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U.S. Department of Health and Human Services

Safety

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Zegerid (omeprazole/sodium bicarbonate) powder for oral suspension and capsules

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

 

November 2012

Summary View

WARNINGS AND PRECAUTIONS

Clostridium difficile Associated Diarrhea
  • Published observational studies suggest that proton pump inhibitor (PPI) therapy like xxxxx may be associated with an increased risk of Clostridium difficile associated diarrhea (CDAD), especially in hospitalized patients. This diagnosis should be considered for diarrhea that does not improve [see Adverse Reactions (6.x)].

    Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.

    CDAD has been reported with use of nearly all antibacterial agents. For more information specific to antibacterial agents (clarithromycin and amoxicillin) indicated for use in combination with xxxxx, refer to WARNINGS and PRECAUTIONS sections of those package inserts.
Interaction with Clopidogrel
  • Avoid concomitant use of esomeprazole/omeprazole with clopidogrel. Clopidogrel is a prodrug. Inhibition of platelet aggregation by clopidogrel is entirely due to an active metabolite. The metabolism of clopidogrel to its active metabolite can be impaired by use with concomitant medications, such as esomeprazole, that inhibit CYP2C19 activity. Concomitant use of clopidogrel with 40 mg esomeprazole/omeprazole reduces the pharmacological activity of clopidogrel. When using esomeprazole/omeprazole, consider alternative anti-platelet therapy
Concomitant use of Zegerid 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.  Avoid concomitant use of ZEGERD with St John’s Wort or rifampin.
Interactions with Investigations for Neuroendocrine Tumors
  • Serum chromogranin A (CgA) levels increase secondary to drug-induced decreases in gastric acidity. The increased CgA level may cause false positive results in diagnostic investigations for neuroendocrine tumors. Providers should temporarily stop omeprazole treatment 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.

DRUG INTERACTIONS

Effects on Hepatic Metabolism/Cytochrome P-450 pathways
  • Clopidogrel: Clopidogrel is metabolized to its active metabolite in part by CYP2C19. Concomitant use of esomeprazole/omeprazole 40 mg results in reduced plasma concentrations of the active metabolite of clopidogrel and a reduction in platelet inhibition. Avoid concomitant administration of esomeprazole/Omeprazole with clopidogrel. When using esomeprazole/omeprazole, consider use of alternative anti-platelet therapy. 

 

 

April 2012

Summary View

 

WARNINGS AND PRECAUTIONS

Concomitant use of Zegerid 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. In high-dose Methotrexate administration, a temporary withdrawal of the PPI may be considered in some patients

 

December 2011

Summary View

 

WARNINGS AND PRECAUTIONS

Diminished Anti-platelet Activity of clopidogrel due to Impaired CYP2C19 Function by Omeprazole
  • Clopidogrel is a prodrug. Inhibition of platelet aggregation by clopidogrel is entirely due to an active metabolite. The metabolism of clopidogrel to its active metabolite can be impaired by use with concomitant medications, such as omeprazole, that interfere with CYP2C19 activity. Avoid concomitant use of clopidogrel and omeprazole. Co-administration of clopidogrel with 80 mg omeprazole, a proton pump inhibitor that is an inhibitor of CYP2C19, reduces the pharmacological activity of clopidogrel if given concomitantly or if given 12 hours apart.

 

DRUG INTERACTIONS

Clopidogrel
  • Omeprazole is an inhibitor of CYP2C19 enzyme. Clopidogrel is metabolized to its active metabolite in part by CYP2C19. Concomitant use of omeprazole 80 mg results in reduced plasma concentrations of the active metabolite of clopidogrel and a reduction in platelet inhibition