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U.S. Department of Health and Human Services

Safety

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Omeprazole, Sodium Bicarbonate and Magnesium Hydroxide Tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – December 2012

Summary View

 

WARNINGS AND PRECAUTIONS

Clostridium Difficile Associated Diarrhea
  • Published observational studies suggest that PPI therapy like Omeprazole/Sodium Bicarbonate/ Magnesium Hydroxide Tablets may be associated with an increased risk of Clostridium difficile associated diarrhea,especially in hospitalized patients…
 
Interaction with Clopidogrel
  • Avoid concomitant use of Omeprazole/Sodium Bicarbonate/Magnesium/Hydroxide Tablets with Clopidogrel…
 
Concomitant Use of Omeprazole/Sodium Bicarbonate/Magnesium Hydroxide Tablets with St. John’s Wort or Rifampin
  • Drugs which induce CYP2C19 OR CYP34A (such as St John’s Wort or rifampin) can substantially decrease omeprazole concentrations…
 
Interactions with Investigations for Neuroendocrine Tumors
  • Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acidity…
 
Concomitant Use of Omeprazole/Sodium Bicarbonate/Magnesium Hydroxide Tablets with Methotrexate
  • Literature suggests that concomitant use of PPIs with Methotrexate (primarily at high dose; see Methotrexate prescribing information) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to Methotrexate toxicities…