Esomeprazole Magnesium 20 mg Capsule, Delayed Release Pellets, 180-count
Other active recalls for Esomeprazole Magnesium (different manufacturers) — 3 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Proton Pump Inhibitor class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
- It's blocking the 'acid pump' — a tiny enzyme in your stomach lining that releases acid. By shutting down that pump, esomeprazole cuts the amount of acid your stomach produces, giv...
- What is esomeprazole actually doing in my body?
- Before eating is best — ideally at least 30 minutes before your first meal of the day. Food can reduce how much of the medicine your body absorbs by nearly half, so timing really d...
- Should I take it before or after eating?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Esomeprazole Magnesium — tap one for details:
Esomeprazole Magnesium may be associated with lower levels of 9 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
Where does this data come from?
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 3K9958V90M
A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
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UNII 8PJ61P6TS3
Butyl alcohol is a clear liquid organic solvent derived from petroleum or natural sources. In medicines, it helps dissolve active ingredients and serves as a solvent in liquid formulations and some topical products.
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UNII 3YC120743U
Diglycerin is a humectant and solvent derived from glycerin. It helps retain moisture in the formulation and improves texture and stability in liquid or semi-solid medicines.
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UNII H3R47K3TBD
FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
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UNII WZB9127XOA
A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
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UNII 2G86QN327L
Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
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UNII 4987GT719I
Glyceryl citrate is a chemical compound made from glycerin and citric acid. It acts as a humectant to retain moisture and may serve as a preservative or flavor enhancer in medications.
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UNII 9159UV381P
Hydroxide ion is a negatively charged chemical form of hydroxide that helps adjust and maintain a medicine's pH level. It's used in liquid formulations to keep the product at a stable, appropriate acidity or alkalinity.
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UNII B1QE5P712K
Hypromellose 2208 is a plant-derived thickening agent that dissolves in water. It's used as a binder to help hold tablet ingredients together and as a coating on pills to control how quickly the medicine releases in your body.
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UNII ND2M416302
Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII NX76LV5T8J
A synthetic plastic polymer made from methacrylic acid and ethyl acrylate. It's used as a coating or binder to control how and where the medicine dissolves in your digestive system.
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UNII 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
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UNII WZH3C48M4T
Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
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UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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UNII 46N107B71O
Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
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UNII 368GB5141J
A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
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UNII 81H2R5AOH3
A natural sweetener and carbohydrate derived from sugarcane plants. In medicines, it sweetens the taste to improve palatability and may serve as a bulking agent or binder in tablets and powders.
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UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
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UNII 8Z96QXD6UM
Triethyl citrate is a clear liquid derived from citric acid. It acts as a plasticizer and solvent in tablet coatings and film formulations, helping the coating remain flexible and adhere properly to the medicine.
21 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.3386 | $60.95 / 180 capsules |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Esomeprazole Magnesium 20 mg 00378-2350-77 | Mylan | 90 capsules | $0.153 | AB | Availability likely | — |
| Esomeprazole Magnesium 20 mg 16714-0979-01 | NorthStar | 30 capsules | $0.153 | AB | Availability likely | — |
| Esomeprazole Magnesium 20 mg 31722-0664-10 | Camber | 1000 capsules | $0.153 | AB | Availability likely | — |
| Esomeprazole magnesium 20 mg 43547-0001-03 | Solco | 30 capsules | $0.153 | AB | Availability likely | — |
| Esomeprazole Magnesium 20 mg 43598-0509-10 | Dr. | 1000 capsules | $0.153 | AB | Availability likely | — |
| Esomeprazole Magnesium 20 mg 62175-0820-32 | Lannett | 30 capsules | $0.153 | AB | Availability likely | — |
| Esomeprazole magnesium 20 mg 63304-0734-10 | Sun | 1000 capsules | $0.153 | AB | Availability likely | — |
| Esomeprazole magnesium 20 mg 64980-0632-03 | Rising | 30 capsules | $0.153 | AB | Availability likely | — |
| esomeprazole magnesium 20 mg 68382-0441-06 | Zydus | 30 capsules | $0.153 | AB | Availability likely | — |
| Esomeprazole Magnesium 20 mg 70069-0814-10 | Somerset | 1000 capsules | $0.153 | AB | Availability likely | — |
| esomeprazole magnesium 20 mg 70377-0055-11 | Biocon | 30 capsules | $0.153 | AB | Availability likely | — |
| Esomeprazole Magnesium 20 mg 82009-0033-10 | Quallent | 1000 capsules | $0.153 | AB | Availability likely | — |
| Esomeprazole Magnesium 20 mg 68462-0390-10 | Glenmark | 1000 capsules | $0.177 | — | FDA listed | — |
| Esomeprazole 20 mg 51660-0027-14 | Ohm | 14 capsules | $0.343 | — | FDA listed | — |
| Good Sense Esomeprazole Magnesium 20 mg 00113-0898-01 | L. | 14 capsules | $0.349 | — | Availability likely | — |
| Esomeprazole Magnesium 20 mg 16571-0880-41 | Rising | 14 capsules | $0.349 | — | Availability likely | — |
| Good Neighbor Pharmacy Esomeprazole Magnesium 20 mg 46122-0641-04 | Amerisource | 14 capsules | $0.349 | — | Availability likely | — |
| Esomeprazole Magnesium 20 mg 46122-0736-03 | Amerisource | 14 capsules | $0.349 | — | Availability likely | — |
| Esomeprazole Magnesium 20 mg 69230-0320-31 | Camber | 14 capsules | $0.349 | — | Availability likely | — |
| leader esomeprazole magnesium 20 mg 70000-0727-01 | Cardinal | 14 capsules | $0.349 | — | Availability likely | — |
| Esomeprazole Magnesium 20 mg 70000-0731-01 | LEADER/ | 14 capsules | $0.349 | — | Availability likely | — |
| Foster and Thrive Acid Reducer 20 mg 70677-1099-01 | Strategic | 14 capsules | $0.349 | — | Availability likely | — |
| Esomeprazole Magnesium 20 mg 43598-0407-27 | Dr. | 14 capsules | $0.349 | — | Availability likely | — |
| Esomeprazole Magnesium 20 mg 63868-0425-14 | CHAIN | 14 capsules | $0.361 | — | FDA listed | — |
| Nexium 20 mg 00186-5020-31 | AstraZeneca | 30 capsules | $8.781 | AB | Availability likely | — |
| good sense esomeprazole magnesium 20 mg 00113-0651-01 | L. | 14 capsules | — | — | Discontinued | — |
