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Lansoprazole

Class: Proton-pump Inhibitors
VA Class: GA900
Chemical Name: 2-[[[3-Methyl-4-(2,2,2-trifluoroethoxy)-2-pyridinyl]methyl]sulfinyl]-1H-benzimidazole
Molecular Formula: C16H14F3N3O2S
CAS Number: 103577-45-3
Brands: Prevacid, Prevpac

Medically reviewed on Jan 31, 2018

Introduction

Acid- or proton-pump inhibitor; gastric antisecretory agent.1 3 4 5 6 8 9 10 12 13 15 17 19 21 22 23 24 36 103 104 125

Uses for Lansoprazole

Gastroesophageal Reflux (GERD)

Short-term treatment of symptomatic GERD (e.g., heartburn).1

Short-term treatment of erosive esophagitis (endoscopically diagnosed) in patients with GERD.1 2 3 5 18 19 20 22 23

Maintain healing and decrease recurrence of erosive esophagitis.1 126

Short-term self-medication for symptomatic relief of frequent (e.g., ≥2 days per week) heartburn in adults ≥18 years of age.191 192 194

Duodenal Ulcer

Short-term treatment of active duodenal ulcer (endoscopically or radiographically confirmed).1 2 3 4 5 6 7 12 13 14

Treatment of Helicobacter pylori infection and duodenal ulcer disease.1 134 Used in conjunction with amoxicillin and clarithromycin (triple therapy) or clarithromycin (dual therapy);1 134 has been used in other multidrug regimens.126 129 131 135

Maintenance therapy following duodenal ulcer healing.1

Gastric Ulcer

Short-term treatment and symptomatic relief of active benign gastric ulcer.1

NSAIA-induced Gastric Ulcer

Short-term treatment of NSAIA-induced gastric ulcer in patients continuing NSAIA use.1 151 153 169

Risk reduction in patients with history of gastric ulcer who require NSAIA treatment.1

Pathologic GI Hypersecretory Conditions

Long-term treatment of pathologic hypersecretory conditions (e.g., Zollinger-Ellison syndrome with or without multiple endocrine adenoma).1

Crohn’s Disease-associated Ulcers

Some evidence for use of proton-pump inhibitors (e.g., omeprazole) for gastric acid suppressive therapy as an adjunct in the management of upper GI Crohn’s disease, including esophageal, gastroduodenal, and jejunoileal disease.162 163 164 166 167

Lansoprazole Dosage and Administration

Administration

Administer orally.1 134 Has been used administered IV (parenteral dosage form no longer commercially available in US).170 195

If a dose is missed, administer the dose as soon as possible, unless it is almost time for the next dose.1 Do not double a dose to make up for a missed dose.1

Oral Administration

Administer orally before a meal.1 3 43 191

Antacids may be used concomitantly as needed for pain relief.1 2 3 4

Capsules

Swallow capsules intact; do not chew or crush.1 191

Alternatively, open capsule and sprinkle contents on 1 tablespoonful of compatible foods (e.g., applesauce, Ensure pudding, cottage cheese, yogurt, strained pears) or mix with about 60 mL of appropriate juice (e.g., apple juice, orange juice, tomato juice); swallow immediately without chewing.1 If mixed with juice, rinse glass with ≥120 mL juice and swallow immediately to ensure complete dose ingestion.1 Do not mix with other foods or liquids.1

Manufacturer recommends swallowing capsules for self-medication with a glass of water.191

Orally Disintegrating Tablets

Do not break, cut, or chew orally disintegrating tablets.1 Place tablets on the tongue and allow to disintegrate (usually in <1 minute) with or without water; swallow particles without chewing.1

To administer using an oral syringe, place 15- or 30-mg tablet in oral syringe, draw up about 4 or 10 mL, respectively, of water in the syringe, gently shake syringe to ensure rapid dispersal of particles, and administer within 15 minutes.1 To ensure complete consumption of dose, draw up an additional 2 mL (15-mg dose) or 5 mL (30-mg dose) of water in syringe, mix gently, and administer remaining contents.1

