Esomeprazole magnesium 40 mg Capsule, Delayed Release
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
Prescription esomeprazole is used to treat the symptoms of gastroesophageal reflux disease (GERD), a condition in which backward flow of acid from the stomach causes heartburn and possible injury of the esophagus (the tube between the throat and stomach) in adults and children 1 year of age and older. Prescription esomeprazole is used to treat damage from GERD in adults and children 1 month of age and older. Prescription esomeprazole is used to allow the esophagus to heal and prevent further damage to the esophagus in adults with GERD. Prescription esomeprazole is also used to decrease the cha...
Read the full MedlinePlus article ↗- 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 5138Q19F1X
Ammonia is a colorless gas made from nitrogen and hydrogen. It's used in medicines as a pH buffer to maintain the correct acidity level and help keep the product stable.
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UNII N487KM8COK
A natural red colorant derived from beets. It's used to give medicines their color and help patients identify the correct dosage form.
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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 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 EX438O2MRT
Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
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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 230OU9XXE4
A waxy substance made from glycerin and stearic acid that acts as an emulsifier to blend oily and watery ingredients together. It also helps thicken and stabilize the medicine's texture.
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UNII R75537T0T4
Hypromellose 2910 is a plant-derived thickening agent made from cellulose. It serves as a binder that holds tablet ingredients together, a film-coating for pills, and a viscosity controller in liquids.
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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 6HG8UB2MUY
Meglumine is a sugar-alcohol compound used as a solubilizer and pH buffer in medicines. It helps dissolve drugs that don't mix well in water and maintains stable acidity levels in the formulation.
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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 Y4S76JWI15
Methyl alcohol, also called methanol, is a simple organic solvent. It helps dissolve and carry active ingredients in liquid medicines, and helps the product mix evenly.
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UNII 588X2YUY0A
Methylene chloride is a volatile organic solvent used in pharmaceutical manufacturing to dissolve and process active ingredients and other substances. It evaporates during production, helping create tablets, capsules, or coatings with uniform quality.
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UNII LQA7B6G8JG
A synthetic polymer made by combining water-soluble compounds. It acts as a surfactant and solubilizer to help mix oil and water-based ingredients, improving the medicine's texture and how active ingredients dissolve.
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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 ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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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 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.
24 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 | $33.86 / 100 capsules |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Esomeprazole Magnesium 40 mg 00378-2351-77 | Mylan | 90 capsules | $0.118 | AB | Availability likely | — |
| Esomeprazole Magnesium 40 mg 00904-6581-68 | Major | 1 capsule | $0.118 | AB | Availability likely | — |
| Esomeprazole Magnesium 40 mg 16714-0980-01 | NorthStar | 30 capsules | $0.118 | AB | Availability likely | — |
| Esomeprazole Magnesium 40 mg 31722-0665-10 | Camber | 1000 capsules | $0.118 | AB | Availability likely | — |
| Esomeprazole magnesium 40 mg 43547-0002-03 | Solco | 30 capsules | $0.118 | AB | Availability likely | — |
| Esomeprazole Magnesium 40 mg 43598-0510-10 | Dr. | 1000 capsules | $0.118 | AB | Availability likely | — |
| Esomeprazole Magnesium 40 mg 50268-0272-13 | AvPAK | 1 capsule | $0.118 | AB | Availability likely | — |