| good sense esomeprazole magnesium 20 mg 00113-2022-02 | L. | 14 capsules | — | — | FDA listed | — |
| Esomeprazole Magnesium 20 mg 00363-0508-05 | WALGREEN | 14 capsules | — | — | FDA listed | — |
| Esomeprazole Magnesium 20 mg 00363-0772-14 | WALGREENS | 14 capsules | — | — | FDA listed | — |
| Esomeprazole Magnesium 20 mg 00363-1699-01 | Walgreen | 14 capsules | — | — | FDA listed | — |
| Esomeprazole Magnesium 20 mg 00363-3298-01 | Walgreens | 14 capsules | — | — | FDA listed | — |
| esomeprazole magnesium 20 mg 00363-7223-01 | Walgreen | 14 capsules | — | — | FDA listed | — |
| Esomeprazole Magnesium Delayed Release 20 mg 00363-7810-41 | WALGREENS | 14 capsules | — | — | FDA listed | — |
| Nexium 24HR 20 mg 00573-2450-02 | Haleon | 2 capsules | — | — | FDA listed | — |
| Nexium 24HR ClearMinis 20 mg 00573-2452-02 | Haleon | 2 capsules | — | — | FDA listed | — |
| Up and Up Esomeprazole Magnesium 20 mg 11673-0753-01 | Target | 14 capsules | — | — | FDA listed | — |
| up and up esomeprazole magnesium 20 mg 11673-0898-01 | Target | 14 capsules | — | — | FDA listed | — |
| esomeprazole magnesium 20 mg 11822-0024-05 | Rite | 1 capsule | — | — | FDA listed | — |
| esomeprazole magnesium 20 mg 11822-0898-01 | Rite | 14 capsules | — | — | Discontinued | — |
| signature care esomeprazole magnesium 20 mg 21130-0088-01 | Safeway | 14 capsules | — | — | FDA listed | — |
| Esomeprazole Magnesium 20 mg 21130-0100-05 | Better | 14 capsules | — | — | FDA listed | — |
| Esomeprazole Magnesium 20 mg 21130-0257-41 | BETTER | 14 capsules | — | — | FDA listed | — |
| signature care esomeprazole magnesium 20 mg 21130-0714-01 | Safeway | 14 capsules | — | — | Discontinued | — |
| Esomeprazole magnesium 20 mg 21130-0718-41 | BETTER | 14 capsules | — | — | FDA listed | — |
| Esomeprazole 20 mg 21130-0926-14 | Safeway, | 14 capsules | — | — | FDA listed | — |
| Esomeprazole Magnesium Delayed-Release Capsules, 20 mg 25000-0075-76 | MARKSANS | 14 capsules | — | — | FDA listed | — |
| Esomeprazole Magnesium Delayed-Release 20 mg (OTC) 25000-0088-76 | MARKSANS | 14 capsules | — | — | FDA listed | — |
| Esomeprazole Magnesium Delayed Release 20 mg mini 25000-0096-76 | MARKSANS | 14 capsules | — | — | FDA listed | — |
| Esomeprazole Magnesium Delayed-Release 20 mg mini 25000-0112-76 | MARKSANS | 14 capsules | — | — | FDA listed | — |
| Esomeprazole Magnesium 20 mg 30142-0261-14 | The | 14 capsules | — | — | FDA listed | — |
| esomeprazole magnesium 20 mg 30142-0273-01 | Kroger | 14 capsules | — | — | FDA listed | — |
| Esomeprazole Magnesium 20 mg 30142-0528-14 | KROGER | 14 capsules | — | — | FDA listed | — |
| esomeprazole 20 mg 30142-0989-28 | THE | 14 capsules | — | — | FDA listed | — |
| esomeprazole 20 mg 33342-0306-07 | Macleods | 30 capsules | — | — | FDA listed | — |
| topcare esomeprazole magnesium 20 mg 36800-0627-01 | Topco | 14 capsules | — | — | FDA listed | — |
| Esomeprazole Magnesium 20 mg 37808-0115-14 | HEB | 14 capsules | — | — | FDA listed | — |
| Esomeprazole Magnesium 20 mg 37808-0364-14 | H | 14 capsules | — | — | FDA listed | — |
| Esomeprazole Magnesium 20 mg 37808-0719-01 | H | 14 capsules | — | — | FDA listed | — |
| esomeprazole magnesium 20 mg 41250-0727-01 | Meijer | 14 capsules | — | — | FDA listed | — |
| esomeprazole magnesium 20 mg 41250-0900-01 | Meijer | 14 capsules | — | — | FDA listed | — |
| careone esomeprazole magnesium 20 mg 41520-0727-01 | American | 14 capsules | — | — | FDA listed | — |
| esomeprazole magnesium 20 mg 42507-0774-42 | HyVee | 14 capsules | — | — | FDA listed | — |
| esomeprazole magnesium 20 mg 42507-0898-42 | HyVee | 14 capsules | — | — | FDA listed | — |
| Esomeprazole Magnesium 20 mg 43598-0067-42 | Dr. | 14 capsules | — | — | FDA listed | — |
| Esomeprazole Magnesium 20 mg 43598-0327-27 | Dr. | 14 capsules | — | — | FDA listed | — |
| Esomeprazole Magnesium 20 mg 43598-0812-14 | Dr. | 14 capsules | — | — | Discontinued | — |
| Esomeprazole Magnesium 20 mg 43598-0926-28 | Dr. | 14 capsules | — | — | FDA listed | — |
| Esomeprazole Magnesium 20 mg 45865-0163-30 | Medsource | 30 capsules | — | AB | FDA listed | — |
| Esomeprazole Magnesium 20 mg 46122-0821-59 | Amerisource | 14 capsules | — | — | FDA listed | — |
| equate esomeprazole magnesium 20 mg 49035-0921-14 | Wal-Mart | 14 capsules | — | — | FDA listed | — |
| Esomeprazole Magnesium 20 mg 49035-0980-05 | Wal-Mart | 14 capsules | — | — | FDA listed | — |
| Esomeprazole magnesium 20 mg 49483-0718-41 | TIME | 14 capsules | — | — | FDA listed | — |
| Nexium 24HR 20 mg 50090-1492-00 | A-S | 14 capsules | — | — | FDA listed | — |
| Esomeprazole Magnesium 20 mg 50090-6198-00 | A-S | 30 capsules | — | AB | FDA listed | — |
| Esomeprazole Magnesium 20 mg 50090-6213-00 | A-S | 30 capsules | — | — | FDA listed | — |
| Esomeprazole Magnesium 20 mg 51316-0220-01 | CVS | 14 capsules | — | — | FDA listed | — |
| Esomeprazole 20 mg 51316-0715-14 | CVS | 14 capsules | — | — | FDA listed | — |
| Esomeprazole magnesium 20 mg 51407-0742-10 | Golden | 1000 capsules | — | AB | FDA listed | — |
| Esomeprazole Magnesium 20 mg 53041-0666-07 | Guardian | 14 capsules | — | — | FDA listed | — |
| Esomeprazole Magnesium 20 mg 53943-0039-14 | DISCOUNT | 14 capsules | — | — | FDA listed | — |
| Esomeprazole Magnesium 20 mg 53943-0527-14 | Discount | 14 capsules | — | — | FDA listed | — |
| Exchange Select Esomeprazole Magnesium 20 mg 55301-0898-01 | Army | 14 capsules | — | — | FDA listed | — |
| Esomeprazole Magnesium 20 mg 55319-0051-03 | Family | 14 capsules | — | — | FDA listed | — |
| dg health esomeprazole magnesium 20 mg 55910-0250-01 | Dolgencorp, | 14 capsules | — | — | FDA listed | — |
| DG Health Esomeprazole Magnesium 20 mg 55910-0593-01 | Dolgencorp | 14 capsules | — | — | FDA listed | — |
| dg health esomeprazole magnesium 20 mg 55910-0640-01 | Dolgencorp | 14 capsules | — | — | FDA listed | — |
| Esomeprazole Magnesium 20 mg 56062-0020-06 | Publix | 14 capsules | — | — | FDA listed | — |
| Esomeprazole Magnesium 20 mg 56062-0898-01 | Publix | 14 capsules | — | — | FDA listed | — |
| Esomeprazole Magnesium 20 mg 57483-0225-42 | INNOVUS | 14 capsules | — | — | FDA listed | — |
| Esomeprazole 20 mg 57483-0900-42 | INNOVUS | 14 capsules | — | — | FDA listed | — |
| Esomeprazole Magnesium 20 mg 58602-0707-05 | Aurohealth | 14 capsules | — | — | FDA listed | — |
| Esomeprazole Magnesium 20 mg 58602-0809-05 | Aurohealth | 14 capsules | — | — | FDA listed | — |
| Esomeprazole Magnesium 20 mg 58602-0822-05 | Aurohealth | 14 capsules | — | — | FDA listed | — |
| Esomeprazole Magnesium 20 mg 58602-0846-05 | Aurohealth | 14 capsules | — | — | FDA listed | — |
| Esomeprazole Magnesium 20 mg 58602-0896-62 | Aurohealth | 14 capsules | — | — | FDA listed | — |
| Esomeprazole Magnesium 20 mg 59651-0561-50 | Aurobindo | 50000 capsules | — | AB | FDA listed | — |
| Esomeprazole Magnesium 20 mg 60000-0109-03 | Ahold | 14 capsules | — | — | FDA listed | — |
| Esomeprazole Magnesium 20 mg 60687-0934-21 | American | 1 capsule | — | AB | FDA listed | — |
| Esomeprazole Magnesium 20 mg 63187-0964-30 | Proficient | 30 capsules | — | AB | FDA listed | — |
| Esomeprazole Magnesium 20 mg 63941-0971-03 | Best | 14 capsules | — | — | FDA listed | — |
| Esomeprazole 20 mg 63941-0999-14 | VALU | 14 capsules | — | — | FDA listed | — |
| kirkland signature esomeprazole magnesium 20 mg 63981-0898-03 | Costco | 14 capsules | — | — | FDA listed | — |
