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Dexlansoprazole 60 mg Capsule, Delayed Release, 90-count — NDC 50090-7451-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Dexlansoprazole 60 mg Capsule, Delayed Release, 90-count — NDC 50090-7451-1 (Billing 50090-7451-01)

by A-S Medication Solutions · 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE

This is a package of 90 capsules of Dexlansoprazole 60 mg Capsule, Delayed Release from A-S Medication Solutions, marketed since Nov 2022 and currently FDA-listed.

NDC 50090-7451-01
🏷️ FDA NDC (as labeled) 50090-7451-1 billing pads the package segment with a zero
This package
Contains90-count Pack sizes2 compare ↓
Also priced by: Part D plans $5.33/unit — full pricing hub ↓
Product page 50090-7451-00 Also comes in: 30 capsules 50090-7451-0
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 50090-7451-1
Product NDC 50090-7451
11-digit billing NDC 50090745101
NCPDP billing unit EA — each (per item)
RxCUI 833213
UNII UYE4T5I70X
Application # ANDA202294
SPL Set ID fc3de800-bfad-4e2f-b664-d58a67550b2f
Established class (EPC) Proton Pump Inhibitor
Mechanism of action Proton Pump Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2022-11-22
Route ORAL
Dosage form CAPSULE, DELAYED RELEASE
Substance DEXLANSOPRAZOLE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 064794
GCN 16306
HICL code 036085
Ingredient (HICL) Dexlansoprazole
HIC1 code D
Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System
HIC2 code D4
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Alimentary Tract
HIC3 code D4J
Therapeutic class — specific (HIC3) Proton-Pump Inhibitors
AHFS code 56:28.36.00
AHFS class Proton-Pump Inhibitors
FDB label name DEXLANSOPRAZOLE DR 60 MG CAP
FDB brand name Dexlansoprazole Dr
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 064794
  • GCN: 16306
  • HICL (First Databank): 036085
  • AHFS class code: 56:28.36.00
  • RxCUI (RxNorm): 833213
Why two NDCs? The FDA registers this code as 50090-7451-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 50090-7451-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Proton Pump Inhibitor class.

Pharmacologic class Proton Pump Inhibitor
Drug family (ATC) Proton pump inhibitors
How it works Proton Pump Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name DEXLANSOPRAZOLE DR 60 MG CAP Ingredient Dexlansoprazole
📖 What it is MedlinePlus · NLM

Dexlansoprazole is used to treat gastroesophageal reflux disease (GERD; a condition where stomach acid flows back into the esophagus (tube between the stomach and throat)) heal and maintain healing of erosive esophagitis (swelling that may damage tissues of the esophagus) Dexlansoprazole is in a class of medications called proton pump inhibitors. It works by decreasing the amount of acid made in the stomach.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Good news — you can take dexlansoprazole with or without food, whichever is easier for you. Unlike some older acid-suppressing medicines, there's no requirement to time it before m...
  • Can I take this medicine with food, or do I need to take it on an empty stomach?
  • Yes, absolutely. You can open the capsule and sprinkle the small pellets or granules onto one tablespoon of applesauce, then swallow the mixture right away — just don't chew the pe...
  • I have trouble swallowing capsules. Is there another way to take this?
📖 Read our full Dexlansoprazole guide →
9
Nutrient depletion considerations

Dexlansoprazole may be associated with lower levels of 9 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Dexlansoprazole nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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 systemPer eachPer 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 $5.33 $479.83 / 90 capsules
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
50090-7451-00 50090-7451-0 Main listing 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE 2024-11-11 — Active
50090-7451-01 You're viewing this 90 CAPSULE, DELAYED RELEASE in 1 BOTTLE 2024-11-11 — Active

You're viewing the largest of 2 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This is a 90-count package — 90 capsule, delayed release in 1 bottle.
How does this package differ from NDC 50090-7451-00?
Both are Dexlansoprazole 60 mg Capsule, Delayed Release — the drug itself is identical. This page's package is the 90-count one, while NDC 50090-7451-00 is the 30 capsules package.
What NDC number is used to bill for this package of Dexlansoprazole 60 mg Capsule, Delayed Release?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Dexlansoprazole 60 mg 00378-2086-77 Mylan 90 capsules $3.707 AB Availability likely —
Dexlansoprazole delayed release 60 mg 24979-0002-06 Upsher-Smith 30 capsules $3.707 AB Availability likely —
Dexlansoprazole 60 mg 49884-0148-09 Par 90 capsules $3.707 AB Availability likely —
Dexlansoprazole 60 mg 62332-0824-30 Alembic 30 capsules $3.707 AB Availability likely —
Dexlansoprazole 60 mg 46708-0824-30 Alembic 30 capsules — AB FDA listed —
Dexlansoprazole delayed release 60 mg 50090-5944-00 A-S 30 capsules — AB FDA listed —
Dexlansoprazole delayed release 60 mg 50090-6514-00 A-S 30 capsules — AB FDA listed —
Dexlansoprazole 60 mgthis 50090-7451-01 A-S 90 capsules — AB FDA listed —
Dexlansoprazole delayed release 60 mg 51407-0747-30 Golden 30 capsules — AB FDA listed —
Dexilant 60 mg 64764-0175-00 Takeda 7 capsules — AB FDA listed —
Dexlansoprazole 60 mg 72162-2214-03 Bryant 30 capsules — AB FDA listed —
Dexlansoprazole delayed release 60 mg 72162-2239-03 Bryant 30 capsules — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2022
On the market since
Nov 2022
📍
2026
Currently FDA-listed
4 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color green
ShapeCapsule
ImprintPAR;148
Size23 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

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.

  • UNII I753WB2F1M
    FD&C Yellow No. 5 is a synthetic yellow colorant approved by the FDA. It is added to medicines to make pills, tablets, or liquids visually distinct and easier to identify.
  • 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.
  • 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.
  • 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.
  • UNII PF5DZW74VN
    Calcium hydroxide is a white powder made from limestone. It's used in medicines as a buffer to adjust acidity and as a disintegrant to help tablets break apart in the stomach.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII RFW2ET671P
    Hydroxypropyl cellulose is a plant-derived thickening agent made from cellulose. It acts as a binder to hold tablet ingredients together and as a film-former to coat tablets or control how fast the medicine releases.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • 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.
  • UNII DIQ16UC154
    A surfactant derived from lauric acid that helps dissolve or disperse ingredients in liquid formulations. It may act as a detergent, emulsifier, or foaming agent to improve how the medicine mixes and is absorbed.
  • UNII 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • UNII 5KY68S2577
    A synthetic plastic polymer made from two chemical compounds combined in a specific ratio. It forms a coating on tablets and capsules to control how and where the medication dissolves in the digestive tract.
  • 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.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • 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.
  • 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.
  • 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.
  • UNII C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • 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.
  • 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.
  • 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.
  • UNII H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.

24 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerA-S Medication Solutions
Application holderPH HEALTH LTD
FDA applicationANDA202294 (ANDA)
Labeler code50090
First marketedNov 2022
Product typeHuman Prescription Drug
Portfolio2,811 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📖 Instructions for Use 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 173 words ▾

1 INDICATIONS AND USAGE Dexlansoprazole is a proton pump inhibitor (PPI) indicated in patients 12 years of age and older for: Healing of all grades of erosive esophagitis (EE). ( 1.1 ) Maintenance of healed EE and relief of heartburn. ( 1.2 ) Treatment of symptomatic non-erosive gastroesophageal reflux disease (GERD). ( 1.3 )

1.1Healing of Erosive Esophagitis Dexlansoprazole delayed-release capsules are indicated in patients 12 years of age and older for healing of all grades of erosive esophagitis (EE) for up to eight weeks.

