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. |
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).
- Cardiovascular System
PATIENT PACKAGE INSERT
- What Are the Possible Side Effects of Norvir?
- Changes in the electrocardiogram (EKG)...