NG Tube

Capsules: Open capsule and mix contents with about 40 mL apple juice and administer immediately (within 3–5 minutes) through NG tube; flush tube with additional apple juice.1 127 Do not mix with other liquids.1

Orally disintegrating tablets: Place 15- or 30-mg tablet in syringe, draw up about 4 or 10 mL, respectively, of water in the syringe, gently shake syringe to ensure rapid dispersal of particles, and administer within 15 minutes through NG tube (8 French or larger).1 Draw up an additional 5 mL of water in syringe, mix gently, and flush NG tube with syringe contents.1

Dosage

Pediatric Patients

Gastroesophageal Reflux
GERD
Oral

Children 1–11 years of age: In those weighing ≤30 kg, 15 mg once daily for up to 12 weeks.1 In those weighing >30 kg, 30 mg once daily for up to 12 weeks.1 Dosage has been increased up to 30 mg twice daily after ≥2 weeks in patients remaining symptomatic.1

Children 12–17 years of age: 15 mg daily for up to 8 weeks.1

Treatment of Erosive Esophagitis
Oral

Children 1–11 years of age: In those weighing ≤30 kg, 15 mg once daily for up to 12 weeks.1 In those weighing >30 kg, 30 mg once daily for up to 12 weeks.1 Dosage has been increased up to 30 mg twice daily after ≥2 weeks in patients remaining symptomatic.1

Children 12–17 years of age: 30 mg daily for up to 8 weeks.1

Adults

Gastroesophageal Reflux

Chronic, lifelong therapy with proton-pump inhibitor is appropriate for many GERD patients.156

GERD
Oral

15 mg once daily for up to 8 weeks.1

Treatment of Erosive Esophagitis
Oral

30 mg once daily for up to 8 weeks.1 2 3 5 22 May give additional 8 weeks of therapy (up to 16 weeks for a single course) if not healed.1 If recurs, consider additional 8 weeks of therapy.1

Maintenance of Healing of Erosive Esophagitis
Oral

15 mg once daily.1 Not studied >1 year.1

Self-medication for Frequent Heartburn
Oral

15 mg once daily in the morning for 14 days.191 Do not exceed recommended dosage or duration; do not administer more than 1 course every 4 months.191 May relieve symptoms within 24 hours, but 1–4 days may be required for complete relief.191

Duodenal Ulcer
Treatment of Active Duodenal Ulcer
Oral

15 mg once daily for 4 weeks.1 2 3 4 5 6 12 13 14

Treatment of Helicobacter pylori Infection and Duodenal Ulcer
Oral

Triple therapy: 30 mg every 12 hours for 10 or 14 days in conjunction with amoxicillin and clarithromycin.1 134

Dual therapy: 30 mg every 8 hours for 14 days in conjunction with amoxicillin.1

Maintenance of Duodenal Ulcer Healing
Oral

15 mg daily.1 Safety and efficacy beyond 1 year not established.1

Gastric Ulcer
Benign Gastric Ulcer
Oral

30 mg once daily for up to 8 weeks.1 2

NSAIA-induced Gastric Ulcer
Treatment
Oral

30 mg once daily for 8 weeks.1

Risk Reduction
Oral

15 mg once daily for up to 12 weeks.1 171

Pathologic GI Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome)
Oral

60 mg once daily initially.1 2 24 25 28 Adjust dosage according to patient response and tolerance; continue therapy as long as necessary.1 2 3 5 May require dosages of up to 90 mg twice daily.1 3 5 10 24 25 26 27 43 Administer daily dosages >120 mg in divided doses.1 7 43 Patients with Zollinger-Ellison syndrome have been treated for up to 4 years.1

Special Populations

Hepatic Impairment

Consider dosage reduction in patients with severe hepatic impairment.1 22 24 36 134

Renal Impairment

Lansoprazole dosage adjustment not necessary.1 24 36 Kit containing lansoprazole, amoxicillin, and clarithromycin (Prevpac) not recommended for use in patients with Clcr <30 mL/minute.134

Geriatric Patients

Lansoprazole dosage adjustment not necessary.1 33 34

Cautions for Lansoprazole

Contraindications

  • Known severe hypersensitivity to lansoprazole or any ingredient in the formulation.1 191 254

