Esomeprazole magnesium 20 mg Capsule, Delayed Release, 90-count — NDC 70010-133-09 (Billing 70010-0133-09)
This is a package of 90 capsules of Esomeprazole magnesium 20 mg Capsule, Delayed Release from Granules Pharmaceuticals Inc., marketed since Oct 2023 and currently FDA-listed; retail pharmacies pay about $0.1446 per capsule (NADAC). It is the main listing for this product, which comes in 3 package sizes.
Other active recalls for Esomeprazole Magnesium (different manufacturers) — 3 · tap to view
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 047525
- GCN: 12867
- GPI-14 (Medi-Span): 49270025106520
- HICL (First Databank): 021607
- AHFS class code: 56:28.36.00
- RxCUI (RxNorm): 606726
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Proton Pump Inhibitor class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- It lowers stomach acid. Doctors prescribe it for GERD, erosive esophagitis, preventing NSAID-related stomach ulcers, H. pylori infection (with antibiotics), and conditions like Zol...
- Oral forms are generally taken once a day. The over-the-counter tablet is swallowed whole with water before eating in the morning for 14 days. Follow your prescriber’s directions f...
- Not the over-the-counter versions. They can take 1 to 4 days for full effect, so they aren’t meant for immediate relief.
- Will it relieve my heartburn right away?
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?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
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 ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.145 | $13.01 / 90 capsules |
| Medicaid paysCMS SDUD · 12 mo | $0.3046 | $27.41 / 90 capsules |
| Medicare drug plans payPart D · Q2 2026 | $0.3386 | $30.47 / 90 capsules |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q3 2025
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 70010-0133-03 70010-133-03 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE | — | — | 2023-10-18 | — | Active |
| 70010-0133-09 You're viewing this Main listing | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE | $0.1446 / ea | $13.01 | 2023-11-13 | — | Active |
| 70010-0133-10 70010-133-10 | 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE | $0.1446 / ea | $144.58 | 2023-10-18 | — | Active |
You're viewing one of 3 pack sizes for this product.
This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.1446 NADAC).
Pack size FAQ
What quantity is in this package?
How does this package differ from NDC 70010-0133-03?
What NDC number is used to bill for this package of Esomeprazole magnesium 20 mg Capsule, Delayed Release?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Esomeprazole Magnesium 20 mg 00378-2350-77 | Mylan | 90 capsules | $0.145 | AB | Availability likely | — |
| Esomeprazole Magnesium 20 mg 16714-0979-01 | NorthStar | 30 capsules | $0.145 | AB | Availability likely | — |
| Esomeprazole Magnesium 20 mg 31722-0664-10 | Camber | 1000 capsules | $0.145 | AB | Availability likely | — |
| Esomeprazole magnesium 20 mg 43547-0001-03 | Solco | 30 capsules | $0.145 | AB | Availability likely | — |
| Esomeprazole Magnesium 20 mg 43598-0509-10 | Dr. | 1000 capsules | $0.145 | AB | Availability likely | — |
| Esomeprazole Magnesium 20 mg 60687-0934-21 | American | 1 capsule | $0.145 | AB | Availability likely | — |
| Esomeprazole Magnesium 20 mg 62175-0820-32 | Lannett | 30 capsules | $0.145 | AB | Availability likely | — |
| Esomeprazole magnesium 20 mg 63304-0734-10 | Sun | 1000 capsules | $0.145 | AB | Availability likely | — |
| Esomeprazole magnesium 20 mg 64980-0632-03 | Rising | 30 capsules | $0.145 | AB | Availability likely | — |
| esomeprazole magnesium 20 mg 68382-0441-06 | Zydus | 30 capsules | $0.145 | AB | Availability likely | — |
| Esomeprazole magnesium 20 mgthis 70010-0133-09 | Granules | 90 capsules | $0.145 | AB | Availability likely | — |
| Esomeprazole Magnesium 20 mg 70069-0814-10 | Somerset | 1000 capsules | $0.145 | AB | Availability likely | — |
| esomeprazole magnesium 20 mg 70377-0055-11 | Biocon | 30 capsules | $0.145 | AB | Availability likely | — |
| Esomeprazole Magnesium 20 mg 82009-0033-10 | Quallent | 1000 capsules | $0.145 | AB | Availability likely | — |
| Esomeprazole Magnesium 20 mg 68462-0390-10 | Glenmark | 1000 capsules | $0.177 | — | FDA listed | +22% |
| Esomeprazole 20 mg 51660-0027-14 | Ohm | 14 capsules | $0.343 | — | FDA listed | +137% |
| Good Sense Esomeprazole Magnesium 20 mg 00113-0898-01 | L. | 14 capsules | $0.346 | — | Availability likely | +139% |
| Esomeprazole Magnesium 20 mg 16571-0880-41 | Rising | 14 capsules | $0.346 | — | Discontinued | +139% |
