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Lansoprazole 30 mg Capsule, Delayed Release, 30-count — NDC 63187-152-30 (Billing 63187-0152-30)

by Proficient Rx LP · 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE

This is a package of 30 capsules of Lansoprazole 30 mg Capsule, Delayed Release from Proficient Rx LP, marketed since Nov 2009 and currently FDA-listed. It is this product's only package size.

NDC 63187-0152-30
🏷️ FDA NDC (as labeled) 63187-152-30 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 63187-152-30
Product NDC 63187-152
11-digit billing NDC 63187015230
NCPDP billing unit EA — each (per item)
RxCUI 311277
UNII 0K5C5T2QPG
Application # ANDA077255
SPL Set ID 7d811f01-f0c2-4753-bb36-80b48dabb58c
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 2009-11-11
Route ORAL
Dosage form CAPSULE, DELAYED RELEASE
Substance LANSOPRAZOLE
TE code (Orange Book) AB · RLD · RS

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

GPI-14 49270040006520
GPI class Lansoprazole
GCN Seq No 030107
GCN 01698
HICL code 008993
Ingredient (HICL) Lansoprazole
HIC1 code D
Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System
HIC2 code D4
Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Alimentary Tract
HIC3 code D4J
Therapeutic class — specific (HIC3) Proton-Pump Inhibitors
AHFS code 56:28.36.00
AHFS class Proton-Pump Inhibitors
FDB label name LANSOPRAZOLE DR 30 MG CAPSULE
FDB brand name Lansoprazole
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 030107
  • GCN: 01698
  • GPI-14 (Medi-Span): 49270040006520
  • HICL (First Databank): 008993
  • AHFS class code: 56:28.36.00
  • RxCUI (RxNorm): 311277
Why two NDCs? The FDA registers this code as 63187-152-30 — a 5-3-2 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 product segment → 63187-0152-30. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Proton Pump Inhibitor class.

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

Clinical

Label name LANSOPRAZOLE DR 30 MG CAPSULE Ingredient Lansoprazole
📗 Our plain-language guide HelloPharmacist
  • It lowers stomach acid. Prescription forms treat ulcers, GERD, erosive esophagitis and conditions with too much acid. It is also used with antibiotics for H. pylori. Over-the-count...
  • Take it once a day, before eating, usually in the morning. Swallow capsules whole. Let orally disintegrating tablets dissolve on your tongue without chewing. For over-the-counter u...
  • For heartburn, the over-the-counter label says full effect can take 1 to 4 days, though some people feel relief within 24 hours. It is not meant for instant relief.
  • The most common are diarrhea, belly pain, nausea and constipation. Call your doctor if you get a severe rash, swelling, trouble breathing, diarrhea that will not clear, or muscle s...
📖 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.

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 $13.31 / 30 capsules
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
63187-0152-30 You're viewing this Main listing 30 CAPSULE, DELAYED RELEASE in 1 BOTTLE 2019-01-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Lansoprazole 30 mg 00093-7351-56 Teva 30 capsules $0.106 AB Availability likely —
Lansoprazole 30 mg 00378-8030-05 Mylan 500 capsules $0.106 AB Availability likely —
Lansoprazole 30 mg 00904-6662-45 Major 1 capsule $0.106 AB Availability likely —
Lansoprazole 30 mg 51079-0121-08 Mylan 1 capsule $0.106 AB Availability likely —
Lansoprazole 30 mg 60687-0123-01 American 1 capsule $0.106 AB Availability likely —
Lansoprazole 30 mg 68001-0112-03 BluePoint 500 capsules $0.106 AB Availability likely —
Lansoprazole 30 mg 70700-0263-05 Xiromed 500 capsules $0.106 AB Availability likely —
Lansoprazole 30 mg 82009-0039-05 Quallent 500 capsules $0.106 AB Availability likely —
Lansoprazole 30 mg 27241-0020-03 Ajanta 30 capsules — — FDA listed —
Lansoprazole 30 mg 31722-0571-01 Camber 100 capsules — AB FDA listed —
Lansoprazole 30 mg 33342-0311-07 Macleods 30 capsules — — FDA listed —
Lansoprazole 30 mg 48433-0051-08 Safecor 1 capsule — AB FDA listed —
Lansoprazole 30 mg 50090-5180-00 A-S 30 capsules — AB FDA listed —
Lansoprazole 30 mg 50090-6154-00 A-S 30 capsules — AB FDA listed —
Lansoprazole 30 mg 50090-6830-00 A-S 90 capsules — AB FDA listed —
Lansoprazole 30 mg 50090-7651-00 A-S 90 capsules — AB FDA listed —
Lansoprazole 30 mg 51407-0324-01 Golden 100 capsules — AB FDA listed —
lansoprazole 30 mg 55111-0399-01 Dr. 100 capsules — — FDA listed —
Lansoprazole 30 mgthis 63187-0152-30 Proficient 30 capsules — AB FDA listed —
Lansoprazole 30 mg 63187-0510-30 Proficient 30 capsules — AB FDA listed —
Lansoprazole 30 mg 63629-2340-01 Bryant 500 capsules — AB FDA listed —
Lansoprazole 30 mg 63629-2341-01 Bryant 90 capsules — AB FDA listed —
Lansoprazole 30 mg 63629-2342-01 Bryant 30 capsules — AB FDA listed —
Prevacid 30 mg 64764-0046-06 Takeda 4 capsules — AB FDA listed —
Lansoprazole 30 mg 67877-0275-30 Ascend 30 capsules — AB FDA listed —
Lansoprazole 30 mg 68071-3572-04 NuCare 14 capsules — AB FDA listed —
Lansoprazole 30 mg 68071-3585-03 NuCare 30 capsules — AB FDA listed —
Lansoprazole 30 mg 68071-3870-03 NuCare 30 capsules — AB FDA listed —
Lansoprazole 30 mg 68071-5119-03 NuCare 30 capsules — AB FDA listed —
Lansoprazole 30 mg 68788-7742-01 Preferred 14 capsules — AB FDA listed —
Lansoprazole 30 mg 68788-8621-01 Preferred 14 capsules — AB FDA listed —
Lansoprazole 30 mg 70756-0807-30 Lifestar 30 capsules — AB FDA listed —
Lansoprazole 30 mg 71335-1425-01 Bryant 30 capsules — AB FDA listed —
Lansoprazole 30 mg 71335-1820-01 Bryant 30 capsules — AB FDA listed —
Lansoprazole 30 mg 72162-1976-03 Bryant 30 capsules — AB FDA listed —
Lansoprazole DR 30 mg 72189-0370-90 Direct_Rx 90 capsules — AB Discontinued —
Lansoprazole 30 mg 76420-0621-90 Asclemed 90 capsules — AB FDA listed —
Lansoprazole DR 30 mg 80425-0174-01 Advanced 30 capsules — AB FDA listed —
Lansoprazole 30 mg 82461-0713-30 Medcore 30 capsules — AB FDA listed —
Lansoprazole 30 mg 67296-2270-03 Redpharm 30 capsules — AB FDA listed —
Lansoprazole 30 mg 68788-4141-03 Preferred 30 capsules — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2009
On the market since
Nov 2009
📍
2026
Currently FDA-listed
17 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.

