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Lansoprazole 15 mg Capsule, Delayed Release, 60-count

by NuCare Pharmaceuticals,Inc. · 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-2274-6)
NDC 68071-2274-06
🏷️ FDA NDC (as labeled) 68071-2274-6 billing pads the package segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced 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

FDA NDC (as labeled) 68071-2274-6
Product NDC 68071-2274
11-digit billing NDC 68071227406
RxCUI 596843
UNII 0K5C5T2QPG
UPC 0368071227468
Application # ANDA205868
SPL Set ID b12cca1c-da28-67e2-e053-2a95a90aaf6b
Established class (EPC) Proton Pump Inhibitor
Mechanism of action Proton Pump Inhibitors
Physiologic effect Inhibition Gastric Acid Secretion
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-06-04
Route ORAL
Dosage form CAPSULE, DELAYED RELEASE
Substance LANSOPRAZOLE
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 68071-2274-6 — 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 → 68071-2274-06. 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.

🏭 Manufacturer & labeler

LabelerNuCare Pharmaceuticals,Inc.
Application holderINVENTIA HEALTHCARE LTD
FDA applicationANDA205868 (ANDA)
Labeler code68071
First marketedJun 2018
Product typeHuman Prescription Drug
Portfolio1,015 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.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist
  • It does a lot more than heartburn relief. Lansoprazole is used to heal ulcers in the stomach and small intestine, treat acid reflux disease (GERD), repair acid damage to the esopha...
  • What exactly is lansoprazole treating — is it just for heartburn?
  • Timing actually matters quite a bit with lansoprazole. It works best when taken before a meal — ideally about 30 minutes before you eat. If you take it after food, your body absorb...
  • Does it matter when I take it — can I just take it whenever it's convenient?
📖 Read our full Lansoprazole guide →
9
Nutrient depletion considerations

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

🧪 Full Lansoprazole 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.

🧪 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 L06K8R7DQK
    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.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • 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 0E53J927NA
    Magnesium carbonate is a mineral powder used in medicines as a filler to add bulk and as a buffer to help regulate acidity in the formulation.
  • 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 B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • 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 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.
  • 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.

12 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.