| Esomeprazole Magnesium 20 mg 64980-0664-19 | Rising | 14 capsules | — | — | FDA listed | — |
| Esomeprazole Magnesium 20 mg 65862-0783-01 | Aurobindo | 100 capsules | — | AB | FDA listed | — |
| Esomeprazole magnesium 20 mg 67877-0478-05 | Ascend | 500 capsules | — | AB | FDA listed | — |
| Esomeprazole magnesium 20 mg 67877-0571-05 | Ascend | 500 capsules | — | AB | FDA listed | — |
| esomeprazole magnesium 20 mg 68071-3419-06 | NuCare | 60 capsules | — | AB | FDA listed | — |
| Esomeprazole Magnesium 20 mg 68071-3735-03 | NuCare | 30 capsules | — | AB | FDA listed | — |
| members mark esomeprazole magnesium 20 mg 68196-0898-03 | Sam's | 14 capsules | — | — | FDA listed | — |
| berkley and jensen heartburn treatment 20 mg 68391-0898-03 | BJWC | 14 capsules | — | — | FDA listed | — |
| Esomeprazole magnesium 20 mg 68788-4014-09 | Preferred | 90 capsules | — | AB | FDA listed | — |
| Esomeprazole Magnesium 20 mg 68788-8511-01 | Preferred | 100 capsules | — | AB | FDA listed | — |
| Esomeprazole Magnesium 20 mg 69168-0472-14 | Allegiant | 14 capsules | — | — | FDA listed | — |
| Esomeprazole magnesium 20 mg 69434-0012-01 | Zhejiang | 30 capsules | — | AB | FDA listed | — |
| Esomeprazole Magnesium 20 mg 69618-0073-42 | Reliable | 14 capsules | — | — | FDA listed | — |
| Riopan 20 mg 69729-0791-14 | OPMX | 14 capsules | — | — | FDA listed | — |
| Esomeprazole Magnesium 20 mg 69842-0248-06 | CVS | 14 capsules | — | — | FDA listed | — |
| esomeprazole magnesium 20 mg 69842-0703-01 | CVS | 14 capsules | — | — | FDA listed | — |
| esomeprazole magnesium 20 mg 69842-0898-01 | CVS | 14 capsules | — | — | FDA listed | — |
| esomeprazole magnesium 20 mg 69844-0115-01 | Graviti | 14 capsules | — | — | FDA listed | — |
| Esomeprazole Magnesium 20 mg 70000-0738-01 | LEADER/ | 14 capsules | — | — | FDA listed | — |
| Esomeprazole magnesium 20 mg 70010-0133-03 | Granules | 30 capsules | — | AB | FDA listed | — |
| esomeprazole magnesium 20 mg 70771-1493-00 | Zydus | 1000 capsules | — | AB | FDA listed | — |
| Esomeprazole magnesium 20 mg 71205-0706-30 | Proficient | 30 capsules | — | AB | FDA listed | — |
| Esomeprazole Magnesium 20 mg 71335-0807-01 | Bryant | 30 capsules | — | AB | FDA listed | — |
| Esomeprazole Magnesium 20 mgthis 71335-1170-07 | Bryant | 180 capsules | — | AB | FDA listed | — |
| esomeprazole magnesium 20 mg 71335-1368-01 | Bryant | 30 capsules | — | AB | FDA listed | — |
| Esomeprazole Magnesium 20 mg 71335-2018-01 | Bryant | 30 capsules | — | AB | FDA listed | — |
| Esomeprazole Magnesium 20 mg 71335-2505-01 | Bryant | 30 capsules | — | AB | FDA listed | — |
| Esomeprazole magnesium 20 mg 71335-9678-01 | Bryant | 30 capsules | — | AB | FDA listed | — |
| esomeprazole magnesium 20 mg 71335-9713-01 | Bryant | 30 capsules | — | AB | FDA listed | — |
| Esomeprazole DR 20 mg 72189-0381-30 | Direct_Rx | 30 capsules | — | AB | FDA listed | — |
| Basic Care Esomeprazole Magnesium 20 mg 72288-0560-01 | Amazon.com | 14 capsules | — | — | FDA listed | — |
| basic care esomeprazole magnesium 20 mg 72288-0700-03 | Amazon.com | 14 capsules | — | — | FDA listed | — |
| basic care esomeprazole magnesium 20 mg 72288-0898-01 | Amazon.com | 14 capsules | — | — | FDA listed | — |
| Esomeprazole Magnesium 20 mg 72476-0500-03 | Retail | 14 capsules | — | — | FDA listed | — |
| Esomeprazole Magnesium 20 mg 72559-0011-06 | LITTLE | 14 capsules | — | — | FDA listed | — |
| esomeprazole magnesium 20 mg 72657-0124-42 | GLENMARK | 14 capsules | — | — | FDA listed | — |
| esomeprazole magnesium 20 mg 72657-0127-42 | GLENMARK | 14 capsules | — | — | FDA listed | — |
| Esomeprazole Magnesium 20 mg 72789-0352-30 | PD-Rx | 30 capsules | — | AB | FDA listed | — |
| Esomeprazole 20 mg 73581-0013-42 | YYBA | 14 capsules | — | — | FDA listed | — |
| Esomeprazole Magnesium 20 mg 73581-0014-42 | YYBA | 42 capsules | — | — | FDA listed | — |
| Esomeprazole magnesium 20 mg 76420-0226-30 | Asclemed | 30 capsules | — | AB | FDA listed | — |
| Esomeprazole Magnesium 20 mg 76420-0904-00 | Asclemed | 1000 capsules | — | AB | FDA listed | — |
| esomeprazole magnesium 20 mg 79481-0411-00 | Meijer, | 14 capsules | — | — | FDA listed | — |
| equate esomeprazole magnesium 20 mg 79903-0293-42 | WALMART | 14 capsules | — | — | FDA listed | — |
| Esomeprazole Magnesium 20 mg 79903-0382-42 | Walmart | 14 capsules | — | — | FDA listed | — |
| Equate Esomeprazole Magnesium 20 mg 79903-0419-42 | WALMART | 14 capsules | — | — | FDA listed | — |
| Esomeprazole Magnesium DR 20 mg 80425-0111-01 | Advanced | 30 capsules | — | AB | FDA listed | — |
| Esomeprazole Magnesium 20 mg 80425-0419-01 | Advanced | 30 capsules | — | AB | FDA listed | — |
| Esomeprazole Magnesium 20 mg 80425-0420-01 | Advanced | 30 capsules | — | AB | FDA listed | — |
| Esomeprazole Magnesium 20 mg 83324-0200-14 | CHAIN | 14 capsules | — | — | FDA listed | — |
| 24 HOUR Esomeprazole Magnesium 20 mg 85828-0718-45 | Grocery | 14 capsules | — | — | FDA listed | — |
| Esomeprazole Magnesium 20 mg 37808-0646-41 | H-E-B | 14 capsules | — | — | FDA listed | — |
| Esomeprazole Magnesium 20 mg 50090-7990-00 | A-S | 30 capsules | — | AB | FDA listed | — |
| Esomeprazole 20 mg 57896-0740-42 | GERI-CARE | 14 capsules | — | — | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 71335-1170-01 | 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-1170-1) | 2019-03-25 | Active |
| 71335-1170-02 | 10 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-1170-2) | 2019-07-01 | Active |
| 71335-1170-03 | 60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-1170-3) | 2019-05-07 | Active |
| 71335-1170-04 | 90 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-1170-4) | 2019-06-10 | Active |
| 71335-1170-05 | 42 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-1170-5) | 2022-09-23 | Active |
| 71335-1170-06 | 120 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-1170-6) | 2022-09-23 | Active |
| 71335-1170-07 You're viewing this | 180 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-1170-7) | 2022-09-23 | Active |
| 71335-1170-08 | 20 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (71335-1170-8) | 2019-09-04 | Active |
You're viewing the largest of 8 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 71335-1170-07?
What is the difference between NDC 71335-1170-07 and NDC 71335-1170-02?
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Esomeprazole Magnesium Delayed-release Capsules is a proton pump inhibitor (PPI). Esomeprazole Magnesium Delayed-release Capsules are indicated for the: Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. ( 1.1 ) Maintenance of healing of EE in adults.
( 1.2 ) Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. ( 1.3 ) Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. ( 1.4 ) Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin.
( 1.5 ) Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. ( 1.6 )
1.1Healing of Erosive Esophagitis (EE) Adults Esomeprazole Magnesium Delayed-release Capsules are indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed EE in adults. For those patients who have not healed after 4 to 8 weeks of treatment, an additional 4- to 8- week course of Esomeprazole Magnesium Delayed-release Capsules may be considered. Pediatric Patients 12 Years to 17 Years of Age Esomeprazole Magnesium Delayed-release Capsules are indicated for the short-term treatment (4 to 8 weeks) for the healing of EE in pediatric patients 12 years to 17 years of age.
