Recommended Topic Related To:

Corvert

"Nov. 13, 2012 -- Transcendental Meditation is good for the heart, according to a new study.

The study was funded by the National Institutes of Health. It found that African-Americans with heart disease who regularly practiced TM reduc"...

Corvert

Corvert

SIDE EFFECTS

CORVERT (ibutilide fumarate injection) Injection was generally well tolerated in clinical trials. Of the 586 patients with atrial fibrillation or atrial flutter who received CORVERT (ibutilide fumarate injection) in phase II/III studies, 149 (25%) reported medical events related to the cardiovascular system, including sustained polymorphic ventricular tachycardia (1.7%) and nonsustained polymorphic ventricular tachycardia (2.7%).

Other clinically important adverse events with an uncertain relationship to CORVERT (ibutilide fumarate injection) include the following (0.2% represents one patient): sustained monomorphic ventricular tachycardia (0.2%), nonsustained monomorphic ventricular tachycardia (4.9%), AV block (1.5%), bundle branch block (1.9%), ventricular extrasystoles (5.1%), supraventricular extrasystoles (0.9%), hypotension/postural hypotension (2.0%), bradycardia/sinus bradycardia (1.2%), nodal arrhythmia (0.7%), congestive heart failure (0.5%), tachycardia/sinus tachycardia/supraventricular tachycardia (2.7%), idioventricular rhythm (0.2%), syncope (0.3%), and renal failure (0.3%). The incidence of these events, except for syncope, was greater in the group treated with CORVERT (ibutilide fumarate injection) than in the placebo group.

Another adverse reaction that may be associated with the administration of CORVERT (ibutilide fumarate injection) was nausea, which occurred with a frequency greater than 1% more in ibutilide-treated patients than those treated with placebo.

The medical events reported for more than 1% of the placebo- and ibutilide-treated patients are shown in the following Table.

Treatment-Emergent Medical Events With Frequency of More Than 1% and Higher Than That of Placebo

Event Placebo
N=127
All Ibutilide
N=586
Patients Patients
n % n %
CARDIOVASCULAR
  Ventricular extrasystoles 1 0.8 30 5.1
  Nonsustained monomorphic VT 1 0.8 29 4.9
  Nonsustained polymorphic VT - - 16 2.7
  Hypotension 2 1.6 12 2.0
  Bundle branch block - - 11 1.9
  Sustained polymorphic VT - - 10 1.7
  AV block 1 0.8 9 1.5
  Hypertension - - 7 1.2
  QT segment prolonged - - 7 1.2
  Bradycardia 1 0.8 7 1.2
  Palpitation 1 0.8 6 1.0
  Tachycardia 1 0.8 16 2.7
GASTROINTESTINAL
  Nausea 1 0.8 11 1.9
CENTRAL NERVOUS SYSTEM
  Headache 4 3.1 21 3.6

In the post-cardiac surgery study (see Clinical Studies), similar types of medical events were reported. In the 1 mg ibutilide fumarate treatment group (N=70), 2 patients (2.9%) developed sustained polymorphic ventricular tachycardia and 2 other patients (2.9%) developed nonsustained polymorphic ventricular tachycardia. Polymorphic ventricular tachycardia was not reported in the 73 patients in the 0.5 mg dose group or in the 75 patients in the 0.25 mg dose group.

DRUG INTERCTIONS

No specific pharmacokinetic or other formal drug interaction studies were conducted.

Digoxin: Supraventricular arrhythmias may mask the cardiotoxicity associated with excessive digoxin levels. Therefore, it is advisable to be particularly cautious in patients whose plasma digoxin levels are above or suspected to be above the usual therapeutic range. Coadministration of digoxin did not have effects on either the safety or efficacy of ibutilide in the clinical trials.

Calcium channel blocking agents: Coadministration of calcium channel blockers did not have any effect on either the safety or efficacy of ibutilide in the clinical trials.

Beta-adrenergic blocking agents: Coadministration of beta-adrenergic blocking agents did not have any effect on either the safety or efficacy of ibutilide in the clinical trials.

Read the Corvert Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 6/25/2008
This monograph has been modified to include the generic and brand name in many instances.

A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Heart Health

Get the latest treatment options.

Health Resources
advertisement
advertisement
Use Pill Finder Find it Now See Interactions

Pill Identifier on RxList

  • quick, easy,
    pill identification

Find a Local Pharmacy

  • including 24 hour, pharmacies

Interaction Checker

  • Check potential drug interactions
Search the Medical Dictionary for Health Definitions & Medical Abbreviations