💲 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 $0.4438 $26.63 / 60 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Lansoprazole 15 mg 00093-7350-56 Teva 30 capsules $0.147 AB Availability likely —
Lansoprazole 15 mg 00378-8015-93 Mylan 30 capsules $0.147 AB Availability likely —
Lansoprazole 15 mg 60687-0111-21 American 1 capsule $0.147 AB Availability likely —
Lansoprazole 15 mg 67877-0274-30 Ascend 30 capsules $0.147 AB Availability likely —
Lansoprazole 15 mg 68001-0111-04 BluePoint 30 capsules $0.147 AB Availability likely —
Lansoprazole 15 mg 70756-0806-30 Lifestar 30 capsules $0.147 AB Availability likely —
Good Sense Lansoprazole 15 mg 00113-1114-01 L. 14 capsules $0.428 — Availability likely —
Lansoprazole 15 mg 00536-1368-13 Rugby 14 capsules $0.428 — Availability likely —
lansoprazole 15 mg 45802-0878-01 Padagis 14 capsules $0.428 — Availability likely —
good neighbor pharmacy lansoprazole 15 mg 46122-0698-04 Amerisource 14 capsules $0.428 — Availability likely —
Lansoprazole 15 mg 46122-0744-04 AMERISOURCEBERGEN 14 capsules $0.428 — Availability likely —
foster and thrive acid reducer 15 mg 70677-1103-01 Strategic 14 capsules $0.428 — Availability likely —
Lansoprazole 15 mg 83324-0001-14 Chain 14 capsules $0.428 — Availability likely —
Lansoprazole 15 mg 70000-0612-01 LEADER/ 14 capsules $0.432 — Availability likely —
Prevacid 24 HR 15 mg 00113-6117-01 L. 14 capsules — — FDA listed —
Lansoprazole 15 mg 00363-0037-14 Walgreens 14 capsules — — FDA listed —
lansoprazole 15 mg 00363-1212-01 Walgreen 14 capsules — — FDA listed —
up and up lansoprazole 15 mg 11673-0280-01 Target 14 capsules — — FDA listed —
Lansoprazole 15 mg 11673-0324-42 Target 14 capsules — — Discontinued —
Lansoprazole 15 mg 11822-0019-01 Rite 14 capsules — — Discontinued —
Lansoprazole 15 mg 11822-3374-05 Rite 14 capsules — — FDA listed —
Lansoprazole 15 mg 21130-0046-14 Albertsons 14 capsules — — Discontinued —
signature care acid reducer 15 mg 21130-0181-01 Safeway 14 capsules — — Discontinued —
Lansoprazole 15 mg 27241-0019-03 Ajanta 30 capsules — — FDA listed —
Lansoprazole 15 mg 30142-0983-14 Kroger 14 capsules — — Discontinued —
Lansoprazole 15 mg 31722-0570-01 Camber 100 capsules — AB FDA listed —
Lansoprazole 15 mg 33342-0310-07 Macleods 30 capsules — — FDA listed —
topcare lansoprazole 15 mg 36800-0392-01 Topco 14 capsules — — FDA listed —
Lansoprazole 15 mg 37808-0934-14 H 14 capsules — — Discontinued —
equaline lansoprazole 15 mg 41163-0150-01 United 14 capsules — — FDA listed —
lansoprazole 15 mg 41250-0391-01 Meijer 14 capsules — — FDA listed —
Lansoprazole 15 mg 43598-0109-27 Dr. 14 capsules — — FDA listed —
Lansoprazole 15 mg 43598-0161-33 Dr. 14 capsules — — FDA listed —
equate lansoprazole delayed release 15 mg 49035-0411-01 Wal-Mart 14 capsules — — FDA listed —
Lansoprazole 15 mg 50090-6079-00 A-S 30 capsules — AB FDA listed —
Lansoprazole 15 mg 51316-0006-14 CVS 14 capsules — — Discontinued —
Lansoprazole 15 mg 55111-0398-01 Dr.Reddy's 100 capsules — AB FDA listed —
Lansoprazole 15 mg 55111-0739-27 Dr. 14 capsules — — FDA listed —
dg health lansoprazole 15 mg 55910-0307-01 Dolgencorp 14 capsules — — FDA listed —
lansoprazole 15 mg 56062-0117-01 Publix 14 capsules — — FDA listed —
lansoprazole 15 mg 56062-0283-01 Publix 14 capsules — — FDA listed —
Kirkland Signature Lansoprazole 15 mg 63981-0582-03 Costco 14 capsules — — FDA listed —
Lansoprazole 15 mgthis 68071-2274-06 NuCare 60 capsules — AB FDA listed —
Lansoprazole 15 mg 68071-3633-03 NuCare 30 capsules — AB FDA listed —
Lansoprazole 15 mg 68071-3634-03 NuCare 30 capsules — AB FDA listed —
Lansoprazole 15 mg 68071-3687-03 NuCare 30 capsules — AB FDA listed —
Lansoprazole 15 mg 68071-4456-06 NuCare 60 capsules — AB FDA listed —
Lansoprazole 15 mg 68196-0045-03 Sam's 14 capsules — — Discontinued —
Members Mark Lansoprazole 15 mg 68196-0279-03 Sam's 14 capsules — — FDA listed —
Berkley And Jensen Lansoprazole 15 mg 68391-0823-03 BJWC 14 capsules — — FDA listed —
Lansoprazole 15 mg 68788-6390-01 Preferred 100 capsules — AB FDA listed —
Lansoprazole 15 mg 69842-0755-14 CVS 14 capsules — — FDA listed —
Lansoprazole 15 mg 70700-0262-30 Xiromed 30 capsules — AB FDA listed —
Lansoprazole 15 mg 71335-0058-01 Bryant 30 capsules — AB FDA listed —
Lansoprazole 15 mg 71335-2957-01 Bryant 30 capsules — AB FDA listed —
Lansoprazole 15 mg 71335-9680-01 Bryant 30 capsules — AB FDA listed —
Lansoprazole 15 mg 71335-9693-01 Bryant 30 capsules — AB FDA listed —
lansoprazole 15 mg 71335-9695-01 Bryant 30 capsules — — FDA listed —
basic care lansoprazole 15 mg 72288-0301-01 Amazon.com 14 capsules — — FDA listed —
basic care lansoprazole 15 mg 72288-0343-01 Amazon.com 14 capsules — — FDA listed —
careone acid reducer 15 mg 72476-0020-01 Retail 14 capsules — — Discontinued —
equate lansoprazole 15 mg 79903-0068-01 WALMART 14 capsules — — FDA listed —
Lansoprazole DR 15 mg 80425-0148-01 Advanced 30 capsules — AB FDA listed —
Lansoprazole 15 mg 68071-2734-06 NuCare 60 capsules — AB FDA listed —
Lansoprazole 15 mg 72288-0827-03 Amazon.com 14 capsules — — 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

🏛️
2018
On the market since
Jun 2018
📍
2026
Currently FDA-listed
8 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.

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

Medicare Part D (outpatient prescription) spending for Lansoprazole — the program that covers self-administered drugs. 13 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 Lansoprazole. 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
$11.11M
Claims incl. refills
326.1K
Beneficiaries
241.2K
Spend / beneficiary
$46.07
Spend / claim
$34.08
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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Lansoprazole — the ingredient across all brands.

Top reported reactions

Chronic Kidney Disease32,791
Acute Kidney Injury18,792
Renal Failure13,844
End Stage Renal Disease9,798
Renal Injury9,520
Nausea9,253
Diarrhoea9,101

Age at onset

Neonate44
Infant117
Child500
Adolescent444
Adult9,550
Elderly9,907

Reporter sex

177,063 reports
Male · 42%
Female · 58%
Unknown · 0%

Serious outcomes

Hospitalization64,594
Life-threatening12,268
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 25,105 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
68071-2274-06 You're viewing this 60 CAPSULE, DELAYED RELEASE in 1 BOTTLE (68071-2274-6) 2020-10-08 Active

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

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.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 68071-2274-6, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 68071-2274-06, written without dashes as 68071227406. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 68071-2274-06, the first segment (68071) is the labeler code FDA assigned to NuCare Pharmaceuticals,Inc.; the middle segment (2274) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (06) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by NuCare Pharmaceuticals,Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
NuCare Pharmaceuticals,Inc. 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.
Do I need a prescription for this product?
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.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. 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 💬 Medication Guide
🎯 Indications and Usage ~3 min read ▾

1. INDICATIONS AND USAGE Lansoprazole delayed-release capsules are proton pump inhibitors (PPIs) indicated for the: Treatment of active duodenal ulcer in adults( 1.1 ) Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults ( 1.2 ) Maintenance of healed duodenal ulcers in adults ( 1.3 ) Treatment of active benign gastric ulcer in adults ( 1.4 ) Healing of non-steroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults ( 1.5 ) Risk reduction of NSAID-associated gastric ulcer in adults( 1.6 ) Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older ( 1.7 ) Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older ( 1.8 ) Maintenance of healing of EE in adults.( 1.9 ) Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults ( 1.10 )

1.1Treatment of Active Duodenal Ulcer Lansoprazole delayed-release capsules are indicated in adults for short-term treatment (for four weeks ) for healing and symptom relief of active duodenal ulcer [see Clinical Studies ( 14.1 ].

