Prevacid lansoprazole 30 mg Capsule, Delayed Release — NDC 64764-046-06 (Billing 64764-0046-06)
This is a package of Prevacid lansoprazole 30 mg Capsule, Delayed Release from Takeda Pharmaceuticals America, Inc., marketed since May 1995 and currently FDA-listed.
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- 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): 206205
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Proton Pump Inhibitor class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- 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...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Lansoprazole — tap one for details:
Lansoprazole may be associated with lower levels of 9 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $13.53 | $270.62 / 20 capsules |
Where does this data come from?
- CMS NADAC weekly file
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · refreshed Oct 2, 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 64764-0046-06 You're viewing this | 5 BLISTER PACK in 1 TRAY / 4 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK | — | — | 1995-05-10 | — | Active |
| 64764-0046-11 64764-046-11 | 10 BLISTER PACK in 1 CARTON / 10 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK | — | — | 1995-05-10 | — | Discontinued by firm |
| 64764-0046-13 64764-046-13 Main listing | 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE | $13.22 / ea | $1,321.94 | 1995-05-10 | — | Active |
| 64764-0046-19 64764-046-19 | 1000 CAPSULE, DELAYED RELEASE in 1 BOTTLE | — | — | 1995-05-10 | — | Discontinued by firm |
This pack shows little to no recent Medicaid volume — the 100 capsules pack carries most fills. See all packs ↓
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of Prevacid lansoprazole 30 mg Capsule, Delayed Release?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price 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 mg 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 mgthis 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 | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file
Availability & generic status
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
Where does this data come from?
- FDA Orange Book · refreshed Sep 3, 2026
What it looks like
Where does this data come from?
- FDA label on DailyMed · label index refreshed Oct 1, 2026
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.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE PREVACID and PREVACID SoluTab 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 nonsteroidal 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 PREVACID and PREVACID SoluTab 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: PREVACID or PREVACID SoluTab/amoxicillin/clarithromycin PREVACID or PREVACID SoluTab 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: PREVACID or PREVACID SoluTab/amoxicillin PREVACID or PREVACID SoluTab 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 PREVACID and PREVACID SoluTab 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 PREVACID and PREVACID SoluTab 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 PREVACID and PREVACID SoluTab 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 PREVACID and PREVACID SoluTab 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) PREVACID and PREVACID SoluTab 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) ] .
1.8Treatment of Erosive Esophagitis (EE) PREVACID and PREVACID SoluTab are indicated for short-term treatment… [Excerpted — this section continues on DailyMed.]
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Recommended Dosage : See full prescribing information for complete dosing information for PREVACID and PREVACID SoluTab by indication and age group and dosage adjustment in patients with severe hepatic impairment. ( 2.1 , 2.2 , 2.3 ) Administration Instructions ( 2.4 ) PREVACID capsules Should be swallowed whole. See full prescribing information for alternative administration options.
PREVACID SoluTab Should not be broken or cut. Should not be chewed. Place the tablet on the tongue and allow it to disintegrate, with or without water, until the particles can be swallowed.
See full prescribing information for alternative administration options.
2.1Recommended Adult Dosage by Indication Indication Recommended Dose Frequency Duodenal Ulcers Short-Term Treatment 15 mg Once daily for 4 weeks Maintenance of Healed 15 mg 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 Warnings and Precautions sections, and for information regarding dosing in elderly and renally-impaired patients. Triple Therapy: PREVACID or PREVACID SoluTab 30 mg Twice daily for 10 or 14 days Amoxicillin 1 gram Twice daily for 10 or 14 days Clarithromycin 500 mg Twice daily for 10 or 14 days Dual Therapy: PREVACID or PREVACID SoluTab 30 mg Three times daily for 14 days Amoxicillin 1 gram 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 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 PREVACID or PREVACID SoluTab 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 PREVACID or PREVACID SoluTab 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 PREVACID for more than four years.