Warnings/Precautions

Gastric Malignancy

Response to lansoprazole therapy does not preclude presence of occult gastric neoplasm.1 134

Clostridium difficile Infection

Proton-pump inhibitors associated with possible increased (1.4–2.75 times) risk of Clostridium difficile infection, including C. difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis).335 336 339 340 Many patients also had other risk factors for CDAD.335 May be severe; colectomy and, rarely, death reported.335

Use the lowest effective dosage and shortest duration of therapy appropriate for the patient's clinical condition.335

Consider CDAD if persistent diarrhea develops and manage accordingly; initiate supportive therapy (e.g., fluid and electrolyte management), anti-infective therapy directed against C. difficile (e.g., metronidazole, vancomycin), and surgical evaluation as clinically indicated.335 336

Phenylketonuria

Each 15- or 30-mg Prevacid Solu-Tab™ orally disintegrating tablet contains aspartame, which is metabolized in the GI tract to provide 2.5 or 5.1 mg of phenylalanine, respectively.1

Respiratory Effects

Administration of proton-pump inhibitors has been associated with an increased risk for developing certain infections (e.g., community-acquired pneumonia).176 177

Bone Fracture

Several observational studies suggest that use of proton-pump inhibitors, particularly in high dosages (i.e., multiple daily doses) and/or for prolonged periods of time (i.e., ≥1 year), may be associated with increased risk of osteoporosis-related fractures of the hip, wrist, or spine.1 178 300 301 302 303 304 305 Magnitude of risk is unclear;178 300 301 302 303 304 305 310 causality not established.305 FDA is continuing to evaluate this safety concern.305

Use the lowest effective dosage and shortest duration of therapy appropriate for the patient’s clinical condition.1 178 301 303 305 307

Individuals at risk for osteoporosis-related fractures should receive an adequate intake of calcium and vitamin D; assess and manage these patients’ bone health according to current standards of care.1 178 303 305 307

Hypomagnesemia

Hypomagnesemia, symptomatic and asymptomatic, reported rarely in patients receiving long-term therapy (≥3 months or, in most cases, >1 year) with proton-pump inhibitors, including lansoprazole.1 317 318 319 320 321 322 323 324 325 326 327 328 329 330 Serious adverse effects include tetany, seizures, tremors, carpopedal spasm, arrhythmias (e.g., atrial fibrillation, supraventricular tachycardia), and abnormal QT interval.1 318 319 321 322 323 325 327 328 329 Paresthesia, muscle weakness, muscle cramps, lethargy, fatigue, and unsteadiness may occur.319 320 321 325 330 Most patients required magnesium replacement and discontinuance of the proton-pump inhibitor.1 317 319 321 322 323 324 325 326 327 330 Hypomagnesemia resolved within 1 week (median) following discontinuance and recurred within 2 weeks (median) of rechallenge.327

In patients expected to receive long-term proton-pump inhibitor therapy or in patients currently receiving digoxin or drugs that may cause hypomagnesemia (e.g., diuretics), consider measuring serum magnesium concentrations prior to initiation of prescription proton-pump inhibitor therapy and periodically thereafter.1 319 326 327 328 330

Use of Combination Preparations

When kits containing lansoprazole and other agents (anti-infectives) are used, consider the cautions, precautions, and contraindications associated with the concomitant agent(s).134

Specific Populations

Pregnancy

Category B.1

Lactation

Distributed into milk in rats; not known whether distributed into human milk.1 134 Discontinue nursing or the drug.1 134

Pediatric Use

Safety and efficacy of oral lansoprazole established for short-term treatment of symptomatic GERD and erosive esophagitis in patients 1–17 years of age.1

Oral lansoprazole is not recommended in infants <1 year of age; the drug was no more effective than placebo in a controlled study in infants 1 month to <1 year of age with symptomatic GERD.1

Safety and efficacy for self-medication of frequent heartburn not established in children <18 years of age.191

Geriatric Use

No substantial differences in efficacy and safety of oral lansoprazole in geriatric patients relative to younger adults.1