1.2Eradication of H. pylori to Reduce the Risk of Duodenal Ulcer Recurrence Triple Therapy: Lansoprazole /amoxicillin /clarithromycin Lansoprazole delayed-release capsules in combination with amoxicillin plus clarithromycin as triple therapy is indicated in adults for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see Clinical Studies ( 14.2 )].

Please refer to the full prescribing information for amoxicillin and clarithromycin. Dual Therapy: Lansoprazole /amoxicillin Lansoprazole delayed-release capsules in combination with amoxicillin as dual therapy is indicated in adults for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected (see the clarithromycin prescribing information, Microbiology section).

Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see Clinical Studies ( 14.2 )]. Please refer to the full prescribing information for amoxicillin.

1.3Maintenance of Healed Duodenal Ulcers Lansoprazole delayed-release capsules are indicated in adults to maintain healing of duodenal ulcers. Controlled studies do not extend beyond 12 months [see Clinical Studies ( 14.3 )].

1.4Treatment of Active Benign Gastric Ulcer Lansoprazole delayed-release capsules are indicated in adults for short-term treatment (up to eight weeks) for healing and symptom relief of active benign gastric ulcer [see Clinical Studies ( 14.4) ].

1.5Healing of NSAID-Associated Gastric Ulcer Lansoprazole delayed-release capsules are indicated in adults for the treatment of NSAID-associated gastric ulcer in patients who continue NSAID use. Controlled studies did not extend beyond eight weeks [see Clinical Studies ( 14.5 )].

1.6Risk Reduction of NSAID-Associated Gastric Ulcer Lansoprazole delayed-release capsules are indicated in adults for reducing the risk of NSAID-associated gastric ulcers in patients with a history of a documented gastric ulcer who require the use of an NSAID. Controlled studies did not extend beyond 12 weeks [see Clinical Studies ( 14.6 )].

1.7Treatment of Symptomatic Gastroesophageal Reflux Disease (GERD) Lansoprazole delayed-release capsules are indicated for short-term treatment in adults and pediatric patients 12 to 17 years of age (up to eight weeks) and pediatric patients one to 11 years of age (up to 12 weeks) for the treatment of heartburn and other symptoms associated with GERD [see Clinical Studies ( 14.7 )].

1.8 Treatment of Erosive Esophagitis (EE) Lansoprazole delayed-release caps…

⏱️ Dosage and Administration ~3 min read ▾

2. DOSAGE AND ADMINISTRATION Recommended Dosage: See full prescribing information for complete dosing information for lansoprazole delayed-release capsules by indication and age group and dosage adjustment in patients with severe hepatic impairment( 2.1 , 2.2 , 2.3 ) Administration Instructions (2.4) Lansoprazole delayed-release capsules Should be swallowed whole. See full prescribing information for alternative administration options.

2.1Recommended Adult Dosage by Indication Indication Recommended Dose Frequency Duodenal Ulcers Short-Term Treatment Maintenance of Healed 15 mg 15 mg Once daily for 4 weeks Once daily Eradication of H . pylori to Reduce the Risk of Duodenal Ulcer Recurrence Please refer to the amoxicillin and clarithromycin full prescribing information, Contraindications and Warningsand Precautions sections, and for information regarding dosing in elderly and renally-impaired patients. Triple Therapy: Lansoprazole Amoxicillin Clarithromycin Dual Therapy: Lansoprazole Amoxicillin 30 mg 1 gram 500 mg 30 mg 1 gram Twice daily for 10 or 14 days Twice daily for 10 or 14 days Twice daily for 10 or 14 days Three times daily for 14 days Three times daily for 14 days Benign Gastric Ulcer Short-Term Treatment 30 mg Once daily for up to 8 weeks NSAID-Associated Gastric Ulcer Healing Risk Reduction 30 mg 15 mg Once daily for 8 weeks Controlled studies did not extend beyond indicated duration.

Once daily for up to 12 weeks Gastroesophageal Reflux Disease (GERD) Short-Term Treatment of Symptomatic GERD Short -Term Treatment of Erosive Esophagitis 15 mg 30 mg Once daily for up to 8 weeks Once daily for up to 8 weeks For patients who do not heal with lansoprazole for eight weeks (5 to 10%), it may be helpful to give an additional eight weeks of treatment. If there is a recurrence of erosive esophagitis, an additional eight week course of lansoprazole may be considered. Maintenance of Healing of Erosive Esophagitis 15 mg Once daily Controlled studies did not extend beyond 12 months Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome 60 mg Once daily Varies with individual patient.

Recommended adult starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Dosages up to 90 mg twice daily have been administered.

Daily dose of greater than 120 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with lansoprazole for more than four years.