Pediatric Patients 1 Year to 11 Years of Age Esomeprazole Magnesium is indicated for the short-term treatment (8 weeks) for the healing of EE in pediatric patients 1 year to 11 years of age.
1.2Maintenance of Healing of EE Esomeprazole Magnesium Delayed-release Capsules are indicated for the maintenance of healing of EE in adults. Controlled studies do not extend beyond 6 months.
1.3Treatment of Symptomatic GERD Adults Esomeprazole Magnesium Delayed-release Capsules are indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults. Pediatric Patients 12 Years to 17 Years of Age Esomeprazole Magnesium Delayed-release Capsules are indicated for short-term treatment (4 weeks) of heartburn and other symptoms associated with GERD in pediatric patients 12 years to 17 years of age. Pediatric Patients 1 Year to 11 Years of Age Esomeprazole Magnesium is indicated for short-term treatment (up to 8 weeks) of heartburn and other symptoms associated with GERD in pediatric patients 1 year to 11 years of age.
1.4Risk Reduction of Nonsteroidal Anti-Inflammatory Drugs (NSAID)-Associated Gastric Ulcer Esomeprazole Magnesium Delayed-release Capsules are indicated for the reduction in the occurrence of gastric ulcers associated with continuous NSAID therapy in adult patients at risk for developing gastric ulcers. Patients are considered to be at risk due to their age (60 years and older) and/or documented history of gastric ulcers. Controlled studies do not extend beyond 6 months.
1.5Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Triple Therapy Esomeprazole Magnesium Delayed-release Capsules in combination with amoxicillin and clarithromycin is indicated for the treatment of adult patients with H. pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori . In patients who fail therapy, susceptibility testing should be done.
If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted [see Clinical Pharmacology ( 12.4 ) and the prescribing information for clarithromycin] .
1.6 Pathological Hypersecretory Conditions Including Zollin…
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Population Recommended Adult ( 2.1 ) and Pediatric Dosage ( 2.2 ) Healing of EE (1 year and older) Adults 20 mg or 40 mg 1 once daily for 4 to 8 weeks; some patients may require an additional 4 to 8 weeks 12 years to 17 years 20 mg or 40 mg 1 once daily for 4 to 8 weeks 1 year to 11 years see full prescribing information for weight-based dosing and duration of treatment ( 2.2 ) Maintenance of Healing of EE Adults 20 mg once daily. Controlled studies do not extend beyond 6 months Treatment of Symptomatic GERD Adults 20 mg once daily for 4 weeks some patients may require an additional 4 weeks 12 years to 17 years 20 mg once daily for 4 weeks 1 year to 11 years 10 mg once daily for up to 8 weeks Risk Reduction of NSAID-Associated Gastric Ulcer Adults 20 mg or 40 mg 1 once daily for up to 6 months 2 H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Adults Esomeprazole Magnesium Delayed-release Capsules 40 mg 1 once daily for 10 days Amoxicillin 1000 mg twice daily for 10 days 3 Clarithromycin 500 mg twice daily for 10 days 3 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome Adults Starting dosage is 40 mg twice daily 4 (varies with the individual patient) as long as clinically indicated.
1 A maximum dosage of 20 mg once daily is recommended for patients with severe liver impairment (Child-Pugh Class C). 2 Controlled studies do not extend beyond 6 months. 3 Refer to the amoxicillin and clarithromycin prescribing information for dosage adjustments in elderly and renally-impaired patients.
4 A starting dosage of 20 mg twice daily is recommended for patients with severe liver impairment (Child-Pugh Class C). Preparation and Administration Information Swallow capsules whole; do not crush or chew. For patients who cannot swallow intact capsule, the capsule can be opened, and the contents mixed with applesauce.
( 2.3 ) Opened capsules can be administered through a nasogastric tube. ( 2.3 )
2.1Recommended Dosage in Adults by Indication Table 1 shows the recommended adult dosage of Esomeprazole Magnesium Delayed-release Capsules by indication. The duration of Esomeprazole Magnesium Delayed-release Capsules treatment should be based on available safety and efficacy data specific to the defined indication and dosing frequency and individual patient medical needs. Esomeprazole Magnesium Delayed-release Capsules should only be initiated and continued if the benefits outweigh the risks of treatment.
Table 1: Recommended Dosage of Esomeprazole Magnesium Delayed-release Capsules in Adults by Indication Adult Indication Recommended Dosage of Esomeprazole Magnesium Delayed-release Capsules Treatment Duration Healing of EE 20 mg or 40 mg 1 once daily 4 to 8 weeks 2 Controlled studies do not extend beyond 6 months Maintenance of Healing of EE 20 mg once daily Treatment of Symptomatic GERD 20 mg once daily 4 weeks; if symptoms do not resolve completely, consider an additional 4 weeks Risk Reduction of NSAID-Associated Gastric Ulcer 20 mg or 40 mg 1 once daily Controlled studies do not extend beyond 6 months H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence (Triple Therapy) Esomeprazole Magnesium Delayed-release Capsules 40 mg once daily 1 10 days Amoxicillin 1000 mg twice daily 3 10 days Clarithromycin 500 mg twice daily 3 10 days Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome Starting dosage is 40 mg twice daily 4 ; individualize the regimen to patient needs.
Dosages of up to 240 mg/day have been administered [see Clinical Studies ( 14.7 )] . As long as clinically indicated 1. A maximum dosage of 20 mg once daily is recommended for patients with severe liver impairment (Child-Pugh Class C) [see Use in Specific Populations ( 8.6 ) ].
2. Most patients are healed within 4 to 8 weeks. For patients who do not heal after 4 to 8 weeks, an additional 4 to 8 weeks of treatment may be required to achieve healing [see Clinical Studies ( 14…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Esomeprazole Magnesium Delayed-release Capsules, USP 20 mg esomeprazole in opaque dark blue cap and opaque white body imprinted with “KU” and “820” in gray and filled with pellets. 40 mg esomeprazole in opaque light blue cap and opaque white body imprinted with “KU” and “840” in black and filled with pellets. Delayed-Release Capsules: 20 mg and 40 mg esomeprazole. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Esomeprazole Magnesium Delayed-release Capsules are contraindicated in patients with known hypersensitivity to substituted benzimidazoles or to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria [see Warnings and Precautions ( 5.2 ), Adverse Reactions ( 6.2 )] . For information about contraindications of amoxicillin and clarithromycin, indicated in combination with Esomeprazole Magnesium Delayed-release Capsules for H. pylori eradication to reduce the risk of duodenal ulcer recurrence, refer to the Contraindications section of the respective prescribing information.
Proton pump inhibitors (PPIs), including Esomeprazole Magnesium Delayed-release Capsules, are contraindicated in patients receiving rilpivirine-containing products [see Drug Interactions ( 7 ) ] . Known hypersensitivity to substituted benzimidazoles or any component of the formulation. ( 4 ) Patients receiving rilpivirine-containing products.
( 4 , 7 ) Refer to the Contraindications section of the prescribing information for amoxicillin and clarithromycin, when administered in combination with Esomeprazole Magnesium Delayed-release Capsules. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Gastric Malignancy : In adults, symptomatic response does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing. ( 5.1 ) Acute Tubulointerstitial Nephritis : Discontinue treatment and evaluate patients.
( 5.2 ) Clostridium difficile -Associated Diarrhea : PPI therapy may be associated with increased risk. ( 5.3 ) Bone Fracture : Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. ( 5.4 ) Severe Cutaneous Adverse Reactions : Discontinue at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation.
( 5.5 ) Cutaneous and Systemic Lupus Erythematosus : Mostly cutaneous; new onset or exacerbation of existing disease; discontinue Esomeprazole Magnesium Delayed-release Capsules and refer to specialist for evaluation. ( 5.6 ) Interaction with Clopidogrel : Avoid concomitant use of Esomeprazole Magnesium Delayed-release Capsules. ( 5.7 ) Cyanocobalamin (Vitamin B-12) Deficiency : Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin.
( 5.8 ) Hypomagnesemia and Mineral Metabolism : Reported rarely with prolonged treatment with PPIs. ( 5.9 ) Interaction with St. John’s Wort or Rifampin : Avoid concomitant use of Esomeprazole Magnesium Delayed-release Capsules.