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.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerProficient Rx LP
Application holderTEVA PHARMACEUTICALS USA
FDA applicationANDA077255 (ANDA)
Labeler code63187
First marketedNov 2009
Product typeHuman Prescription Drug
Portfolio1,729 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide 🍼 Nursing Mothers 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📖 Instructions for Use 📄 Recent Major Changes 📄 Package Label / Principal Display Panel
🎯 Indications and Usage ~3 min read ▾

1 INDICATIONS AND USAGE Lansoprazole is a proton pump inhibitor (PPI). Refer to DOSAGE AND ADMINISTRATION table (below) for indications and usage. ( 1 )

1.1Short-Term Treatment of Active Duodenal Ulcer Lansoprazole delayed-release capsules USP are indicated for short-term treatment (for 4 weeks) for healing and symptom relief of active duodenal ulcer [ see Clinical Studies ( 14 ) ].

1.2H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Triple Therapy: Lansoprazole delayed-release capsules USP/amoxicillin/clarithromycin Lansoprazole delayed-release capsules USP in combination with amoxicillin plus clarithromycin as triple therapy is indicated 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 ) ].

Please refer to the full prescribing information for amoxicillin and clarithromycin. Dual Therapy: Lansoprazole delayed-release capsules USP/amoxicillin Lansoprazole delayed-release capsules USP in combination with amoxicillin as dual therapy is indicated 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 package insert, MICROBIOLOGY section).

Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [ see Clinical Studies ( 14 ) ]. Please refer to the full prescribing information for amoxicillin.

1.3Maintenance of Healed Duodenal Ulcers Lansoprazole delayed-release capsules USP are indicated to maintain healing of duodenal ulcers. Controlled studies do not extend beyond 12 months [ see Clinical Studies ( 14 ) ].

1.4Short-Term Treatment of Active Benign Gastric Ulcer Lansoprazole delayed-release capsules USP are indicated for short-term treatment (up to 8 weeks) for healing and symptom relief of active benign gastric ulcer [ see Clinical Studies ( 14 ) ].

1.5Healing of NSAID-Associated Gastric Ulcer Lansoprazole delayed-release capsules USP are indicated for the treatment of NSAID-associated gastric ulcer in patients who continue NSAID use. Controlled studies did not extend beyond 8 weeks [ see Clinical Studies ( 14 ) ].

1.6Risk Reduction of NSAID-Associated Gastric Ulcer Lansoprazole delayed-release capsules USP are indicated 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 ) ].

1.7Gastroesophageal Reflux Disease (GERD) Short-Term Treatment of Symptomatic GERD Lansoprazole delayed-release capsules USP are indicated for the treatment of heartburn and other symptoms associated with GERD [ see Clinical Studies ( 14 ) ]. Short-Term Treatment of Erosive Esophagitis Lansoprazole delayed-release capsules USP are indicated for short-term treatment (up to 8 weeks) for healing and symptom relief of all grades of erosive esophagitis. For patients who do not heal with lansoprazole delayed-release capsules USP for 8 weeks (5 to 10%), it may be helpful to give an additional 8 weeks of treatment.

If there is a recurrence of erosive esophagitis an additional 8 week course of lansoprazole delayed-release capsules USP may be considered [ see Clinical Studies ( 14 ) ].

1.8Maintenance of Healing of Erosive Esophagitis (EE) Lansoprazole delayed-release capsules USP are indicated to maintain healing of erosive esophagitis. Controlled studies did not extend beyond 12 months [ see Clinical Studies ( 14 ) ].

1.9Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (ZES) Lansoprazole delayed-release capsules USP are indicated for the long-term treatment of pathological hyper… [Excerpted — this section continues on DailyMed.]

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Lansoprazole delayed-release capsules are available in 15 mg and 30 mg strengths. Directions for use specific to the route and available methods of administration for this dosage form is presented below. Lansoprazole delayed-release capsules should be taken before eating.

Lansoprazole delayed-release capsules SHOULD NOT BE CRUSHED OR CHEWED. In the clinical trials, antacids were used concomitantly with lansoprazole. Indication Dose Frequency Duodenal Ulcers ( 1.1 , 1.3 ) Short-Term Treatment 15 mg Once daily for 4 wks Maintenance of Healed 15 mg Once daily H. pylori Eradication to Reduce Recurrence of Duodenal Ulcer ( 1.2 ) Triple Therapy: Lansoprazole Delayed-Release Capsules 30 mg Twice daily for 10 or 14 days Amoxicillin 1 gram Clarithromycin 500 mg Dual Therapy: Lansoprazole Delayed-Release Capsules 30 mg Three times daily for 14 days Amoxicillin 1 gram Benign Gastric Ulcer ( 1.4 ) Short-Term Treatment 30 mg Once daily up to 8 wks NSAID-associated Gastric Ulcer ( 1.6 ) Healing 30 mg Once daily for 8 wks Risk Reduction 15 mg Once daily up to 12 wks GERD ( 1.7 ) Short-Term Treatment of Symptomatic GERD 15 mg Once daily up to 8 wks Short-Term Treatment of EE 30 mg Once daily up to 8 wks Pediatric ( 8.4 ) (1 to 11 years of age) Short-Term Treatment of Symptomatic GERD and Short-Term Treatment of EE ≤ 30 kg 15 mg Once daily up to 12 wks > 30 kg 30 mg Once daily up to 12 wks (12 to 17 years of age) Short-Term Treatment of Symptomatic GERD Nonerosive GERD 15 mg Once daily up to 8 wks EE 30 mg Once daily up to 8 wks Maintenance of Healing of EE ( 1.8 ) 15 mg Once daily Pathological Hypersecretory Conditions (i.e., ZES) ( 1.9 ) 60 mg Once daily