2.2Recommended Pediatric Dosage by Indication Pediatric Patients 1 to 11 Years of Age In clinical studies, PREVACID was not administered beyond 12 weeks in 1 to 11 year olds. It is not known if PREVACID 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 PREVACID or PREVACID SoluTab before meals. Do not crush or chew PREVACID capsule… [Excerpted — this section continues on DailyMed.]
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS PREVACID delayed-release capsules: 15 mg strength is not currently marketed by Takeda Pharmaceuticals America, Inc. 30 mg strength is an opaque, pink and black capsule imprinted with "TAP" and "PREVACID 30". PREVACID SoluTab delayed-release orally disintegrating tablets: 15 mg strength is a white to yellowish white, uncoated round tablet containing orange to dark brown speckles with "15" debossed on one side.
30 mg strength is a white to yellowish white, uncoated round tablet containing orange to dark brown speckles with "30" debossed on one side. Delayed-release capsules: 30 mg. ( 3 ) Delayed-release orally disintegrating tablets: 15 mg and 30 mg.
( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS PREVACID and PREVACID SoluTab are contraindicated in patients with known hypersensitivity to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria [see Warnings and Precautions (5.2) , Adverse Reactions (6) ] . Proton Pump Inhibitors (PPIs), including PREVACID and PREVACID SoluTab, are contraindicated with rilpivirine-containing products [see Drug Interactions (7) ] .
For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with PREVACID or PREVACID SoluTab, refer to the Contraindications section of their prescribing information. Contraindicated in patients with known hypersensitivity to any component of the PREVACID or PREVACID SoluTab formulations. ( 4 ) Patients receiving rilpivirine-containing products.
( 4 , 7 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Gastric Malignancy : In adults, symptomatic response with PREVACID or PREVACID SoluTab does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing. ( 5.1 ) Acute Tubulointerstitial Nephritis : Discontinue treatment and evaluate patients.
( 5.2 ) Clostridium difficile -Associated Diarrhea : PPI therapy may be associated with increased risk 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 ) Severe Cutaneous Adverse Reactions: Discontinue at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation.
( 5.5 ) Cutaneous and Systemic Lupus Erythematosus : Mostly cutaneous; new onset or exacerbation of existing disease; discontinue PREVACID and PREVACID SoluTab and refer to specialist for evaluation. ( 5.6 ) Cyanocobalamin (Vitamin B12) Deficiency : Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin. ( 5.7 ) Hypomagnesemia and Mineral Metabolism : Hypomagnesemia has been reported rarely with prolonged treatment with PPIs.
( 5.8 ) Interactions with Investigations for Neuroendocrine Tumors : Increases in intragastric pH may result in hypergastrinemia and enterochromaffin-like cell hyperplasia and increased chromogranin A levels which may interfere with diagnostic investigations for neuroendocrine tumors. ( 5.9 , 7 ) Interaction with Methotrexate : Concomitant use with PPIs may elevate and/or prolong serum concentrations of methotrexate and/or its metabolite, possibly leading to toxicity. With high-dose methotrexate administration, consider a temporary withdrawal of PREVACID.
( 5.10 , 7 ) Patients with Phenylketonuria : Each 15 mg PREVACID SoluTab contains 2.5 mg and each 30 mg PREVACID SoluTab contains 5.1 mg of phenylalanine. ( 5.11 ) Fundic Gland Polyps : Risk increases with long-term use, especially beyond 1 year. Use the shortest duration of therapy.
( 5.12 ) Risk of Heart Valve Thickening in Pediatric Patients Less than One Year of Age : PREVACID is not recommended in pediatric patients less than 1 year of age. ( 5.13 , 8.4 )
5.1Presence of Gastric Malignancy In adults, symptomatic response to therapy with PREVACID or PREVACID SoluTab does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with a PPI. In older patients, also consider an endoscopy.
5.2Acute Tubulointerstitial Nephritis Acute tubulointerstial nephritis (TIN) has been observed in patients taking PPIs and may occur at any point during PPI therapy. Patients may present with varying signs and symptoms from symptomatic hypersensitivity reactions to non-specific symptoms of decreased renal function (e.g., malaise, nausea, anorexia). In reported case series, some patients were diagnosed on biopsy and in the absence of extra-renal manifestations (e.g., fever, rash or arthralgia).