2.2Recommended Pediatric Dosage by Indication Pediatric Patients 1 to 11 Years of Age In clinical studies, lansoprazole was not administered beyond 12 weeks in 1 to 11 year olds. It is not known if lansoprazole is safe and effective if used longer than the recommended duration. Do not exceed the recommended dose and duration of use in pediatric patients as outlined below [ see Use in Specific Populations (8.4) ].

Indication Recommended Dose Frequency Short-Term Treatment of Symptomatic GERD and Short-Term Treatment of Erosive Esophagitis ≤ 30 kg 15 mg Once daily for up to 12 weeks > 30 kg 30 mg Once daily for up to 12 weeks Pediatric Patients 12 to 17 Years of Age Indication Recommended Dose Frequency Short-Term Treatment of Symptomatic GERD Non-erosive GERD 15 mg Once daily for up to 8 weeks Erosive Esophagitis 30 mg Once daily for up to 8 weeks

2.3Hepatic Impairment The recommended dosage is 15 mg orally daily in patients with severe liver impairment (Child-Pugh C) [see Use in Specific Populations ( 8.6)

2.4Important Administration Information Take lansoprazole delayed-release capsules before meals . Do not crush or chew lansoprazole delayed-release capsules. Take lansoprazole delayed-release capsules at least 30 minutes prior to sucralfate [see Drug Interactions ( 7 ) ] Antacids may be used concomitantly with lansoprazole delayed-release capsules. Missed doses: If a dose is missed, administer as soon as possible.…

💊 Dosage Forms and Strengths 111 words ▾

3. DOSAGE FORMS AND STRENGTHS Delayed-release capsules: 15 mg and 30 mg. ( 3 ) Lansoprazole delayed-release capsules, USP: • 15 mg capsules are white to off white, spherical to oval pellets filled in hard gelatin capsule shells of size 3 with " " imprinted in grey ink on green opaque colored cap and “806” imprinted in black ink on white opaque colored body. • 30 mg capsules are white to off white spherical to oval pellets filled in hard gelatin capsule shells of size 1 with " " imprinted in white ink on black opaque colored cap and “807” imprinted in black ink on white opaque colored body. f53ca2be-a290-4157-ad95-d24dfe3344f9-06 f53ca2be-a290-4157-ad95-d24dfe3344f9-07

⛔ Contraindications 156 words ▾

4. CONTRAINDICATIONS • Contraindicated in patients with known severe hypersensitivity to any component of the lansoprazole delayed-release capsules formulation. ( 4 ) •Patients receiving rilpivirine-containing products.

( 4.7 ) Lansoprazole is contraindicated in patients with known severe hypersensitivity to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticaria [ see Adverse Reactions (6) ]. Proton Pump Inhibitors (PPIs), including lansoprazole, are contraindicated with rilpivirine-containing products [see Drug Interactions ( 7) ].

Proton Pump Inhibitors (PPIs), including lansoprazole, are contraindicated with rilpivirine-containing products [see Drug Interactions ( 7) ]. Proton Pump Inhibitors (PPIs), including lansoprazole, are contraindicated with rilpivirine-containing products [see Drug Interactions ( 7) ]. Proton Pump Inhibitors (PPIs), including lansoprazole, are contraindicated with rilpivirine-containing products [see Drug Interactions ( 7) ].

For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with lansoprazole, refer to the Contraindications section of their prescribing information.

⚠️ Warnings and Cautions ~3 min read ▾

5. WARNINGS AND PRECAUTIONS Gastric Malignancy : In adults, symptomatic response with lansoprazole delayed-release capsule does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing .

( 5.1 ) Acute Interstitial Nephritis : Acute interstitial nephritis has been observed in patients taking PPIs. ( 5.2 ) Clostridium difficile -Associated Diarrhea : PPI therapy may be associated with increased risk of Clostridium difficile associated diarrhea. ( 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 ) Cutaneous and Systemic Lupus Erythematosus : Mostly cutaneous; new onset or exacerbation of existing disease; discontinue lansoprazole delayed-release capsules and refer to specialist for evaluation. ( 5.5 ) Cyanocobalamin (Vitamin B12) Deficiency : Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin ( 5.6 ) Hypomagnesemia : Hypomagnesemia has been reported rarely with prolonged treatment with PPIs. ( 5.7 ) 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.

( 5.8 , 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 lansoprazole delayed-release capsules ( 5.9 , 7 ) Fundic Gland Polyps : Risk increases with long-term use, especially beyond 1 year. Use the shortest duration of therapy.

( 5.11 )

5.1Presence of Gastric Malignancy In adults, symptomatic response to therapy with lansoprazole 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 Interstitial Nephritis Acute interstitial nephritis has been observed in patients taking PPIs including lansoprazole. Acute interstitial nephritis may occur at any point during PPI therapy and is generally attributed to an idiopathic hypersensitivity reaction. Discontinue lansoprazole if acute interstitial nephritis develops [see Contraindications (4 )].

5.3Clostridium difficile -Associated Diarrhea Published observational studies suggest that PPI therapy like lansoprazole may be associated with an increased risk of Clostridium difficile -associated diarrhea (CDAD), 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.

CDAD has been reported with use of nearly all antibacterial agents. For more information specific to antibacterial agents (clarithromycin and amoxicillin) indicated for use in combination with lansoprazole refer to Warnings and Precautions section of their prescribing information.

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 received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer). Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the conditions being treated.

Patients at risk for osteoporosis-related fractures should be managed according to established treatment guidelines [see Dosage and Administration ( 2 ),Adverse Reactions ( 6.2 )].

