Extended-Release Tablets USP
PRONESTYL (procainamide hydrochloride), a Group 1A cardiac antiarrhythmic drug, is p-amino-N-[2-(diethylamino)ethyl]-benzamide monohydrochloride, molecular weight 271.
PRONESTYL-SR Tablets (Procainamide Hydrochloride Extended-Release Tablets) are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgement of the physician, are life-threatening. Because of the proarrhythmic effects of PRONESTYL-SR, its use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided.
Initiation of PRONESTYL-SR treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital.
Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias.
Because procainamide has the potential to produce serious hematological disorders (0.5 percent) particularly leukopenia or agranulocytosis (sometimes fatal), its use should be reserved for patients in whom, in the opinion of the physician, the benefits of treatment clearly outweigh the risks. (See WARNINGS and Boxed WARNING.)
Published Studies Related to Pronestyl-SR (Procainamide)
Levofloxacin and ciprofloxacin decrease procainamide and N-acetylprocainamide renal clearances. [2005.04]
Ten healthy adults participated in a randomized, crossover drug interaction study testing procainamide only, procainamide plus levofloxacin, and procainamide plus ciprofloxacin.
Transesophageal pacemaker therapy in atrial flutter after procainamide pretreatment. [1999.09]
Transesophageal atrial stimulation was applied in 56 patients to terminate atrial flutter. Extrastimulation and atrial burst techniques were applied using programmable stimulator (Medtronic 5328) and hexapolar esophageal electrode catheters...
Comparison of propafenone versus procainamide for the acute treatment of atrial fibrillation after cardiac surgery. [1999.08.01]
A prospective, randomized, double-blind study to compare the efficacy in terminating postoperative atrial fibrillation of the class Ic drug propafenone versus class Ia drug procainamide was conducted. Intravenous propafenone was superior to procainamide in achieving rapid cardioversion and a better rate control with a lower incidence of symptomatic hypotension..
Propafenone versus procainamide for conversion of atrial fibrillation to sinus rhythm. [1998.10]
BACKGROUND AND HYPOTHESIS: Antiarrhythmic drugs are widely used for treatment of atrial fibrillation (AF) and restoration of sinus rhythm. This prospective, randomized, and controlled study compared the efficiency and safety of propafenone versus procainamide for the treatment of acute AF... CONCLUSION: In the present study, procainamide was more effective than propafenone for the treatment of AF of short duration.
Conversion efficacy and safety of intravenous ibutilide compared with intravenous procainamide in patients with atrial flutter or fibrillation. [1998.05]
OBJECTIVES: This multicenter study compared the efficacy and safety of ibutilide versus procainamide for conversion of recent-onset atrial flutter or fibrillation. BACKGROUND: Ibutilide fumarate is an intravenous (IV) class III antiarrhythmic agent that has been shown to be significantly more effective than placebo in the pharmacologic conversion of atrial flutter and fibrillation to sinus rhythm. Procainamide is commonly used for conversion of recent-onset atrial fibrillation to normal sinus rhythm... CONCLUSIONS: This study establishes the superior efficacy of ibutilide over procainamide when administered to patients to convert either atrial fibrillation or atrial flutter to sinus rhythm. Hypotension was the major adverse effect seen with procainamide. A low incidence of serious proarrhythmia was seen with the administration of ibutilide occurring at the end of infusion.
Clinical Trials Related to Pronestyl-SR (Procainamide)
Certain People With A Fib May Have Changes on Ecg When Given Procainamide That May be Related to a Genetic Difference [Recruiting]
The purpose of this study is to look for a similarity in people's genes that may help
understand which people could benefit from certain drugs for the treatment of atrial
Iv Amiodarone Versus Iv Procainamide to Treat Haemodynamically Well Tolerated Ventricular Tachycardia [Recruiting]
The purpose of this study is to determine whether intravenous amiodarone has less cardiac
significant adverse events compared to intravenous procainamide in the acute treatment of
haemodynamically well tolerated wide QRS tachycardia, the majority of them of probably
Ajmaline Utilization in the Diagnosis and Treatment of Cardiac Arrhythmias [Recruiting]
The study evaluates 3 different populations:
It is an open, randomized, parallel-group study comparing the effectiveness of intravenous
(iv) ajmaline with currently used antiarrhythmic drugs in the acute treatment of :
1. recent-onset atrial fibrillation versus iv flecainide
2. sustained monomorphous ventricular tachycardia versus iv procainamide
The study also evaluates in an open, randomized, crossover study, the use of iv ajmaline
versus iv flecainide in the diagnosis of Brugada syndrome
Cardiac Arrest in Seattle: Conventional Versus Amiodarone Drug Evaluation (CASCADE) [Completed]
To compare the efficacy of amiodarone to conventional anti-arrhythmic therapy in individuals
who had survived one episode of out-of-hospital cardiac arrest.
Electrophysiologic Study Versus Electrocardiographic Monitoring (ESVEM) [Completed]
To determine whether electrophysiologic study (EPS) or Holter monitoring (HM) was the better
method for selecting effective long-term antiarrhythmic drug therapy in patients with
sustained ventricular tachycardia, ventricular fibrillation, or an episode of aborted sudden