( 5.10 , 7 ) Interactions with Diagnostic Investigations for Neuroendocrine Tumors : Increased chromogranin A (CgA) levels may interfere with diagnostic investigations for neuroendocrine tumors, temporarily stop Esomeprazole Magnesium Delayed-release Capsules at least 14 days before assessing CgA levels. ( 5.11 , 12.2 ) Interaction with Methotrexate : Concomitant use with PPIs may elevate and/or prolong serum concentrations of methotrexate and/or its metabolite, possibly leading to toxicity. With high dose methotrexate administration, consider temporary withdrawal of Esomeprazole Magnesium Delayed-release Capsules.
( 5.12 , 7 ) Fundic Gland Polyps : Risk increases with long-term use, especially beyond one year. Use the shortest duration of therapy. ( 5.13 )
5.1Presence of Gastric Malignancy In adults, symptomatic response to therapy with Esomeprazole Magnesium Delayed-release Capsules does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with a PPI. In older patients, also consider an endoscopy.
5.2Acute Tubulointerstitial Nephritis Acute tubulointerstitial nephritis (TIN) has been observed in patients taking PPIs and may occur at any point during PPI therapy. Patients may present with varying signs and symptoms from symptomatic hypersensitivity reactions to non-specific symptoms of decreased renal function (e.g., malaise, nausea, anorexia). In reported case series, some patients were diagnosed on biopsy and in the absence of extra-renal manifestations (e.g., fever, rash or arthralgia).
Discontinue Esomeprazole Magnesium Delayed-release Capsules and evaluate patients with suspected acute TIN [see Contraindications ( 4 )] .
5.3Clostridium difficile -Associated Diarrhea Published observational studies suggest that PPI therapy like Esomeprazole Magnesium Delayed-release Capsules may be associated with an increased risk of Clostridium difficile -associated diarrhea, especially in hospitalized patients. This diagnosis should be considered for diarrhea that does not improve [see Adverse Reactions ( 6.2 )] . Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.
Clostridium difficile -associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents. For more information specific to antibacterial agents (clarithromycin and amoxicillin) indicated fo…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in labeling: Acute Tubulointerstitial Nephritis [see W arnings and Precautions ( 5.2 ) ] Clostridium difficile -Associated Diarrhea [see W arnings and Precautions ( 5.3 )] Bone Fracture [see W arnings and Precautions ( 5.4 ) ] Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.5 )] Cutaneous and Systemic Lupus Erythematosus [see W arnings and Precautions ( 5.6 ) ] Cyanocobalamin (Vitamin B-12) Deficiency [see W arnings and Precautions ( 5.8 ) ] Hypomagnesemia and Mineral Metabolism [see W arnings and Precautions ( 5.9 ) ] Fundic Gland Polyps [see Warnings and Precautions ( 5.13 )] Most common adverse reactions ( 6.1 ): Adults (≥ 18 years) (≥1%) are: headache, diarrhea, nausea, flatulence, abdominal pain, constipation, and dry mouth.
Pediatrics (1 to 17 years) (≥ 2%) are: headache, diarrhea, abdominal pain, nausea, and somnolence. To report SUSPECTED ADVERSE REACTIONS, contact Lannett Company, Inc. at 1-844-834-0530 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adults The safety of Esomeprazole Magnesium Delayed-release Capsules was evaluated in over 15,000 patients (aged 18 to 84 years) in clinical trials worldwide including over 8,500 patients in the United States and over 6,500 patients in Europe and Canada.
Over 2,900 patients were treated in long-term studies for up to 6 to 12 months. The safety in the treatment of healing of EE in adults was assessed in four randomized comparative clinical trials, which included 1,240 patients who received Esomeprazole Magnesium Delayed-release Capsules 20 mg once daily, 2,434 patients on Esomeprazole Magnesium Delayed-release Capsules 40 mg once daily, and 3,008 patients on omeprazole 20 mg once daily. The most frequently occurring adverse reactions (at least 1%) in all three groups were headache (5.5%, 5%, and 3.8%, respectively) and diarrhea (no difference among the three groups).
Nausea, flatulence, abdominal pain, constipation, and dry mouth occurred at similar rates among patients taking Esomeprazole Magnesium Delayed-release Capsules or omeprazole. Less common adverse reactions with an incidence of less than 1% are listed below by body system: Body as a Whole: abdomen enlarged, allergic reaction, asthenia, back pain, chest pain, substernal chest pain, facial edema, peripheral edema, hot flushes, fatigue, fever, flu-like disorder, generalized edema, leg edema, malaise, pain, rigors; Cardiovascular: flushing, hypertension, tachycardia; Endocrine: goiter; Gastrointestinal: bowel irregularity, constipation aggravated, dyspepsia, dysphagia, dysplasia GI, epigastric pain, eructation, esophageal disorder, frequent stools, gastroenteritis, GI hemorrhage, GI symptoms not otherwise specified, hiccup, melena, mouth disorder, pharynx disorder, rectal disorder, serum gastrin increased, tongue disorder, tongue edema, ulcerative stomatitis, vomiting; Hearing: earache, tinnitus; Hematologic: anemia, anemia hypochromic, cervical lymphadenopathy, epistaxis, leukocytosis, leukopenia, thrombocytopenia; Hepatic: bilirubinemia, hepatic function abnormal, SGOT increased, SGPT increased; Metabolic/Nutritional: glycosuria, hyperuricemia, hyponatremia, increased alkaline phosphatase, thirst, vitamin B12 deficiency, weight increase, weight decrease; Musculoskeletal: arthralgia, arthritis aggravated, arthropathy, cramps, fibromyalgia syndrome, hernia, polymyalgia rheumatica; Nervous System/Psychiatric: anorexia, apathy, appetite increased, confusion, depression aggravated, dizziness, hypertonia, nervousness, hypoesthesia, impotence, insomnia, migraine, migraine aggravated, paresthesia, sleep disorder, som…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Tables 3 and 4 include drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with esomeprazole and instructions for preventing or managing them. Consult the labeling of concomitantly used drugs to obtain further information about interactions with PPIs. Table 3: Clinically Relevant Interactions Affecting Drugs Co-Administered with Esomeprazole and Interaction with Diagnostics Antiretrovirals Clinical Impact: The effect of PPIs on antiretroviral drugs is variable.
The clinical importance and the mechanisms behind these interactions are not always known. Decreased exposure of some antiretroviral drugs (e.g., rilpivirine atazanavir, and nelfinavir) when used concomitantly with esomeprazole may reduce antiviral effect and promote the development of drug resistance [see Clinical Pharmacology ( 12.3 ) ]. Increased exposure of other antiretroviral drugs (e.g., saquinavir) when used concomitantly with esomeprazole may increase toxicity [see Clinical Pharmacology ( 12.3 ) ].
There are other antiretroviral drugs which do not result in clinically relevant interactions with esomeprazole. Intervention: Rilpivirine-containing products: Concomitant use with Esomeprazole Magnesium Delayed-release Capsules is contraindicated [see Contraindications ( 4 )] . Atazanavir: See prescribing information for atazanavir for dosing information.
Nelfinavir: Avoid concomitant use with Esomeprazole Magnesium Delayed-release Capsules. See prescribing information for nelfinavir. Saquinavir: See the prescribing information for saquinavir for monitoring of potential saquinavir-related toxicities.
Other antiretrovirals: See prescribing information for specific antiretroviral drugs Warfarin Clinical Impact: Increased INR and prothrombin time in patients receiving PPIs, including esomeprazole, and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. Intervention: Monitor INR and prothrombin time and adjust the dose of warfarin, if needed, to maintain the target INR range.
Methotrexate Clinical Impact: Concomitant use of esomeprazole with methotrexate (primarily at high dose) may elevate and prolong serum concentrations of methotrexate and/or its metabolite hydroxymethotrexate, possibly leading to methotrexate toxicities. No formal drug interaction studies of high-dose methotrexate with PPIs have been conducted [see Warnings and Precautions ( 5.12 )]. Intervention: A temporary withdrawal of Esomeprazole Magnesium Delayed-release Capsules may be considered in some patients receiving high-dose methotrexate.
2C19 Substrates (e.g., clopidogrel, citalopram, cilostazol) Clopidogrel Clinical Impact: Concomitant use of esomeprazole 40 mg resulted in reduced plasma concentrations of the active metabolite of clopidogrel and a reduction in platelet inhibition [see Clinical Pharmacology ( 12.3 ) ]. There are no adequate combination studies of a lower dose of esomeprazole or a higher dose of clopidogrel in comparison with the approved dose of clopidogrel . Intervention: Avoid concomitant use with Esomeprazole Magnesium Delayed-release Capsules.