5.5 Cu…

🤒 Adverse Reactions ~3 min read ▾

6. ADVERSE REACTIONS Most commonly reported adverse reactions (≥1%): diarrhea, abdominal pain, nausea and constipation.( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Lifestar Pharma LLC at 1-888-995-4337 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. The following serious adverse reactions are described below and elsewhere in labeling: Acute Interstitial 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 )] Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions ( 5.5 )] Cyanocobalamin (Vitamin B12) Deficiency [see Warnings and Precautions ( 5.6 )] Hypomagnesemia [see Warnings and Precautions ( 5.7 )] Fundic Gland Polyps [see Warnings and Precautions ( 5.11 )]

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 clinical practice. Worldwide, over 10,000 patients have been treated with lansoprazole in Phase 2 or Phase 3 clinical trials involving various dosages and durations of treatment. In general, lansoprazole treatment has been well-tolerated in both short-term and long-term trials.

The following adverse reactions were reported by the treating physician to have a possible or probable relationship to drug in 1% or more of lansoprazole -treated patients and occurred at a greater rate in lansoprazole-treated patients than placebo-treated patients in Table 1. Table 1: Incidence of Possibly or Probably Treatment-Related Adverse Reactions in Short-Term, Placebo-Controlled Lansoprazole Studies Body System/Adverse Reaction Lansoprazole (N= 2768) % Placebo (N= 1023) % Body as a Whole Abdominal Pain 2.1

1.2Digestive System Constipation Diarrhea Nausea 1.0 3.8 1.3 0.4 2.3

1.2Headache was also seen at greater than 1% incidence but was more common on placebo. The incidence of diarrhea was similar between patients who received placebo and patients who received 15 mg and 30 mg of lansoprazole, but higher in the patients who received 60 mg of lansoprazole (2.9%, 1.4%, 4.2%, and 7.4%, respectively). The most commonly reported possibly or probably treatment-related adverse event during maintenance therapy was diarrhea.

In the risk reduction study of lansoprazole for NSAID-associated gastric ulcers, the incidence of diarrhea for patients treated with lansoprazole, misoprostol, and placebo was 5, 22,and 3%, respectively. Another study for the same indication, where patients took either a COX-2 inhibitor or lansoprazole and naproxen, demonstrated that the safety profile was similar to the prior study. Additional reactions from this study not previously observed in other clinical trials with lansoprazole included contusion, duodenitis, epigastric discomfort, esophageal disorder, fatigue, hunger, hiatal hernia, hoarseness, impaired gastric emptying, metaplasia, and renal impairment.

Additional adverse experiences occurring in less than 1% of patients or subjects who received lansoprazole in domestic trials are shown below: Body as a Whole – abdomen enlarged, allergic reaction, asthenia, back pain, candidiasis, carcinoma, chest pain (not otherwise specified), chills, edema, fever, flu syndrome, halitosis, infection (not otherwise specified), malaise, neck pain, neck rigidity, pain, pelvic pain Cardiovascular System - angina, arrhythmia, bradycardia, cerebrovascular accident/ cerebral infarction, hypertension/hypotension, migraine, myocardial infarction, palpitations, shock (circulatory failure), syncope, tachycardia, vasodilation Digestive System – abnormal stools, anorexia, bezoar, cardiospasm, cholelithiasis, colitis, dry mouth, dyspepsia, dysphagia, enteritis, eructation, esophageal stenosis, esophageal ulcer, esophagitis, fecal discoloration, flatulence, gastri…

🔄 Drug Interactions ~2 min read ▾

7. DRUG INTERACTIONS Tables 2 and 3 include drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with lansoprazole delayed-release capsules and instructions for preventing or managing them. Consult the labeling of concomitantly used drugs to obtain further information about interactions with PPIs.

Table 2. Clinically Relevant Interactions Affecting Drugs Co-Administered with Lansoprazole Delayed-Release Capsules 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 lansoprazole may reduce antiviral effect and promote the development of drug resistance. Increased exposure of other antiretroviral drugs (e.g., saquinavir) when used concomitantly with lansoprazole may increase toxicity of the antiretroviral drugs. There are other antiretroviral drugs which do not result in clinically relevant interactions with lansoprazole.

Intervention: Rilpivirine-containing products: Concomitant use with lansoprazole is contraindicated [see Contraindications (4)] . See prescribing information. Atazanavir : See prescribing information for atazanavir for dosing information.

Nelfinavir: Avoid concomitant use with Lansoprazole. 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 (5.8)] . Intervention: A temporary withdrawal of lansoprazole 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. Theophylline Clinical Impact: Increased clearance of theophylline [see Clinical Pharmacology (12.3)] . Intervention: Individual patients may require additional titration of their theophylline dosage when lansoprazole is started or stopped to ensure clinically effective blood concentrations.

Drugs Dependent on Gastric pH for Absorption (e.g., iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole/itraconazole) Clinical Impact: Lansoprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity. Intervention: Mycophenolate mofetil (MMF): Co-administration 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 lansoprazole and MMF. Use lansoprazole with caution in transplant patients receiving MMF. See the prescribing information for other drugs dependent on gastric pH for absorption.

Combination Therapy with Clarithromycin and Amoxicillin Clinic…

👥 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 : Lansoprazole delayed-release capsule are 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 Available data from published observational studies overall do not indicate an association of adverse pregnancy outcomes with lansoprazole treatment (See Data) . In animal reproduction studies, oral administration of lansoprazole to rats during organogenesis through lactation at 6.4 times the maximum recommended human 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 a fetus. The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. If lansoprazole is administered with clarithromycin, the pregnancy information for clarithromycin also applies to the combination regimen. Refer to the prescribing information for clarithromycin for more information on use in pregnancy.

