Label Changes for:

Coreg CR (carvedilol phosphate) 10 mg, 20 mg, 40 mg, and 80 mg Extended Release Capsules

June 2009

Changes have been made to the WARNINGS, PRECAUTIONS and PATIENT PACKAGE INSERT sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- June 2009

WARNINGS AND PRECUATIONS

Hypotension
  • In a trial comparing heart failure patients switched to Coreg CR or maintained on immediate-release carvedilol, there  was a 2-fold increase in the combined incidence of hypotension, syncope or dizziness in elderly patients (> 65 years) switched from the highest dose of carvedilol (25 mg twice daily) to Coreg CR 80 mg once daily.

USE IN SPECIFIC POPULATIONS

Geriatric Use
  • A randomized study (n = 405) comparing mild to severe heart failure patients switched to Coreg CR or maintained on immediate-release carvedilol included 220 patients who were 65 years of age or older. In this elderly subgroup, the combined incidence of dizziness, hypotension, or syncope was 24% (18/75) in patients switched from the highest dose of immediate-release carvedilol (25 mg twice daily) to the highest dose of Coreg CR (80 mg once daily) compared to 11% (4/36) in patients maintained on immediate release carvedilol (25 mg twice daily). When switching from the higher doses of immediate-release carvedilol to COREG CR, a lower starting dose is recommended for elderly patients.

PATIENT INFORMATION LEAFLET

What are possible side effects of COREG CR?
  • rare but serious allergic reactions (including hives or swelling of the face, lips, tongue, and/or throat that may cause difficulty in breathing or swallowing) have happened in patients who were on Coreg or Coreg CR. These reactions can be life-threatening. In some cases, these reactions happened in patients who had been on Coreg before taking Coreg CR.
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