| Good Neighbor Pharmacy Esomeprazole Magnesium 20 mg 46122-0641-04 | Amerisource | 14 capsules | $0.346 | — | Availability likely | +139% |
| Esomeprazole Magnesium 20 mg 46122-0736-03 | Amerisource | 14 capsules | $0.346 | — | Availability likely | +139% |
| Esomeprazole Magnesium 20 mg 69230-0320-31 | Camber | 14 capsules | $0.346 | — | Availability likely | +139% |
| leader esomeprazole magnesium 20 mg 70000-0727-01 | Cardinal | 14 capsules | $0.346 | — | Availability likely | +139% |
| Esomeprazole Magnesium 20 mg 70000-0731-01 | LEADER/ | 14 capsules | $0.346 | — | Availability likely | +139% |
| Foster and Thrive Acid Reducer 20 mg 70677-1099-01 | Strategic | 14 capsules | $0.346 | — | Availability likely | +139% |
| Esomeprazole Magnesium 20 mg 43598-0407-27 | Dr. | 14 capsules | $0.349 | — | Availability likely | +142% |
| Esomeprazole Magnesium 20 mg 63868-0425-14 | CHAIN | 14 capsules | $0.361 | — | FDA listed | +150% |
| Nexium 20 mg 00186-5020-31 | AstraZeneca | 30 capsules | $8.777 | AB | Availability likely | +5971% |
| 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 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 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 mg 71335-1170-01 | Bryant | 30 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 | — |
| Esomeprazole Magnesium 20 mg 60760-0877-60 | St. | 60 capsules | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
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?
- FDA Orange Book · refreshed Sep 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 1, 2026
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.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Esomeprazole magnesium 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.
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.
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] .
1.6Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome Esomeprazole magnesium delayed-release capsules are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome, in adults.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Population Recommended Adult ( 2.1 ) and Pediatric Dosage ( 2.2 ) Healing of EE (12 years 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 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 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 E someprazole Magnesium Delayed-Release Capsules Treatment Duration Healing of EE 20 mg or 40 mg 1 once daily 4 to 8 weeks 2 Maintenance of Healing of EE 20 mg once daily Controlled studies do not extend beyond 6 months 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 (14.1) ] .
3. Refer to the amoxicillin and clarithromycin prescribing information for dosage adjustments in elderly and renally-impaired patients. 4.
A starting dosage… [Excerpted — this section continues on DailyMed.]
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Esomeprazole Magnesium Delayed-Release Capsules, USP • 20 mg – off white to pale brown colored pellets filled in size “4” blue opaque hard gelatin capsules imprinted with “G” on cap and “59” on the body. • 40 mg – off white to pale brown colored pellets filled in size “3 white opaque hard gelatin capsules imprinted with “G” on cap and “60” on the body. • Delayed-Release Capsules: 20 mg and 40 mg esomeprazole. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS • Esomeprazole magnesium is 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 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, 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 atleast 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 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 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 for use in combination with… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in labeling: • Acute Tubulointerstitial Nephritis [ see Warnings and Precautions (5.2) ] • Clostridium difficile -Associated Diarrhea [ see Warnings and Precautions (5.3) ] • Bone Fracture [ see Warnings and Precautions (5.4) ] • Severe Cutaneous Adverse Reactions [ see Warnings and Precautions (5.5) ] • Cutaneous and Systemic Lupus Erythematosus [ see Warnings and Precautions (5.6) ] • Cyanocobalamin (Vitamin B-12) Deficiency [ see Warnings and Precautions (5.8) ] • Hypomagnesemia and Mineral Metabolism [ see Warnings 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 Granules Pharmaceuticals Inc at 1-877-770-3183 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 20 mg once daily, 2,434 patients on esomeprazole magnesium 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 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, somnolence, tremor, vertigo, visual field defect; Reproductive:… [Excerpted — this section continues on DailyMed.]