1.2Maintenance of Healed Erosive Esophagitis and Relief of Heartburn Dexlansoprazole delayed-release capsules are indicated in patients 12 years of age and older to maintain healing of EE and relief of heartburn for up to six months in adults and 16 weeks in patients 12 to 17 years of age.

1.3Treatment of Symptomatic Non-Erosive Gastroesophageal Reflux Disease Dexlansoprazole delayed-release capsules are indicated in patients 12 years of age and older for the treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) for four weeks.

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION Recommended dosage in patients 12 years of age and older: See full prescribing information for complete dosing information for dexlansoprazole delayed-release capsules by indication and age group and dosage adjustment in patients with hepatic impairment. ( 2.1 , 2.2 ) Administration Instructions ( 2.3 ) : Take without regard to food. Swallow whole; do not chew.

See full prescribing information for alternative administration options.

2.1Recommended Dosage in Patients 12 Years of Age and Older Table 1: Recommended Dexlansoprazole Delayed-Release Capsules Dosage Regimen by Indication in Patients 12 Years of Age and Older Indication Dosage of Dexlansoprazole Capsules Duration Healing of EE One 60 mg capsule once daily. Up to 8 weeks. Maintenance of Healed EE and Relief of Heartburn One 30 mg capsule once daily.

Controlled studies did not extend beyond 6 months in adults and 16 weeks in patients 12 to 17 years of age. Symptomatic Non-Erosive GERD One 30 mg capsule once daily. 4 weeks.

2.2Dosage Adjustment in Patients with Hepatic Impairment for the Healing of Erosive Esophagitis For patients with moderate hepatic impairment (Child-Pugh Class B), the recommended dosage is 30 mg dexlansoprazole delayed-release capsule once daily for up to eight weeks. Dexlansoprazole delayed-release capsule is not recommended in patients with severe hepatic impairment (Child-Pugh Class C) [see Use in Specific Populations (8.6) ] .

2.3Important Administration Information Take without regard to food. Missed doses: If a dose is missed, administer as soon as possible. However, if the next scheduled dose is due, do not take the missed dose, and take the next dose on time.

Do not take two doses at one time to make up for a missed dose. Swallow whole; do not chew. For patients who have trouble swallowing capsules, dexlansoprazole delayed-release capsules can be opened and administered with applesauce as follows: Place one tablespoonful of applesauce into a clean container.

Open capsule. Sprinkle intact granules on applesauce. Swallow applesauce and granules immediately.

Do not chew granules. Do not save the applesauce and granules for later use. Alternatively, the capsule can be administered with water via oral syringe or nasogastric (NG) tube.

Administration with Water in an Oral Syringe Open the capsule and empty the granules into a clean container with 20 mL of water. Withdraw the entire mixture into a syringe. Gently swirl the syringe in order to keep granules from settling.

Administer the mixture immediately into the mouth. Do not save the water and granule mixture for later use. Refill the syringe with 10 mL of water, swirl gently, and administer.

Refill the syringe again with 10 mL of water, swirl gently, and administer. Administration with Water via a NG Tube (≥16 French) Open the capsule and empty the granules into a clean container with 20 mL of water. Withdraw the entire mixture into a catheter-tip syringe.

Swirl the catheter-tip syringe gently in order to keep the granules from settling, and immediately inject the mixture through the NG tube into the stomach. Do not save the water and granule mixture for later use. Refill the catheter-tip syringe with 10 mL of water, swirl gently, and flush the tube.

Refill the catheter-tip syringe again with 10 mL of water, swirl gently, and administer.

💊 Dosage Forms and Strengths 58 words ▾

3 DOSAGE FORMS AND STRENGTHS Dexlansoprazole Delayed-Release Capsules 30 mg: strength is an opaque, white capsule with “par” imprinted on the cap and “147” imprinted on the body. 60 mg: strength is an opaque, green capsule with “par” imprinted on the cap and “148” imprinted on the body. Delayed-Release Capsules: 30 mg and 60 mg. ( 3 )

⛔ Contraindications 85 words ▾

4 CONTRAINDICATIONS Dexlansoprazole delayed-release capsules are contraindicated in patients with known hypersensitivity to any component of the formulation [see Description (11) ] . Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis and urticaria [see Warnings and Precautions (5.2) , Adverse Reactions (6) ] . PPIs, including dexlansoprazole delayed-release capsules, are contraindicated with rilpivirine-containing products [see Drug Interactions (7) ].

Patients with known hypersensitivity to any component of the formulation. ( 4 ) Patients receiving rilpivirine-containing products. ( 4 , 7 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Dexlansoprazole Delayed-Release Capsules, 60 mg contain FD&C Yellow # 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow # 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity. Gastric Malignancy : In adults, symptomatic response with dexlansoprazole 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 dexlansoprazole delayed-release capsules and refer to specialist for evaluation.

( 5.6 ) Cyanocobalamin (Vitamin B12) Deficiency : Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin. ( 5.7 ) Hypomagnesemia and Mineral Metabolism : Reported rarely with prolonged treatment with PPIs. ( 5.8 ) Interactions with Investigations for Neuroendocrine Tumors: Increases in intragastric pH may result in hypergastrinemia and enterochromaffin-like cell hyperplasia and increased chromogranin A levels which may interfere with diagnostic investigations for neuroendocrine tumors.

( 5.9 , 7 ) 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 a temporary withdrawal of dexlansoprazole delayed-release capsules. ( 5.10 , 7 ) Fundic Gland Polyps : Risk increases with long-term use, especially beyond 1 year.

Use the shortest duration of therapy. ( 5.11 ) Risk of Heart Valve Thickening in Pediatric Patients Less than Two Years of Age : Dexlansoprazole is not recommended in pediatric patients less than 2 years of age. ( 5.12 , 8.4 )

5.1Presence of Gastric Malignancy In adults, symptomatic response to therapy with dexlansoprazole 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 dexlansoprazole and evaluate patients with suspected acute TIN [see Contraindications (4) ] .

5.3Clostridium difficile -Associated Diarrhea Published observational studies suggest that PPI therapy like dexlansoprazole 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.

5.4Bone Fracture Severa… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

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 B12) Deficiency [see Warnings and Precautions ( 5.7 )] Hypomagnesemia and Mineral Metabolism [see Warnings and Precautions ( 5.8 )] Fundic Gland Polyps [see Warnings and Precautions ( 5.11 )] Risk of Heart Valve Thickening in Pediatric Patients Less than Two Years of Age [see Warnings and Precautions ( 5.12 )] The most common adverse reactions are: Adults (≥2%): diarrhea, abdominal pain, nausea, upper respiratory tract infection, vomiting, and flatulence.

( 6.1 ) Patients 12 to 17 years of age (≥5%): headache, abdominal pain, diarrhea, nasopharyngitis, and oropharyngeal pain. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Endo at 1-800-828-9393 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 dexlansoprazole was evaluated in 4,548 adult patients in controlled and single-arm clinical trials, including 863 patients treated for at least six months and 203 patients treated for one year. Patients ranged in age from 18 to 90 years (median age 48 years), with 54% female, 85% Caucasian, 8% Black, 4% Asian, and 3% Other races.