| Esomeprazole Magnesium 40 mg 62175-0840-32 | Lannett | 30 capsules | $0.118 | AB | Availability likely | — |
| Esomeprazole magnesium 40 mg 63304-0735-10 | Sun | 1000 capsules | $0.118 | AB | Availability likely | — |
| Esomeprazole magnesium 40 mg 64980-0633-03 | Rising | 30 capsules | $0.118 | AB | Availability likely | — |
| esomeprazole magnesium 40 mg 68382-0442-06 | Zydus | 30 capsules | $0.118 | AB | Availability likely | — |
| Esomeprazole magnesium 40 mg 70010-0134-03 | Granules | 30 capsules | $0.118 | AB | Availability likely | — |
| Esomeprazole Magnesium 40 mg 70069-0815-10 | Somerset | 1000 capsules | $0.118 | AB | Availability likely | — |
| esomeprazole magnesium 40 mg 70377-0056-11 | Biocon | 30 capsules | $0.118 | AB | Availability likely | — |
| Esomeprazole Magnesium 40 mg 82009-0034-10 | Quallent | 1000 capsules | $0.118 | AB | Availability likely | — |
| Esomeprazole Magnesium 40 mg 68462-0391-10 | Glenmark | 1000 capsules | $0.149 | — | FDA listed | — |
| Nexium 40 mg 00186-5040-05 | AstraZeneca | 5 capsules | — | AB | Discontinued | — |
| Esomeprazole Magnesium 40 mg 00615-8628-39 | NCS | 30 capsules | — | AB | FDA listed | — |
| esomeprazole 40 mg 33342-0307-07 | Macleods | 30 capsules | — | — | FDA listed | — |
| Esomeprazole Magnesium 40 mg 50090-5134-00 | A-S | 30 capsules | — | AB | FDA listed | — |
| Esomeprazole Magnesium 40 mg 50090-6128-01 | A-S | 90 capsules | — | — | FDA listed | — |
| Esomeprazole Magnesium 40 mg 50090-6943-00 | A-S | 90 capsules | — | AB | FDA listed | — |
| Esomeprazole Magnesium 40 mg 50090-7360-01 | A-S | 90 capsules | — | AB | FDA listed | — |
| Esomeprazole Magnesium 40 mg 50090-7896-00 | A-S | 90 capsules | — | AB | FDA listed | — |
| Esomeprazole Magnesium 40 mg 50090-7949-00 | A-S | 90 capsules | — | AB | FDA listed | — |
| Esomeprazole Magnesium 40 mg 50090-7950-01 | A-S | 90 capsules | — | AB | FDA listed | — |
| Esomeprazole magnesium 40 mg 51407-0743-10 | Golden | 1000 capsules | — | AB | FDA listed | — |
| Esomeprazole Magnesium 40 mg 59651-0562-25 | Aurobindo | 25000 capsules | — | AB | FDA listed | — |
| Esomeprazole Magnesium 40 mg 65862-0784-01 | Aurobindo | 100 capsules | — | AB | FDA listed | — |
| Esomeprazole magnesium 40 mgthis 67877-0479-38 | Ascend | 10 capsules | — | AB | FDA listed | — |
| Esomeprazole magnesium 40 mg 67877-0572-05 | Ascend | 500 capsules | — | AB | FDA listed | — |
| Esomeprazole Magnesium 40 mg 68071-3934-09 | NuCare | 90 capsules | — | AB | FDA listed | — |
| esomeprazole magnesium 40 mg 68788-8524-01 | Preferred | 100 capsules | — | AB | FDA listed | — |
| Esomeprazole Magnesium 40 mg 68788-8812-01 | Preferred | 100 capsules | — | AB | FDA listed | — |
| Esomeprazole magnesium 40 mg 69434-0013-01 | Zhejiang | 30 capsules | — | AB | FDA listed | — |
| esomeprazole magnesium 40 mg 70518-3850-00 | REMEDYREPACK | 30 capsules | — | AB | FDA listed | — |
| Esomeprazole Magnesium 40 mg 70518-4581-00 | REMEDYREPACK | 30 capsules | — | AB | FDA listed | — |
| esomeprazole magnesium 40 mg 70771-1494-00 | Zydus | 1000 capsules | — | AB | FDA listed | — |
| Esomeprazole Magnesium 40 mg 71205-0143-30 | Proficient | 30 capsules | — | AB | FDA listed | — |
| esomeprazole magnesium 40 mg 71335-1335-01 | Bryant | 90 capsules | — | AB | FDA listed | — |
| Esomeprazole Magnesium 40 mg 71335-2040-01 | Bryant | 90 capsules | — | AB | FDA listed | — |
| Esomeprazole magnesium 40 mg 71335-2449-01 | Bryant | 90 capsules | — | AB | FDA listed | — |
| esomeprazole magnesium 40 mg 71335-2476-01 | Bryant | 90 capsules | — | AB | FDA listed | — |
| Esomeprazole Magnesium 40 mg 71335-3149-01 | Bryant | 90 capsules | — | AB | FDA listed | — |
| Esomeprazole Magnesium 40 mg 72189-0318-30 | Direct | 30 capsules | — | AB | FDA listed | — |
| Esomeprazole Magnesium 40 mg 72789-0391-90 | PD-Rx | 90 capsules | — | AB | FDA listed | — |
| Esomeprazole magnesium 40 mg 76420-0227-30 | Asclemed | 30 capsules | — | AB | FDA listed | — |
| Esomeprazole Magnesium 40 mg 76420-0905-00 | Asclemed | 1000 capsules | — | AB | FDA listed | — |
| Esomeprazole Magnesium DR 40 mg 80425-0331-01 | Advanced | 30 capsules | — | AB | FDA listed | — |
| Esomeprazole magnesium 40 mg 80425-0440-01 | Advanced | 30 capsules | — | AB | FDA listed | — |
| esomeprazole magnesium 40 mg 82804-0078-30 | Proficient | 30 capsules | — | AB | FDA listed | — |