Discontinue PREVACID or PREVACID SoluTab and evaluate patients with suspected acute TIN [see Contraindications (4) ] .
5.3Clostridium difficile -Associated Diarrhea Published observational studies suggest that PPI therapy like PREVACID and PREVACID SoluTab 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… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following serious adverse reactions are described below and elsewhere in labeling: Acute Tubulointerstitial Nephritis [see Warnings and Precautions (5.2) ] Clostridium difficile -Associated Diarrhea [see Warnings and Precautions (5.3) ] Bone Fracture [see Warnings and Precautions (5.4) ] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.5) ] Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions (5.6) ] Cyanocobalamin (Vitamin B12) Deficiency [see Warnings and Precautions (5.7) ] Hypomagnesemia and Mineral Metabolism [see Warnings and Precautions (5.8) ] Fundic Gland Polyps [see Warnings and Precautions (5.12) ] Most commonly reported adverse reactions (≥1%): diarrhea, abdominal pain, nausea and constipation.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals America, Inc. at 1-877-TAKEDA-7 (1-877-825-3327) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Worldwide, over 10,000 patients have been treated with PREVACID in Phase 2 or Phase 3 clinical trials involving various dosages and durations of treatment. In general, PREVACID 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 PREVACID-treated patients and occurred at a greater rate in PREVACID-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 PREVACID Studies Body System/Adverse Reaction PREVACID (N=2768) % Placebo (N=1023) % Body as a Whole Abdominal Pain 2.1
1.2Digestive System Constipation 1.0
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 and 30 mg of PREVACID, but higher in the patients who received 60 mg of PREVACID (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 PREVACID for NSAID-associated gastric ulcers, the incidence of diarrhea for patients treated with PREVACID, 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 PREVACID 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 PREVACID 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 stenos… [Excerpted — this section continues on DailyMed.]
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Tables 2 and 3 include drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with PREVACID or PREVACID SoluTab 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 Coadministered with PREVACID or PREVACID SoluTab 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 PREVACID or PREVACID SoluTab is contraindicated [see Contraindications (4) ] .
See prescribing information. Atazanavir : See prescribing information for atazanavir for dosing information. Nelfinavir : Avoid concomitant use with PREVACID or PREVACID SoluTab.
See prescribing information for nelfinavir. Saquinavir : See the prescribing information for saquinavir and monitor for potential saquinavir toxicities. Other antiretrovirals : See prescribing information.
Warfarin Clinical Impact: Increased INR and prothrombin time in patients receiving PPIs and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. Intervention: Monitor INR and prothrombin time.
Dose adjustment of warfarin may be needed to maintain target INR range. See prescribing information for warfarin. Methotrexate Clinical Impact: Concomitant use of PPIs with methotrexate (primarily at high dose) may elevate and prolong serum concentrations of methotrexate and/or its metabolite hydroxymethotrexate, possibly leading to methotrexate toxicities.
No formal drug interaction studies of high-dose methotrexate with PPIs have been conducted [see Warnings and Precautions (5.10) ] . Intervention: A temporary withdrawal of PREVACID or PREVACID SoluTab 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 PREVACID or PREVACID SoluTab 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): Coadministration of PPIs in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic acid (MPA), possibly due to a decrease in MMF solubility at an increased gastric pH. The clinical relevance of reduced MPA exposure on organ rejection has not been established in transplant patients receiving PREVACID and MMF. Use PREVACID and PREVACID SoluTab with caution in transplant patients receiving MMF.
See the prescribing information for other drugs dependent on gastric pH for absorption.… [Excerpted — this section continues on DailyMed.]