Hepatic Impairment

Increased systemic exposure (AUC) and decreased clearance.1 134 Consider dosage reduction in patients with severe hepatic impairment.1 22 24 36 134

Common Adverse Effects

In children 1–11 years of age, constipation and headache.1 In children 12–17 years of age, headache, abdominal pain, nausea, dizziness.1 Pediatric adverse effect profile similar to that in adults.1

In adults receiving oral lansoprazole, diarrhea, abdominal pain, nausea, constipation.1 134

Interactions for Lansoprazole

Metabolized by CYP2C19 and CYP3A.1 134 189 190

Drugs Metabolized by Hepatic Microsomal Enzymes

Unlikely to have clinically important interaction with drugs metabolized by CYP3A, 1A2, 2C9, 2C19, 2D6.1 134

Drugs that Cause Hypomagnesemia

Potential pharmacologic interaction (possible increased risk of hypomagnesemia).327 Consider monitoring magnesium concentrations prior to initiation of prescription proton-pump inhibitor therapy and periodically thereafter.1 327 (See Hypomagnesemia under Cautions.)

Specific Drugs

Drug

Interaction

Comments

Amoxicillin

No evidence of clinically important interaction 1 134

Antacids

Administered concomitantly with lansoprazole in clinical studies1 134

Antipyrine

No evidence of clinically important interaction 1 134

Atazanavir

Possible altered oral absorption of atazanavir, resulting in decreased plasma atazanavir concentrations;1 134 possible loss of virologic response180

Manufacturer of lansoprazole states that concomitant administration with atazanavir is not recommended1 134

Antiretroviral treatment-naive patients: If a proton-pump inhibitor is used concomitantly with atazanavir, administer ritonavir-boosted atazanavir (atazanavir 300 mg and ritonavir 100 mg once daily with food); administer the proton-pump inhibitor approximately 12 hours before ritonavir-boosted atazanavir179 180

For treatment-naive patients, dosage of proton-pump inhibitor should not exceed omeprazole 20 mg daily (or equivalent)179 180

Antiretroviral treatment-experienced patients: Concomitant use of proton-pump inhibitors with atazanavir not recommended179 180

Clarithromycin

No evidence of clinically important interaction 1 134

Clopidogrel

Certain CYP2C19 inhibitors (e.g., omeprazole, esomeprazole) reduce exposure to clopidogrel’s active metabolite and decrease platelet inhibitory effects; potentially may reduce clopidogrel’s clinical efficacy.186 224 225 228 232 233 236 311 350

Dexlansoprazole, lansoprazole, or pantoprazole had less effect on clopidogrel's antiplatelet activity than did omeprazole or esomeprazole;224 350 351

Lansoprazole decreased exposure to the metabolite by about 14%;1 350 observed effects on metabolite exposure and clopidogrel-induced platelet inhibition not considered clinically important1 350

Manufacturer of lansoprazole states clopidogrel dosage adjustment not required if used with recommended lansoprazole dosages1

Assess risks and benefits of concomitant proton-pump inhibitor and clopidogrel use in individual patients237 240 243 248 250

American College of Cardiology Foundation/American College of Gastroenterology/American Heart Association (ACCF/ACG/AHA) states that GI bleeding risk reduction with concomitant proton-pump inhibitor in patients with risk factors for GI bleeding (e.g., advanced age; concomitant use of warfarin, corticosteroids, or NSAIAs); H. pylori infection) may outweigh potential reduction in cardiovascular efficacy of antiplatelet treatment associated with a drug-drug interaction.311 In patients without such risk factors, ACCF/ACG/AHA states that risk/benefit balance may favor use of antiplatelet therapy without a proton-pump inhibitor.311

If concomitant therapy with a proton-pump inhibitor and clopidogrel is deemed necessary, consider using an agent with little or no CYP2C19-inhibitory activity;186 187 224 230 253 350 alternatively, consider using a histamine H2-receptor antagonist (ranitidine, famotidine, nizatidine)186 187 230 but not cimetidine (also a potent CYP2C19 inhibitor)232 233

Diazepam

No evidence of clinically important interaction 1 134

Digoxin

Hypomagnesemia (e.g., resulting from long-term use of proton-pump inhibitors) sensitizes the myocardium to digoxin and, thus, may increase risk of digoxin-induced cardiotoxic effects327 331