2.1Recommended Dose Indication Recommended Dose Frequency Duodenal Ulcers Short-Term Treatment 15 mg Once daily for 4 weeks Maintenance of Healed 15 mg Once daily H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Please refer to amoxicillin and clarithromycin full prescribing information for CONTRAINDICATIONS and WARNINGS, and for information regarding dosing in elderly and renally-impaired patients. Triple Therapy: Lansoprazole Delayed-Release Capsules 30 mg Twice daily (q12h) for 10 or 14 days Amoxicillin 1 gram Twice daily (q12h) for 10 or 14 days Clarithromycin 500 mg Twice daily (q12h) for 10 or 14 days Dual Therapy: Lansoprazole Delayed-Release Capsules 30 mg Three times daily (q8h) for 14 days Amoxicillin 1 gram Three times daily (q8h) for 14 days Benign Gastric Ulcer Short-Term Treatment 30 mg Once daily for up to 8 weeks NSAID-associated Gastric Ulcer Healing 30 mg Once daily for 8 weeks Controlled studies did not extend beyond indicated duration.

Risk Reduction 15 mg Once daily for up to 12 weeks Gastroesophageal Reflux Disease (GERD) Short-Term Treatment of Symptomatic GERD 15 mg Once daily for up to 8 weeks Short-Term Treatment of Erosive Esophagitis 30 mg Once daily for up to 8 weeks For patients who do not heal with lansoprazole delayed-release capsules for 8 weeks (5 to 10%), it may be helpful to give an additional 8 weeks of treatment. If there is a recurrence of erosive esophagitis, an additional 8 week course of lansoprazole delayed-release capsules may be considered.

Pediatric (1 to 11 years of age) Short-Term Treatment of Symptomatic GERD and Short-Term Treatment of Erosive Esophagitis ≤ 30 kg 15 mg Once daily for up to 12 weeks The lansoprazole dose was increased (up to 30 mg twice daily) in some pediatric patients after 2 or more weeks of treatment if they remained symptomatic. For pediatric patients unable to swallow an intact capsule please see Administration Options. > 30 kg 30 mg Once daily for up to 12 weeks (12 to 17 years of age) Short-Term Treatment of Symptomatic GERD Nonerosive GERD 15 mg Once daily for up to 8 weeks Erosive Esophagitis 30 mg Once daily for up to 8 weeks Maintenance of Healing of Erosive Esophagitis 15 mg Once daily Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome 60 m… [Excerpted — this section continues on DailyMed.]

💊 Dosage Forms and Strengths 56 words ▾

3 DOSAGE FORMS AND STRENGTHS • 15 mg are hard gelatin capsules, with a light-blue opaque cap and flesh-colored opaque body, imprinted with “93” and “7350”. • 30 mg are hard gelatin capsules, with a light-gray opaque cap and flesh-colored opaque body, imprinted with “93” and “7351”. Capsules: 15 mg and 30 mg. ( 3 )

⛔ Contraindications 68 words ▾

4 CONTRAINDICATIONS Lansoprazole delayed-release capsules are contraindicated in patients with known severe hypersensitivity to any component of the formulation of lansoprazole delayed-release capsules. For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with lansoprazole delayed-release capsules, refer to the CONTRAINDICATIONS section of their package inserts. Contraindicated in patients with known severe hypersensitivity to any component of the lansoprazole delayed-release capsule formulation.

( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS • Symptomatic response with lansoprazole does not preclude the presence of gastric malignancy. ( 5.1 ) • PPI therapy may be associated with increased risk of ClostridiumDifficile associated diarrhea. ( 5.2 ) • 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.

( 5.3 ) • Hypomagnesemia has been reported rarely with prolonged treatment with PPIs. ( 5.4 )

5.1Gastric Malignancy Symptomatic response to therapy with lansoprazole does not preclude the presence of gastric malignancy.

5.2Clostridium Difficile Associated Diarrhea Published observational studies suggest that proton pump inhibitor (PPI) therapy like lansoprazole delayed-release capsules 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 delayed-release capsules, refer to WARNINGS and PRECAUTIONS sections of those package inserts.

5.3Bone 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 ) and Adverse Reactions ( 6.2 ) ].

5.4Hypomagnesemia Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs for at least three months, in most cases after a year of therapy. Serious adverse events include tetany, arrhythmias, and seizures. In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuation of the PPI.

For patients expected to be on prolonged treatment or who take PPIs with medications such as digoxin or drugs that may cause hypomagnesemia (e.g., diuretics), healthcare professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically [ see Adverse Reactions ( 6.2 ) ].

5.5Concomitant Use of Lansoprazole With Methotrexate Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. In high-dose methotrexate administration, a temporary withdrawal of the PPI may be considered in some patients [ see Drug Interactions ( 7.6 ) and Clinical Pharmacology ( 12.3 ) ].

🤒 Adverse Reactions ~2 min read ▾

6 ADVERSE REACTIONS Most commonly reported adverse reactions (≥ 1%): diarrhea, abdominal pain, nausea and constipation. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact TEVA USA, PHARMACOVIGILANCE at 1-866-832-8537 or [email protected]; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical 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. 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.

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 Event Lansoprazole Placebo (N = 2768) (N = 1023) % % Body as a Whole Abdominal Pain 2.1

1.2 Digestive System Constipation 1

0.4Diarrhea 3.8

2.3Nausea 1.3

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, gastric nodules/fundic gland polyps, gastritis, gastroenteritis, gastrointestinal anomaly, gastrointestinal disorder, gastrointestinal hemorrhage, glossitis, gum hemorrhage, hematemesis, increased appetite, increased salivation, melena, mouth ulceration, nausea and vomiting, nausea and vomiting and diarrhea, gastrointestinal moniliasis, rectal disorder, rectal hemorrhage, stomatitis, tenesmus, thirst, tongue disorder, ulcerative colitis, ulcerative stomatitis Endocrine System - diabetes mellitus, goiter, hypothyroidism Hemic and Lymphatic System… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS • Atazanavir: Do not coadminister with atazanavir. ( 7.1 ) • Drugs With pH-Dependent Absorption: May interfere with the absorption of drugs where gastric pH is important for bioavailability. ( 7.1 ) • Warfarin: Concomitant warfarin use may require monitoring for increases in INR and prothrombin time.

( 7.2 ) • Tacrolimus: Concomitant tacrolimus use may increase tacrolimus whole blood concentrations. ( 7.3 ) • Theophylline: Titration of theophylline dosage may be required when concomitant lansoprazole use is started or stopped. ( 7.4 ) • Methotrexate: Lansoprazole may increase serum levels of methotrexate.

