Dexlansoprazole 30 mg Capsule, Delayed Release Pellets, 30-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Proton Pump Inhibitor class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Dexlansoprazole 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 [tube between the throat and stomach]) in adults and children 12 years of age and older. It is also used to treat esophagitis (swelling that may damage tissues of the esophagus) in adults and children 12 years of age and older. Dexlansoprazole is used for the maintenance treatment of esophagitis and healing in adults and children 12 years of age and older. Dexlansoprazole is in a class of medica...
Read the full MedlinePlus article ↗- Dexlansoprazole is used to treat two main problems caused by too much stomach acid. First, it heals erosive esophagitis — actual damage to the lining of your esophagus from acid —...
- What is dexlansoprazole actually used for?
- You can take dexlansoprazole with or without food — it doesn't matter. That's one of the more convenient things about it compared to some other acid medications. Just try to take i...
- Can I take this with food, or do I need to take it on an empty stomach?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Dexlansoprazole — tap one for details:
Dexlansoprazole may be associated with lower levels of 9 nutrients — worth a chat with your pharmacist, not a cause for alarm.
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Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
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🧪 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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Carrageenan is a natural thickener and stabilizer extracted from red seaweed. It's used in medicines to create gel-like textures, improve consistency, and help keep ingredients from separating during storage.
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A plant-based polymer that forms a protective coating on tablets or capsules. It helps control how quickly the medicine dissolves and protects the contents from moisture and air.
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A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
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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.
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A waxy substance made from glycerin and fatty acids. It acts as an emulsifier to help mix oil and water components, and as a thickener to give the medicine proper texture and consistency.
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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.
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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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Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
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Potassium chloride is a mineral salt used in medicines as a buffer and to help maintain the proper pH balance and stability of the formulation during storage and use.
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Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
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Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
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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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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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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.
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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.
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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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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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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.
18 inactive ingredients listed in the exact product block matched to this NDC.
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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
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $3.966 | $118.99 / 30 capsules |
| Medicaid paysCMS SDUD · 12 mo | $5.05 | $151.49 / 30 capsules |
| Medicare drug plans payPart D · Q2 2026 | $5.33 | $159.94 / 30 capsules |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Dexlansoprazole 30 mgthis 00378-2085-93 | Mylan | 30 capsules | $3.966 | AB | Availability likely | — |
| Dexlansoprazole delayed release 30 mg 24979-0001-06 | Upsher-Smith | 30 capsules | $3.966 | AB | Availability likely | — |
| Dexlansoprazole 30 mg 49884-0147-11 | Par | 30 capsules | $3.966 | AB | Availability likely | — |
| Dexlansoprazole 30 mg 62332-0823-30 | Alembic | 30 capsules | $3.966 | AB | Availability likely | — |
| Dexlansoprazole 30 mg 46708-0823-30 | Alembic | 30 capsules | — | AB | FDA listed | — |
| Dexlansoprazole delayed release 30 mg 51407-0746-30 | Golden | 30 capsules | — | AB | FDA listed | — |
| Dexilant 30 mg 64764-0171-00 | Takeda | 7 capsules | — | AB | FDA listed | — |
| Dexlansoprazole delayed release 30 mg 71335-3071-01 | Bryant | 30 capsules | — | AB | FDA listed | — |
| Dexlansoprazole 30 mg 72162-2244-03 | Bryant | 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?
🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00378-2085-93 You're viewing this | 30 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE, PLASTIC (0378-2085-93) | 2024-01-22 | Active |
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Dexlansoprazole delayed-release capsules are 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 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 Delayed-Release 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 capsules once daily for up to eight weeks. Dexlansoprazole delayed-release capsules are 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: 1.
Place one tablespoonful of applesauce into a clean container. 2. Open capsule.
3. Sprinkle intact pellets on applesauce. 4.
Swallow applesauce and pellets immediately. Do not chew pellets. Do not save the applesauce and pellets 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 1. Open the capsule and empty the pellets into a clean container with 20 mL of water. 2.
Withdraw the entire mixture into a syringe. 3. Gently swirl the syringe in order to keep pellets from settling.
4. Administer the mixture immediately into the mouth. Do not save the water and pellet mixture for later use.
5. Refill the syringe with 10 mL of water, swirl gently, and administer. 6.
Refill the syringe again with 10 mL of water, swirl gently, and administer. Administration with Water via a NG Tube (≥ 16 French) 1. Open the capsule and empty the pellets into a clean container with 20 mL of water.
