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

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

 

Summary View

 

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.