Label Changes for:
Prilosec (omeprazole) Delayed- Release Granules for Oral Suspension, 2.5 mg and 10 mgPrilosec (omeprazole) Delayed-Release Capsules, 10 mg, 20 mg, and 40 mg
Changes have been made to the PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
8 USE IN SPECIFIC POPULATIONS
Pregnancy Category C
- There are no adequate and well-controlled studies with PRILOSEC in pregnant women. Available epidemiologic data ....
- Human Data - extensive study data added
- Animal Data - extensive study data added
8.3 Nursing Mothers
- Omeprazole is present in human milk. Omeprazole concentrations were measured ....... Caution should be exercised when PRILOSEC is administered to a nursing woman
8.4 Pediatric Use
- Use of PRILOSEC in pediatric and adolescent patients 1 to 16 years of age for the treatment of GERD and maintenance of healing of erosive esophagitis is supported by a) extrapolation of results from ..... and b) safety and pharmacokinetic studies performed in pediatric and adolescent patients. .....The safety and effectiveness of PRILOSEC for the treatment of GERD in patients <1 year of age have not been established. The safety and effectiveness of PRILOSEC for other pediatric uses have not been established.
WARNINGS AND PRECAUTIONS
Concomitant use of Prilosec with St John’s Wort or rifampin
- Drugs which induce CYP2C19 or CYP3A4 (such as St John’s Wort or rifampin) can substantially decrease omeprazole concentrations. Avoid concomitant use of Prilosec with St John’s Wort or rifampin. Warning and Precautions (5) section with information regarding interactions with diagnostic investigations for neuroendocrine tumors, and concomitant use 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.
- with information regarding interactions with diagnostic investigations for neuroendocrine tumors, and concomitant use with tacrolimus, digoxin, St. John’s Wort or rifampin, and clopidogrel.
PATIENT PACKAGE INSERT
Tell your doctor about all of the medicines you take
- addition of St. John’s Wort (Hypericum perforatum) and Rifampin to the medication list
5 WARNING AND PRECAUTIONS
5.4 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 [see Drug Interactions (7)]