Consider use of alternative anti-platelet therapy [see Warnings and Precautions ( 5.7 )]. Citalopram Clinical Impact: Increased exposure of citalopram leading to an increased risk of QT prolongation [see Clinical Pharmacology ( 12.3 )]. Intervention: Limit the dose of citalopram to a maximum of 20 mg per day.
See prescribing information for citalopram. Cilostazol Clinical Impact: Increased exposure of cilostazol and one of its active metabolites (3,4-dihydro-cilostazol) [see Clinical Pharmacology ( 12.3 )]. Intervention: Consider reducing the dose of cilostazol to 50 mg twice daily.
See prescribing information for cilostazol. Digoxin Clinical Impact: Potential for increased exposure of digoxin [see Clinical Pharmacology ( 12.3 )]. Intervention: Monitor digoxin concentrations and adjust the dose, if neede…
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pediatrics: Use is not recommended for the treatment of symptomatic GERD in patients 1 month to less than 1 year of age; efficacy was not demonstrated. ( 8.4 )
8.1Pregnancy Risk Summary There are no adequate and well-controlled studies with esomeprazole in pregnant women. Esomeprazole is the S-isomer of omeprazole. Available epidemiologic data fail to demonstrate an increased risk of major congenital malformations or other adverse pregnancy outcomes with first trimester omeprazole use ( see Data ).
Reproduction studies in rats and rabbits resulted in dose-dependent embryo-lethality at omeprazole doses that were approximately 3.4 to 34 times an oral human dose of 40 mg (based on a body surface area for a 60 kg person). Teratogenicity was not observed in animal reproduction studies with administration of oral esomeprazole magnesium in rats and rabbits with doses about 68 times and 42 times, respectively, an oral human dose of 40 mg (based on a body surface area basis for a 60 kg person). Changes in bone morphology were observed in offspring of rats dosed through most of pregnancy and lactation at doses equal to or greater than approximately 34 times an oral human dose of 40 mg.
When maternal administration was confined to gestation only, there were no effects on bone physeal morphology in the offspring at any age ( see Data ). The estimated background risks of major birth defects and miscarriage for the indicated population are unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Human Data Esomeprazole is the S-isomer of omeprazole. Four epidemiological studies compared the frequency of congenital abnormalities among infants born to women who used omeprazole during pregnancy with the frequency of abnormalities among infants of women exposed to H 2 -receptor antagonists or other controls.
A population-based retrospective cohort epidemiological study from the Swedish Medical Birth Registry, covering approximately 99% of pregnancies, from 1995 to 1999, reported on 955 infants (824 exposed during the first trimester with 39 of these exposed beyond first trimester, and 131 exposed after the first trimester) whose mothers used omeprazole during pregnancy. The number of infants exposed in utero to omeprazole that had any malformation, low birth weight, low Apgar score, or hospitalization was similar to the number observed in this population.
The number of infants born with ventricular septal defects and the number of stillborn infants was slightly higher in the omeprazole-exposed infants than the expected number in this population. A population-based retrospective cohort study covering all live births in Denmark from 1996 to 2009, reported on 1,800 live births whose mothers used omeprazole during the first trimester of pregnancy and 837,317 live births whose mothers did not use any proton pump inhibitor. The overall rate of birth defects in infants born to mothers with first trimester exposure to omeprazole was 2.9% and 2.6% in infants born to mothers not exposed to any proton pump inhibitor during the first trimester.
A retrospective cohort study reported on 689 pregnant women exposed to either H 2 -blockers or omeprazole in the first trimester (134 exposed to omeprazole) and 1,572 pregnant women unexposed to either during the first trimester. The overall malformation rate in offspring born to mothers with first trimester exposure to omeprazole, an H 2 -blocker, or were unexposed was 3.6%, 5.5%, and 4.1% respectively. A small prospective observational cohort study followed 113 women exposed to omeprazole during pregnancy (89% with first trimester exposures).
The reported rate of major congenital malformations was 4% in the omeprazole group, 2% in controls exposed to non-teratoge…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no adequate and well-controlled studies with esomeprazole in pregnant women. Esomeprazole is the S-isomer of omeprazole. Available epidemiologic data fail to demonstrate an increased risk of major congenital malformations or other adverse pregnancy outcomes with first trimester omeprazole use ( see Data ).
Reproduction studies in rats and rabbits resulted in dose-dependent embryo-lethality at omeprazole doses that were approximately 3.4 to 34 times an oral human dose of 40 mg (based on a body surface area for a 60 kg person). Teratogenicity was not observed in animal reproduction studies with administration of oral esomeprazole magnesium in rats and rabbits with doses about 68 times and 42 times, respectively, an oral human dose of 40 mg (based on a body surface area basis for a 60 kg person). Changes in bone morphology were observed in offspring of rats dosed through most of pregnancy and lactation at doses equal to or greater than approximately 34 times an oral human dose of 40 mg.
When maternal administration was confined to gestation only, there were no effects on bone physeal morphology in the offspring at any age ( see Data ). The estimated background risks of major birth defects and miscarriage for the indicated population are unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Human Data Esomeprazole is the S-isomer of omeprazole. Four epidemiological studies compared the frequency of congenital abnormalities among infants born to women who used omeprazole during pregnancy with the frequency of abnormalities among infants of women exposed to H 2 -receptor antagonists or other controls.
A population-based retrospective cohort epidemiological study from the Swedish Medical Birth Registry, covering approximately 99% of pregnancies, from 1995 to 1999, reported on 955 infants (824 exposed during the first trimester with 39 of these exposed beyond first trimester, and 131 exposed after the first trimester) whose mothers used omeprazole during pregnancy. The number of infants exposed in utero to omeprazole that had any malformation, low birth weight, low Apgar score, or hospitalization was similar to the number observed in this population.
The number of infants born with ventricular septal defects and the number of stillborn infants was slightly higher in the omeprazole-exposed infants than the expected number in this population. A population-based retrospective cohort study covering all live births in Denmark from 1996 to 2009, reported on 1,800 live births whose mothers used omeprazole during the first trimester of pregnancy and 837,317 live births whose mothers did not use any proton pump inhibitor. The overall rate of birth defects in infants born to mothers with first trimester exposure to omeprazole was 2.9% and 2.6% in infants born to mothers not exposed to any proton pump inhibitor during the first trimester.
A retrospective cohort study reported on 689 pregnant women exposed to either H 2 -blockers or omeprazole in the first trimester (134 exposed to omeprazole) and 1,572 pregnant women unexposed to either during the first trimester. The overall malformation rate in offspring born to mothers with first trimester exposure to omeprazole, an H 2 -blocker, or were unexposed was 3.6%, 5.5%, and 4.1% respectively. A small prospective observational cohort study followed 113 women exposed to omeprazole during pregnancy (89% with first trimester exposures).
The reported rate of major congenital malformations was 4% in the omeprazole group, 2% in controls exposed to non-teratogens, and 2.8% in disease paired controls. Rates of spontaneous and elective abortions, preterm deliveries, gestational age at delivery, and mean birth weight were similar among the groups. Se…
🧒 Pediatric Use ▾
8.4Pediatric Use Healing of EE Pediatric Patients 1 Year to 17 Years of Age The safety and effectiveness of Esomeprazole Magnesium Delayed-release Capsules have been established in pediatric patients 12 years to 17 years for short-term treatment (4 to 8 weeks) for healing of EE. The safety and effectiveness of Esomeprazole Magnesium have been established in pediatric patients 1 year to 11 years for short-term treatment (up to 8 weeks) for healing of EE. Use of Esomeprazole Magnesium Delayed-release Capsules for this indication is supported by evidence from adequate and well-controlled studies in adults with additional safety and pharmacokinetic data in pediatric patients 1 year to 17 years of age.
The safety profile in pediatric patients 1 year to 17 years of age was similar to adults [ see Adverse Reactions ( 6.1 ), Clinical Pharmacology ( 12.3 ), Clinical Studies ( 14.4 )] . The safety and effectiveness of Esomeprazole Magnesium Delayed-release Capsules for the treatment of EE due to acid-mediated GERD in pediatric patients less than 1 year of age have not been established. Symptomatic GERD Pediatric Patients 1 Year to 17 Years of Age The safety and effectiveness of Esomeprazole Magnesium Delayed-release Capsules have been established in pediatric patients 12 years to 17 years of age for the short-term treatment (4 weeks) of heartburn and other symptoms associated with GERD.
