Label Changes for:

Norvir (ritonavir capsules) Soft Gelatin

August 2008

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


Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- August 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary.


Summary View

Sections Modified

PRECAUTIONS

  • PR Interval Prolongation
  • Information for Patients
    • Patients should be informed that Norvir may produce changes in the electrocardiogram (eg, PR prolongation)...

ADVERSE REACTIONS

  • Postmarketing Experience
    • Cardiovascular System
      • First–degree AV block, second-degree AV block, third-degree AV block, right bundle branch block have been reported (See PRECAUTIONS – PR Interval Prolongation).

PATIENT PACKAGE INSERT

  • What Are the Possible Side Effects of Norvir?
    • Changes in the electrocardiogram (EKG)...
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