Six randomized controlled clinical trials were conducted for the treatment of EE, maintenance of healed EE, and symptomatic GERD, which included 896 patients on placebo, 455 patients on dexlansoprazole 30 mg capsules, 2,218 patients on dexlansoprazole 60 mg capsules, and 1,363 patients on lansoprazole 30 mg once daily. Common Adverse Reactions The most common adverse reactions (≥2%) that occurred at a higher incidence for dexlansoprazole capsules than placebo in the controlled studies are presented in Table 2 . Table 2: Common Adverse Reactions in Controlled Studies in Adults Adverse Reaction Placebo (N=896) % Dexlansoprazole capsules 30 mg (N=455) % Dexlansoprazole capsules 60 mg (N=2,218) % Dexlansoprazole capsules Total (N=2,621) % Lansoprazole 30 mg (N=1,363) % Diarrhea 2.9 5.1 4.7 4.8

3.2Abdominal Pain 3.5 3.5 4 4

2.6Nausea 2.6 3.3 2.8 2.9

1.8Upper Respiratory Tract Infection 0.8 2.9 1.7 1.9

0.8Vomiting 0.8 2.2 1.4 1.6

1.1Flatulence 0.6 2.6 1.4 1.6

1.2Adverse Reactions Resulting in Discontinuation In controlled clinical studies, the most common adverse reaction leading to discontinuation from dexlansoprazole was diarrhea (0.7%). Less Common Adverse Reactions Other adverse reactions that were reported in controlled studies at an incidence of less than 2% are listed below by body system: Blood and Lymphatic System Disorders: anemia, lymphadenopathy Cardiac Disorders: angina, arrhythmia, bradycardia, chest pain, edema, myocardial infarction, palpitation, tachycardia Ear and Labyrinth Disorders: ear pain, tinnitus, vertigo Endocrine Disorders: goiter Eye Disorders: eye irritation, eye swelling Gastrointestinal Disorders: abdominal discomfort, abdominal tenderness, abnormal feces, anal discomfort, Barrett’s esophagus, bezoar, bowel sounds abnormal, breath odor, colitis microscopic, colonic polyp, constipation, dry mouth, duodenitis, dyspepsia, dysphagia, enteritis, eructation, esophagitis, gastric polyp, gastritis, gastroenteritis, gastrointestinal disorders, gastrointestinal hypermotility disorders, GERD, GI ulcers and perforation, hematemesis, hematochezia, hemorrhoids, impaired gastric emptying, irr… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Tables 3 and 4 include drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with dexlansoprazole 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 Coadministered with Dexlansoprazole and Interactions 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 dexlansoprazole may reduce antiviral effect and promote the development of drug resistance. Increased exposure of other antiretroviral drugs (e.g., saquinavir) when used concomitantly with dexlansoprazole may increase toxicity of the antiretroviral drugs.

There are other antiretroviral drugs which do not result in clinically relevant interactions with dexlansoprazole. Intervention: Rilpivirine-containing products : Concomitant use with dexlansoprazole is contraindicated [see Contraindications (4) ]. See prescribing information.

Atazanavir : See prescribing information for atazanavir for dosing information. Nelfinavir : Avoid concomitant use with dexlansoprazole. See prescribing information for nelfinavir.

Saquinavir : See the prescribing information for saquinavir and monitor for potential saquinavir toxicities. Other antiretrovirals : See prescribing information. Warfarin Clinical Impact: Increased INR and prothrombin time in patients receiving PPIs and warfarin concomitantly.

Increases in INR and prothrombin time may lead to abnormal bleeding and even death. Intervention: Monitor INR and prothrombin time. Dose adjustment of warfarin may be needed to maintain target INR range.

See prescribing information for warfarin. Methotrexate Clinical Impact: Concomitant use of PPIs 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 (5.10) ].

Intervention: A temporary withdrawal of dexlansoprazole may be considered in some patients receiving high-dose methotrexate. Digoxin Clinical Impact: Potential for increased exposure of digoxin. Intervention: Monitor digoxin concentrations.

Dose adjustment of digoxin may be needed to maintain therapeutic drug concentrations. See prescribing information for digoxin. Drugs Dependent on Gastric pH for Absorption (e.g., iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole/itraconazole) Clinical Impact: Dexlansoprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity.

Intervention: Mycophenolate mofetil (MMF): Coadministration of PPIs in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic acid (MPA), possibly due to a decrease in MMF solubility at an increased gastric pH. The clinical relevance of reduced MPA exposure on organ rejection has not been established in transplant patients receiving dexlansoprazole and MMF. Use dexlansoprazole with caution in transplant patients receiving MMF.

See the prescribing information for other drugs dependent on gastric pH for absorption. Tacrolimus Clinical Impact: Potentially increased exposure of tacrolimus, especially in transplant patients who are intermediate or poor metabolizers of CYP2C19. Intervention: Monitor tacrolimus whole blood trough concentrations.

Dose adjustment of tacrolimus may be needed to maintain therapeutic drug concentrations. See prescribing information for tacrolimus. Interac… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy : Based on animal data, may cause adverse effects on fetal bone growth and development. ( 8.1 ) Pediatrics : Based on data with lansoprazole, dexlansoprazole is not effective in patients with symptomatic GERD 1 month to less than 1 year of age and nonclinical studies have demonstrated adverse effects in juvenile rats. ( 8.4 )

8.1Pregnancy Risk Summary There are no studies with dexlansoprazole use in pregnant women to inform a drug-associated risk. Dexlansoprazole is the R-enantiomer of lansoprazole, and published observational studies of lansoprazole use during pregnancy did not demonstrate an association of adverse pregnancy-related outcomes with lansoprazole ( see Data ). In animal reproduction studies, oral administration of lansoprazole to rats during organogenesis through lactation at 1.8 times the maximum recommended human dexlansoprazole dose produced reductions in the offspring in femur weight, femur length, crown-rump length and growth plate thickness (males only) on postnatal Day 21 ( see Data ).

These effects were associated with reduction in body weight gain. Advise pregnant women of the potential risk to the fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the US 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 Dexlansoprazole is the R-enantiomer of lansoprazole.

Available data from published observational studies failed to demonstrate an association of adverse pregnancy-related outcomes and lansoprazole use. Methodological limitations of these observational studies cannot definitely establish or exclude any drug-associated risk during pregnancy. In a prospective study by the European Network of Teratology Information Services, outcomes from a group of 62 pregnant women administered median daily doses of 30 mg of lansoprazole were compared to a control group of 868 pregnant women who did not take any PPIs.

There was no difference in the rate of major malformations between women exposed to PPIs and the control group, corresponding to a Relative Risk (RR)=1.04, [95% Confidence Interval (CI) 0.25 to 4.21]. In a population-based retrospective cohort study covering all live births in Denmark from 1996 to 2008, there was no significant increase in major birth defects during analysis of first trimester exposure to lansoprazole in 794 live births. A meta-analysis that compared 1,530 pregnant women exposed to PPIs in at least the first trimester with 133,410 unexposed pregnant women showed no significant increases in risk for congenital malformations or spontaneous abortion with exposure to PPIs (for major malformations Odds Ratio (OR)=1.12, [95% CI 0.86 to 1.45] and for spontaneous abortions OR=1.29, [95% CI 0.84 to 1.97]).