2. Withdraw the entire mixture into a catheter-tip syringe. 3.
Swirl the catheter-tip syringe gently in order to keep the pellets from settling, and immediately inject the mixture through the NG tube into the stomach. Do not save the water and pellet mixture for later use. 4.
Refill the catheter-tip syringe with 10 mL of water, swirl gently, and flush the tube. 5. Refill the catheter-tip syringe again with 10 mL of water, swirl gently, and administer.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Dexlansoprazole Delayed-Release Capsules are available containing 30 mg or 60 mg of dexlansoprazole sesquihydrate as enteric-coated pellets. • The 30 mg capsules are cellulose capsules with a light blue opaque cap and white opaque body filled with creamish yellow to brownish yellow pellets. The capsules are axially printed with MYLAN over DX 30 in black ink on cap and body. • The 60 mg capsules are cellulose capsules with a light blue opaque cap and light blue opaque body filled with creamish yellow to brownish yellow pellets.
The capsules are axially printed with MYLAN over DX 60 in black ink on cap and body. Delayed-release capsules: 30 mg and 60 mg. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS • Dexlansoprazole extended-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 ▾
5 WARNINGS AND PRECAUTIONS • Gastric Malignancy : In adults, symptomatic response with dexlansoprazole delayed-release capsules 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 delayed-release capsules are 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 extended-release capsules does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with a PPI. In older patients, also consider an endoscopy.
5.2Acute Tubulointerstitial Nephritis Acute tubulointerstitial nephritis (TIN) has been observed in patients taking PPIs and may occur at any point during PPI therapy. Patients may present with varying signs and symptoms from symptomatic hypersensitivity reactions to non-specific symptoms of decreased renal function (e.g., malaise, nausea, anorexia). In reported case series, some patients were diagnosed on biopsy and in the absence of extra-renal manifestations (e.g., fever, rash or arthralgia).
Discontinue dexlansoprazole extended-release capsules and evaluate patients with suspected acute TIN [see Contraindications (4) ] .
5.3Clostridium difficile -Associated Diarrhea Published observational studies suggest that PPI therapy like dexlansoprazole extended-release capsules may be associated with an increased risk of Clostridium difficile -associated diarrhea, especially in hospitalized patients. This diagnosis should be considered for diarrhea that does not improve [see Adverse Reactions (6.2) ] . Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.
5.4Bone Fracture Several published observational studies suggest that PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. The risk of fracture was increased in patients who…
🤒 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 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 Mylan at 1-877-446-3679 (1-877-4-INFO-RX) 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 4548 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, 2218 patients on dexlansoprazole 60 mg, and 1363 patients on lansoprazole 30 mg once daily. Common Adverse Reactions The most common adverse reactions (> 2%) that occurred at a higher incidence for dexlansoprazole 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 30 mg (N = 455) % Dexlansoprazole 60 mg (N = 2218) % Dexlansoprazole Total (N = 2621) % Lansoprazole 30 mg (N = 1363) % Diarrhea 2.9 5.1 4.7 4.8
3.2Abdominal Pain 3.5 3.5 4.0 4.0
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, irritable bowe…
🔄 Drug Interactions ▾
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.…
👥 Use in Specific Populations ▾
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 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 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) 0.25-4.21]. 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 0.86-1.45] and for spontaneous abortions OR = 1.29, [95% CI 0.84-1.97]).
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 d…
🤰 Pregnancy ▾
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 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 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) 0.25-4.21]. 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 0.86-1.45] and for spontaneous abortions OR = 1.29, [95% CI 0.84-1.97]).
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, a…
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of dexlansoprazole delayed-release capsules 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 delayed-release capsules in this age group is supported by evidence from adequate and well-controlled studies of dexlansoprazole delayed-release capsules 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 delayed-release capsules 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 ▾
8.5Geriatric Use Of the total number of patients (n = 4548) in clinical studies of dexlansoprazole delayed-release capsules, 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 ▾
10 OVERDOSAGE There have been no reports of significant overdose with dexlansoprazole delayed-release capsules. Multiple doses of dexlansoprazole delayed-release capsules 120 mg and a single dose of dexlansoprazole delayed-release capsules 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 delayed-release capsules 60 mg.
Nonserious adverse reactions observed with twice daily doses of dexlansoprazole delayed-release capsules 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 ▾
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 (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 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 3460 patients in clinical trials up to eight weeks and in 1023 patients for up to six to 12 months. The mean fasting gastrin concentrations increased from baseline during treatment with 30 and 60 mg dexlansoprazole.