Data Human Data 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 No adverse effects on embryo-fetal development occurred in studies performed in pregnant rats at oral lansoprazole doses up to 150 mg/kg/day (40 times the recommended human dose [30 mg/day] based on body surface area) administered during organogenesis and pregnant rabbits at oral lansoprazole doses up to 30 mg/kg/day (16 times the recommended human dose based on body surface area) administered during organogenesis. 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 (0.7 to 6.4 times the maximum recommended human lansoprazole dose of 30 mg based on AUC [area under the plasma concentration-time curve]) administered during organogenesis through lactation.

Maternal effects observed at 100 mg/kg/day (6.4 times the maximum recommended human lansoprazole dose of 30 mg based on AUC) included increased gestation period, decreased body weight gain during gestati…

🤰 Pregnancy ~3 min read ▾

8.1Pregnancy Risk Summary Available data from published observational studies overall do not indicate an association of adverse pregnancy outcomes with lansoprazole treatment (See Data) . In animal reproduction studies, oral administration of lansoprazole to rats during organogenesis through lactation at 6.4 times the maximum recommended human 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 a fetus. The estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. If lansoprazole is administered with clarithromycin, the pregnancy information for clarithromycin also applies to the combination regimen. Refer to the prescribing information for clarithromycin for more information on use in pregnancy.

Data Human Data 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 No adverse effects on embryo-fetal development occurred in studies performed in pregnant rats at oral lansoprazole doses up to 150 mg/kg/day (40 times the recommended human dose [30 mg/day] based on body surface area) administered during organogenesis and pregnant rabbits at oral lansoprazole doses up to 30 mg/kg/day (16 times the recommended human dose based on body surface area) administered during organogenesis. 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 (0.7 to 6.4 times the maximum recommended human lansoprazole dose of 30 mg based on AUC [area under the plasma concentration-time curve]) administered during organogenesis through lactation.

Maternal effects observed at 100 mg/kg/day (6.4 times the maximum recommended human lansoprazole dose of 30 mg based on AUC) included increased gestation period, decreased body weight gain during gestation, and decreased food consumption. The number of stillbirths was increased at this dose, which may have been secondary to maternal toxicity. Body weight of pups was reduced at 100 mg/kg/day starting on postnatal Day 11.

Femur weight, femur length, and crown-rump length were reduced at 100 mg/kg/day on postnatal Day 21. Femur weight was still decreased in…

🧒 Pediatric Use ~3 min read ▾

8.4Pediatric Use Lansoprazole was not effective in pediatric patients with symptomatic GERD one month to less than one year of age in a multicenter, double-blind, placebo controlled study. Therefore, safety and effectiveness have not been established in patients less than one year. Nonclinical studies in juvenile rats have demonstrated an adverse effect of heart valve thickening and bone changes at lansoprazole doses higher than the maximum recommended equivalent human dose.

The safety and effectiveness of lansoprazole have been established in pediatric patients one to 17 years of age for short-term treatment of symptomatic GERD and erosive esophagitis. In clinical studies of symptomatic GERD and erosive esophagitis, lansoprazole was not administered beyond 12 weeks in one to 11 year olds. It is not known if lansoprazole is safe and effective if used longer than the recommended duration.

Do not exceed the recommended dose and duration of use in pediatric patients (see Juvenile Animal Toxicity Data). Neonate to less than one year of age The pharmacokinetics of lansoprazole were studied in pediatric patients with GERD aged less than 28 days and one to 11 months. Compared to healthy adults receiving 30 mg, neonates had higher exposure (mean weight-based normalized AUC values 2.04 and 1.88 fold higher at doses of 0.5 and 1 mg/kg/day, respectively).

Infants aged ≤ 10 weeks had clearance and exposure values that were similar to neonates. Infants aged greater than 10 weeks who received 1 mg/kg/day had mean AUC values that were similar to adults who received a 30 mg dose. Lansoprazole was not found to be effective in a U.S. and Polish four week multi-center, double-blind, placebo-controlled, parallel-group study of 162 patients between one month and less than 12 months of age with symptomatic GERD based on a medical history of crying/fussing/irritability associated with feedings who had not responded to conservative GERD management (i.e., non-pharmacologic intervention) for seven to 14 days.

Patients received lansoprazole as a suspension daily (0.2 to 0.3 mg/kg/day in infants ≤ 10 weeks of age or 1.0 to 1.5 mg/kg/day in infants greater than 10 weeks or placebo) for up to four weeks of double-blind treatment. The primary efficacy endpoint was assessed by greater than 50% reduction from baseline in either the percent of feedings with a crying/fussing/irritability episode or the duration (minutes) of a crying/fussing/irritability episode within one hour after feeding. There was no difference in the percentage of responders between the lansoprazole pediatric suspension group and placebo group (54% in both groups).

There were no adverse events reported in pediatric clinical studies (one month to less than 12 months of age) that were not previously observed in adults. Based on the results of the Phase 3 efficacy study, lansoprazole was not shown to be effective. Therefore, these results do not support the use of lansoprazole in treating symptomatic GERD in infants.