Animal Data An embryo-fetal development study conducted in rabbits at oral dexlansoprazole doses up to 30 mg/kg/day (approximately nine times the maximum recommended human dexlansoprazole dose [60 mg/day] based on body surface area) during organogenesis showed no effects on fetuses due to dexlansoprazole. In addition, embryo-fetal development studies performed in rats with oral lansoprazole at doses up to 150 mg/kg/day (40 times the recommended human lansoprazole dose based on body surface area) during organogenesis and in rabbits with oral lansoprazole at doses up to 30 mg/kg/day (16 times the recommended human lansoprazole dose based on body surface area) during organogenesis revealed no effects on fetuses due to lansoprazole.

A pre- and postnatal developmental toxicity study in rats with additional endpoints to evaluate bone development was performed with lansoprazole at oral doses of 10 to 100 mg/kg/day (0.2 to 1.8 times the maximum recommended human dexlansoprazole dose… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary There are no studies with dexlansoprazole use in pregnant women to inform a drug-associated risk. Dexlansoprazole is the R-enantiomer of lansoprazole, and published observational studies of lansoprazole use during pregnancy did not demonstrate an association of adverse pregnancy-related outcomes with lansoprazole ( see Data ). In animal reproduction studies, oral administration of lansoprazole to rats during organogenesis through lactation at 1.8 times the maximum recommended human dexlansoprazole dose produced reductions in the offspring in femur weight, femur length, crown-rump length and growth plate thickness (males only) on postnatal Day 21 ( see Data ).

These effects were associated with reduction in body weight gain. Advise pregnant women of the potential risk to the fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the US 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 Dexlansoprazole is the R-enantiomer of lansoprazole.

Available data from published observational studies failed to demonstrate an association of adverse pregnancy-related outcomes and lansoprazole use. Methodological limitations of these observational studies cannot definitely establish or exclude any drug-associated risk during pregnancy. In a prospective study by the European Network of Teratology Information Services, outcomes from a group of 62 pregnant women administered median daily doses of 30 mg of lansoprazole were compared to a control group of 868 pregnant women who did not take any PPIs.

There was no difference in the rate of major malformations between women exposed to PPIs and the control group, corresponding to a Relative Risk (RR)=1.04, [95% Confidence Interval (CI) 0.25 to 4.21]. In a population-based retrospective cohort study covering all live births in Denmark from 1996 to 2008, there was no significant increase in major birth defects during analysis of first trimester exposure to lansoprazole in 794 live births. A meta-analysis that compared 1,530 pregnant women exposed to PPIs in at least the first trimester with 133,410 unexposed pregnant women showed no significant increases in risk for congenital malformations or spontaneous abortion with exposure to PPIs (for major malformations Odds Ratio (OR)=1.12, [95% CI 0.86 to 1.45] and for spontaneous abortions OR=1.29, [95% CI 0.84 to 1.97]).

Animal Data An embryo-fetal development study conducted in rabbits at oral dexlansoprazole doses up to 30 mg/kg/day (approximately nine times the maximum recommended human dexlansoprazole dose [60 mg/day] based on body surface area) during organogenesis showed no effects on fetuses due to dexlansoprazole. In addition, embryo-fetal development studies performed in rats with oral lansoprazole at doses up to 150 mg/kg/day (40 times the recommended human lansoprazole dose based on body surface area) during organogenesis and in rabbits with oral lansoprazole at doses up to 30 mg/kg/day (16 times the recommended human lansoprazole dose based on body surface area) during organogenesis revealed no effects on fetuses due to lansoprazole.

A pre- and postnatal developmental toxicity study in rats with additional endpoints to evaluate bone development was performed with lansoprazole at oral doses of 10 to 100 mg/kg/day (0.2 to 1.8 times the maximum recommended human dexlansoprazole dose of 60 mg based on dexlansoprazole AUC [area under the plasma concentration-time curve]) administered during organogenesis through lactation. Maternal effects observed at 100 mg/kg/day (1.8 times the maximum recommended human dexlansoprazole dose of 60 mg based on dexlansoprazole AUC) included increased gestation period, decreased body weight gain during gestation,… [Excerpted — this section continues on DailyMed.]

🧒 Pediatric Use ~3 min read ▾

8.4Pediatric Use The safety and effectiveness of dexlansoprazole have been established in pediatric patients 12 years to 17 years of age for the healing of all grades of EE, the maintenance of healed EE and relief of heartburn, and treatment of heartburn associated with symptomatic non-erosive GERD. Use of dexlansoprazole in this age group is supported by evidence from adequate and well-controlled studies of dexlansoprazole in adults with additional safety, efficacy and pharmacokinetic data in pediatric patients 12 to 17 years of age.

The adverse reaction profile in patients 12 to 17 years of age was similar to adults [see Dosage and Administration ( 2.1 ), Adverse Reactions ( 6.1 ), Clinical Pharmacology ( 12.3 ), Clinical Studies ( 14 )] . The safety and effectiveness of dexlansoprazole have not been established in pediatric patients less than 12 years of age. Dexlansoprazole is not recommended in pediatric patients less than two years of age [see Warnings and Precautions ( 5.12 )] .

Nonclinical studies in juvenile rats treated with lansoprazole (the racemic mixture) have demonstrated adverse effects of heart valve thickening and bone changes at dexlansoprazole exposures which are expected to be similar to or higher than the dexlansoprazole exposure in pediatric patients one year to two years of age, as described below in Juvenile Animal Toxicity Data . The use of dexlansoprazole is not recommended for the treatment of symptomatic GERD in pediatric patients one month to less than one year of age because lansoprazole was not shown to be effective in a multicenter, double-blind controlled trial.

Juvenile Animal Toxicity Data Heart Valve Thickening In two oral toxicity studies, thickening of the mitral heart valve occurred in juvenile rats treated with lansoprazole. Heart valve thickening was observed primarily with oral dosing initiated on postnatal Day 7 (age equivalent to neonatal humans) and postnatal Day 14 (human age equivalent of approximately one year) at doses of 250 mg/kg/day and higher (at postnatal Day 7 and postnatal Day 14 respectively, 2.5 and 1.8 times the expected dexlansoprazole exposure based on AUC in pediatric patients one year to two years of age).

The treatment durations associated with heart valve thickening ranged from 5 days to 8 weeks. The findings reversed or trended towards reversibility after a 4-week drug-free recovery period. The incidence of heart valve thickening after initiation of dosing on postnatal Day 21 (human age equivalent of approximately two years) was limited to a single rat (1/24) in groups given 500 mg/kg/day for 4 or 8 weeks (2.1 times the expected dexlansoprazole exposure based on AUC in pediatric patients one year to two years of age).

Based on the low incidence of heart valve thickening in 21-day old rats and the equivalent human age, the risk of heart valve injury does not appear to be relevant to patients two years of age and older. Bone Changes In an eight-week oral toxicity study of lansoprazole in juvenile rats with dosing initiated on postnatal Day 7, doses equal to or greater than 100 mg/kg/day (dexlansoprazole exposure based on AUC approximately equal to that in pediatric patients one year to two years of age) produced delayed growth, with impairment of weight gain observed as early as postnatal Day 10 (age equivalent to neonatal humans).

At the end of treatment, the signs of impaired growth at 100 mg/kg/day and higher included reductions in body weight (14 to 44% compared to controls), absolute weight of multiple organs, femur weight, femur length and crown-rump length. Femoral growth plate thickness was reduced only in males and only at the 500 mg/kg/day dose. The effects related to delayed growth persisted through the end of the four-week recovery period.

Longer term data were not collected.