See table entry for gastric pH-dependent drugs

Consider monitoring magnesium concentrations prior to initiation of prescription proton-pump inhibitor therapy and periodically thereafter1 327

Diuretics (i.e., loop or thiazide diuretics)

Possible increased risk of hypomagnesemia327

Consider monitoring magnesium concentrations prior to initiation of prescription proton-pump inhibitor therapy and periodically thereafter1 327

Fosamprenavir

Use of esomeprazole with fosamprenavir (with or without ritonavir) did not substantially affect concentrations of amprenavir (active metabolite of fosamprenavir)345

No dosage adjustment required when proton-pump inhibitors used with fosamprenavir (with or without ritonavir)179 345

Gastric pH-dependent drugs (e.g., ampicillin esters, digoxin, iron salts, ketoconazole)

Lansoprazole may alter drug absorption1 134

Ibuprofen

No evidence of clinically important interaction 1 134

Indomethacin

No evidence of clinically important interaction 1 134

Lopinavir

Lopinavir/ritonavir: Omeprazole had no clinically important effect on plasma concentrations or AUC of lopinavir179 344

No dosage adjustment required when proton-pump inhibitors used with lopinavir/ritonavir179

Methotrexate

Possible delayed clearance and increased serum concentrations of methotrexate and/or its metabolite hydroxymethotrexate; possible methotrexate toxicity1 333 334

Reported mainly with high-dose methotrexate (300 mg/m2 to 12 g/m2),1 333 but also reported with low dosages (e.g., 15 mg per week)333

Manufacturer of lansoprazole recommends considering temporary discontinuance of proton-pump inhibitor therapy in some patients receiving high-dose methotrexate1

Some clinicians recommend withholding the proton-pump inhibitor for several days before and after administration of either high-dose or low-dose methotrexate or, alternatively, substituting a histamine H2-receptor antagonist for the proton-pump inhibitor333 334

Phenytoin

No evidence of clinically important interaction 1 134

Prednisone

No evidence of clinically important interaction 1 134

Propranolol

No evidence of clinically important interaction 1 134

Raltegravir

Omeprazole increased peak plasma concentration and AUC of raltegravir179 348

No dosage adjustment recommended when proton-pump inhibitors used with raltegravir179 348

Rilpivirine

Omeprazole decreased plasma concentrations and AUC of rilpivirine179 343

Concomitant use of rilpivirine and proton-pump inhibitors contraindicated179 343

Saquinavir

Ritonavir-boosted saquinavir: Omeprazole increased peak plasma concentration and AUC of saquinavir179 346

Caution advised if proton-pump inhibitor used with ritonavir-boosted saquinavir; monitor for saquinavir toxicity179 346

Sucralfate

Lansoprazole absorption delayed, bioavailability decreased1 134

Administer at least 30 minutes before sucralfate1 134

Tacrolimus

Possible increased concentrations of tacrolimus, particularly in transplant patients who are intermediate or poor metabolizers of CYP2C19 substrates1

Theophylline

Minor increase in theophylline clearance1 134

Usually not clinically important; may require theophylline dosage adjustment when lansoprazole is initiated or discontinued1 134

Warfarin

May increase PT and INR1 134

May need to monitor PT and INR1 134

Lansoprazole Pharmacokinetics

Absorption

Bioavailability

Well absorbed from GI tract (absolute bioavailability >80%).1 134 Peak plasma concentrations attained about 1.7 hours after oral administration.1 134

Onset

Increased gastric pH occurred within 1–2 or 2–3 hours after a single 30- or 15-mg oral dose, respectively.1 134

Duration

Gastric acid secretion normalized over 2–4 days after discontinuance; no apparent rebound.1 134

Food

Absorption (peak plasma concentration, AUC) decreased by 50–70% when administered 30 minutes after food.1 134 No substantial food effect when administered before meals.1 134

Special Populations

Peak plasma concentration and time to peak plasma concentration in patients with renal impairment similar to healthy individuals.1 134