( 7.6 )

7.1Drugs With pH-Dependent Absorption Kinetics Lansoprazole causes long-lasting inhibition of gastric acid secretion. Lansoprazole and other PPIs are likely to substantially decrease the systemic concentrations of the HIV protease inhibitor atazanavir, which is dependent upon the presence of gastric acid for absorption, and may result in a loss of therapeutic effect of atazanavir and the development of HIV resistance. Therefore, lansoprazole and other PPIs should not be coadministered with atazanavir [ see Clinical Pharmacology ( 12.3 ) ].

Lansoprazole and other PPIs may interfere with the absorption of other drugs where gastric pH is an important determinant of oral bioavailability (e.g., ampicillin esters, digoxin, iron salts, ketoconazole) [ see Clinical Pharmacology ( 12.3 ) ].

7.2Warfarin In a study of healthy subjects, coadministration of single or multiple 60 mg doses of lansoprazole and warfarin did not affect the pharmacokinetics of warfarin nor prothrombin time [ see Clinical Pharmacology ( 12.3 ) ]. However, there have been reports of 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.

Patients treated with PPIs and warfarin concomitantly may need to be monitored for increases in INR and prothrombin time [ see Clinical Pharmacology ( 12.3 ) ].

7.3Tacrolimus Concomitant administration of lansoprazole and tacrolimus may increase whole blood levels of tacrolimus, especially in transplant patients who are intermediate or poor metabolizers of CYP2C19.

7.4Theophylline A minor increase (10%) in the clearance of theophylline was observed following the administration of lansoprazole concomitantly with theophylline. Although the magnitude of the effect on theophylline clearance is small, individual patients may require additional titration of their theophylline dosage when lansoprazole is started or stopped to ensure clinically effective blood levels [ see Clinical Pharmacology ( 12.3 ) ].

7.5Clopidogrel Concomitant administration of lansoprazole and clopidogrel in healthy subjects had no clinically important effect on exposure to the active metabolite of clopidogrel or clopidogrel-induced platelet inhibition [ see Clinical Pharmacology ( 12.3 ) ]. No dose adjustment of clopidogrel is necessary when administered with an approved dose of lansoprazole.

7.6Methotrexate Case reports, published population pharmacokinetic studies, and retrospective analyses suggest that concomitant administration of PPIs and methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate and prolong serum levels of methotrexate and/or its metabolite hydroxymethotrexate. However, no formal drug interaction studies of high dose methotrexate with PPIs have been conducted [ see Warnings and Precautions ( 5.5 ) ]. In a study of rheumatoid arthritis patients receiving low-dose methotrexate, lansoprazole and naproxen, no effect on pharmacokinetics of methotrexate was observed [ see Clinical Pharmacology ( 12.3 ) ].

7.7Combination Therapy With Clarithromycin Concomitant administration of clarithromycin with other drugs can lead to serious adverse reactions due to drug interactions [see Warnings and Precautions in prescribing information for clarithromycin]. Because of these… [Excerpted — this section continues on DailyMed.]

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS • Consider dose adjustment in patients with severe liver impairment. ( 8.7 ) • Lansoprazole is not effective in patients with symptomatic GERD 1 month to less than 1 year of age. ( 8.4 )

8.1Pregnancy Teratogenic Effects Pregnancy Category B Reproduction studies have been performed in pregnant rats at oral doses up to 40 times the recommended human dose and in pregnant rabbits at oral doses up to 16 times the recommended human dose and have revealed no evidence of impaired fertility or harm to the fetus due to lansoprazole. There are, however, no adequate or well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed [ see Nonclinical Toxicology ( 13.2 ) ].

See full prescribing information for clarithromycin before using in pregnant women.

8.3Nursing Mothers Lansoprazole or its metabolites are excreted in the milk of rats. It is not known whether lansoprazole is excreted in human milk. Because many drugs are excreted in human milk, because of the potential for serious adverse reactions in nursing infants from lansoprazole, and because of the potential for tumorigenicity shown for lansoprazole in rat carcinogenicity studies, a decision should be made whether to discontinue nursing or to discontinue lansoprazole, taking into account the importance of lansoprazole to the mother.

8.4Pediatric Use The safety and effectiveness of lansoprazole have been established in pediatric patients 1 to 17 years of age for short-term treatment of symptomatic GERD and erosive esophagitis, however, lansoprazole was not effective in patients with symptomatic GERD 1 month to less than 1 year of age in a multicenter, double-blind, placebo controlled study. Neonate to less than 1 year of age The pharmacokinetics of lansoprazole were studied in pediatric patients with GERD aged less than 28 days and 1 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 mg/kg/day 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 4 week multicenter, 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 7 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 to 1.5 mg/kg/day in infants greater than 10 weeks or placebo) for up to 4 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 (1 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. multicenter study, 66 pediatric patients (1 to 11 years of age) with GERD were assigned, based on body weight, to receive an initial dos… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy 109 words ▾

8.1Pregnancy Teratogenic Effects Pregnancy Category B Reproduction studies have been performed in pregnant rats at oral doses up to 40 times the recommended human dose and in pregnant rabbits at oral doses up to 16 times the recommended human dose and have revealed no evidence of impaired fertility or harm to the fetus due to lansoprazole. There are, however, no adequate or well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed [ see Nonclinical Toxicology ( 13.2 ) ].

See full prescribing information for clarithromycin before using in pregnant women.

🧒 Pediatric Use ~3 min read ▾

8.4Pediatric Use The safety and effectiveness of lansoprazole have been established in pediatric patients 1 to 17 years of age for short-term treatment of symptomatic GERD and erosive esophagitis, however, lansoprazole was not effective in patients with symptomatic GERD 1 month to less than 1 year of age in a multicenter, double-blind, placebo controlled study. Neonate to less than 1 year of age The pharmacokinetics of lansoprazole were studied in pediatric patients with GERD aged less than 28 days and 1 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 mg/kg/day 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 4 week multicenter, 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 7 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 to 1.5 mg/kg/day in infants greater than 10 weeks or placebo) for up to 4 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 (1 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. multicenter study, 66 pediatric patients (1 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 8 to 12 weeks.