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Pregnancy : Based on animal data, may cause adverse effects on fetal bone growth and development. ( 8.1 ) Pediatrics : Use is not recommended for the treatment of symptomatic GERD in patients 1 month to less than 1 year of age; efficacy was not demonstrated and nonclinical studies have demonstrated adverse effects in juvenile rats. ( 5.13 , 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 the 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 US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. If PREVACID or PREVACID SoluTab 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, d… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
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 the 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 US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. If PREVACID or PREVACID SoluTab 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… [Excerpted — this section continues on DailyMed.]
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of PREVACID and PREVACID SoluTab have been established in pediatric patients one year to 17 years of age for short-term treatment of symptomatic GERD and erosive esophagitis. In clinical studies of symptomatic GERD and erosive esophagitis, PREVACID was not administered beyond 12 weeks in patients one year to 11 years of age. It is not known if PREVACID and PREVACID SoluTab are 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 ) . PREVACID 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 of age.
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. 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 US and Polish four 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., nonpharmacologic 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 year to 11 years of age In an uncontrolled, open-label, US multicenter study, 66 pediatric patients (one year to 11 years of age) with GERD were assigned, based on body weight, to receive an initial dose of either PREVACID 15 mg daily if ≤30 kg or PREVACID 30 mg daily if greater than 30 kg administered for eight to 12 weeks. The PREVACID 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 PREVACID 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 wer… [Excerpted — this section continues on DailyMed.]
🧓 Geriatric Use ▾
8.5Geriatric Use Of the total number of patients (n=21,486) in clinical studies of PREVACID, 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 ▾
10 OVERDOSAGE Lansoprazole is not removed from the circulation by hemodialysis. In one reported overdose, a patient consumed 600 mg of PREVACID 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 ▾
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 and 30 mg of once daily lansoprazole are presented in Table 6 : Table 6. Mean Antisecretory Effects After Single and Multiple Daily PREVACID Dosing PREVACID Parameter Baseline Value 15 mg 30 mg Day 1 Day 5 Day 1 Day 5 NOTE: An intragastric pH of greater than four reflects a reduction in gastric acid by 99%.
Mean 24 Hour pH 2.1 2.7 (p<0.05) vs baseline only. 4.0 3.6 (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 postdosing with 30 mg of lansoprazole and within one to two hours postdosing 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 PREVACID 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 PREVACID 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 PREVACID 30 mg daily 77 (p<0.05) vs PREVACID 30 mg daily, 15 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… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
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 ▾
16 HOW SUPPLIED/STORAGE AND HANDLING PREVACID 15 mg strength is not currently marketed by Takeda Pharmaceuticals America, Inc. PREVACID 30 mg delayed-release capsules are opaque, pink and black with "TAP" and "PREVACID 30" imprinted on the capsules. They are available as follows: NDC Number Size 64764-046-13 Bottles of 100: 30 mg capsules PREVACID SoluTab delayed-release orally disintegrating tablets, 15 mg, are white to yellowish white, round uncoated tablets containing orange to dark brown speckles, with "15" debossed on one side of the tablet.
The 30 mg are white to yellowish white, round uncoated tablets containing orange to dark brown speckles, with "30" debossed on one side of the tablet. The tablets are available as follows: NDC Number Size 64764-543-11 Unit dose packages of 100: 15 mg tablets 64764-544-11 Unit dose packages of 100: 30 mg tablets Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].
📦 Storage and Handling ▾
Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].
📋 Description ▾
11 DESCRIPTION The active ingredient in PREVACID Delayed-Release Capsules and PREVACID SoluTab Delayed-Release Orally Disintegrating Tablets is lansoprazole, 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 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 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. PREVACID is supplied in delayed-release capsules and PREVACID SoluTab is supplied in delayed-release orally disintegrating tablets (SoluTab) for oral administration. PREVACID is available in one dosage strength: 30 mg of lansoprazole per capsule.
Each delayed-release capsule contains enteric-coated granules consisting of 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: sugar sphere, sucrose, methacrylic acid copolymer, low substituted hydroxypropyl cellulose, starch, magnesium carbonate, talc, polyethylene glycol, titanium dioxide, polysorbate 80, hydroxypropyl cellulose, colloidal silicon dioxide, D&C Red No. 28, FD&C Blue No. 1, and FD&C Red No.