Peak plasma concentrations were comparable in patients in Asian and US studies.1 134

Distribution

Extent

Distributed into milk in rats; not known whether distributed into human milk.1 134

Prolonged binding to gastric parietal proton pump enzyme.1

Plasma Protein Binding

97%.1

Special Populations

Severe renal impairment decreased plasma protein binding by 1–1.5% after administration of 60 mg dose.1 134

Elimination

Metabolism

In parietal cell secretory canaliculi, thought to be transformed into 2 active sulfenamide metabolites not present in systemic circulation.1 2 4 9 19 33 134 Also metabolized in the liver by CYP3A and CYP2C19.1 134 189 190 Metabolites found in plasma are inactive.1 134

Lansoprazole is a racemic mixture of R- and S-isomers.188 189 Plasma clearance of the R-isomer (dexlansoprazole) is slower than that of the S-isomer; plasma concentrations of the R-isomer are markedly higher than those of the S-isomer.188 189

Elimination Route

Excreted principally in feces (about 67%) with remainder in urine; no unchanged drug excreted in urine.1 134

Half-life

<2 hours.1 134

Special Populations

Hepatic impairment increased plasma half-life to 3.2–7.2 hours.1 134

Renal impairment decreased elimination half-life.1 134

Stability

Storage

Oral

Capsules and Orally Disintegrating Tablets

25°C (may be exposed to 15–30°C).1

Capsules for Self-medication

20–25°C; protect from high heat, humidity, and moisture.191

Prevpac Kit

20–25°C.134 Protect from light and moisture.134

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Oral

Capsules

Immediately use extemporaneous mixtures of capsule contents and food or juice.1 (See Oral Administration under Dosage and Administration.)

Actions

  • Inhibits basal and stimulated gastric acid secretion.1 2 3 4

  • Concentrates in acid conditions of parietal cell secretory canaliculi; forms active sulfenamide metabolite that irreversibly binds to and inactivates hydrogen-potassium ATPase (proton or acid pump), blocking final step in secretion of hydrochloric acid.1 2 4 9 18 19 33

  • Acid secretion is inhibited until additional hydrogen-potassium ATPase is synthesized, resulting in prolonged duration of action.9 21 24 25 33 43 125

  • Lansoprazole is a racemic mixture of R- and S-isomers.188 189 Both isomers inhibit hydrogen-potassium ATPase.188 189

  • Combined therapy with lansoprazole and appropriate anti-infectives (i.e., amoxicillin, clarithromycin) can effectively eradicate H. pylori infection.1 3 16 103 104 134

Advice to Patients

  • Importance of taking before a meal.1 191

  • Importance of swallowing capsule intact, without crushing or chewing.1 191

  • For orally disintegrating tablets, importance of allowing tablet to dissolve on tongue with or without water, then swallowing particles without chewing.1

  • If capsule contents are mixed with food or juice, importance of immediately swallowing mixture without crushing or chewing.1

  • Importance of advising patients that use of multiple daily doses of the drug for an extended period of time may increase the risk of fractures of the hip, wrist, or spine.1 305

  • Risk of hypomagnesemia; importance of immediately reporting and seeking care for any cardiovascular or neurologic manifestations (e.g., palpitations, dizziness, seizures, tetany).1

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.1 134 191 Antacids may be used concomitantly as needed for pain relief.1 2 3 4

  • Importance of women informing their clinicians if they are or plan to become pregnant or plan to breast-feed.1 134 191

  • Importance of informing patients with phenylketonuria that orally disintegrating tablets contain aspartame.1

  • Possible increased risk of Clostridium difficile infection; importance of contacting a clinician if persistent watery stools, abdominal pain, and fever occur.335

  • Importance of following dosage instructions when lansoprazole is used for self-medication.191 Advise patients that they should use the drug for self-medication only as directed for no longer than 14 days of continuous use and that they should not exceed one course of therapy every 4 months.305

    Importance of discontinuing use as self-medication and consulting a clinician if heartburn persists or worsens, use of the drug for >14 days is needed, or >1 course of therapy is required every 4 months.191

  • Self-medication with lansoprazole is not intended for immediate relief of heartburn; may relieve symptoms within 24 hours, but 1–4 days may be required for complete relief.191