🔄 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 is contraindicated [ see Contraindications (4) ] . Atazanavir : See prescribing information for atazanavir for dosing information. Nelfinavir : Avoid concomitant use with esomeprazole magnesium.
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 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 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 needed, to maintain therapeutic drug concentrations. See prescribing information for digoxin.
Comb… [Excerpted — this section continues on DailyMed.]
👥 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 H2-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,… [Excerpted — this section continues on DailyMed.]
🤰 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 H2-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. Severa… [Excerpted — this section continues on DailyMed.]
🧒 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 and esomeprazole magnesium for delayed-release oral suspension have been established in pediatric patients 12 to 17 years of age for short-term treatment (4 to 8 weeks) for healing of EE. The safety and effectiveness of esomeprazole magnesium for delayed-release oral suspension 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 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) ] . Pediatric Patients 1 Month to Less Than 1 Year of Age The safety and effectiveness of esomeprazole magnesium for delayed-release oral suspension have been established in pediatric patients 1 month to less than 1 year of age for short-term treatment (up to 6 weeks) of EE due to acid-mediated GERD.
Use of esomeprazole magnesium for this indication is supported by evidence from adequate and well-controlled studies in adults with additional safety, pharmacokinetic, and pharmacodynamic data in pediatric patients 1 month to less than 1 year of age. The safety profile in pediatric patients 1 month to less than 1 year of age was similar to adults [ see Adverse Reactions (6.1) , Clinical Pharmacology (12.2 , 12.3 )] . The safety and effectiveness of esomeprazole magnesium for the treatment of EE due to acid-mediated GERD in pediatric patients less than 1 month of age have not been established.
Symptomatic GERD Pediatric Patients 1 Year to 17 Years of Age The safety and effectiveness of esomeprazole magnesium for delayed-release capsules and esomeprazole magnesium for delayed-release oral suspension have been established in pediatric patients 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 for delayed-release oral suspension have been established in pediatric patients 1 year to 11 years for short-term treatment (up to 8 weeks) of heartburn and other symptoms associated with GERD.
Use of esomeprazole magnesium 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 for the treatment of symptomatic GERD in pediatric patients less than 1 year of age have not been established.
Infants 1 Month to Less Than 1 Year of Age Esomeprazole magnesium was not found to be effective in a multicenter, randomized, double-blind, controlled, treatment-withdrawal study of 98 infants aged 1 month to 11 months for the treatment of symptomatic GERD. Patients were enrolled if they had either a clinical diagnosis of suspected GERD, symptomatic GERD, or endoscopically proven GERD. Twenty of 98 enrolled patients underwent endoscopy, and 6 patients were found to have EE on endoscopy at baseline.
All patients received esomeprazole magnesium for delayed-release oral suspension once daily during a two-week, open-label phase of the study. There were 80 patients who attained a pre-specified level of symptom improvement and who entered the double-blind phase, in which they were randomized in equal proportions to receive esomeprazole magnesium or placebo for the next four weeks. Efficacy was assessed by observing t… [Excerpted — this section continues on DailyMed.]
🧓 Geriatric Use ▾
8.5Geriatric Use Of the total number of patients who received esomeprazole magnesium in clinical trials, 1,459 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 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 were administered once daily over 5 days as shown in 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< 0.01 esomeprazole 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). Pediatrics In infants (1 to 11 months old, inclusive) with GERD given esomeprazole magnesium for delayed-release oral suspension 1 mg/kg once daily, the percent time with intragastric pH > 4 increased from 29% at baseline to 69% on Day 7, which is similar to the pharmacodynamic effect in adults.
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 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… [Excerpted — this section continues on DailyMed.]
🧬 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 esomeprazole, are off white to pale brown colored pellets filled in size “4” blue opaque hard gelatin capsules imprinted with “G” on cap and “59” on the body. They are supplied as follows: Bottles of 30 NDC 70010-133-03 Bottles of 90 NDC 70010-133-09 Bottles of 1000 NDC 70010-133-10 Esomeprazole magnesium delayed-release capsules USP, 40 mg esomeprazole, are off white to pale brown colored pellets filled in size “3” white opaque hard gelatin capsules imprinted with “G” on cap and “60” on the body.
They are supplied as follows: Bottles of 30 NDC 70010-134-03 Bottles of 90 NDC 70010-134-09 Bottles of 1000 NDC 70010-134-10 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.