The lansoprazole dose was increased (up to 30 mg twice daily) in 24 of 66 pediatric patients after 2 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 8 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 8 weeks and 100% of patients were healed at 12 weeks by endoscopy ( Table 2 ). Table 2: GERD Symptom Improvement and Erosive Esophagitis Healing Rates in Pediatric Patients Age 1 to 11 GERD Final Visit At Week 8 or Week 12 % (n/N) Symptomatic GERD Improvement in Overall GERD Symptoms Symptoms assessed by patients diary kept by caregiver. 76% (47/62 No data were available for 4 pediatric patients. ) Erosive Esophagitis Improvement in Overall GERD Symptoms 81% (22/27) Healing Rate 100% (27/27) In a study of 66 pediatric patients in the age group 1 year to 11 years old after treatment with lansoprazole given orally in doses of 15 mg daily to 30 mg twice daily, increases in serum gastrin levels were similar to those observed in adult studies.

Median… [Excerpted — this section continues on DailyMed.]

🧓 Geriatric Use 40 words ▾

8.5Geriatric Use No dosage adjustment of lansoprazole is necessary in geriatric patients. The incidence rates of lansoprazole-associated adverse reactions and laboratory test abnormalities are similar to those seen in younger patients [ see Clinical Pharmacology ( 12.3 ) ].

🆘 Overdosage 71 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.

🧬 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 3 and greater than 4. 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 4 : Table 4: Mean Antisecretory Effects After Single and Multiple Daily Lansoprazole Dosing Lansoprazole Parameter Baseline Value 15 mg 30 mg Day 1 Day 5 Day 1 Day 5 Mean 24 Hour pH 2.1 2.7 (p < 0.05) versus baseline only. 4 3.6 (p < 0.05) versus baseline and lansoprazole 15 mg.

4.9Mean Nighttime pH 1.9 2.4 3 2.6 3.8 % Time Gastric pH > 3 18 33 59 51 72 % Time Gastric pH > 4 12 22 49 41 66 NOTE: An intragastric pH of greater than 4 reflects a reduction in gastric acid by 99%. After the initial dose in this study, increased gastric pH was seen within 1 to 2 hours with 30 mg of lansoprazole and 2 to 3 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 1 to 2 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 5 and 6 was evaluated in a crossover study of lansoprazole given daily, twice daily and three times daily ( Table 5 ). Table 5: Mean Antisecretory Effects After 5 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) versus lansoprazole 30 mg daily.

77 (p < 0.05) versus lansoprazole 30 mg daily, 15 mg twice daily 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 significantl… [Excerpted — this section continues on DailyMed.]

🧬 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 87 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Lansoprazole delayed-release capsules USP are available as follows: 30 mg - hard gelatin capsules, with a light-gray opaque cap and flesh-colored opaque body, imprinted with “93” and “7351”, filled with off-white to beige pellets, in bottles of 30. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture.

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

📋 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. Lansoprazole, USP has the following structure: C 16 H 14 F 3 N 3 O 2 S M.W. 369.36 Lansoprazole, USP is a white to brownish-white odorless crystalline powder which melts with decomposition at approximately 166°C.

Lansoprazole, USP 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 and approximately 18 hours at pH 7. The lansoprazole delayed-release capsules USP for oral administration are available in two dosage strengths: 15 mg and 30 mg of lansoprazole, USP per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 mg or 30 mg of lansoprazole, USP (active ingredient) and the following inactive ingredients: black iron oxide, gelatin, hypromellose, magnesium carbonate, methacrylic acid copolymer dispersion, propylene glycol, red iron oxide, shellac, sugar spheres (which contain sucrose and corn starch), talc, titanium dioxide, and triethyl citrate.

Additionally, 15 mg capsule contains brilliant blue FCF - FD&C blue 1. The imprinting ink may contain potassium hydroxide. lansoprazole structural formula

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION [See FDA-Approved Medication Guide and Patient Instructions for Use] Patient should be informed of the following: • Advise patients to immediately report and seek care for diarrhea that does not improve. This may be a sign of ClostridiumDifficile associated diarrhea [ see Warnings and Precautions ( 5.2 )]. • Advise patients to immediately report and seek care for any cardiovascular or neurological symptoms including palpitations, dizziness, seizures, and tetany as these may be signs of hypomagnesemia [ see Warnings and Precautions ( 5.4 )].

Information for Patients Lansoprazole is available as a capsule and is available in 15 mg and 30 mg strengths. Directions for use specific to the route and available methods of administration for this dosage form is presented below [ see Dosage and Administration ( 2.3 ) ]. • Lansoprazole delayed-release capsules should be taken before eating. • Lansoprazole delayed-release capsules SHOULD NOT BE CRUSHED OR CHEWED. Administration Options Lansoprazole Delayed-Release Capsules - Oral Administration • Lansoprazole delayed-release capsules should be swallowed whole. • Alternatively, for patients who have difficulty swallowing capsules, lansoprazole delayed-release capsules can be opened and administered as follows: • Open capsule. • Sprinkle intact granules on one tablespoon of either applesauce, ENSURE ® pudding, cottage cheese, yogurt or strained pears. • Swallow immediately. • Lansoprazole delayed-release capsules may also be emptied into a small volume of either apple juice, orange juice or tomato juice and administered as follows: • Open capsule. • Sprinkle intact granules into a small volume of either apple juice, orange juice or tomato juice (60 mL — approximately 2 ounces). • Mix briefly. • Swallow immediately. • To ensure complete delivery of the dose, the glass should be rinsed with two or more volumes of juice and the contents swallowed immediately.

Lansoprazole Delayed-Release Capsules – Nasogastric Tube (≥ 16 French) Administration • For patients who have a nasogastric tube in place, lansoprazole delayed-release capsules can be administered as follows: • Open capsule. • Mix intact granules into 40 mL of apple juice. DO NOT USE OTHER LIQUIDS. • Inject through the nasogastric tube into the stomach. • Flush with additional apple juice to clear the tube. USE IN OTHER FOODS AND LIQUIDS HAS NOT BEEN STUDIED CLINICALLY AND IS THEREFORE NOT RECOMMENDED.

All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA. Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD.

Jerusalem, 91010, Israel Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. J 10/2012 Repackaged by: PROFICIENT RX LP Westlake Village, CA 91362

💬 Medication Guide ~3 min read ▾

MEDICATION GUIDE Lansoprazole (lan soe pra zole) Delayed-Release Capsules USP Read this Medication Guide before you start taking lansoprazole 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 lansoprazole delayed-release capsules? 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: • Diarrhea. Lansoprazole 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 proton pump inhibitor 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 lansoprazole 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 lansoprazole delayed-release capsules. 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?