One to 11 years of age In an uncontrolled, open-label, U.S. multi-center study, 66 pediatric patients (one to 11 years of age) with GERD were assigned, based on body weight, to receive an initial dose of either lansoprazole 15 mg daily if ≤ 30 kg or lansoprazole 30 mg daily if greater than 30 kg administered for eight to 12 weeks. The lansoprazole dose was increased (up to 30 mg twice daily) in 24 of 66 pediatric patients after two or more weeks of treatment if they remained symptomatic. At baseline 85% of patients had mild to moderate overall GERD symptoms (assessed by investigator interview), 58% had non-erosive GERD and 42% had erosive esophagitis (assessed by endoscopy).

After eight to 12 weeks of lansoprazole treatment, the intent-to-treat analysis demonstrated an approximate 50% reduction in frequency and severity of GERD symptoms. Twenty one of 27 erosive esophagitis patients were healed at eight weeks and 100% of patients were healed at 12 weeks by endoscopy ( Table 4 ).…

🧓 Geriatric Use 80 words ▾

8.5Geriatric Use Of the total number of patients (n=21,486) in clinical studies of lansoprazole 16% of patients were aged 65 years and over, while 4% 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 102 words ▾

10. OVERDOSAGE Lansoprazole is not removed from the circulation by hemodialysis. In one reported overdose, a patient consumed 600 mg of lansoprazole with no adverse reaction.

Oral lansoprazole doses up to 5000 mg/kg in rats [approximately 1300 times the 30 mg human dose based on body surface area (BSA)] and in mice (about 675.7 times the 30 mg human dose based on BSA) did not produce deaths or any clinical signs. 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 Lansoprazole belongs to a class of antisecretory compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the (H + , K + )-ATPase enzyme system at the secretory surface of the gastric parietal cell. Because this enzyme system is regarded as the acid (proton) pump within the parietal cell, lansoprazole has been characterized as a gastric acid-pump inhibitor, in that it blocks the final step of acid production. This effect is dose-related and leads to inhibition of both basal and stimulated gastric acid secretion irrespective of the stimulus.

Lansoprazole does not exhibit anticholinergic or histamine type-2 antagonist activity.

12.2Pharmacodynamics Antisecretory Activity: After oral administration, lansoprazole was shown to significantly decrease the basal acid output and significantly increase the mean gastric pH and percent of time the gastric pH was greater than three and greater than four. Lansoprazole also significantly reduced meal-stimulated gastric acid output and secretion volume, as well as pentagastrin-stimulated acid output. In patients with hypersecretion of acid, lansoprazole significantly reduced basal and pentagastrin-stimulated gastric acid secretion.

Lansoprazole inhibited the normal increases in secretion volume, acidity and acid output induced by insulin. The intragastric pH results of a five day, pharmacodynamic, crossover study of 15 mg and 30 mg of once daily lansoprazole are presented in Table 6 : NOTE: An intragastric pH of greater than four reflects a reduction in gastric acid by 99%. Table 6 : Mean Antisecretory Effects After Single and Multiple Daily Lansoprazole Dosing Lansoprazole Parameter Baseline 15 mg 30 mg Value Day 1 Day 5 Day 1 Day 5 Mean 24 Hour pH 2.1 2.7 (p<0.05) vs baseline only.

4.03.6 (p<0.05) vs baseline and lansoprazole 15 mg.

4.9Mean Nighttime pH 1.9 2.4 3.0 2.6 3.8 % Time Gastric pH>3 18 33 59 51 72 % Time Gastric pH>4 12 22 49 41 66 After the initial dose in this study, increased gastric pH was seen within one to two hours with 30 mg of lansoprazole and two to three hours with 15 mg of lansoprazole. After multiple daily dosing, increased gastric pH was seen within the first hour post-dosing with 30 mg of lansoprazole and within one to two hours post-dosing with 15 mg of lansoprazole. Acid suppression may enhance the effect of antimicrobials in eradicating Helicobacter pylori ( H. pylori ).

The percentage of time gastric pH was elevated above five and six was evaluated in a crossover study of lansoprazole given daily, twice daily and three times daily (Table 7) . Table 7 : Mean Antisecretory Effects After Five Days of Twice Daily and Three Times Daily Dosing Lansoprazole Parameter 30 mg daily 15 mg twice daily 30 mg twice daily 30 mg three times daily % Time Gastric pH>5 43 47 59 (p<0.05) vs lansoprazole 30 mg daily 77 (p<0.05) vs lansoprazole 30 mg daily, 15 mg and 30 mg twice daily. % Time Gastric pH>6 20 23 28 45 The inhibition of gastric acid secretion as measured by intragastric pH gradually returned to normal over two to four days after multiple doses.

There was no indication of rebound gastric acidity. Enterochromaffin-like (ECL) Cell Effects During lifetime exposure of rats with up to 150 mg/kg/day of lansoprazole dosed seven days per week, marked hypergastrinemia was observed followed by ECL cell proliferation and formation of carcinoid tumors, especially in female rats. Gastric biopsy specimens from the body of the stomach from approximately 150 patients treated continuously with lansoprazole for at least one year did not show evidence of ECL cell effects similar to those seen in rat studies.

Longer term data are needed to rule out the possibility of an increased risk of the development of gastric tumors in patients receiving long-term therapy with lansoprazole [see Nonclinical Toxicology ( 13.1 )]. Other Gastric Effects in Humans Lansoprazole did not significantly affect…

🧬 Mechanism of Action 106 words ▾

12.1Mechanism of Action Lansoprazole belongs to a class of antisecretory compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the (H + , K + )-ATPase enzyme system at the secretory surface of the gastric parietal cell. Because this enzyme system is regarded as the acid (proton) pump within the parietal cell, lansoprazole has been characterized as a gastric acid-pump inhibitor, in that it blocks the final step of acid production. This effect is dose-related and leads to inhibition of both basal and stimulated gastric acid secretion irrespective of the stimulus.