🧓 Geriatric Use 80 words ▾

8.5Geriatric Use Of the total number of patients (n=4,548) in clinical studies of dexlansoprazole, 11% of patients were aged 65 years and over, while 2% were 75 years and over. No overall differences in safety or effectiveness were observed between these patients and younger patients and other reported clinical experience has not identified significant differences in responses between geriatric and younger patients, but greater sensitivity of some older individuals cannot be ruled out [see Clinical Pharmacology ( 12.3 )].

🆘 Overdosage 119 words ▾

10 OVERDOSAGE There have been no reports of significant overdose with dexlansoprazole. Multiple doses of dexlansoprazole 120 mg and a single dose of dexlansoprazole 300 mg did not result in death or other severe adverse events. However, serious adverse events of hypertension have been reported in association with twice daily doses of dexlansoprazole 60 mg.

Nonserious adverse reactions observed with twice daily doses of dexlansoprazole 60 mg include hot flashes, contusion, oropharyngeal pain, and weight loss. Dexlansoprazole is not expected to be removed from the circulation by hemodialysis. In the event of over-exposure, 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 over-exposure.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Dexlansoprazole belongs to a class of antisecretory compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the (H + , K + )-ATPase at the secretory surface of the gastric parietal cell. Because this enzyme is regarded as the acid (proton) pump within the parietal cell, dexlansoprazole has been characterized as a gastric proton-pump inhibitor, in that it blocks the final step of acid production.

12.2Pharmacodynamics Antisecretory Activity The effects of dexlansoprazole 60 mg capsules (n=20) or lansoprazole 30 mg (n=23) once daily for five days on 24 hour intragastric pH were assessed in healthy subjects in a multiple-dose crossover study. The results are summarized in Table 5 . Table 5: Effect on 24 Hour Intragastric pH on Day 5 After Administration of Dexlansoprazole or Lansoprazole Dexlansoprazole 60 mg capsules Lansoprazole 30 mg Mean Intragastric pH 4.55 4.13 % Time Intragastric pH > 4 (hours) 71 (17 hours) 60 (14 hours) Serum Gastrin Effects The effect of dexlansoprazole on serum gastrin concentrations was evaluated in approximately 3,460 patients in clinical trials up to eight weeks and in 1,023 patients for up to six to 12 months.

The mean fasting gastrin concentrations increased from baseline during treatment with dexlansoprazole 30 mg and 60 mg capsules. In patients treated for more than six months, mean serum gastrin levels increased during approximately the first three months of treatment and were stable for the remainder of treatment. Mean serum gastrin levels returned to pretreatment levels within one month of discontinuation of treatment.

Increased gastrin causes enterochromaffin-like cell hyperplasia and increased serum CgA levels. The increased CgA levels may cause false positive results in diagnostic investigations for neuroendocrine tumors [see Warnings and Precautions ( 5.9 )] . Enterochromaffin-Like Cell (ECL) Effects There were no reports of ECL cell hyperplasia in gastric biopsy specimens obtained from 653 patients treated with dexlansoprazole 30 mg, 60 mg or 90 mg capsules for up to 12 months.

During lifetime exposure of rats dosed daily with up to 150 mg/kg/day of lansoprazole, marked hypergastrinemia was observed followed by ECL cell proliferation and formation of carcinoid tumors, especially in female rats [see Nonclinical Toxicology ( 13.1 )] . Cardiac Electrophysiology At a dose five times the maximum recommended dose, dexlansoprazole does not prolong the QT interval to any clinically relevant extent.

12.3Pharmacokinetics The dual delayed-release formulation of dexlansoprazole capsules results in a dexlansoprazole plasma concentration-time profile with two distinct peaks; the first peak occurs one to two hours after administration, followed by a second peak within four to five hours ( see Figure 1 ). Dexlansoprazole is eliminated with a half-life of approximately one to two hours in healthy subjects and in patients with symptomatic GERD. No accumulation of dexlansoprazole occurs after multiple, once daily doses of dexlansoprazole 30 mg or 60 mg capsules although mean AUC t and C max values of dexlansoprazole were slightly higher (less than 10%) on Day 5 than on Day 1.

Figure 1: Mean Plasma Dexlansoprazole Concentration - Time Profile Following Oral Administration of 30 mg or 60 mg Dexlansoprazole Delayed-Release Capsules Once Daily for 5 Days in Healthy Adult Subjects Figure 1 The pharmacokinetics of dexlansoprazole are highly variable, with percent coefficient of variation (%CV) values for C max , AUC, and CL/F of greater than 30% ( see Table 6 ). Table 6: Mean (%CV) Pharmacokinetic Parameters for Adult Subjects on Day 5 After Administration of Dexlansoprazole Delayed-Release Capsules Dose (mg) C max (ng/mL) AUC 24 (ng·h/mL) CL/F (L/h) 30 658 (40%) (N=44) 3,275 (47%) (N=43) 11.4 (48%) (N=43) 60 1,397 (51%) (N=79) 6,529 (60%) (N=73) 11.6 (46%) (N=41) Absorption After oral administration of dexlansop… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 73 words ▾

12.1Mechanism of Action Dexlansoprazole belongs to a class of antisecretory compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the (H + , K + )-ATPase at the secretory surface of the gastric parietal cell. Because this enzyme is regarded as the acid (proton) pump within the parietal cell, dexlansoprazole has been characterized as a gastric proton-pump inhibitor, in that it blocks the final step of acid production.

📦 How Supplied / Storage and Handling 25 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Product: 50090-7451 NDC: 50090-7451-0 30 CAPSULE, DELAYED RELEASE in a BOTTLE NDC: 50090-7451-1 90 CAPSULE, DELAYED RELEASE in a BOTTLE

📋 Description ~1 min read ▾

11 DESCRIPTION The active ingredient in dexlansoprazole delayed-release capsules, a proton pump inhibitor, is (+)-2-[( R )-{[3-methyl-4-(2,2,2-trifluoroethoxy)pyridin-2-yl] methyl} sulfinyl]- 1H -benzimidazole, a compound that inhibits gastric acid secretion. Dexlansoprazole is the R -enantiomer of lansoprazole (a racemic mixture of the R - and S -enantiomers). Its molecular formula is: C 16 H 14 F 3 N 3 O 2 S, with a molecular weight of 369.36.

Dexlansoprazole has the following chemical structure: Structure Dexlansoprazole is a white to off white crystalline powder which melts with decomposition at 143° to 144°C. Dexlansoprazole is practically insoluble in water, freely soluble in dimethylformamide, soluble in methanol, slightly soluble in ethyl acetate and acetonitrile, practically insoluble in hexane. Dexlansoprazole is stable when exposed to light.

Dexlansoprazole is more stable in neutral and alkaline conditions than acidic conditions. Dexlansoprazole is supplied for oral administration as a dual delayed-release formulation in capsules. The capsules contain dexlansoprazole in a mixture of two types of enteric-coated granules with different pH-dependent dissolution profiles [see Clinical Pharmacology (12.3)] .

Dexlansoprazole delayed-release capsules are available in two dosage strengths: 30 mg and 60 mg per capsule. Each capsule contains enteric-coated granules consisting of dexlansoprazole (active ingredient) and the following inactive ingredients: calcium hydroxide, colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, mannitol, methacrylic acid and ethyl acrylate copolymer, methacrylic acid copolymer type B, polyethylene glycol, polysorbate 80, sodium lauryl sulfate, sugar spheres, talc and triethyl citrate.

The black imprinting ink contains: ammonium hydroxide, iron oxide black, isopropyl alcohol, N-butyl alcohol, propylene glycol and shellac glaze in ethanol. The capsule shells contain hypromellose and titanium dioxide. In addition, 60 mg contain FD&C Blue #1, FD&C Yellow #5*, and FD&C Yellow #6. *60 mg capsule contains FD&C Yellow No.