📋 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]-1H-benzimidazole-1-yl) magnesium trihydrate, 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)2Mg x 3 H 2 O with molecular weight of 767.2 as a trihydrate and 713.1 on an anhydrous basis. The structural formula is: The magnesium salt is a white to slightly cream or slightly yellow colored powder. It contains 3 moles of water of solvation and is slightly soluble in water, soluble in methanol, practically insoluble in heptane.
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 is supplied in delayed-release capsules.
Each esomeprazole magnesium delayed-release capsule contains 20 mg of esomeprazole (equivalent to 22.3 mg esomeprazole magnesium trihydrate USP) or 40 mg of esomeprazole (equivalent to 44.5 mg esomeprazole magnesium trihydrate USP) in the form of enteric-coated granules with the following inactive ingredients: hydroxypropyl cellulose, hypromellose, magnesium stearate, methacrylic acid and ethyl acrylate copolymer dispersion, mono- and di-glycerides, polysorbate 80, simethicone emulsion, sugar spheres, talc, and triethyl citrate.
Capsule shell contains FD&C Blue #1, gelatin, sodium lauryl sulfate, and titanium dioxide. In addition, capsule imprinting ink contains black iron oxide, potassium hydroxide, propylene glycol, shellac and strong ammonia solution. Meets USP Dissolution Test 2. esome-structure
💬 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 patient 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 reaction or other sign of hypersensitivity signs or symptoms associated 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 granules inside the capsule onto the applesauce. 3. Mix the granules with the applesauce.
4. Administer the mixture immediately. Do not chew or crush the granules 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 . Dispense with Medication Guide available at: https://granulespharma.com/products/esomeprazole-dr-caps Manufactured by: Granules India Limited Hyderabad-500 081, India Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA 20151 Revised: 11/2023
💬 Medication Guide ▾
SPL MEDGUIDE SECTION Dispense with Medication Guide available at: https://granulespharma.com/products/esomeprazole-dr-caps MEDICATION GUIDE Esomeprazole Magnesium Delayed-Release Capsules (es" oh mep' ra zole mag nee' zee um) 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 are 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 to 8 weeks of esomeprazole magnesium delayed-release capsules in patients whose EE does not heal. · maintaining healing of EE. · 4 to 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. It is not known if esomeprazole magnesium is safe and effective in children under 1 month of age for the treatment of GERD with EE.
It is not known if esomeprazole magnesium is safe and effective in children less than 1 year of age for the treatment of GERD symptoms.It is not known if Esomeprazole Magnesium Delayed-Release Capsules are safe and effective in… [Excerpted — this section continues on DailyMed.]
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Absorption Esomeprazole magnesium delayed-release capsules and esomeprazole magnesium for delayed-release oral suspension showed similar bioavailability after a single dose (40 mg) administration in 94 healthy male and female subjects under fasting conditions. After oral administration, peak plasma levels (C max ) of esomeprazole occur at approximately 1.5 hours (T max ). The C max increases proportionally when the dose is increased, and there is a three-fold increase in the area under the plasma concentration- time curve (AUC) from 20 to 40 mg.
At repeated once-daily dosing with 40 mg, the systemic bioavailability is approximately 90% compared to 64% after a single dose of 40 mg. The mean exposure (AUC) to esomeprazole increases from 4.32 micromol*hr/L on Day 1 to 11.2 micromol*hr/L on Day 5 after 40 mg once daily dosing. The AUC after administration of a single 40 mg dose of esomeprazole magnesium delayed-release capsules is decreased by 43% to 53% after food intake compared to fasting conditions [ see Dosage and Administration (2.3) ] .
The pharmacokinetics of esomeprazole in adult patients with symptomatic GERD following repeated once daily administration of 20 mg and 40 mg esomeprazole magnesium delayed-release capsules over a period of five days are shown in Table 6: Table 6: Geometric Mean (95% CI) Pharmacokinetic Parameters of Esomeprazole on Day 5 Following Once Daily Dosing of Esomeprazole Magnesium Delayed-Release Capsules in Adult Patients with Symptomatic GERD Esomeprazole Magnesium Delayed-Release Capsules Parameter 1 (CV) 40 mg once daily (n=36) 20 mg once daily (n=36) AUC (micromol·h/L) 12.6 (42%) 4.2 (59%) C max (micromol/L) 4.7 (37%) 2.1 (45%) T max (hours) 1.6 1.6 t 1/2 (hours) 1.5 1.2 1.