Lansoprazole delayed-release capsules are a prescription medicine called a proton pump inhibitor (PPI). Lansoprazole delayed-release capsules reduce the amount of acid in your stomach. Lansoprazole delayed-release capsules are used in adults: • for 4 weeks for the healing and symptom relief of duodenal ulcers.

The duodenal area is the area where food passes when it leaves the stomach. • with certain antibiotics to treat an infection called H. pylori. Sometimes H. pylori bacteria can cause duodenal ulcers. The infection needs to be treated to prevent ulcers from coming back. • for continued healing of duodenal ulcers. • for up to 8 weeks to heal stomach ulcers. • for up to 8 weeks to heal stomach ulcers in some people taking pain medicines called non-steroidal anti-inflammatory drugs (NSAIDs). • for reducing the risk of stomach ulcers in some people taking NSAIDs. • for up to 8 weeks for the relief of heartburn and other symptoms of 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. • for 8 weeks to heal the acid-related damage to the lining of the esophagus (called erosive esophagitis) and to relieve symptoms. If needed, your doctor may prescribe another 8 weeks of lansoprazole delayed-release capsules. • for continued healing of erosive esophagitis. • for the long-term treatment of conditions where your stomach makes too much acid.

This includes a condition called Zollinger-Ellison syndrome. Lansoprazole delayed-release capsules are used in children and adolescents (ages 1 to 17): • for up to 12 weeks to treat GERD and erosive esophagitis in children 1 to 11 years old. • for up to 8 weeks to treat GERD and erosive esophagitis in adolescents 12 to 17 years old. Lansoprazole delayed-release capsules are not effective for symptoms of GERD in children under the age of 1 year.

Who should not take lansoprazole delayed-release capsules? • Do not take lansoprazole delayed-release capsules if you are allergic to lansoprazole or any of the other ingredients in lansoprazole delayed-release capsules. See the end of this Medication Guide for a complete list of ingredients in lansoprazole delayed-release capsules. What should I tell my doctor befo… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 83 words ▾

8.3Nursing Mothers Lansoprazole or its metabolites are excreted in the milk of rats. It is not known whether lansoprazole is excreted in human milk. Because many drugs are excreted in human milk, because of the potential for serious adverse reactions in nursing infants from lansoprazole, and because of the potential for tumorigenicity shown for lansoprazole in rat carcinogenicity studies, a decision should be made whether to discontinue nursing or to discontinue lansoprazole, taking into account the importance of lansoprazole to the mother.

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Lansoprazole delayed-release capsules contain an enteric-coated granule formulation of lansoprazole. Absorption of lansoprazole begins only after the granules leave the stomach. Absorption is rapid, with mean peak plasma levels of lansoprazole occurring after approximately 1.7 hours.

After a single-dose administration of 15 mg to 60 mg of oral lansoprazole, the peak plasma concentrations (C max ) of lansoprazole and the area under the plasma concentration curves (AUCs) of lansoprazole were approximately proportional to the administered dose. Lansoprazole does not accumulate and its pharmacokinetics are unaltered by multiple dosing. Absorption: The absorption of lansoprazole is rapid, with the mean C max occurring approximately 1.7 hours after oral dosing, and the absolute bioavailability is over 80%.

In healthy subjects, the mean (± SD) plasma half-life was 1.5 (± 1) hours. Both the C max and AUC are diminished by about 50% to 70% if lansoprazole is given 30 minutes after food, compared to the fasting condition. There is no significant food effect if lansoprazole is given before meals.

Distribution: Lansoprazole is 97% bound to plasma proteins. Plasma protein binding is constant over the concentration range of 0.05 to 5 mcg/mL. Metabolism: Lansoprazole is extensively metabolized in the liver.

Two metabolites have been identified in measurable quantities in plasma (the hydroxylated sulfinyl and sulfone derivatives of lansoprazole). These metabolites have very little or no antisecretory activity. Lansoprazole is thought to be transformed into two active species which inhibit acid secretion by blocking the proton pump [(H + , K + )-ATPase enzyme system] at the secretory surface of the gastric parietal cell.

The two active species are not present in the systemic circulation. The plasma elimination half-life of lansoprazole is less than 2 hours while the acid inhibitory effect lasts more than 24 hours. Therefore, the plasma elimination half-life of lansoprazole does not reflect its duration of suppression of gastric acid secretion.

Elimination: Following single-dose oral administration of lansoprazole, virtually no unchanged lansoprazole was excreted in the urine. In one study, after a single oral dose of 14 C-lansoprazole, approximately one-third of the administered radiation was excreted in the urine and two-thirds was recovered in the feces. This implies a significant biliary excretion of the lansoprazole metabolites.

Specific Populations Pediatric Use: One to 17 years of age The pharmacokinetics of lansoprazole were studied in pediatric patients with GERD aged 1 to 11 years and 12 to 17 years in two separate clinical studies. In children aged 1 to 11 years, lansoprazole was dosed 15 mg daily for subjects weighing ≤ 30 kg and 30 mg daily for subjects weighing greater than 30 kg. Mean C max and AUC values observed on Day 5 of dosing were similar between the two dose groups and were not affected by weight or age within each weight-adjusted dose group used in the study.

In adolescent subjects aged 12 to 17 years, subjects were randomized to receive lansoprazole at 15 mg or 30 mg daily. Mean C max and AUC values of lansoprazole were not affected by body weight or age; and nearly dose-proportional increases in mean C max and AUC values were observed between the two dose groups in the study. Overall, lansoprazole pharmacokinetics in pediatric patients aged 1 to 17 years were similar to those observed in healthy adult subjects.

Neonate to less than one year of age Refer to Section 8.4 for the pharmacokinetics of lansoprazole in pediatric patients with GERD aged less than 28 days and 1 to 11 months. Geriatric Use: The clearance of lansoprazole is decreased in the elderly, with elimination half-life increased approximately 50% to 100%. Because the mean half-life in the elderly remains between 1.9 to 2.9 hours, repeated once daily dosing does not result in accumulation of lansoprazole.

Peak plasma levels were not inc… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics ~3 min read ▾

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 3 and greater than 4. 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 4 : Table 4: Mean Antisecretory Effects After Single and Multiple Daily Lansoprazole Dosing Lansoprazole Parameter Baseline Value 15 mg 30 mg Day 1 Day 5 Day 1 Day 5 Mean 24 Hour pH 2.1 2.7 (p < 0.05) versus baseline only. 4 3.6 (p < 0.05) versus baseline and lansoprazole 15 mg.