Lansoprazole does not exhibit anticholinergic or histamine type-2 antagonist activity.

📦 How Supplied / Storage and Handling 75 words ▾

16. HOW SUPPLIED/STORAGE AND HANDLING Lansoprazole delayed-release capsules, USP are available as: • 15 mg capsules are white to off white, spherical to oval pellets filled in hard gelatin capsule shells of size 3 with imprinted in grey ink on green opaque colored cap and 806 imprinted in black ink on white opaque colored body. Bottles of 60: NDC 68071-2274-6 Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

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📋 Description ~1 min read ▾

11. DESCRIPTION The active ingredient in Lansoprazole Delayed-Release Capsules, USP is lansoprazole USP, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C 16 H 14 F 3 N 3 O 2 S with a molecular weight of 369.37.

Lansoprazole has the following structure: Lansoprazole USP is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water. Lansoprazole USP is stable when exposed to light for up to two months.

The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole is supplied in delayed-release capsules, USP for oral administration.

Lansoprazole delayed-release capsules,USP are available in two dosage strengths: 15 mg and 30 mg of lansoprazole USP per capsule. Each delayed-release capsule contains enteric-coated pellets consisting of 15 mg or 30 mg of lansoprazole USP (active ingredient) and the following inactive ingredients: corn starch, gelatin, hydroxypropyl cellulose, magnesium carbonate, methacrylic acid and ethyl acrylate copolymer dispersion, polyethylene glycol, polysorbate 80, sucrose, sugar spheres, talc, titanium dioxide, FD&C Blue 2 1 , Iron oxide yellow 1 , Iron oxide black 2 .

1 Lansoprazole delayed-release capsules, USP 15 mg only. 2 Lansoprazole delayed-release capsules, USP 30 mg only. f53ca2be-a290-4157-ad95-d24dfe3344f9-01

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Lansoprazole (lan-SO-pruh-zole) Delayed-Release Capsules, for oral use What is the most important information that I should know about lansoprazole delayed-release capsules? You should take lansoprazole delayed-release capsules exactly as prescribed, at the lowest dose possible and for the shortest time needed. Lansoprazole delayed-release capsules may help your acid-related symptoms, but you could still have serious stomach problems.

Talk with your doctor. Lansoprazole delayed-release capsules can cause serious side effects, including: A type of kidney problem (acute interstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including lansoprazole delayed-release capsules, may develop a kidney problem called acute interstitial nephritis, that can happen at any time during treatment with PPI medicines including lansoprazole delayed-release capsules.

Call your doctor right away if you have a decrease in the amount that you urinate or if you have blood in your urine. Diarrhea caused by an infection (Clostridium difficile) in your intestines. Call your doctor right away if you have watery stools or stomach pain that does not go away.

You may or may not have a fever. Bone fractures (hip, wrist, or spine). Bone fractures in the hip, wrist, or spine may happen in people who take multiple daily doses of PPI medicines and for a long period of time (a year or longer).

Tell your doctor if you have a bone fracture, especially in the hip, wrist, or spine. Certain types of lupus erythematosus. Lupus erythematosus is an autoimmune disorder (the body’s immune cells attack other cells or organs in the body).

Some people who take PPI medicines, including lansoprazole delayed-release capsules, may develop certain types of lupus erythematosus or have worsening of the lupus they already have. Call your doctor right away if you have new or worsening joint pain or a rash on your cheeks or arms that gets worse in the sun. Talk to your doctor about your risk of these serious side effects.

Lansoprazole delayed-release capsules can have other serious side effects. See "What are the possible side effects of lansoprazole delayed-release capsules?" What are lansoprazole delayed-release capsules? A prescription medicine called a proton pump inhibitor (PPI) used to reduces the amount of acid in your stomach.

In adults Lansoprazole delayed-release capsules used for: for 4 weeks for the healing and symptom relief of duodenal ulcers. 10 to 14 days with certain antibiotics to treat an infection caused by bacteria called H. pylori. maintaining healing of duodenal ulcers. Lansoprazole has not been studied beyond 12 months for this purpose. up to 8 weeksfor the healing and symptom relief of stomach ulcers. up to 8 weeks for the healing of stomach ulcers in people taking pain medicines called non-steroidal anti-inflammatory drugs (NSAIDs).Lansoprazole has not been studied beyond 8 weeks for this purpose. reducing the risk of stomach ulcers in people who are at risk of developing stomach ulcers with NSAIDs.

Lansoprazolehas not been studied beyond 12 weeks for this purpose. up to 8 weeks of to treat heartburn and other symptoms of that happen with gastroesophageal reflux disease (GERD). GERD happens when acid in your stomach backs up into 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.

Up to 8 weeks for thehealing and symptom relief of acid-related damage to the lining of the esophagus (called erosive esophagitis or EE).Your doctor may prescribe another 8 to 16 weeks of lansoprazole for patients whose EE does not improve or whose symptoms return. maintaining healing of EE. Lansoprazole has not been studied beyond 12 months for this purpose. the long-term treatment of conditions where your stomach makes too much acid. This includes a rare condition called Zollinger-Ellison syndrome.

Pediatrics: Give lansoprazole delayed-release cap…

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