Values represent the geometric mean, except the T max , which is the arithmetic mean; CV = Coefficient of variation Esomeprazole is a time-dependent inhibitor of CYP2C19, resulting in autoinhibition and nonlinear pharmacokinetics. The systemic exposure increases in a more than dose proportional manner after multiple oral doses of esomeprazole. Compared to the first dose, the systemic exposure (C max and AUC 0-24h ) at steady state following once a day dosing increased by 43% and 90%, respectively, compared to after the first dose for the 20 mg dose and increased by 95% and 159%, respectively, for the 40 mg dose.
Distribution Esomeprazole is 97% bound to plasma proteins. Plasma protein binding is constant over the concentration range of 2 to 20 micromol/L. The apparent volume of distribution at steady state in healthy subjects is approximately 16 L.
Elimination Metabolism Esomeprazole is extensively metabolized in the liver by the cytochrome P450 (CYP) enzyme system. The metabolites of esomeprazole lack antisecretory activity. The major part of esomeprazole’s metabolism is dependent upon the CYP2C19 isoenzyme, which forms the hydroxy and desmethyl metabolites.
The remaining amount is dependent on CYP3A4 which forms the sulphone metabolite. Excretion The plasma elimination half-life of esomeprazole is approximately 1 to 1.5 hours. Less than 1% of parent drug is excreted in the urine.
Approximately 80% of an oral dose of esomeprazole is excreted as inactive metabolites in the urine, and the remainder is found as inactive metabolites in the feces. Combination Therapy with Amoxicillin and Clarithromycin Esomeprazole magnesium delayed-release capsules 40 mg once daily was given in combination with amoxicillin 1000 mg twice daily and clarithromycin 500 mg twice daily for 7 days to 17 healthy male and female subjects. The mean steady state AUC and C max of esomeprazole increased by 70% and 18%, respectively during combination therapy compared to treatment with esomeprazole magnesium alone.
The observed increase in esomeprazole exposure during co-administration with amoxicillin and clarithromycin is not expected to be clinically relevant. The pharmacokinetic parameters for amoxicillin and clarithromycin were si… [Excerpted — this section continues on DailyMed.]
🧬 Pharmacodynamics ▾
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 were administered once daily over 5 days as shown in 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< 0.01 esomeprazole 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). Pediatrics In infants (1 to 11 months old, inclusive) with GERD given esomeprazole magnesium for delayed-release oral suspension 1 mg/kg once daily, the percent time with intragastric pH > 4 increased from 29% at baseline to 69% on Day 7, which is similar to the pharmacodynamic effect in adults.
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 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.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES
14.1Healing of EE in Adults The healing rates of esomeprazole magnesium delayed-release capsules 40 mg, esomeprazole magnesium delayed-release capsules 20 mg, and omeprazole delayed-release capsules 20 mg (the approved dose for this indication) once daily were evaluated in adult patients with endoscopically diagnosed EE in four multicenter, double-blind, randomized studies. The healing rates at Weeks 4 and 8 were evaluated and are shown in Table 11: Table 11: EE Healing Rate (Life-Table Analysis) in Adults with EE Treated with Esomeprazole Magnesium Delayed-Release Capsules or Omeprazole Delayed-Release Capsules Once Daily in Four Clinical Studies Study No. of Patients Treatment Group EE Healing Rates Significance Level 1 Week 4 Week 8 1 588 Esomeprazole magnesium delayed-release capsules 20 mg 68.7% 90.6% N.S.
588 Omeprazole 20 mg 69.5% 88.3% 2 654 Esomeprazole magnesium delayed-release capsules 40 mg 75.9% 94.1% p < 0.001 656 Esomeprazole magnesium delayed-release capsules 20 mg 70.5% 89.9% p < 0.05 650 Omeprazole 20 mg 64.7% 86.9% 3 576 Esomeprazole magnesium delayed-release capsules 40 mg 71.5% 92.2% N.S. 572 Omeprazole 20 mg 68.6% 89.8% 4 1216 Esomeprazole magnesium delayed-release capsules 40 mg 81.7% 93.7% p < 0.001 1209 Omeprazole 20 mg 68.7% 84.2% N.S.= not significant (p > 0.05) 1. log-rank test vs. omeprazole 20 mg In these same studies of patients with EE, sustained heartburn resolution and time to sustained heartburn resolution were evaluated and are shown in Table 12: Table 12: Sustained Resolution 1 of Heartburn in Adults with EE Treated with Esomeprazole Magnesium Delayed-Release Capsules or Omeprazole Delayed-Release Capsules Once Daily in Four Clinical Studies Study No. of Patients Treatment Group Cumulative Percent 2 with Sustained Resolution Significance Level 3 Day 14 Day 28 1 573 Esomeprazole magnesium delayed-release capsules 20 mg 64.3% 72.7% N.S.
