- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
-
Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
Therapeutische plasmaconcentratie: 4-8 mg/l, metaboliet N-acetylprocaïnamide (NAPA) tot 15 mg/l.
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dose recommendation of formulary compared to licensed use (on-label versus off-label)
Unlicensed
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Available formulations
No information is present at this moment.
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Dosages
| Ventricular arrhythmias |
|---|
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Renal impaiment in children > 3 months
No information available on dose adjustment in renal impairment.
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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
Maagdarmstoornissen, allergieën, hallucinaties, lupus erythematodes, verlenging van QT-interval, torsade de pointes, hypotensie, ventriculaire dysfunctie.
The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here
Adult Side Effects
Geleidingsstoornissen, torsade de pointes (vooral bij verlengd QTc-interval en tevens hypokaliëmie), compleet AV-block, ventriculaire tachycardie en premature ventriculaire contracties kunnen voorkomen. Bij snelle infusie kan hypotensie optreden. Bij hoge doses kunnen ventrikelfibrilleren en asystolie optreden. Soms maagdarmstoornissen, bittere smaak, duizeligheid, blozen, spierzwakte, depressie, psychose met hallucinaties, vergrote lever met stijging van de transaminasewaarden en overgevoeligheidsreacties, zoals urticaria, jeuk, maculopapuleuze uitslag, angio-oedeem en stijging van de antinucleaire antistoffentiter. Dit laatste kan gepaard gaan met systemische lupus erythematodes. Bloedbeeldafwijkingen, zoals agranulocytose, hemolytische anemie, trombocytopenie, leukopenie en neutropenie zijn bij 0.5% van de patiënten gemeld en treden meestal gedurende de eerste 3 maanden van de behandeling op. Bij het optreden van bloedbeeldafwijkingen dient de therapie te worden gestaakt. Bij aritmieën ten gevolge van digitalisintoxicatie kan additionele vertraging van de geleiding optreden, hetgeen kan leiden tot ventriculaire asystolie of ventrikelfibrilleren. Bij myasthenia gravis kunnen de symptomen verergeren.
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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 in children
Verlengd QTc-interval.
The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here
Contra-indications in adults
Overgevoeligheid voor procaïnamide en verwante stoffen. Verlengd QTc-interval, tweede- of derdegraads AV-block of een geleidingsstoornis in één van de takken van de bundel van His, indien geen pacemaker is geïmplanteerd, ernstig hartfalen, systemische lupus erythematodes, myasthenia gravis en ernstige leverfunctiestoornis. Voorzichtigheid is geboden bij eerstegraads AV-block, hartfalen, aritmie ten gevolge van digitalisintoxicatie, beenmergfunctiestoornis en leverfunctiestoornis. Bij verminderde nierfunctie (creatinineklaring groter dan 10 ml/min) is aanpassing van de dosering niet noodzakelijk.
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
Toediening dient uitsluitend in het ziekenhuis, onder medische controle en bewaking van ECG en bloeddruk, plaats te vinden. Cave langzame acetyleerders. Langdurig gebruik wordt ontraden.
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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 | ||
|---|---|---|
| C01BA01 | ||
| Antiarrhythmics, class Ic | ||
|---|---|---|
| C01BC04 | ||
| C01BC03 | ||
| Antiarrhythmics, class III | ||
|---|---|---|
| C01BD01 | ||
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References
- Luedtke SA, et al., Pharmacologic management of supraventricular tachycardias in children. Part 1: Wolff-Parkinson-White and atrioventricular nodal reentry., Ann Pharmacother, 1997, 3, 1227-43
- Luedtke SA, et al., Pharmacologic management of supraventricular tachycardias in children. Part 2: Atrial flutter, atrial fibrillation, and junctional and atrial ectopic tachycardia., Ann Pharmacother, 1997, 3, 1347-59
- Mandapati R, et al., Procainamide for rate control of postsurgical junctional tachycardia., Pediatr Cardiol, 2000, 2, 123-8
- Singh S, et al., Procainamide elimination kinetics in pediatric patients., Clin Pharmacol Ther., 1982, 32, 607-11
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Changes
Changes
