al., Efficacy and safety of intravenous and oral propafenone in pediatric cardiac dysrhythmias, Am J Cardiol, 1991, 68, 741-4
7. Piersigilli F et al., Profuse oral secretions after propafenone administration in neonates., J Pediatr, 2010, Nov;157(5), 856-7

Changes

Therapeutic Drug Monitoring

Overdose