The safety and effectiveness of Esomeprazole Magnesium have been established in pediatric patients 1 year to 11 years of age for the short-term treatment (up to 8 weeks) of heartburn and other symptoms associated with GERD. Use of Esomeprazole Magnesium Delayed-release Capsules for this indication is supported by evidence from adequate and well-controlled studies in adults with additional safety and pharmacokinetic data in pediatric patients 1 year to 17 years of age. The safety profile in pediatric patients 1 year to 17 years of age was similar to adults [see Adverse Reactions ( 6.1 ), Clinical Pharmacology ( 12.3 ), Clinical Studies ( 14.4 )] .
The safety and effectiveness of Esomeprazole Magnesium Delayed-release Capsules for the treatment of symptomatic GERD in pediatric patients less than 1 year of age have not been established. Other Conditions The safety and effectiveness of Esomeprazole Magnesium Delayed-release Capsules for the risk reduction of NSAID-associated gastric ulcer, H. pylori eradication to reduce the risk of duodenal ulcer recurrence and treatment of pathological hypersecretory conditions have not been established in pediatric patients. Juvenile Animal Toxicity Studies In a juvenile rat toxicity study, esomeprazole was administered with both magnesium and strontium salts at oral doses about 34 to 68 times a daily human dose of 40 mg based on body surface area.
Increases in death were seen at the high dose, and at all doses of esomeprazole, there were decreases in body weight, body weight gain, femur weight and femur length, and decreases in overall growth [see Nonclinical Toxicology ( 13.2 )] .
🧓 Geriatric Use ▾
8.5Geriatric Use Of the total number of patients who received Esomeprazole Magnesium Delayed-release Capsules in clinical trials, 1459 were 65 to 74 years of age and 354 patients were 75 years of age and older. No overall differences in safety and efficacy were observed between the elderly and younger individuals, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
🆘 Overdosage ▾
10 OVERDOSAGE Manifestations in patients exposed to omeprazole, the racemic mixture, at doses up to 2,400 mg (120 times the usual recommended clinical dose) include confusion, drowsiness, blurred vision, tachycardia, nausea, diaphoresis, flushing, headache, dry mouth, and other adverse reactions similar to those seen at recommended dosages. See the full prescribing information for omeprazole for complete safety information. No specific antidote for esomeprazole is known.
Since esomeprazole is extensively protein bound, it is not expected to be removed by dialysis. In the event of overdosage, treatment should be symptomatic and supportive. If over-exposure occurs, call your Poison Control Center at 1-800-222-1222 for current information on the management of poisoning or overdosage.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Esomeprazole belongs to a class of antisecretory compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the H+/K+ ATPase enzyme system at the secretory surface of the gastric parietal cell. Esomeprazole is protonated and converted in the acidic compartment of the parietal cell forming the active inhibitor, the achiral sulphenamide. Because this enzyme system is regarded as the acid (proton) pump within the gastric mucosa, esomeprazole has been characterized as a gastric acid-pump inhibitor, in that it blocks the final step of acid production.
This effect is dose-related and leads to inhibition of both basal and stimulated acid secretion irrespective of the stimulus.
12.2Pharmacodynamics Antisecretory Activity Adults The effect of esomeprazole on intragastric pH was determined in adult patients with symptomatic GERD in two separate studies. In the first study of 36 patients, Esomeprazole Magnesium Delayed-release Capsules 40 mg and 20 mg delayed-release capsules were administered over 5 days as shown in the Table 5: Table 5: Effect of Esomeprazole on Intragastric pH on Day 5 (N=36) Following Once Daily Dosing of Esomeprazole Magnesium Delayed-release Capsules in Adult Patients with Symptomatic GERD Parameter Esomeprazole Magnesium Delayed-release Capsules 40 mg once daily 20 mg once daily % Time Gastric pH >4 1 (Hours) 70% 2 (16.8 h) 53% (12.7 h) Coefficient of variation 26% 37% Median 24 Hour pH 4.9 2
4.1Coefficient of variation 16% 27% 1. Gastric pH was measured over a 24-hour period 2. p<
0.01Esomeprazole Magnesium Delayed-release Capsules 40 mg vs. Esomeprazole Magnesium Delayed-release Capsules 20 mg In a second study, the effect on intragastric pH of Esomeprazole Magnesium Delayed-release Capsules 40 mg administered once daily over a five-day period was similar to the first study, (% time with pH > 4 was 68% or 16.3 hours). Serum Gastrin Effects The effect of esomeprazole on serum gastrin concentrations was evaluated in approximately 2,700 patients in clinical trials of oral esomeprazole for up to 8 weeks and in over 1,300 patients for up to 12 months.
The mean fasting gastrin level increased in a dose-related manner. The increase in serum gastrin concentrations reached a plateau within two to three months of therapy and returned to baseline levels within four weeks after discontinuation of therapy. Increased gastrin causes enterochromaffin-like cell hyperplasia and increased serum Chromogranin A (CgA) levels.
The increased CgA levels may cause false positive results in diagnostic investigations for neuroendocrine tumors [ see Warnings and Precautions ( 5.11 ) ] . Enterochromaffin-like (ECL) Cell Effects Human gastric biopsy specimens have been obtained from more than 3,000 patients (both pediatrics and adults) treated with omeprazole in long-term clinical trials. The incidence of ECL cell hyperplasia in these studies increased with time; however, no case of ECL cell carcinoids, dysplasia, or neoplasia has been found in these patients [ see Nonclinical Toxicology ( 13.1 ) ] .
In over 1,000 patients treated with oral esomeprazole (10 mg, 20 mg or 40 mg/day) for up to 12 months, the prevalence of ECL cell hyperplasia increased with time and dose. No patient developed ECL cell carcinoids, dysplasia, or neoplasia in the gastric mucosa. Endocrine Effects Esomeprazole had no effect on thyroid function in adults when given Esomeprazole Magnesium Delayed-release Capsules 20 mg or 40 mg delayed-release capsules once daily for 4 weeks.
Other effects of esomeprazole on the endocrine system were assessed in studies of omeprazole. Oral doses of omeprazole 30 mg or 40 mg once daily for 2 to 4 weeks had no effect on carbohydrate metabolism, circulating levels of parathyroid hormone, cortisol, estradiol, testosterone, prolactin, cholecystokinin, or secretin.
12.3 Pharmacokinetics Absorption Esomeprazole Magnesium Delayed-release Capsul…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Esomeprazole belongs to a class of antisecretory compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the H+/K+ ATPase enzyme system at the secretory surface of the gastric parietal cell. Esomeprazole is protonated and converted in the acidic compartment of the parietal cell forming the active inhibitor, the achiral sulphenamide. Because this enzyme system is regarded as the acid (proton) pump within the gastric mucosa, esomeprazole has been characterized as a gastric acid-pump inhibitor, in that it blocks the final step of acid production.
This effect is dose-related and leads to inhibition of both basal and stimulated acid secretion irrespective of the stimulus.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Esomeprazole Magnesium Delayed-Release Capsules, USP, 20 mg, are opaque dark blue cap and opaque white body imprinted with “KU” and “820” in gray and filled with pellets. They are supplied as follows: NDC: 71335-1170-1: 30 Capsules in a BOTTLE NDC: 71335-1170-2: 10 Capsules in a BOTTLE NDC: 71335-1170-3: 60 Capsules in a BOTTLE NDC: 71335-1170-4: 90 Capsules in a BOTTLE NDC: 71335-1170-5: 42 Capsules in a BOTTLE NDC: 71335-1170-6: 120 Capsules in a BOTTLE NDC: 71335-1170-7: 180 Capsules in a BOTTLE NDC: 71335-1170-8: 20 Capsules in a BOTTLE Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature].
Keep Esomeprazole Magnesium Delayed-release Capsules container tightly closed. Dispense in a tight container if the Esomeprazole Magnesium Delayed-release Capsules product package is subdivided. Repackaged/Relabeled by: Bryant Ranch Prepack Burbank, CA 91504
📋 Description ▾
11 DESCRIPTION The active ingredient in Esomeprazole Magnesium Delayed-release Capsules, USP for oral administration is bis(5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1 H -benzimidazole-1-yl) magnesium dihydrate, a PPI. Esomeprazole is the S-isomer of omeprazole, which is a mixture of the S- and R- isomers. (Initial U.S. approval of esomeprazole magnesium: 2001).
Its molecular formula is (C 17 H 18 N 3 O 3 S) 2 Mg x 2 H 2 O with molecular weight of 749.2 as a dihydrate and 713.1 on an anhydrous basis. The structural formula is: The magnesium salt is a white to slightly colored crystalline powder. It contains 2 moles of water of solvation and is slightly soluble in water.
