- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
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.
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dose recommendation of formulary compared to licensed use (on-label versus off-label)
No information is present at this moment.
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Available formulations
No information is present at this moment.
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Dosages
| Severe ventricular and supraventricular arrhythmias |
|---|
|
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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.
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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
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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
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Interactions
The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here
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| Antiarrhythmics, class Ia | ||
|---|---|---|
| C01BA02 | ||
| C01BA01 | ||
| Antiarrhythmics, class Ic | ||
|---|---|---|
| C01BC04 | ||
| Antiarrhythmics, class III | ||
|---|---|---|
| C01BD01 | ||
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References
- 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
- 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
- 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
- Kishore AG, et al., Guidelines for the use of propafenone in treating supraventricular arrhythmias., Drugs, 1995, 50, 250-62
- Paul T, et al., New antiarrhythmic drugs in pediatric use: propafenone., Pediatr Cardiol, 1994, 15, 190-7
- Reimer A, et al., Efficacy and safety of intravenous and oral propafenone in pediatric cardiac dysrhythmias, Am J Cardiol, 1991, 68, 741-4
- Piersigilli F et al., Profuse oral secretions after propafenone administration in neonates., J Pediatr, 2010, Nov;157(5), 856-7
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Changes
Changes