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, 60, or 90 mg 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 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 or 60 mg 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 or 60 mg Dexlansoprazole Once Daily for 5 Days in Healthy Adult Subjects 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 Dose (mg) C max (ng/mL) AUC 24 (ng·h/mL) CL/F (L/h) 30 658 (40%) (N = 44) 3275 (47%) (N = 43) 11.4 (48%) (N = 43) 60 1397 (51%) (N = 79) 6529 (60%) (N = 73) 11.6 (46%) (N = 41) Absorption After oral administration of dexlansoprazole delayed-release capsules 30 or 60 mg to healthy subjects and symptomatic GERD patients, mean C max and AUC values…
🧬 Mechanism of Action ▾
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 ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Dexlansoprazole Delayed-Release Capsules are available containing 30 mg or 60 mg of dexlansoprazole sesquihydrate as enteric-coated pellets. The 30 mg capsules are cellulose capsules with a light blue opaque cap and white opaque body filled with creamish yellow to brownish yellow pellets. The capsules are axially printed with MYLAN over DX 30 in black ink on cap and body.
They are available as follows: NDC 0378-2085-93 bottles of 30 capsules NDC 0378-2085-77 bottles of 90 capsules NDC 0378-2085-05 bottles of 500 capsules The 60 mg capsules are cellulose capsules with a light blue opaque cap and light blue opaque body filled with creamish yellow to brownish yellow pellets. The capsules are axially printed with MYLAN over DX 60 in black ink on cap and body. They are available as follows: NDC 0378-2086-93 bottles of 30 capsules NDC 0378-2086-77 bottles of 90 capsules NDC 0378-2086-05 bottles of 500 capsules Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.
PHARMACIST: Dispense a Medication Guide with each prescription.
📋 Description ▾
11 DESCRIPTION The active ingredient in dexlansoprazole delayed-release capsules, a proton pump inhibitor, is 2-[( R )-[[3-methyl-4-(2,2,2-trifluoroethoxy)-2- pyridinyl]methyl]sulfinyl]-1 H -benzimidazole Sesquihydrate, a compound that inhibits gastric acid secretion. Dexlansoprazole is the R -enantiomer of lansoprazole (a racemic mixture of the R - and S -enantiomers). Dexlansoprazole sesquihydrate’s molecular formula is: C 16 H 14 F 3 N 3 O 2 S•1½ H 2 O, with a molecular weight of 396.39.
Dexlansoprazole sesquihydrate has the following chemical structure: Dexlansoprazole sesquihydrate is a white to brown color powder which melts with decomposition at 85.5°C. Dexlansoprazole sesquihydrate is freely soluble in N,N-dimethylformamide and practically insoluble in water. Dexlansoprazole sesquihydrate is not stable when exposed to light.
Dexlansoprazole sesquihydrate is not stable in alkaline or acidic conditions. Dexlansoprazole is supplied for oral administration as a dual delayed-release formulation in capsules. The capsules contain dexlansoprazole sesquihydrate in a single type of enteric-coated pellets [see Clinical Pharmacology (12.3) ] .
Dexlansoprazole delayed-release capsules are available in two dosage strengths: 30 and 60 mg, per capsule. Each capsule contains enteric-coated pellets consisting of dexlansoprazole sesquihydrate (active ingredient) and the following inactive ingredients: colloidal silicon dioxide, ethyl cellulose dispersion type B, hypromellose, methacrylic acid - ethyl acrylate copolymer (1:1) type A, mono- and di-glycerides, polysorbate 80, potassium hydroxide, povidone, sucrose, sugar spheres (corn starch and sucrose), talc and triethyl citrate.
The components of the capsule shells include the following inactive ingredients: carrageenan, FD&C Blue No. 2, hypromellose, potassium chloride and titanium dioxide. The black imprinting ink contains black iron oxide, potassium hydroxide and shellac.
Dexlansoprazole Structural Formula
💬 Information for Patients ▾
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 ▾
Medication Guide Dexlansoprazole Delayed-Release Capsules, for oral use (dex″ lan soe′ pra zole) 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.
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. • Diarrhea.
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. • Bone 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 of GERD in children under 1 year of age. Who should not take dexlansoprazole delayed-release capsules? Do not take dexlansoprazole delayed-release capsules if you: • are allergic to dexlansoprazole or any of the other ingredients in dexlansoprazole delayed-release capsules.
See the end of this Medication Guide for a complete list of ingredients in dexlanso…