Lansoprazole (Monograph)

Brand names: Prevacid, Prevpac
Drug class: Proton-pump Inhibitors

Medically reviewed by Drugs.com on Jun 10, 2024. Written by ASHP.

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^{† [off-label]}.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^{† [off-label]}, 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

Administer orally before a meal.¹ ³ ⁴³ ¹⁹¹

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

Extemporaneously Compounded Oral Suspension

An extemporaneously compounded 3 mg/mL oral suspension of lansoprazole has been prepared using the commercially available capsules and an 8.4% sodium bicarbonate vehicle.²⁵⁵ ²⁵⁶ An extemporaneous suspension also has been prepared by pulverizing one 30-mg enteric-coated microgranule tablet in 10 mL of Ora-Blend to provide a suspension containing 3 mg/mL.²⁵⁷

Standardize 4 Safety

Standardized concentrations for an extemporaneously prepared oral suspension of lansoprazole have been established through Standardize 4 Safety (S4S), a national patient safety initiative to reduce medication errors, especially during transitions of care.²⁵² Because recommendations from the S4S panels may differ from the manufacturer’s prescribing information, caution is advised when using concentrations that differ from labeling, particularly when using rate information from the label²⁵² . For additional information on S4S (including updates that may be available), see [Web].²⁵²

Table 1: Standardize 4 Safety Compounded Oral Liquid Standards for Lansoprazole252
Concentration Standards
3 mg/mL

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 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 Cl_cr <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

Drug Interactions

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

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.)

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

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

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

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