4.9Mean Nighttime pH 1.9 2.4 3 2.6 3.8 % Time Gastric pH > 3 18 33 59 51 72 % Time Gastric pH > 4 12 22 49 41 66 NOTE: An intragastric pH of greater than 4 reflects a reduction in gastric acid by 99%. After the initial dose in this study, increased gastric pH was seen within 1 to 2 hours with 30 mg of lansoprazole and 2 to 3 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 1 to 2 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 5 and 6 was evaluated in a crossover study of lansoprazole given daily, twice daily and three times daily ( Table 5 ). Table 5: Mean Antisecretory Effects After 5 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) versus lansoprazole 30 mg daily.

77 (p < 0.05) versus lansoprazole 30 mg daily, 15 mg twice daily 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 mucosal blood flow in the fundus of the stomach.

Due to the normal physiologic effect caused by the inhibition of gastric acid secretion, a decrease of about 17% in blood flow in the antrum, pylorus, and duodenal bulb was seen. Lansoprazole significantly slowed the gastric emptying of digestible solids. Lansoprazole increased serum pepsinogen levels and decreased pepsin activity under basal conditions and in response to meal stimulation or insulin injection.

As with other agents that elevate intragastric pH, increases in gastric pH were associated with increases in nitrate-reducing bacteria and elevation of nitrite concentration in gastric juice in patients with gastric ulcer. No significant increase in nitrosamine… [Excerpted — this section continues on DailyMed.]

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES Duodenal Ulcer In a U.S. multicenter, double-blind, placebo-controlled, dose-response (15, 30, and 60 mg of lansoprazole once daily) study of 284 patients with endoscopically documented duodenal ulcer, the percentage of patients healed after two and four weeks was significantly higher with all doses of lansoprazole than with placebo. There was no evidence of a greater or earlier response with the two higher doses compared with lansoprazole 15 mg. Based on this study and the second study described below, the recommended dose of lansoprazole in duodenal ulcer is 15 mg per day ( Table 7 ).

Table 7: Duodenal Ulcer Healing Rates Week Lansoprazole 15 mg daily 30 mg daily 60 mg daily Placebo (N = 68) (N = 74) (N = 70) (N = 72) 2 42.4% (p ≤ 0.001) versus placebo. 35.6% 39.1% 11.3% 4 89.4% 91.7% 89.9% 46.1% Lansoprazole 15 mg was significantly more effective than placebo in relieving day and nighttime abdominal pain and in decreasing the amount of antacid taken per day. In a second U.S. multicenter study, also double-blind, placebo-controlled, dose-comparison (15 and 30 mg of lansoprazole once daily), and including a comparison with ranitidine, in 280 patients with endoscopically documented duodenal ulcer, the percentage of patients healed after four weeks was significantly higher with both doses of lansoprazole than with placebo.

There was no evidence of a greater or earlier response with the higher dose of lansoprazole. Although the 15 mg dose of lansoprazole was superior to ranitidine at 4 weeks, the lack of significant difference at 2 weeks and the absence of a difference between 30 mg of lansoprazole and ranitidine leaves the comparative effectiveness of the two agents undetermined ( Table 8 ) [ see Indications and Usage ( 1.1 ) ]. Table 8: Duodenal Ulcer Healing Rates Week Lansoprazole Ranitidine 15 mg daily 30 mg daily 300 mg h.s.

Placebo (N = 80) (N = 77) (N = 82) (N = 41) 2 35% 44.2% 30.5% 34.2% 4 92.3% (p ≤ 0.05) versus placebo and ranitidine. 80.3% (p ≤ 0.05) versus placebo. 70.5% 47.5% H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Randomized, double-blind clinical studies performed in the U.S. in patients with H. pylori and duodenal ulcer disease (defined as an active ulcer or history of an ulcer within one year) evaluated the efficacy of lansoprazole in combination with amoxicillin capsules and clarithromycin tablets as triple 14 day therapy or in combination with amoxicillin capsules as dual 14 day therapy for the eradication of H. pylori .

Based on the results of these studies, the safety and efficacy of two different eradication regimens were established: Triple therapy: Lansoprazole 30 mg twice daily/amoxicillin 1 g twice daily/clarithromycin 500 mg twice daily Dual therapy: Lansoprazole 30 mg three times daily/amoxicillin 1 g three times daily All treatments were for 14 days. H. pylori eradication was defined as two negative tests (culture and histology) at 4 to 6 weeks following the end of treatment. Triple therapy was shown to be more effective than all possible dual therapy combinations.

Dual therapy was shown to be more effective than both monotherapies. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. A randomized, double-blind clinical study performed in the U.S. in patients with H. pylori and duodenal ulcer disease (defined as an active ulcer or history of an ulcer within one year) compared the efficacy of lansoprazole triple therapy for 10 and 14 days.

This study established that the 10 day triple therapy was equivalent to the 14 day triple therapy in eradicating H. pylori ( Tables 9 and 10 ) [ see Indications and Usage ( 1.2 ) ]. Table 9: H. pylori Eradication Rates - Triple Therapy (Lansoprazole/amoxicillin/clarithromycin) Percent of Patients Cured [95% Confidence Interval] (Number of patients) Study Duration Triple Therapy Evaluable Analysis Based on evaluable patients with confirmed duodenal ulcer (active or within one year… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In two 24 month carcinogenicity studies, Sprague-Dawley rats were treated with oral lansoprazole doses of 5 to 150 mg/kg/day, about 1 to 40 times the exposure on a body surface (mg/m 2 ) basis of a 50 kg person of average height [1.46 m 2 body surface area (BSA)] given the recommended human dose of 30 mg/day. Lansoprazole produced dose-related gastric enterochromaffin-like (ECL) cell hyperplasia and ECL cell carcinoids in both male and female rats. It also increased the incidence of intestinal metaplasia of the gastric epithelium in both sexes.

In male rats, lansoprazole produced a dose-related increase of testicular interstitial cell adenomas. The incidence of these adenomas in rats receiving doses of 15 to 150 mg/kg/day (4 to 40 times the recommended human dose based on BSA) exceeded the low background incidence (range = 1.4 to 10%) for this strain of rat. In a 24 month carcinogenicity study, CD-1 mice were treated with oral lansoprazole doses of 15 to 600 mg/kg/day, 2 to 80 times the recommended human dose based on BSA.