40. The 15 mg strength of PREVACID is not currently marketed by Takeda Pharmaceuticals America, Inc. PREVACID SoluTab is available in two dosage strengths: 15 and 30 mg of lansoprazole per tablet.
Each delayed-release orally disintegrating tablet contains enteric-coated microgranules consisting of 15 or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: mannitol, methacrylic acid, hydroxypropyl cellulose, lactose monohydrate-microcrystalline cellulose sphere, triethyl citrate, crospovidone, polyacrylate, magnesium carbonate, aspartame Phenylketonurics: PREVACID SoluTab Contains Phenylalanine 2.5 mg per 15 mg Tablet and 5.1 mg per 30 mg Tablet. , glyceryl monostearate, hypromellose, magnesium stearate, citric acid, titanium dioxide, talc, artificial strawberry flavor, polyethylene glycol, polysorbate 80 and ferric oxide.
Chemical Structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Advise patients to: Acute Tubulointerstitial Nephritis To call their healthcare provider if they experience signs and/or symptoms associated with acute tubulointerstitial nephritis [see Warnings and Precautions (5.2) ] . Clostridium difficile -Associated Diarrhea To immediately call their healthcare provider if they experience diarrhea that does not improve [see Warnings and Precautions (5.3) ] .
Bone Fracture To report any fractures, especially of the hip, wrist or spine, to their healthcare provider [see Warnings and Precautions (5.4) ] . Severe Cutaneous Adverse Reactions To discontinue PREVACID or PREVACID SoluTab and immediately call their healthcare provider for further evaluation [see Warnings and Precautions (5.5) ]. Cutaneous and Systemic Lupus Erythematosus To immediately call their healthcare provider for any new or worsening of symptoms associated with cutaneous or systemic lupus erythematosus [see Warnings and Precautions (5.6) ] .
Cyanocobalamin (Vitamin B12) Deficiency To report any clinical symptoms that may be associated with cyanocobalamin deficiency to their healthcare provider, if they have been receiving PREVACID or PREVACID SoluTab for longer than three years [see Warnings and Precautions (5.7) ] . Hypomagnesemia and Mineral Metabolism To report any clinical symptoms that may be associated with hypomagnesemia, hypocalcemia, and/or hypokalemia to their healthcare provider, if they have been receiving PREVACID or PREVACID SoluTab for at least three months [see Warnings and Precautions (5.8) ] .
Drug Interactions Advise patients to report to their healthcare provider if they are taking rilpivirine-containing products [see Contraindications (4) ] or high-dose methotrexate [see Warnings and Precautions (5.10) ] . Pregnancy Advise a pregnant woman of the potential risk to a fetus. Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy [see Use in Specific Populations (8.1) ].
Administration Missed doses: If a dose is missed, administer as soon as possible. However, if the next scheduled dose is due, do not take the missed dose, and take the next dose on time. Do not take two doses at one time to make up for a missed dose.
PREVACID or PREVACID SoluTab should be taken before eating. Do not crush or chew PREVACID capsule or PREVACID SoluTab. Take PREVACID or PREVACID SoluTab at least 30 minutes prior to sucralfate.
Phenylketonurics: Contains Phenylalanine 2.5 mg per 15 mg PREVACID SoluTab Tablet and 5.1 mg per 30 mg PREVACID SoluTab Tablet. PREVACID Capsules Swallow whole; do not chew. For patients who have difficulty swallowing capsules: PREVACID capsules can be opened and sprinkled on applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears PREVACID capsules may also be emptied into a small volume of either apple juice, orange juice or tomato juice Alternatively, PREVACID capsules can be administered with apple juice via nasogastric tube See the Instructions for Use for a description of all preparation and administration instructions PREVACID SoluTab Do not break or cut.
Place the tablet on the tongue; allow it to disintegrate, with or without water, until the particles can be swallowed. Do not chew the particles. The tablet typically disintegrates in less than one minute.