5 (tartrazine) [see Warnings and Precautions ( 5 )] . Structure

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling ( Medication Guide and Instructions for Use ). Adverse Reactions Advise patients to report to their healthcare provider if they experience any signs or symptoms consistent with: Hypersensitivity Reactions [see Contraindications (4) ] 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 B12) Deficiency [see Warnings and Precautions (5.7) ] Hypomagnesemia and Mineral Metabolism [see Warnings and Precautions (5.8) ] Drug Interactions Advise patients to report to their healthcare provider if they are taking rilpivirine-containing products [see Contraindications (4) ] or high-dose methotrexate [see Warnings and Precautions (5.10) ].

Pregnancy Advise a pregnant woman of the potential risk to a fetus. Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy [see Use in Specific Populations (8.1) ]. Administration Take without regard to food.

Missed doses: If a dose is missed, administer as soon as possible. However, if the next scheduled dose is due, do not take the missed dose, and take the next dose on time. Do not take two doses at one time to make up for a missed dose.

Swallow whole; do not chew. Can be opened and sprinkled on applesauce for patients who have trouble swallowing the capsule. Alternatively, the capsule can be administered with water via oral syringe or NG tube, as described in the Instructions for Use.

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Dexlansoprazole (DEX lan SOE pra zol) Delayed-Release Capsules, for oral use Read this Medication Guide before you start taking dexlansoprazole delayed-release capsules and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.

Dexlansoprazole delayed-release capsules, 60 mg contain FD&C Yellow # 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow # 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity. What is the most important information that I should know about dexlansoprazole delayed-release capsules?

Dexlansoprazole delayed-release capsules may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor. Dexlansoprazole 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 dexlansoprazole delayed-release capsules, may develop a kidney problem called acute tubulointerstitial nephritis, that can happen at any time during treatment with PPI medicines. Call your doctor right away if you have a decrease in the amount that you urinate or if you have blood in your urine. D i arrhea .

Dexlansoprazole delayed-release capsules may increase your risk of getting severe diarrhea. This diarrhea may be caused by an infection ( Clostridium difficile ) in your intestines. Call your doctor right away if you have watery stool, stomach pain, and fever that does not go away.

B one fractures . People who take multiple daily doses of PPI medicines for a long period of time (a year or longer) may have an increased risk of fractures of the hip, wrist or spine. You should take dexlansoprazole delayed-release capsules exactly as prescribed, at the lowest dose possible for your treatment and for the shortest time needed.

Talk to your doctor about your risk of bone fracture if you take dexlansoprazole delayed-release capsules. 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 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. Dexlansoprazole delayed-release capsules can have other serious side effects.

See “What are the possible side effects of dexlansoprazole delayed-release capsules?” What are dexlansoprazole delayed-release capsules? Dexlansoprazole delayed-release capsules are a prescription medicine called a proton pump inhibitor (PPI). Dexlansoprazole delayed-release capsules reduce the amount of acid in your stomach.

Dexlansoprazole delayed-release capsules are used in people 12 years of age and older: for up to 8 weeks to heal acid-related damage to the lining of the esophagus (called erosive esophagitis or EE). for up to 6 months in adults and up to 16 weeks in children 12 to 17 years of age to continue healing of erosive esophagitis and relief of heartburn. for 4 weeks to treat heartburn related to gastroesophageal reflux disease (GERD). GERD happens when acid from your stomach enters the tube (esophagus) that connects your mouth to your stomach.

This may cause a burning feeling in your chest or throat, sour taste or burping. It is not known if dexlansoprazole delayed-release capsules are safe and effective in children under 12 years of age. Dexlansoprazole delayed-release capsules are not recommended in children under 2 years of age and may harm them.

Dexlansoprazole delayed-release capsules are not effective for symptoms… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics The dual delayed-release formulation of dexlansoprazole capsules results in a dexlansoprazole plasma concentration-time profile with two distinct peaks; the first peak occurs one to two hours after administration, followed by a second peak within four to five hours ( see Figure 1 ). Dexlansoprazole is eliminated with a half-life of approximately one to two hours in healthy subjects and in patients with symptomatic GERD. No accumulation of dexlansoprazole occurs after multiple, once daily doses of dexlansoprazole 30 mg or 60 mg capsules although mean AUC t and C max values of dexlansoprazole were slightly higher (less than 10%) on Day 5 than on Day 1.

Figure 1: Mean Plasma Dexlansoprazole Concentration - Time Profile Following Oral Administration of 30 mg or 60 mg Dexlansoprazole Delayed-Release Capsules Once Daily for 5 Days in Healthy Adult Subjects Figure 1 The pharmacokinetics of dexlansoprazole are highly variable, with percent coefficient of variation (%CV) values for C max , AUC, and CL/F of greater than 30% ( see Table 6 ). Table 6: Mean (%CV) Pharmacokinetic Parameters for Adult Subjects on Day 5 After Administration of Dexlansoprazole Delayed-Release Capsules Dose (mg) C max (ng/mL) AUC 24 (ng·h/mL) CL/F (L/h) 30 658 (40%) (N=44) 3,275 (47%) (N=43) 11.4 (48%) (N=43) 60 1,397 (51%) (N=79) 6,529 (60%) (N=73) 11.6 (46%) (N=41) Absorption After oral administration of dexlansoprazole 30 mg or 60 mg capsules to healthy subjects and symptomatic GERD patients, mean C max and AUC values of dexlansoprazole increased approximately dose proportionally ( see Figure 1 ).

When granules of dexlansoprazole 60 mg capsules are mixed with water and dosed via NG tube or orally via syringe, the bioavailability (C max and AUC) of dexlansoprazole was similar to that when dexlansoprazole 60 mg was administered as an intact capsule [see Dosage and Administration ( 2.3 )] . Effect on Food In food-effect studies in healthy subjects receiving dexlansoprazole capsules under various fed conditions compared to fasting, increases in C max ranged from 12 to 55%, increases in AUC ranged from 9 to 37%, and T max varied (ranging from a decrease of 0.7 hours to an increase of three hours) [see Dosage and Administration ( 2.3 )].

Distribution Plasma protein binding of dexlansoprazole ranged from 96 to 99% in healthy subjects and was independent of concentration from 0.01 to 20 mcg/mL. The apparent volume of distribution (V z /F) after multiple doses in symptomatic GERD patients was 40 L. Elimination Metabolism Dexlansoprazole is extensively metabolized in the liver by oxidation, reduction, and subsequent formation of sulfate, glucuronide and glutathione conjugates to inactive metabolites.

Oxidative metabolites are formed by the cytochrome P450 (CYP) enzyme system including hydroxylation mainly by CYP2C19, and oxidation to the sulfone by CYP3A4. CYP2C19 is a polymorphic liver enzyme which exhibits three phenotypes in the metabolism of CYP2C19 substrates; extensive metabolizers (*1/*1), intermediate metabolizers (*1/mutant) and poor metabolizers (mutant/mutant). Dexlansoprazole is the major circulating component in plasma regardless of CYP2C19 metabolizer status.

In CYP2C19 intermediate and extensive metabolizers, the major plasma metabolites are 5-hydroxy dexlansoprazole and its glucuronide conjugate, while in CYP2C19 poor metabolizers dexlansoprazole sulfone is the major plasma metabolite. Excretion Following the administration of dexlansoprazole delayed-release capsules, no unchanged dexlansoprazole is excreted in urine. Following the administration of [ 14 C] dexlansoprazole to six healthy male subjects, approximately 50.7% (standard deviation (SD): 9%) of the administered radioactivity was excreted in urine and 47.6% (SD: 7.3%) in the feces.

