Label Changes for:
Zegerid (omeprazole/sodium bicarbonate) powder for oral suspension
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)
WARNINGS AND PRECAUTIONS
Acute Interstitial Nephritis
Cyanocobalamin (vitamin B12) Deficiency
*Addition of information regarding concomitant dosing of mycophenolate mofetil with PPIs resulting in reduced systemic exposure of mycophenolate mofetil
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.
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.