  • Advise patients to consult their clinician before using lansoprazole for self-medication if they have liver disease, have had heartburn for >3 months, or are experiencing heartburn with lightheadedness, dizziness, or sweating; chest or shoulder pain with shortness of breath, sweating, lightheadedness, or pain spreading to the arms, neck, or shoulders; frequent chest pain; frequent wheezing (especially with heartburn); unexplained weight loss; nausea or vomiting; or stomach pain.191

  • Advise patients not to use lansoprazole for self-medication and to consult a clinician if they have difficulty or pain with swallowing, are vomiting blood, or have bloody or blackened stools.191

  • Importance of informing patients of other important precautionary information.1 134 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Lansoprazole

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Capsules, delayed-release (containing enteric-coated granules)

15 mg*

Lansoprazole Delayed-Release Capsules

Prevacid

Takeda

Prevacid 24HR

Novartis

30 mg*

Lansoprazole Delayed-Release Capsules

Prevacid

Takeda

Tablets, delayed-release (containing enteric-coated microgranules), orally disintegrating

15 mg

Prevacid SoluTab

Takeda

30 mg

Prevacid SoluTab

Takeda

Lansoprazole Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Kit

4 Capsules, Amoxicillin (trihydrate) 500 mg (of amoxicillin)

2 Capsules, delayed-release (containing enteric-coated granules), Lansoprazole, 30 mg (Prevacid)

2 Tablets, film-coated, Clarithromycin, 500 mg (Biaxin Filmtab)

Prevpac

Takeda

AHFS DI Essentials. © Copyright 2018, Selected Revisions January 31, 2013. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

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3. Spencer CM, Faulds D. Lansoprazole: a reappraisal of its pharmacodynamic and pharmacokinetic properties, and its therapeutic efficacy in acid-related disorders. Drugs. 1994; 48:403-30.

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9. Sachs G, Shin JM, Besancon M et al. The continuing development of gastric acid pump inhibitors. Altern Pharmacol Ther. 1993; 7(Suppl 1):4-12.

10. Nagata K, Takagi E, Tsuda M et al. Inhibitory action of lansoprazole and its analogs against helicobacter pylori: inhibition of growth is not related to inhibition of urease. Antimicrob Agents Chemother. 1995; 39:567-70. http://www.ncbi.nlm.nih.gov/pubmed/7726537?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=162584&blobtype=pdf

11. Verdü EF, Fraser R, Armstrong D et al. Effects of omeprazole and lansoprazole on 24-hour intragastric pH in helicobacter pylori-positive volunteers. Scand J Gastroenterol. 1994; 29:1065-9. http://www.ncbi.nlm.nih.gov/pubmed/7886393?dopt=AbstractPlus

12. Lanza F, Goff J, Scowcroft C et al. Double-blind comparison of lansoprazole, ranitidine, and placebo in the treatment of acute duodenal ulcer. Am J Gastroenterol. 1994; 89:1191-200. http://www.ncbi.nlm.nih.gov/pubmed/8053433?dopt=AbstractPlus

13. Hawkey CJ, Long RG, Bardham KD et al. Improved symptom relief and duodenal ulcer healing with lansoprazole, a new proton pump inhibitor, compared with ranitidine. Gut. 1993; 34:1458-62. http://www.ncbi.nlm.nih.gov/pubmed/8244121?dopt=AbstractPlus http://www.pubmedcentral.nih.gov/picrender.fcgi?tool=pmcentrez&artid=1374562&blobtype=pdf

14. Ekstrom P, Carling L, Unge P et al. Lansoprazole versus omeprazole in active duodenal ulcer. Scand J Gastroenterol. 1995; 30:210-5. http://www.ncbi.nlm.nih.gov/pubmed/7770708?dopt=AbstractPlus

15. Hongo M, Ohara S, Hirasawa Y et al. Effect of lansoprazole on intragastric pH: comparison between morning and evening dosing. Dig Dis Sci. 1992; 37:882-90. http://www.ncbi.nlm.nih.gov/pubmed/1534047?dopt=AbstractPlus

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