Apparent clearance (CL/F) in healthy subjects was 11.4 to

11.6L/h, respectively, after five days of 30 or 60 mg once daily administration. Specific Populations Age: Pediatric Population The ph… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics ~1 min read ▾

12.2Pharmacodynamics Antisecretory Activity The effects of dexlansoprazole 60 mg capsules (n=20) or lansoprazole 30 mg (n=23) once daily for five days on 24 hour intragastric pH were assessed in healthy subjects in a multiple-dose crossover study. The results are summarized in Table 5 . Table 5: Effect on 24 Hour Intragastric pH on Day 5 After Administration of Dexlansoprazole or Lansoprazole Dexlansoprazole 60 mg capsules Lansoprazole 30 mg Mean Intragastric pH 4.55 4.13 % Time Intragastric pH > 4 (hours) 71 (17 hours) 60 (14 hours) Serum Gastrin Effects The effect of dexlansoprazole on serum gastrin concentrations was evaluated in approximately 3,460 patients in clinical trials up to eight weeks and in 1,023 patients for up to six to 12 months.

The mean fasting gastrin concentrations increased from baseline during treatment with dexlansoprazole 30 mg and 60 mg capsules. In patients treated for more than six months, mean serum gastrin levels increased during approximately the first three months of treatment and were stable for the remainder of treatment. Mean serum gastrin levels returned to pretreatment levels within one month of discontinuation of treatment.

Increased gastrin causes enterochromaffin-like cell hyperplasia and increased serum CgA levels. The increased CgA levels may cause false positive results in diagnostic investigations for neuroendocrine tumors [see Warnings and Precautions ( 5.9 )] . Enterochromaffin-Like Cell (ECL) Effects There were no reports of ECL cell hyperplasia in gastric biopsy specimens obtained from 653 patients treated with dexlansoprazole 30 mg, 60 mg or 90 mg capsules for up to 12 months.

During lifetime exposure of rats dosed daily with up to 150 mg/kg/day of lansoprazole, marked hypergastrinemia was observed followed by ECL cell proliferation and formation of carcinoid tumors, especially in female rats [see Nonclinical Toxicology ( 13.1 )] . Cardiac Electrophysiology At a dose five times the maximum recommended dose, dexlansoprazole does not prolong the QT interval to any clinically relevant extent.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Healing of Erosive Esophagitis in Adults Two multicenter, double-blind, active-controlled, randomized, eight week studies were conducted in patients with endoscopically confirmed EE. Severity of the disease was classified based on the Los Angeles Classification Grading System (Grades A to D). Patients were randomized to one of the following three treatment groups: Dexlansoprazole 60 mg once daily, dexlansoprazole 90 mg once daily or lansoprazole 30 mg once daily.

Patients who were H. pylori positive or who had Barrett’s Esophagus and/or definite dysplastic changes at baseline were excluded from these studies. A total of 4,092 patients were enrolled and ranged in age from 18 to 90 years (median age 48 years) with 54% male. Race was distributed as follows: 87% Caucasian, 5% Black and 8% Other.

Based on the Los Angeles Classification, 71% of patients had mild EE (Grades A and B) and 29% of patients had moderate to severe EE (Grades C and D) before treatment. The studies were designed to test noninferiority. If noninferiority was demonstrated then superiority would be tested.

Although noninferiority was demonstrated in both studies, the finding of superiority in one study was not replicated in the other. The proportion of patients with healed EE at Week 4 or 8 is presented below in Table 8 . Table 8: EE Healing Rates* in Adults: All Grades Study Number of Patients (N) † Treatment Group (daily) Week 4 % Healed Week 8 ‡ % Healed (95% CI) for the Treatment Difference (Dexlansoprazole–Lansoprazole) by Week 8 1 657 Dexlansoprazole 60 mg capsules 70 87 (-1.5, 6.1) § 648 Lansoprazole 30 mg 65 85 2 639 Dexlansoprazole 60 mg capsules 66 85 (2.2, 10.5) § 656 Lansoprazole 30 mg 65 79 CI = Confidence interval * Based on crude rate estimates, patients who did not have endoscopically documented healed EE and prematurely discontinued were considered not healed. † Patients with at least one postbaseline endoscopy. ‡ Primary efficacy endpoint. § Demonstrated noninferiority to lansoprazole.

Dexlansoprazole 90 mg once daily was studied and did not provide additional clinical benefit over dexlansoprazole 60 mg once daily.

14.2Maintenance of Healed Erosive Esophagitis and Relief of Heartburn in Adults A multicenter, double-blind, placebo-controlled, randomized study was conducted in patients who successfully completed an EE study and showed endoscopically confirmed healed EE. Maintenance of healing and symptom resolution over a six month period was evaluated with dexlansoprazole 30 mg or 60 mg capsules once daily compared to placebo. A total of 445 patients were enrolled and ranged in age from 18 to 85 years (median age 49 years), with 52% female.

Race was distributed as follows: 90% Caucasian, 5% Black and 5% Other. Sixty-six percent of patients treated with 30 mg of dexlansoprazole capsules remained healed over the six month time period as confirmed by endoscopy (see Table 9) . Table 9: Maintenance Rates* of Healed EE at Month 6 in Adults Number of Patients (N) † Treatment Group (daily) Maintenance Rate (%) 125 Dexlansoprazole 30 mg capsules 66.4 ‡ 119 Placebo 14.3 *Based on crude rate estimates, patients who did not have endoscopically documented relapse and prematurely discontinued were considered to have relapsed. † Patients with at least one postbaseline endoscopy ‡ Statistically significant vs placebo Dexlansoprazole 60 mg capsules once daily was studied and did not provide additional clinical benefit over dexlansoprazole 30 mg capsules once daily.

The effect of dexlansoprazole 30 mg capsules on maintenance of relief of heartburn was also evaluated. Upon entry into the maintenance study, a majority of patients’ baseline heartburn severity was rated as none. Dexlansoprazole 30 mg capsules demonstrated a statistically significantly higher percent of 24 hour heartburn-free periods compared to placebo over the six month treatment period (see Table 10) .

The majority of patients treated with placebo discontinued due to rela… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility The carcinogenic potential of dexlansoprazole was assessed using lansoprazole studies. In two, 24 month carcinogenicity studies, Sprague-Dawley rats were treated orally with lansoprazole at doses of 5 to 150 mg/kg/day, about one to 40 times the exposure on a body surface (mg/m 2 ) basis of a 50 kg person of average height [1.46 m 2 body surface area (BSA)] given the recommended human dose of lansoprazole 30 mg/day. Lansoprazole produced dose-related gastric ECL cell hyperplasia and ECL cell carcinoids in both male and female rats [see Clinical Pharmacology ( 12.2 )].

In rats, lansoprazole also increased the incidence of intestinal metaplasia of the gastric epithelium in both sexes. In male rats, lansoprazole produced a dose-related increase of testicular interstitial cell adenomas. The incidence of these adenomas in rats receiving doses of 15 to 150 mg/kg/day (four to 40 times the recommended human lansoprazole dose based on BSA) exceeded the low background incidence (range = 1.4 to 10%) for this strain of rat.

