Label Changes for:

Kerlone (betaxolol hydrochloride) Tablets

August 2011

Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – August 2011

 

 

WARNINGS

Major surgery
  • Chronically administered beta-blocking therapy should not be routinely withdrawn prior to major surgery, however the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and surgical procedures (see Precautions, Drug Interactions). Titrate Kerlone dose to maintain effective heart rate control while avoiding frank hypotension and bradycardia

 

PRECAUTIONS

Drug Interactions
  • Particular care should be taken when using anesthetic agents which depress the myocardium, such as ether, cyclopropane, and trichloroethylene (see Warnings, Major surgery).
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