Label Changes for:
Januvia (sitagliptin) tablets (PPI/MG)
February 2012
Changes have been made to the PATIENT PACKAGE INSERT sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- July 2008, April 2011 and February 2012
| 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. |
February 2012
DOSAGE AND ADMINISTRATION
Recommended Dosing
- The tablets must not be split, crushed, or chewed before swallowing.
PATIENT COUNSELING INFORMATION
Instructions
- Patients should be informed that the tablets must be swallowed whole and never split, crushed or chewed.
How should I take Januvia
- Take Januvia tablets whole. Do not split, crush, or chew Januvia tablets before swallowing. If you cannot swallow Januvia tablets whole tell your doctor.
April 2011
5 WARNINGS AND PRECAUTIONS
5.2 Renal Impairment
- section added
6 ADVERSE REACTIONS
6.2 Postmarketing Experience
- ...worsening renal function..
MEDICATION GUIDE
- ...worsening renal function...
July 2008
| Sections Modified | Summary of Changes to Contraindications and Warnings |
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WARNINGS AND PRECAUTIONS
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WARNINGS AND PRECAUTIONS Macrovascular Outcomes There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Januvia or any other anti-diabetic drug. |
