Finished product reference

Procainamide Hydrochloride

Injection · Parenteral · 100 mg/1mL · 10 mL

List code
1054
Pharmacologic class
Class Ia antiarrhythmic

What it is and how it works

Procainamide blocks fast sodium channels, slowing conduction and prolonging the effective refractory period in atrial and ventricular myocardium and accessory pathways. Its active metabolite N-acetylprocainamide (NAPA) has class III (potassium channel blocking) activity and prolongs the QT interval.

Indications

Treatment of ventricular arrhythmias and of atrial arrhythmias, including pre-excited atrial fibrillation (Wolff–Parkinson–White syndrome), when other agents are unsuitable.

Dosage and administration (summary)

Given by slow intravenous injection or loading infusion (commonly up to 15–17 mg/kg, not exceeding 50 mg/minute, maximum about 1 g) under ECG and blood pressure monitoring, followed if required by a maintenance infusion of 1–4 mg/minute.

Contraindications

Complete heart block or second-degree AV block without a pacemaker, QT prolongation or torsade de pointes, systemic lupus erythematosus and myasthenia gravis.

Warnings and precautions

Stop the infusion if hypotension occurs, QRS widens by more than 50% or QT prolongs excessively; reduce dose in renal or heart failure. Long-term use may cause drug-induced lupus and, rarely, agranulocytosis.

Storage and supply

Store below 25 °C; do not use if the solution is darker than light amber.

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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