| Esomeprazole Magnesium 40 mg 50090-7991-00 | A-S | 30 capsules | — | AB | 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 | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 67877-0479-05 | 500 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-479-05) | — | — | 2017-10-20 | Active |
| 67877-0479-10 | 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-479-10) | $0.1180 / ea | $118.02 | 2017-10-20 | Active |
| 67877-0479-30 | 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-479-30) | $0.1180 / ea | $3.54 | 2017-10-20 | Active |
| 67877-0479-38 You're viewing this | 10 BLISTER PACK in 1 CARTON (67877-479-38) / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK | — | — | 2017-10-20 | Active |
| 67877-0479-90 | 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE (67877-479-90) | $0.1180 / ea | $10.62 | 2017-10-20 | Active |
Pack size FAQ
What quantity is in NDC 67877-0479-38?
What NDC number is used to bill for this package of Esomeprazole magnesium 40 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.
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 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 may be considered. Pediatric Patients 12 Years to 17 Years of Age Esomeprazole magnesium delayed-release capsules 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 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 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 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 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 ) Mix packets with water to create an oral suspension. ( 2.3 ) Opened capsules can be administered through a nasogastric tube and oral suspension can be administered through a nasogastric or gastric tube. ( 2.3 )
2.1Recommended Dosage in Adults by Indication Table 1 shows the recommended adult dosage of esomeprazole magnesium by indication. The duration of esomeprazole magnesium 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 should only be initiated and continued if the benefits outweigh the risks of treatment.
Table 1: Recommended Dosage of esomeprazole magnesium 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 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 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 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 ) ]. 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 ) ] . Refer to the amoxicillin and clarithromycin prescribing information for dosage adjustments in elderly and renally-impaired patients. A starting dosage of 20 mg tw…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Esomeprazole magnesium delayed-release capsules, USP 20 mg - hard gelatin capsule shell, Dark blue opaque cap & body imprinted with "ESO" on cap and "20" on the body in golden yellow ink. Esomeprazole magnesium delayed-release capsules, USP 40 mg - hard gelatin capsule shell, Dark blue opaque cap & body imprinted with "ESO" on cap and "40" on the body in golden yellow ink. Esomeprazole delayed-release capsules, USP: 20 mg and 40 mg.
( 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. ( 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 and refer to specialist for evaluation. ( 5.6 ) Interaction with Clopidogrel : Avoid concomitant use of esomeprazole magnesium. ( 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.
( 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 at least 14 days before assessing CgA levels. ( 5.11, 12.2 ) Interact ion 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.
( 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 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 esomeprazole magnesium, refer to Warnings and Precautions section of the corresponding prescribing information.
5.4 Bone Fracture Several published observational studies sugg…
🤒 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 Ascend Laboratories, LLC at 1-877-272-7901 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: dysme…
🔄 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.
Combinatio…
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
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 H2-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 H2-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 simil…
🤰 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 H2-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 H2-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. Several s…
🧒 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. 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 ) ] .