555 Omeprazole 20 mg 64.1% 70.9% 2 621 Esomeprazole magnesium delayed-release capsules 40 mg 64.8% 74.2% p <0.001 620 Esomeprazole magnesium delayed-release capsules 20 mg 62.9% 70.1% N.S. 626 Omeprazole 20 mg 56.5% 66.6% 3 568 Esomeprazole magnesium delayed-release capsules 40 mg 65.4% 73.9% N.S. 551 Omeprazole 20 mg 65.5% 73.1% 4 1187 Esomeprazole magnesium delayed-release capsules 40 mg 67.6% 75.1% p <0.001 1188 Omeprazole 20 mg 62.5% 70.8% 1.
Defined as 7 consecutive days with no heartburn reported in daily patient diary. 2. Defined as the cumulative proportion of patients who have reached the start of sustained resolution.
3. log-rank test vs. omeprazole 20 mg. N.S. = not significant (p > 0.05) In these four studies, the range of median days to the start of sustained resolution (defined as 7 consecutive days with no heartburn) was 5 days for esomeprazole magnesium delayed-release capsules 40 mg, 7 to 8 days for esomeprazole magnesium delayed-release capsules 20 mg and 7 to 9 days for omeprazole 20 mg. There are no comparisons of 40 mg of esomeprazole magnesium delayed-release capsules with 40 mg of omeprazole in clinical trials assessing either healing or symptomatic relief of EE.
14.2Maintenance of Healing of EE in Adults Two multicenter, randomized, double-blind placebo-controlled 4-arm studies were conducted in adult patients with endoscopically confirmed, healed EE to evaluate esomeprazole magnesium delayed-release capsules 40 mg (n=174), 20 mg (n=180), 10 mg (n=168) or placebo (n=171) once daily over six months of treatment. No additional clinical benefit was seen with esomeprazole magnesium delayed-release capsules 40 mg over esomeprazole magnesium delayed-release capsules 20 mg. Esomeprazole magnesium delayed-release capsules 40 mg once daily is not a recommended regimen for the maintenance of healing of EE in adults.
The percentages of patients that maintained healing of EE at the various time points are shown in the Figures 2 and 3: Figure 2: Maintenance of Healing Rates of EE in Adults by Month (Study 177) Figure 3: Mainten… [Excerpted — this section continues on DailyMed.]
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility The carcinogenic potential of esomeprazole magnesium delayed-release capsules was assessed using studies of omeprazole, of which esomeprazole is an enantiomer. In two 24-month oral carcinogenicity studies in rats, omeprazole at daily doses of 1.7, 3.4, 13.8, 44, and 140.8 mg/kg/day (about 0.4 to 34 times the human dose of 40 mg/day expressed on a body surface area basis) produced gastric ECL cell carcinoids in a dose-related manner in both male and female rats; the incidence of this effect was markedly higher in female rats, which had higher blood levels of omeprazole.
Gastric carcinoids seldom occur in the untreated rat. In addition, ECL cell hyperplasia was present in all treated groups of both sexes. In one of these studies, female rats were treated with 13.8 mg omeprazole/kg/day (about 3.4 times the human dose of 40 mg/day on a body surface area basis) for 1 year, then followed for an additional year without the drug.
No carcinoids were seen in these rats. An increased incidence of treatment-related ECL cell hyperplasia was observed at the end of 1 year (94% treated vs. 10% controls).
By the second year the difference between treated and control rats was much smaller (46% vs. 26%) but still showed more hyperplasia in the treated group. Gastric adenocarcinoma was seen in one rat (2%).
No similar tumor was seen in male or female rats treated for 2 years. For this strain of rat no similar tumor has been noted historically, but a finding involving only one tumor is difficult to interpret. A 78-week mouse carcinogenicity study of omeprazole did not show increased tumor occurrence, but the study was not conclusive.
