BOX WARNING Mortality
In the National Heart, Lung and Blood Institute's Cardiac Arrhythmia Suppression Trial (CAST), a long-term, multi-center, randomized, double-blind study in patients with asymptomatic non-life-threatening ventricular arrhythmias who had had a myocardial infarction more than 6 days but less than 2 years previously, an excessive mortality or non-fatal cardiac arrest rate (7.7%) was seen in patients treated with encainide or flecainide compared with that seen in patients assigned to carefully matched placebo-treated groups (3.0%). The average duration of treatment with encainide or flecainide in this study was 10 months.
The applicability of the CAST results to other populations (e.g., those without recent myocardial infarction) is uncertain. Considering the known proarrhythmic properties of Norpace or Norpace CR and the lack of evidence of improved survival for any antiarrhythmic drug in patients without life-threatening arrhythmias, the use of Norpace or Norpace CR as well as other antiarrhythmic agents should be reserved for patients with life-threatening ventricular arrhythmias.
|
| |
NORPACE SUMMARY
Norpace®
disopyramide phosphate capsules
Norpace® CR
disopyramide phosphate
extended-release capsules
Norpace (disopyramide phosphate) is an antiarrhythmic drug available for oral administration in immediate-release and controlled-release capsules containing 100 mg or 150 mg of disopyramide base, present as the phosphate. The base content of the phosphate salt is 77.6%.
Norpace and Norpace CR are indicated for the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening. Because of the proarrhythmic effects of Norpace and Norpace CR, their use with lesser arrhythmias is generally not recommended. Treatment of patients with asymptomatic ventricular premature contractions should be avoided.
Initiation of Norpace or Norpace CR treatment, as with other antiarrhythmic agents used to treat life-threatening arrhythmias, should be carried out in the hospital. Norpace CR should not be used initially if rapid establishment of disopyramide plasma levels is desired.
Antiarrhythmic drugs have not been shown to enhance survival in patients with ventricular arrhythmias.
|
NEWS HIGHLIGHTS
Published Studies Related to Norpace (Disopyramide)
Mechanism of disopyramide-induced hypoglycaemia in a patient with Type 2 diabetes. [2009.01]
CONCLUSIONS: Disopyramide therapy is not recommended for patients treated with K(ATP) channel inhibitors.
Nifekalant and disopyramide in a patient with short QT syndrome: evaluation of pharmacological effects and electrophysiological properties. [2008.09]
We assessed several pharmacological effects on electrocardiogram parameters and effective refractory period (ERP) in a patient with a short QT syndrome (SQTS)... Moreover, QT interval was paradoxically prolonged at higher heart rates induced with isoproterenol infusion or an exercise test, although the mechanism of this QT prolongation remains to be investigated.
Effects of serum concentrations of disopyramide and its metabolite mono-N-dealkyldisopyramide on the anticholinergic side effects associated with disopyramide. [2008.07]
The aim of this study was to evaluate the relationship between the anticholinergic side effects associated with disopyramide (DP) and serum DP or mono-N-dealkyldisopyramide (MND) concentrations and the safety range of DP or MND for prevention of anticholinergic side effects in 141 inpatients... These results suggest that not only DP concentration but also MND concentration should be monitored in patients whose renal function is decreased to prevent anticholinergic side effects associated with DP, and that when serum MND concentration was over approximately 1 microg/ml, the dose should be decreased or discontinued.
Oral disopyramide for the acute treatment of severe outflow obstruction in hypertrophic cardiomyopathy in the ICU setting. [2008.05]
When severe COPD and obstructive hypertrophic cardiomyopathy (HCM) coexist, management is challenging and complex... Two and a half hours after oral administration of disopyramide, LVOT gradient had decreased to 25 mm Hg with a corresponding immediate improvement in symptoms.
Severe respiratory failure and torsades de pointes induced by disopyramide in a patient with myasthenia gravis. [2008]
Class 1a anti-arrhythmic drugs are often used for the treatment of atrial fibrillation (AF), but it is not well known that myasthenia gravis (MG)-like symptoms can be generated by their anti-cholinergic effects. We had a patient with MG who developed symptomatic MG aggravation after AF treatment with disopyramide...
Clinical Trials Related to Norpace (Disopyramide)
Atrial Fibrillation Follow-Up Investigation of Rhythm Management (AFFIRM) [Completed]
To compare two standard treatment strategies for atrial fibrillation: ventricular rate
control and anticoagulation vs. rhythm control and anticoagulation.
AV Node Ablation and Pacemaker Therapy Compared to Drug Therapy for Atrial Fibrillation - Pilot Study [Recruiting]
The purpose of this study is to determine whether early atrioventricular node (AVN) ablation
with pacing device therapy will reduce death and hospitalization when compared to the
conventional drug therapy in elderly patients with recurrent and symptomatic atrial
fibrillation (AF).
|
|
|
|
Page last updated: 2009-10-20
|