Alternatively, for children or other patients who have difficulty swallowing tablets, PREVACID SoluTab can be administered with water via oral syringe or NG tube, as described in the Instructions for Use.
💬 Medication Guide ▾
MEDICATION GUIDE PREVACID (prev-a-sid) (lansoprazole) delayed-release capsules, for oral use and PREVACID SoluTab (prev-a-sid sol-u-tab) (lansoprazole) delayed-release orally disintegrating tablets This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 3/2025 What is the most important information that I should know about PREVACID and PREVACID SoluTab?
You should take PREVACID and PREVACID SoluTab exactly as prescribed, at the lowest dose possible and for the shortest time needed. PREVACID and PREVACID SoluTab may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor.
PREVACID and PREVACID SoluTab can cause serious side effects, including: A type of kidney problem (acute tubulointerstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including PREVACID and PREVACID SoluTab, may develop a kidney problem called acute tubulointerstitial nephritis that can happen at any time during treatment with PPI medicines including PREVACID and PREVACID SoluTab. 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 PREVACID and PREVACID SoluTab, 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. PREVACID and PREVACID SoluTab can have other serious side effects.
See " What are the possible side effects of PREVACID and PREVACID SoluTab? " . What are PREVACID and PREVACID SoluTab? A prescription medicine called a proton pump inhibitor (PPI) used to reduce the amount of acid in your stomach.
In adults, PREVACID and PREVACID SoluTab are used 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. PREVACID has not been studied beyond 12 months for this purpose. up to 8 weeks for the healing and symptom relief of stomach ulcers. up to 8 weeks for the healing of stomach ulcers in people taking pain medicines called nonsteroidal anti-inflammatory drugs (NSAIDs).
PREVACID 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. PREVACID has not been studied beyond 12 weeks for this purpose. up to 8 weeks to treat heartburn and other symptoms 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 the healing 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 PREVACID or PREVACID SoluTab for patients whose EE does not improve or whose symptoms return. maintaining healing of EE. PREVACID has not been studied beyond 12 months for this purpose. the long-term treatment of conditions where your stomac… [Excerpted — this section continues on DailyMed.]
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Absorption : PREVACID and PREVACID SoluTab contain an enteric-coated granule formulation of lansoprazole (because lansoprazole is acid-labile), so that absorption of lansoprazole begins only after the granules leave the stomach. The mean peak plasma levels of lansoprazole occur at approximately 1.7 hours. After a single-dose administration of 15 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. The absolute bioavailability is over 80%. In healthy subjects, the mean (±SD) plasma half-life was 1.5 (±1.0) 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. Elimination 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 two 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. Excretion: Following single-dose oral administration of PREVACID, 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 Patients: One to 17 years of age The pharmacokinetics of lansoprazole were studied in pediatric patients with GERD aged one to 11 years and 12 to 17 years in two separate clinical studies.
In children aged one 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 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 one to 17 years were similar to those observed in healthy adult subjects. Geriatric Patients: 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 increased in the elderly [see Use in Specific Populations (8.5) ] . Male and Female Patients: In a study comparing 12 male and six female human subjects who received lansoprazole, no sex-related differences were found in pharmacokinetics and intragastric pH results.
Ra… [Excerpted — this section continues on DailyMed.]
🧬 Pharmacodynamics ▾
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 and 30 mg of once daily lansoprazole are presented in Table 6 : Table 6. Mean Antisecretory Effects After Single and Multiple Daily PREVACID Dosing PREVACID Parameter Baseline Value 15 mg 30 mg Day 1 Day 5 Day 1 Day 5 NOTE: An intragastric pH of greater than four reflects a reduction in gastric acid by 99%.
Mean 24 Hour pH 2.1 2.7 (p<0.05) vs baseline only. 4.0 3.6 (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 postdosing with 30 mg of lansoprazole and within one to two hours postdosing 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 PREVACID 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 PREVACID 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 PREVACID 30 mg daily 77 (p<0.05) vs PREVACID 30 mg daily, 15 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 concentrations was observed. Serum Gastrin E… [Excerpted — this section continues on DailyMed.]