The stability of esomeprazole magnesium is a function of pH; it rapidly degrades in acidic media, but it has acceptable stability under alkaline conditions. At pH 6.8 (buffer), the half-life of the magnesium salt is about 19 hours at 25°C and about 8 hours at 37°C. Esomeprazole Magnesium Delayed-release Capsules are supplied in delayed-release capsules.
Each delayed-release capsule contains 20 mg, or 40 mg of esomeprazole (present as 21.7 mg, or 43.4 mg esomeprazole magnesium dihydrate) in the form of enteric-coated pellets with the following inactive ingredients: diglycerin, hypromellose, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, monoglycerides, polysorbate 80, sugar spheres, talc, and triethyl citrate. The capsule shells have the following inactive ingredients: gelatin, FD&C Blue #1, sodium lauryl sulfate, and titanium dioxide.
In addition, the 20 mg capsule shell contains FD & C Red #40 and the 40 mg capsule shell contains FD&C Red #3. The imprinting ink also contains ammonium hydroxide, butyl alcohol, black iron oxide, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol and shellac. The 20 mg ink also contains titanium dioxide.
The 40 mg ink may also contain n-butyl alcohol. Esomeprazole Magnesium Delayed-release Capsules meet USP Dissolution Test 4.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Acute Tubulointerstitial Nephritis Advise the patient or caregiver to call the patient’s healthcare provider immediately if they experience signs and/or symptoms associated with suspected acute TIN [see Warnings and Precautions ( 5.2 )] . Clostridium difficile -Associated Diarrhea Advise the patient or caregiver to immediately call the patient’s healthcare provider if they experience diarrhea that does not improve [see Warnings and Precautions ( 5.3 )] .
Bone Fracture Advise the patient or caregiver to report any fractures, especially of the hip, wrist or spine, to the patient’s healthcare provider [see Warnings and Precautions ( 5.4 )] . Severe Cutaneous Adverse Reactions Advise the patients or caregiver to discontinue Esomeprazole Magnesium Delayed-release Capsules and immediately call the patient’s healthcare provider for at first appearance of a severe cutaneous adverse reactions or other sign of hypersensitivity signs or symptoms with Severe Cutaneous Adverse Reactions [ see Warnings and Precautions ( 5.5 )] .
Cutaneous and Systemic Lupus Erythematosus Advise the patient or caregiver to immediately call the patient’s healthcare provider for any new or worsening of symptoms associated with cutaneous or systemic lupus erythematosus [see Warnings and Precautions ( 5.6 )] . Cyanocobalamin (Vitamin B-12) Deficiency Advise the patient or caregiver to report any clinical symptoms that may be associated with cyanocobalamin deficiency to the patient’s healthcare provider if they have been receiving Esomeprazole Magnesium Delayed-release Capsules for longer than 3 years [see Warnings and Precautions ( 5.8 )] .
Hypomagnesemia and Mineral Metabolism Advise the patient or caregiver to report any clinical symptoms that may be associated with hypomagnesemia, hypocalcemia, and/or hypokalemia to the patient’s healthcare provider, if they have been receiving Esomeprazole Magnesium Delayed-release Capsules for at least 3 months [see Warnings and Precautions ( 5.9 )] . Drug Interactions Advise the patient or caregiver to report to their healthcare provider if starting treatment with rilpivirine-containing products, clopidogrel, St.
John’s Wort or rifampin; or, if they take high-dose methotrexate [see Contraindications ( 4 ), Warnings and Precautions ( 5.7 , 5.10 , 5.12 )]. Administration Take Esomeprazole Magnesium Delayed-release Capsules at least one hour before meals. Antacids may be used concomitantly with Esomeprazole Magnesium Delayed-release Capsules.
Swallow Esomeprazole Magnesium Delayed-release Capsules whole; do not chew or crush the capsules. For patients who have difficulty swallowing capsules, Esomeprazole Magnesium Delayed-release Capsules can be opened, and the contents sprinkled on applesauce. Use with other foods is not recommended.
1. Add one tablespoon of applesauce to an empty bowl. The applesauce used should not be hot and should be soft enough to be swallowed without chewing.
2. Open the Esomeprazole Magnesium Delayed-release Capsule and carefully empty the pellets inside the capsule onto the applesauce. 3.
Mix the pellets with the applesauce. 4. Administer the mixture immediately.
Do not chew or crush the pellets. 5. Discard any remaining mixture.
Do not store the mixture for future use. Esomeprazole Magnesium Delayed-release Capsules can also be administered via a nasogastric tube, as described in the Instructions for Use . Distributed by: Lannett Company, Inc.
Philadelphia, PA 19136 Dispense with Medication Guide available at: www.lannett.com/med-guide/esomeprazole CIA77977H Rev. 07/2023 All brand names are the trademarks of their respective owners.
💬 Medication Guide ▾
MEDICATION GUIDE Dispense with Medication Guide available at: www.lannett.com/med-guide/esomeprazole Esomeprazole Magnesium ( es” oh mep’ ra zole mag nee’ zee um ) Delayed-release Capsules, USP What is the most important information I should know about Esomeprazole Magnesium Delayed-release Capsules? Esomeprazole Magnesium Delayed-release Capsules may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor.
Esomeprazole Magnesium Delayed-release Capsules can cause serious side effects, including: A type of kidney problem (acute tubulointerstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including Esomeprazole Magnesium Delayed-release Capsules, may develop a kidney problem called acute tubulointerstitial nephritis that can happen at any time during treatment with Esomeprazole Magnesium Delayed-release Capsules. Call your doctor right away if you have a decrease in the amount that you urinate or if you have blood in your urine.
Diarrhea caused by an infection ( Clostridium difficile ) in your intestines. Call your doctor right away if you have watery stools or stomach pain that does not go away. You may or may not have a fever.
Bone fractures (hip, wrist, or spine). Bone fractures in the hip, wrist, or spine may happen in people who take multiple daily doses of PPI medicines and for a long period of time (a year or longer). Tell your doctor if you have a bone fracture, especially in the hip, wrist, or spine.
Certain types of lupus erythematosus. Lupus erythematosus is an autoimmune disorder (the body’s immune cells attack other cells or organs in the body). Some people who take PPI medicines, including Esomeprazole Magnesium Delayed-release Capsules, may develop certain types of lupus erythematosus or have worsening of the lupus they already have.
Call your doctor right away if you have new or worsening joint pain or a rash on your cheeks or arms that gets worse in the sun. Talk to your doctor about your risk of these serious side effects. Esomeprazole Magnesium Delayed-release Capsules can have other serious side effects.
See “ What are the possible side effects of Esomeprazole Magnesium Delayed-release Capsules? ” What is Esomeprazole Magnesium Delayed-release Capsules? A prescription medicine called a proton pump inhibitor (PPI) used to reduce the amount of acid in your stomach. Esomeprazole Magnesium Delayed-release Capsules is used in adults for: 4 to 8 weeks for the healing and symptom relief of acid-related damage to the esophagus (erosive esophagitis or EE).
Your doctor may prescribe another 4-8 weeks of Esomeprazole Magnesium Delayed-release Capsules in patients whose EE does not heal. maintaining healing of EE. 4-8 weeks to treat heartburn and other symptoms that happen with gastroesophageal reflux disease (GERD). up to 6 months to reduce the risk of stomach ulcers in some people taking pain medicines called non-steroidal anti-inflammatory drugs (NSAIDs). treating patients with a stomach infection ( Helicobacter pylori ) and a stomach ulcer, along with the antibiotics amoxicillin and clarithromycin. the long-term treatment of conditions where your stomach makes too much acid, including Zollinger-Ellison Syndrome.
Zollinger-Ellison Syndrome is a rare condition in which the stomach produces a more than normal amount of acid. Esomeprazole Magnesium Delayed-release Capsules are used in children and adolescents 12 to 17 years of age for: 4 to 8 weeks to heal EE. 4 weeks to treat heartburn and other symptoms that happen with GERD.
Esomeprazole Magnesium Delayed-release Capsules are used in children 1 to 11 years of age for: 8 weeks to heal EE. up to 8 weeks to treat heartburn and other symptoms that happen with GERD. It is not known if Esomeprazole Magnesium Delayed-release Capsules are safe and effective in children under 1 year of age for the treatment of GERD with EE. It is not known if Esomeprazole Magnesium Delayed-release Capsules are saf…