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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

Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

WARNINGS AND PRECAUTIONS

  • Macrovascular Outcomes

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.

 

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