In a 24 month carcinogenicity study, CD-1 mice were treated orally with lansoprazole doses of 15 to 600 mg/kg/day, two to 80 times the recommended human lansoprazole dose based on BSA. Lansoprazole produced a dose-related increased incidence of gastric ECL cell hyperplasia. It also produced an increased incidence of liver tumors (hepatocellular adenoma plus carcinoma).

The tumor incidences in male mice treated with 300 and 600 mg lansoprazole/kg/day (40 to 80 times the recommended human lansoprazole dose based on BSA) and female mice treated with 150 to 600 mg lansoprazole/kg/day (20 to 80 times the recommended human lansoprazole dose based on BSA) exceeded the ranges of background incidences in historical controls for this strain of mice. Lansoprazole treatment produced adenoma of rete testis in male mice receiving 75 to 600 mg/kg/day (10 to 80 times the recommended human lansoprazole dose based on BSA).

A 26 week p53 (+/-) transgenic mouse carcinogenicity study of lansoprazole was not positive. Lansoprazole was positive in the Ames test and the in vitro human lymphocyte chromosomal aberration assay. Lansoprazole was not genotoxic in the ex vivo rat hepatocyte unscheduled DNA synthesis (UDS) test, the in vivo mouse micronucleus test or the rat bone marrow cell chromosomal aberration test.

Dexlansoprazole was positive in the Ames test and in the in vitro chromosome aberration test using Chinese hamster lung cells. Dexlansoprazole was negative in the in vivo mouse micronucleus test. The potential effects of dexlansoprazole on fertility and reproductive performance were assessed using lansoprazole studies.

Lansoprazole at oral doses up to 150 mg/kg/day (40 times the recommended human lansoprazole dose based on BSA) was found to have no effect on fertility and reproductive performance of male and female rats.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~2 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility The carcinogenic potential of dexlansoprazole was assessed using lansoprazole studies. In two, 24 month carcinogenicity studies, Sprague-Dawley rats were treated orally with lansoprazole at doses of 5 to 150 mg/kg/day, about one to 40 times the exposure on a body surface (mg/m 2 ) basis of a 50 kg person of average height [1.46 m 2 body surface area (BSA)] given the recommended human dose of lansoprazole 30 mg/day. Lansoprazole produced dose-related gastric ECL cell hyperplasia and ECL cell carcinoids in both male and female rats [see Clinical Pharmacology ( 12.2 )].

In rats, lansoprazole also increased the incidence of intestinal metaplasia of the gastric epithelium in both sexes. In male rats, lansoprazole produced a dose-related increase of testicular interstitial cell adenomas. The incidence of these adenomas in rats receiving doses of 15 to 150 mg/kg/day (four to 40 times the recommended human lansoprazole dose based on BSA) exceeded the low background incidence (range = 1.4 to 10%) for this strain of rat.

In a 24 month carcinogenicity study, CD-1 mice were treated orally with lansoprazole doses of 15 to 600 mg/kg/day, two to 80 times the recommended human lansoprazole dose based on BSA. Lansoprazole produced a dose-related increased incidence of gastric ECL cell hyperplasia. It also produced an increased incidence of liver tumors (hepatocellular adenoma plus carcinoma).

The tumor incidences in male mice treated with 300 and 600 mg lansoprazole/kg/day (40 to 80 times the recommended human lansoprazole dose based on BSA) and female mice treated with 150 to 600 mg lansoprazole/kg/day (20 to 80 times the recommended human lansoprazole dose based on BSA) exceeded the ranges of background incidences in historical controls for this strain of mice. Lansoprazole treatment produced adenoma of rete testis in male mice receiving 75 to 600 mg/kg/day (10 to 80 times the recommended human lansoprazole dose based on BSA).

A 26 week p53 (+/-) transgenic mouse carcinogenicity study of lansoprazole was not positive. Lansoprazole was positive in the Ames test and the in vitro human lymphocyte chromosomal aberration assay. Lansoprazole was not genotoxic in the ex vivo rat hepatocyte unscheduled DNA synthesis (UDS) test, the in vivo mouse micronucleus test or the rat bone marrow cell chromosomal aberration test.

Dexlansoprazole was positive in the Ames test and in the in vitro chromosome aberration test using Chinese hamster lung cells. Dexlansoprazole was negative in the in vivo mouse micronucleus test. The potential effects of dexlansoprazole on fertility and reproductive performance were assessed using lansoprazole studies.

Lansoprazole at oral doses up to 150 mg/kg/day (40 times the recommended human lansoprazole dose based on BSA) was found to have no effect on fertility and reproductive performance of male and female rats.

📖 Instructions for Use ~2 min read ▾

INSTRUCTIONS FOR USE Dexlansoprazole (DEX lan SOE pra zol) Delayed-Release Capsules, for oral use Taking dexlansoprazole delayed-release capsules with applesauce: Place 1 tablespoon of applesauce into a clean container. Carefully open the capsule and sprinkle the granules onto the applesauce. Swallow the applesauce and granules right away.

Do not chew the granules. Do not save the applesauce and granules for later use. Giving dexlansoprazole delayed-release capsules with water using an oral syringe: Place 20 mL of water into a clean container.

Carefully open the capsule and empty the granules into the container of water. Use an oral syringe to draw up the water and granule mixture. Gently swirl the oral syringe to keep the granules from settling.

Place the tip of the oral syringe in your mouth. Give the medicine right away. Do not save the water and granule mixture for later use.

Refill the syringe with 10 mL of water and swirl gently. Place the tip of the oral syringe in your mouth and give the medicine that is left in the syringe. Repeat step 6.

Giving dexlansoprazole delayed-release capsules with water through a nasogastric tube (NG tube): For people who have an NG tube that is size 16 French or larger , dexlansoprazole delayed-release capsules may be given as follows: Place 20 mL of water into a clean container. Carefully open the capsule and empty the granules into the container of water. Use a 60 mL catheter-tip syringe to draw up the water and granule mixture.

Gently swirl the catheter-tip syringe to keep the granules from settling. Connect the catheter-tip syringe to the NG tube. Give the mixture right away through the NG tube that goes into the stomach.

Do not save the water and granule mixture for later use. Refill the catheter-tip syringe with 10 mL of water and swirl gently. Flush the NG tube with the water.

Repeat step 7. How should I store dexlansoprazole delayed-release capsules? Store dexlansoprazole delayed-release capsules at room temperature between 68° to 77°F (20° to 25°C).

Keep dexlansoprazole delayed-release capsules and all medicines out of the reach of children. This Instructions for Use has been approved by the U.S. Food and Drug Administration.

All other trademark names are the property of their respective owners. For Medication Guide, please visit www.endo.com Manufactured for: Endo USA Malvern, PA 19355 U.S.A. Made in India Neutral Code: TN/DRUGS/TN00002121 ©2024 Endo, Inc. or one of its affiliates.

OS147-01-74-04 Revised: 05/2024

📄 Package Label / Principal Display Panel 3 words ▾

Dexlansoprazole Label Image

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Dexlansoprazole Dr (matched by generic name) — the program that covers self-administered drugs. 5 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Dexlansoprazole Dr. CMS lists 2 products for this generic; we show the highest-spend one. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$43.55M
Claims incl. refills
208.8K
Beneficiaries
114.8K
Spend / beneficiary
$379.32
Spend / claim
$208.64
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

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Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
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Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
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Orange Book / therapeutic-equivalence data ✓ Available
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Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
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Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 30 capsules (50090-7451-00). Each has its own NDC and its own page — see the package list near the top of this page.
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A-S Medication Solutions is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
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This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
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