FDA Label for Esomeprazole Magnesium

View Indications, Usage & Precautions

    1. 1.1 TREATMENT OF GASTROESOPHAGEAL REFLUX DISEASE (GERD)
    2. 1.2 RISK REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER
    3. 1.3 H. PYLORI ERADICATION TO REDUCE THE RISK OF DUODENAL ULCER RECURRENCE
    4. 1.4 PATHOLOGICAL HYPERSECRETORY CONDITIONS INCLUDING ZOLLINGER-ELLISON SYNDROME
    5. 2 DOSAGE AND ADMINISTRATION
    6. 3 DOSAGE FORMS AND STRENGTHS
    7. 4 CONTRAINDICATIONS
    8. 5.1 PRESENCE OF GASTRIC MALIGNANCY
    9. 5.2 ACUTE INTERSTITIAL NEPHRITIS
    10. 5.3 CLOSTRIDIUM DIFFICILE-ASSOCIATED DIARRHEA
    11. 5.4 BONE FRACTURE
    12. 5.5 CUTANEOUS AND SYSTEMIC LUPUS ERYTHEMATOSUS
    13. 5.6 INTERACTION WITH CLOPIDOGREL
    14. 5.7 CYANOCOBALAMIN (VITAMIN B-12) DEFICIENCY
    15. 5.8 HYPOMAGNESEMIA
    16. 5.9 INTERACTION WITH ST. JOHN’S WORT OR RIFAMPIN
    17. 5.10 INTERACTIONS WITH DIAGNOSTIC INVESTIGATIONS FOR NEUROENDOCRINE TUMORS
    18. 5.11 INTERACTION WITH METHOTREXATE
    19. 5.12 FUNDIC GLAND POLYPS
    20. 6 ADVERSE REACTIONS
    21. 6.1 CLINICAL TRIALS EXPERIENCE
    22. 6.2 POSTMARKETING EXPERIENCE
    23. 7.1 INTERFERENCE WITH ANTIRETROVIRAL THERAPY
    24. 7.2 DRUGS FOR WHICH GASTRIC PH CAN AFFECT BIOAVAILABILITY
    25. 7.3 EFFECTS ON HEPATIC METABOLISM/CYTOCHROME P-450 PATHWAYS
    26. 7.4 INTERACTIONS WITH INVESTIGATIONS OF NEUROENDOCRINE TUMORS
    27. 7.5 TACROLIMUS
    28. 7.6 COMBINATION THERAPY WITH CLARITHROMYCIN
    29. 7.7 METHOTREXATE
    30. 8.1 PREGNANCY
    31. 8.2 LACTATION
    32. 8.4 PEDIATRIC USE
    33. 8.5 GERIATRIC USE
    34. 10 OVERDOSAGE
    35. 11 DESCRIPTION
    36. 12.1 MECHANISM OF ACTION
    37. 12.2 PHARMACODYNAMICS
    38. 12.3 PHARMACOKINETICS
    39. 12.4 MICROBIOLOGY
    40. 13.1 CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY
    41. 13.2 ANIMAL TOXICOLOGY AND/OR PHARMACOLOGY
    42. 14.1 HEALING OF EROSIVE ESOPHAGITIS
    43. 14.2 SYMPTOMATIC GASTROESOPHAGEAL REFLUX DISEASE (GERD)
    44. 14.3 PEDIATRIC GASTROESOPHAGEAL REFLUX DISEASE (GERD)
    45. 14.4 RISK REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER
    46. 14.5 HELICOBACTER PYLORI (H. PYLORI) ERADICATION IN PATIENTS WITH DUODENAL ULCER DISEASE
    47. 14.6 PATHOLOGICAL HYPERSECRETORY CONDITIONS INCLUDING ZOLLINGER-ELLISON SYNDROME
    48. 16  HOW SUPPLIED/STORAGE AND HANDLING
    49. 17 PATIENT COUNSELING INFORMATION
    50. MEDICATION GUIDE
    51. PRINCIPAL DISPLAY PANEL - 20 MG CAPSULES BOTTLE LABEL
    52. PRINCIPAL DISPLAY PANEL - 40 MG CAPSULES BOTTLE LABEL

Esomeprazole Magnesium Product Label

The following document was submitted to the FDA by the labeler of this product Amta Labs Limited. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

5.9 Interaction With St. John’S Wort Or Rifampin



Drugs which induce CYP2C19 or CYP3A4 (such as St. John’s Wort or rifampin) can substantially decrease esomeprazole concentrations [see Drug Interactions (7.3)] . Avoid concomitant use of esomeprazole magnesium delayed-release capsules with St. John’s Wort or rifampin.


5.10 Interactions With Diagnostic 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. 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  [see Clinical Pharmacology (12.2)] .


Principal Display Panel - 40 Mg Capsules Bottle Label



NDC 72322-1040-1

Rx only

Esomeprazole Magnesium Delayed-Release Capsules, USP

40 mg, 30 Capsules

NDC 72322-1040-2

Rx only

Esomeprazole Magnesium Delayed-Release Capsules, USP

40 mg, 90 Capsules 

NDC 72322-1040-3

Rx only

Esomeprazole Magnesium Delayed-Release Capsules, USP

40 mg, 1,000 Capsules


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