🔬 Clinical Studies ▾
14 CLINICAL STUDIES
14.1Duodenal Ulcer In a US multicenter, double-blind, placebo-controlled, dose-response (15, 30, and 60 mg of PREVACID 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 PREVACID than with placebo. There was no evidence of a greater or earlier response with the two higher doses compared with PREVACID 15 mg. Based on this study and the second study described below, the recommended dose of PREVACID in duodenal ulcer is 15 mg per day (Table 9) .
Table 9. Duodenal Ulcer Healing Rates Week PREVACID Placebo (N=72) 15 mg daily (N=68) 30 mg daily (N=74) 60 mg daily (N=70) 2 42.4% (p≤0.001) vs placebo. 35.6% 39.1% 11.3% 4 89.4% 91.7% 89.9% 46.1% PREVACID 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 US multicenter study, also double-blind, placebo-controlled, dose-comparison (15 and 30 mg of PREVACID 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 PREVACID than with placebo. There was no evidence of a greater or earlier response with the higher dose of PREVACID. Although the 15 mg dose of PREVACID was superior to ranitidine at four weeks, the lack of significant difference at two weeks and the absence of a difference between 30 mg of PREVACID and ranitidine leaves the comparative effectiveness of the two agents undetermined (Table 10) [see Indications and Usage (1.1) ] .
Table 10. Duodenal Ulcer Healing Rates Week PREVACID Ranitidine Placebo (N=41) 15 mg daily (N=80) 30 mg daily (N=77) 300 mg h.s. (N=82) 2 35.0% 44.2% 30.5% 34.2% 4 92.3% (p≤0.05) vs placebo and ranitidine.
80.3% (p≤0.05) vs placebo. 70.5% 47.5%
14.2Eradication of H. pylori to Reduce the Risk of Duodenal Ulcer Recurrence Randomized, double-blind clinical studies performed in the US 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 PREVACID in combination with amoxicillin and clarithromycin as triple 14 day therapy or in combination with amoxicillin 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: PREVACID 30 mg twice daily/amoxicillin 1 g twice daily/clarithromycin 500 mg twice daily Dual therapy: PREVACID 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 four to six 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 US 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 PREVACID 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 11 and 12) [see Indications and Usage (1.2) ] .
Table 11. H. pylori Eradication Rates – Triple Therapy (PREVACID/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) and H. pylori infection at baseline defined as at least two of three positive endoscopic tests from CLOtest, histo… [Excerpted — this section continues on DailyMed.]
🧪 Nonclinical Toxicology ▾
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 one to 40 times the exposure on a body surface (mg/m 2 ) basis of a 50 kg person of average height [1.46 m 2 body surface area (BSA)] given the recommended human dose of 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 (four 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, two 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.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
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 one to 40 times the exposure on a body surface (mg/m 2 ) basis of a 50 kg person of average height [1.46 m 2 body surface area (BSA)] given the recommended human dose of 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 (four 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, two 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.
📖 Instructions for Use ▾
INSTRUCTIONS FOR USE PREVACID (prev-a-sid) (lansoprazole) delayed-release capsules, for oral use and PREVACID SoluTab (prev-a-sid sol-u-tab) (lansoprazole) delayed-release orally disintegrating tablets Important: Take PREVACID or PREVACID SoluTab before meals. Do not crush or chew PREVACID capsules or PREVACID SoluTab. PREVACID or PREVACID SoluTab should only be used with the foods and juices listed below.
PREVACID delayed-release capsules (PREVACID capsules) Taking PREVACID capsules with certain foods: You can only use applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears. Open the capsule. Sprinkle the granules on 1 tablespoon of applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears.
Swallow right away. Taking PREVACID 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 apple juice, orange juice or tomato juice. Stir. Swallow right away.
To make sure that the entire dose is taken, add 1/2 cup or more of juice to the glass, stir and swallow right away. Giving PREVACID capsules through a nasogastric tube (NG tube) size 16 French or larger: You can only use apple juice. Place 40 mL of apple juice into a clean container.
