Label Changes for:

Coreg (carvedilol) Tablets Coreg CR (carvedilol phosphate) Extended Release Capsules

July 2011

Changes have been made to the ADVERSE REACTIONS sections of the safety label.

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

 

July 2011

 

ADVERSE REACTIONS

Postmarketing Experience
  • Blood and Lymphatic System Disorders: Aplastic anemia.
  • Immune System Disorders: Hypersensitivity (e.g., anaphylactic reactions, angioedema, urticaria).
  • Renal and Urinary Disorders: Urinary incontinence.
  • Respiratory, Thoracic and Mediastinal Disorders: Interstitial pneumonitis.
  • Skin and Subcutaneous Tissue Disorders: Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme.

  

January 2011

 

5 WARNINGS AND PRECAUTIONS
 

5.9 Anesthesia and Major Surgery
  • Changed to 5.9 Major Surgery; Chronically administered beta-blocking therapy should not be routinely withdrawn prior to major surgery; however, the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and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.
5.14 Floppy Iris Syndrome
  • Intraoperative Floppy Iris Syndrome (IFIS) has been observed during cataract surgery in some patients treated with alpha-1 blockers (Coreg is an alpha/beta blocker). This variant of small pupil syndrome‚Ķ...

 

7 DRUG INTERACTIONS

7.10 Anesthesia
  • If treatment with COREG CR is to be continued perioperatively, particular care should be taken when anesthetic agents which depress myocardial function, such as ether, cyclopropane, and trichloroethylene, are used [see Overdosage (10)].

 

17 PATIENT COUNSELING INFORMATION

17.2 Patient Information Leaflet
  • What should I tell my doctor before taking‚Ķ.."are scheduled for cataract surgery and have taken or are currently taking Coreg."

 

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