Lansoprazole produced a dose-related increased incidence of gastric ECL cell hyperplasia. It also produced an increased incidence of liver tumors (hepatocellular adenoma plus carcinoma). The tumor incidences in male mice treated with 300 and 600 mg/kg/day (40 to 80 times the recommended human dose based on BSA) and female mice treated with 150 to 600 mg/kg/day (20 to 80 times the recommended human dose based on BSA) exceeded the ranges of background incidences in historical controls for this strain of mice.

Lansoprazole treatment produced adenoma of rete testis in male mice receiving 75 to 600 mg/kg/day (10 to 80 times the recommended human dose based on BSA). A 26 week p53 (+/-) transgenic mouse carcinogenicity study was not positive. Lansoprazole was positive in the Ames test and the in vitro human lymphocyte chromosomal aberration assay.

Lansoprazole was not genotoxic in the ex vivo rat hepatocyte unscheduled DNA synthesis (UDS) test, the in vivo mouse micronucleus test, or the rat bone marrow cell chromosomal aberration test. Lansoprazole at oral doses up to 150 mg/kg/day (40 times the recommended human dose based on BSA) was found to have no effect on fertility and reproductive performance of male and female rats.

13.2Animal Toxicology and/or Pharmacology Reproductive Toxicology Studies Reproduction studies have been 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 (BSA)] and pregnant rabbits at oral lansoprazole doses up to 30 mg/kg/day (16 times the recommended human dose based on BSA) and have revealed no evidence of impaired fertility or harm to the fetus due to lansoprazole.

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

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility In two 24 month carcinogenicity studies, Sprague-Dawley rats were treated with oral lansoprazole doses of 5 to 150 mg/kg/day, about 1 to 40 times the exposure on a body surface (mg/m 2 ) basis of a 50 kg person of average height [1.46 m 2 body surface area (BSA)] given the recommended human dose of 30 mg/day. Lansoprazole produced dose-related gastric enterochromaffin-like (ECL) cell hyperplasia and ECL cell carcinoids in both male and female rats. It also increased the incidence of intestinal metaplasia of the gastric epithelium in both sexes.

In male rats, lansoprazole produced a dose-related increase of testicular interstitial cell adenomas. The incidence of these adenomas in rats receiving doses of 15 to 150 mg/kg/day (4 to 40 times the recommended human dose based on BSA) exceeded the low background incidence (range = 1.4 to 10%) for this strain of rat. In a 24 month carcinogenicity study, CD-1 mice were treated with oral lansoprazole doses of 15 to 600 mg/kg/day, 2 to 80 times the recommended human dose based on BSA.

Lansoprazole produced a dose-related increased incidence of gastric ECL cell hyperplasia. It also produced an increased incidence of liver tumors (hepatocellular adenoma plus carcinoma). The tumor incidences in male mice treated with 300 and 600 mg/kg/day (40 to 80 times the recommended human dose based on BSA) and female mice treated with 150 to 600 mg/kg/day (20 to 80 times the recommended human dose based on BSA) exceeded the ranges of background incidences in historical controls for this strain of mice.

Lansoprazole treatment produced adenoma of rete testis in male mice receiving 75 to 600 mg/kg/day (10 to 80 times the recommended human dose based on BSA). A 26 week p53 (+/-) transgenic mouse carcinogenicity study was not positive. Lansoprazole was positive in the Ames test and the in vitro human lymphocyte chromosomal aberration assay.

Lansoprazole was not genotoxic in the ex vivo rat hepatocyte unscheduled DNA synthesis (UDS) test, the in vivo mouse micronucleus test, or the rat bone marrow cell chromosomal aberration test. Lansoprazole at oral doses up to 150 mg/kg/day (40 times the recommended human dose based on BSA) was found to have no effect on fertility and reproductive performance of male and female rats.

📚 References 21 words ▾

15 REFERENCES 1. National Committee for Clinical Laboratory Standards. Summary Minutes, Subcommittee on Antimicrobial Susceptibility Testing, Tampa, FL, January 11-13, 1998.

📖 Instructions for Use ~2 min read ▾

INSTRUCTIONS FOR USE Lansoprazole (lan soe pra zole) Delayed-Release Capsules USP Lansoprazole Delayed-Release Capsules • Swallow lansoprazole delayed-release capsules whole. Do not crush or chew them. • You should take lansoprazole delayed-release capsules before eating. • Lansoprazole Delayed-Release Capsules with certain food: You can only use applesauce, ENSURE ® pudding, cottage cheese, yogurt or strained pears. • Open the capsule. • Sprinkle the granules on 1 tablespoon of either applesauce, ENSURE ® pudding, cottage cheese, yogurt or strained pears. • Swallow right away. • Lansoprazole Delayed-Release Capsules with certain juices: You can only use apple juice, orange juice or tomato juice. • Open the capsule. • Sprinkle the granules into 60 mL (about ¼ cup) of either apple juice, orange juice or tomato juice. • Stir. • Swallow right away. • To make sure that the entire dose is taken, rinse the glass with 1/2 cup or more of juice to get out any leftover granules.

Swallow the juice right away. Lansoprazole Delayed-Release Capsules through a nasogastric tube (NG tube) 16 French or larger, as prescribed by your doctor: You can only use apple juice. • Open the capsule and empty the granules into a syringe. • Do not break or crush the granules. • Mix with 40 mL of apple juice. Do not use other liquids. • Attach the syringe to the NG tube and give the medicine in the syringe through the NG tube into the stomach. • After giving the granules, flush the NG tube with more apple juice to clear the tube.

Lansoprazole delayed-release capsules should not be used in foods or liquids not listed above. How should I store lansoprazole delayed-release capsules? • Store lansoprazole delayed-release capsules at room temperature between 20° to 25°C (68° to 77°F). Keep lansoprazole delayed-release capsules and all medicines out of the reach of children.

All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA. This Instruction for Use has been approved by the U.S. Food and Drug Administration.

Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 91010, Israel Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev.

A 10/2012 Repackaged by: PROFICIENT RX LP Westlake Village, CA 91362

📄 Recent Major Changes 23 words ▾

WARNINGS AND PRECAUTIONS • Clostridium Difficile Associated Diarrhea ( 5.2 ) 9/2012 • Concomitant Use of Lansoprazole With Methotrexate ( 5.5 ) 5/2012

📄 Package Label / Principal Display Panel 4 words ▾

PRINCIPAL DISPLAY PANEL 63187-152-30

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

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

Medicare Part D (outpatient prescription) spending for 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.

About this NDC listing & data coverage

Finished prescription product
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Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
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Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
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Orange Book / therapeutic-equivalence data ✓ Available
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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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Proficient Rx LP. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Proficient Rx LP 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.
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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.