Esomeprazole was negative in the Ames mutation test, in the in vivo rat bone marrow cell chromosome aberration test, and the in vivo mouse micronucleus test. Esomeprazole, however, was positive in the in vitro human lymphocyte chromosome aberration test. Omeprazole was positive in the in vitro human lymphocyte chromosome aberration test, the in vivo mouse bone marrow cell chromosome aberration test, and the in vivo mouse micronucleus test.
The potential effects of esomeprazole on fertility and reproductive performance were assessed using omeprazole studies. Omeprazole at oral doses up to 138 mg/kg/day in rats (about 34 times the human dose of 40 mg/day on a body surface area basis) was found to have no effect on reproductive performance of parental animals.
13.2Animal Toxicology and/or Pharmacology Reproduction Studies Reproduction studies have been performed in rats at oral doses up to 280 mg/kg/day (about 68 times an oral human dose of 40 mg on a body surface area basis) and in rabbits at oral doses up to 86 mg/kg/day (about 42 times an oral human dose of 40 mg on a body surface area basis) and have revealed no evidence of impaired fertility or harm to the fetus due to esomeprazole [ see Use in Specific Populations (8.1) ] . Juvenile Animal Study A 28-day toxicity study with a 14-day recovery phase was conducted in juvenile rats with esomeprazole magnesium at doses of 70 to 280 mg /kg/day (about 17 to 68 times a daily oral human dose of 40 mg on a body surface area basis).
An increase in the number of deaths at the high dose of 280 mg/kg/day was observed when juvenile rats were administered esomeprazole magnesium from postnatal day 7 through postnatal day 35. In addition, doses equal to or greater than 140 mg/kg/day (about 34 times a daily oral human dose of 40 mg on a body surface area basis), produced treatment-related decreases in body weight (approximately 14%) and body weight gain, decreases in femur weight and femur length, and affected overall growth. Comparable findings described above have also been observed in this study with another esomeprazole salt, esomeprazole strontium, at equimolar doses of esomeprazole.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility The carcinogenic potential of esomeprazole magnesium delayed-release capsules was assessed using studies of omeprazole, of which esomeprazole is an enantiomer. In two 24-month oral carcinogenicity studies in rats, omeprazole at daily doses of 1.7, 3.4, 13.8, 44, and 140.8 mg/kg/day (about 0.4 to 34 times the human dose of 40 mg/day expressed on a body surface area basis) produced gastric ECL cell carcinoids in a dose-related manner in both male and female rats; the incidence of this effect was markedly higher in female rats, which had higher blood levels of omeprazole.
Gastric carcinoids seldom occur in the untreated rat. In addition, ECL cell hyperplasia was present in all treated groups of both sexes. In one of these studies, female rats were treated with 13.8 mg omeprazole/kg/day (about 3.4 times the human dose of 40 mg/day on a body surface area basis) for 1 year, then followed for an additional year without the drug.
No carcinoids were seen in these rats. An increased incidence of treatment-related ECL cell hyperplasia was observed at the end of 1 year (94% treated vs. 10% controls).
By the second year the difference between treated and control rats was much smaller (46% vs. 26%) but still showed more hyperplasia in the treated group. Gastric adenocarcinoma was seen in one rat (2%).
No similar tumor was seen in male or female rats treated for 2 years. For this strain of rat no similar tumor has been noted historically, but a finding involving only one tumor is difficult to interpret. A 78-week mouse carcinogenicity study of omeprazole did not show increased tumor occurrence, but the study was not conclusive.
Esomeprazole was negative in the Ames mutation test, in the in vivo rat bone marrow cell chromosome aberration test, and the in vivo mouse micronucleus test. Esomeprazole, however, was positive in the in vitro human lymphocyte chromosome aberration test. Omeprazole was positive in the in vitro human lymphocyte chromosome aberration test, the in vivo mouse bone marrow cell chromosome aberration test, and the in vivo mouse micronucleus test.
The potential effects of esomeprazole on fertility and reproductive performance were assessed using omeprazole studies. Omeprazole at oral doses up to 138 mg/kg/day in rats (about 34 times the human dose of 40 mg/day on a body surface area basis) was found to have no effect on reproductive performance of parental animals.
📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL esome-20mg-30s esome-40mg-30s