Label Changes for:

Vimovo (naproxen/esomeprazole magnesium) Delayed-Release Tablets

March 2014

Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.

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

 

March 2014

WARNINGS AND PRECAUTIONS

Renal Effects
  • Patients at greatest risk of this reaction are those with impaired renal function, hypovolemia, heart failure, liver dysfunction, salt depletion, those taking diuretics, ACE inhibitors, or angiotensin II receptor antagonists and the elderly.
Laboratory Tests
  • Healthcare providers should temporarily stop esomeprazole treatment at least 14 days before assessing CgA levels and consider repeating the test if initial CgA levels are high. If serial tests are performed (e.g. for monitoring), the same commercial laboratory should be used for testing, as reference ranges between tests may vary

 

January 2012

5 WARNINGS AND PRECAUTIONS

5.21 Concomitant use of VIMOVO with Methotrexate
  • Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate...

6 ADVERSE REACTIONS

6.2 Postmarketing Experience
  • esomeprazole - microsopic colitis....added

7 DRUG INTERACTIONS

7.8 Methotrexate
  • NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. NSAIDs have been reported.....
7.14 Interactions Related to Absorption
  • ...Like with other drugs that decrease the intragastric acidity, the absorption of drugs such as ketoconazle, iron salts and erlotinib can decrease...

MEDICATION GUIDE

Tell your healthcare provider about all the medicines you take.....

Especially tell your healthcare provider if you take:

  • Erlotinib (or another anticancer drug from the same class)

 

 

November 2011

WARNINGS AND PRECAUTIONS

Bone Fracture
  • Several published observational studies suggest that proton pump inhibitor (PPI) therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer).
  • Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Patients at risk for osteoporosis-related fractures should be managed according to the established treatment guidelines.
  • Vimovo (a combination PPI/NSAID) is approved for use twice a day and does not allow for administration of a lower daily dose of the PPI.

ADVERSE REACTIONS

Postmarketing Experience
  • bone fracture 

 

 

June 2011

 

WARNINGS AND PRECAUTIONS

  • information regarding severe hepatic impairment, interactions with diagnostic investigations for neuroendocrine tumors, and concomitant use with St. John’s Wort or rifampin

DRUG INTERACTIONS

  • information regarding interactions with diagnostic investigations for neuroendocrine tumors, and concomitant use with cyclosporine, tacrolimus, anticoagulants, digoxin, and St. John’s Wort or rifampin

SPECIAL POPULATIONS

  • information regarding severe hepatic impairment

 

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