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. 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 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 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 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 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 40 mg and 20 mg delayed-release capsules 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 4.92
4.1Coefficient of variation 16% 27% 16% 27% Gastric pH was measured over a 24-hour period p< 0.01 esomeprazole magnesium 40 mg vs. esomeprazole magnesium 20 mg In a second study, the effect on intragastric pH of esomeprazole magnesium 40 mg delayed-release capsules 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 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.
12.3Pharmacokinetics Absorption Esomeprazole magnesium delayed-release capsules showed similar bioavailability after a single dose (40 mg) administration in 94 healthy male…
🧬 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, hard gelatin, Dark blue colored capsules imprinted with "ESO" on cap and "20" on the body in golden yellow ink. They are supplied as follows: NDC 67877-478-30 bottles of 30 NDC 67877-478-90 bottles of 90 NDC 67877-478-05 bottles of 500 NDC 67877-478-10 bottles of 1000 NDC 67877-478-38 Carton of 100 (10×10 Unit-dose) Capsules Esomeprazole magnesium delayed-release capsules, USP 40 mg, are opaque, hard gelatin, Dark blue colored capsules imprinted with "ESO" on cap and "40" on the body in golden yellow ink.
They are supplied as follows: NDC 67877-479-30 bottles of 30 NDC 67877-479-90 bottles of 90 NDC 67877-479-05 bottles of 500 NDC 67877-479-10 bottles of 1000 NDC 67877-479-38 Carton of 100 (10×10 Unit-dose) Capsules 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, USP 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 for oral administration is bis (5-methoxy-2-[(S)-[(4-methoxy-3,5-dimethyl-2-pyridinyl) methyl] sulfinyl] benzimidazole, magnesium salt 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 749.15 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 is supplied as Esmoprazole magnesium delayed-release capsules.
Each Esomeprazole magnesium delayed-release capsule contains 20 mg of esomeprazole (equivalent to 21.75 mg esomeprazole magnesium dihydrate) or 40 mg of esomeprazole (equivalent to 43.50 mg esomeprazole magnesium dihydrate) in the form of enteric-coated granules with the following inactive ingredients: Colloidal silicon dioxide, hypromellose, isopropyl alcohol, magnesium stearate, meglumine, methacrylic acid copolymer dispersion, methyl alcohol, methylene chloride, mono & diglycerides, poloxamer, Talc, triethyl citrate, and Sugar spheres (composed of sucrose, maize starch and purified water).
The capsule shells have the following inactive ingredients: FD & C Blue 1, FD & C Red 40, gelatin, sodium lauryl sulphate and titanium dioxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, propylene glycol, Shellac, strong ammonia solution, and yellow iron oxide. Esomeprazole-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 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 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 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. 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. 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. Open the esomeprazole magnesium delayed-release capsule and carefully empty the granules inside the capsule onto the applesauce. Mix the granules with the applesauce.
Administer the mixture immediately. Do not chew or crush the granules. 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 . Manufactured by: Alkem Laboratories Ltd., INDIA.
Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054
💬 Medication Guide ▾
MEDICATION GUIDE Esomeprazole Magnesium Delayed-Release Capsules, USP for oral use (es ″ oh mep′ ra zole mag nee′ zee um) What is the most important information I should know about esomeprazole magnesium delayed-release capsules, USP? 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 t ubulointerstitial nephritis) . Some people who take proton pump inhibitor (PPI) medicines, including Esomeprazole magnesium, may develop a kidney problem called acute tubulointerstitial nephritis that can happen at any time during treatment with Esomeprazole magnesium. 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.
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 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 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 is 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 is safe and effective in children to reduce the risk of stomach ulcers in children who take medicines called NSAIDs, to treat Helicobacter pylori stomach infection to lower the risk of a stomach ulcer returning, and to treat conditions where your stomach makes too much acid. Do not take esomeprazole magnesium if you are: allergic to esomeprazole magnesium, any other PPI medicine, or any of the ingredients in esomeprazole magnesium.
See the end of this Medication Guide for a complete list of ingredients in esomeprazole magnesium. Tell your doctor right away or get emergency medical help if you get any of the following symptoms of an allergic reaction with esomeprazole magnesium: o rash o throat tightness o face swelling o difficulty breathing taking a medicine that…