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- Changed to 5.9 Major Surgery; Chronically administered beta-blocking therapy should not be routinely withdrawn prior to major surgery; however, the impaired ability of the heart to respond to reflex adrenergic stimuli may augment the risks of general anesthesia and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…...
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….."are scheduled for cataract surgery and have taken or are currently taking Coreg."