Open the capsule and empty the granules into the container of apple juice. Use a catheter-tip syringe to draw up the apple juice and granule mixture. Gently mix the catheter-tip syringe to keep the granules from settling.
Attach the catheter-tip syringe to the NG tube. Give the mixture right away through the NG tube that goes into the stomach. Do not save the apple juice and granule mixture for later use.
Refill the catheter-tip syringe with 40 mL of apple juice and mix gently. Flush the NG tube with apple juice. PREVACID SoluTab Delayed-Release Orally Disintegrating Tablets (PREVACID SoluTab) Do not chew, crush, cut or break the tablets.
Put the tablet on the tongue and let it dissolve, with or without water. Swallow after the tablet dissolves. The tablet usually dissolves in less than 1 minute.
For patients who have trouble swallowing tablets, PREVACID SoluTab can be given as follows: Giving PREVACID SoluTab with water using an oral syringe: Put a 15 mg tablet in an oral syringe and draw up 4 mL of water into the oral syringe, or put a 30 mg tablet in an oral syringe and draw up 10 mL of water into the oral syringe. Gently shake the oral syringe to mix the tablet and the water. After the tablet is mixed in the water, place the tip of the oral syringe in the mouth.
Give the medicine within 15 minutes of mixing. Do not save the tablet and water mixture for later use. Refill the oral syringe with about 2 mL of water for the 15 mg tablet or 5 mL of water for the 30 mg tablet, and shake gently.
Place the tip of the oral syringe in the mouth and give the medicine that is left in the syringe. Giving PREVACID SoluTab with water through a nasogastric tube (NG tube) size 8 French or larger: Put a 15 mg tablet in a catheter-tip syringe and draw up 4 mL of water, or put a 30 mg tablet in a catheter-tip syringe and draw up 10 mL of water. Gently shake the catheter-tip syringe to mix the tablet and the water.
Connect the catheter-tip syringe to the NG tube. Give the mixture right away through the NG tube that goes into the stomach. Give the medicine within 15 minutes of mixing.
Do not save the granule and water mixture for later use. Refill the catheter-tip syringe with about 5 mL of water and shake gently. Flush the NG tube with the water.
How should I store PREVACID and PREVACID SoluTab? Store PREVACID capsules and PREVACID SoluTab at room temperature between 68°F to 77°F (20°C to 25°C). Keep PREVACID and PREVACID SoluTab and all medicines out of the reach of children.
This Instruction for Use has been approved by the U.S. Food and Drug Administration. Distributed by: Takeda Pharmaceuticals America, Inc.
Cambridge, MA 02142 Revised: March 2025 PREVACID is a trademark registered in the U.S… [Excerpted — this section continues on DailyMed.]
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL - 30 mg Capsule Bottle Label NDC 64764-046-13 100 Capsules PREVACID ® LANSOPRAZOLE DELAYED-RELEASE CAPSULES 30 mg Dispense the accompanying Medication Guide to each patient. Takeda Rx only PRINCIPAL DISPLAY PANEL - 30 mg Capsule Bottle Label
PRINCIPAL DISPLAY PANEL - 15 mg Tablet Blister Pack Carton NDC 64764-543-11 PREVACID ® SoluTab TM LANSOPRAZOLE Delayed-Release Orally Disintegrating Tablets 15 mg Rx only Takeda Dispense the enclosed Medication Guide to each patient. 100 Tablets Contains: 10 Packs of 10 Tablets Each PRINCIPAL DISPLAY PANEL - 15 mg Tablet Blister Pack Carton
PRINCIPAL DISPLAY PANEL - 30 mg Tablet Blister Pack Carton NDC 64764-544-11 PREVACID ® SoluTab TM LANSOPRAZOLE Delayed-Release Orally Disintegrating Tablets 30 mg Rx only Takeda Dispense the enclosed Medication Guide to each patient. 100 Tablets Contains: 10 Packs of 10 Tablets Each PRINCIPAL DISPLAY PANEL - 30 mg Tablet Blister Pack Carton
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