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U.S. Department of Health and Human Services

Safety

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Kapvay (clonidine hydrochloride) extended-release tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – February 2013

Summary View

 

WARNINGS AND PRECAUTIONS

Cardiac Conduction Abnormalities
  • The sympatholytic action of clonidine may worsen sinus node dysfunction and atrioventricular (AV) block, especially in patients taking other sympatholytic drugs. There have been post-marketing reports of patients with conduction abnormalities and/or taking other sympatholytic drugs who developed severe bradycardia requiring IV atropine, IV isoproterenol, and temporary cardiac pacing while taking clonidine. Uptitrate Kapvay slowly and monitor vital signs frequently in patients with cardiac conduction abnormalities or patients concomitantly treated with other sympatholytic drugs.
 

ADVERSE REACTIONS

Postmarketing Experience
  • Hallucinations and atrioventricular (AV) block have been identified during post approval use of Kapvay.