Export

EN
FR
Procainamide
Not recommended as an essential medicine
Section:
12. Cardiovascular medicines 12.2. Antiarrhythmic medicines
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ATC codes: C01BA02
Indication
Cardiac arrhythmia ICD11 code: BC8Z
INN
Procainamide
Medicine type
Chemical agent
List type
Complementary
Formulations
Parenteral > General injections > IV: 100 mg per mL in 10 mL ampoule (hydrochloride)
Oral > Solid: 500 mg (hydrochloride) ; 250 mg (hydrochloride)
EML status history
First added in 1977 (TRS 615)
Changed in 1979 (TRS 641)
Changed in 1982 (TRS 685)
Changed in 1984 (TRS 722)
Removed in 2009 (TRS 958)
Sex
All
Age
Adolescents and adults
Therapeutic alternatives
Medicines within the same pharmacological class can be used
Patent information
Patents have expired in most jurisdictions
Wikipedia
Procainamide
DrugBank
Procainamide
Summary of evidence and Expert Committee recommendations
Procainamide was deleted from the complementary list of the EML in 2009. An application was prepared by the Public Health and Pharmacology Department, Weill Medical College of Cornell University, New York, USA, for the deletion of quinidine 200 mg from the Model List. The Committee noted that a recent Cochrane Review (1) and a large multicentre RCT (2) were cited in the application to support the lack of superior efficacy of quinidine over other antiarrhythmic medicines and strategies in prolonging the life of cardiac patients. The Committee recognized that quinidine has many serious adverse effects; it is associated with increased morbidity, risk of QT prolongation and induction of fatal arrhythmias in the adult population. It interacts with a large number of other medicines with potentially fatal consequences, including anti-infectives and antifungals, which are used extensively in developing countries. The Committee accepted that the evidence presented could also apply to procainamide, another class IA antiarrhythmic agent currently on the Model List. The Committee recommended the deletion of quinidine and procainamide from the Complementary Model List because of the lack of evidence of superior efficacy or safety when compared to other antiarrhythmic medicines, and the availability of effective and safer alternatives, on the Model List. References: 1. Lafuente-Lafuente C et al. Antiarrhythmias for maintaining sinus rhythm after cardioversion of atrial fibrillation. Cochrane Database of Systematic Reviews, 2007, (4):CD005049. 2. The Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) Investigators. A comparison of rate control and rhythm control in patients with atrial fibrillation. New England Journal of Medicine, 2002, 347:1825–1833.