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
Uses for Lansoprazole
Gastroesophageal Reflux (GERD)
Short-term treatment of symptomatic GERD (e.g., heartburn).1
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
Short-term treatment and symptomatic relief of active benign gastric ulcer.1
NSAIA-induced Gastric Ulcer
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
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
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
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
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 EsophagitisOral
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
Chronic, lifelong therapy with proton-pump inhibitor is appropriate for many GERD patients.156
15 mg once daily for up to 8 weeks.1
Treatment of Erosive EsophagitisOral
Maintenance of Healing of Erosive EsophagitisOral
Self-medication for Frequent HeartburnOral
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
Treatment of Active Duodenal UlcerOral
Treatment of Helicobacter pylori Infection and Duodenal UlcerOral
Dual therapy: 30 mg every 8 hours for 14 days in conjunction with amoxicillin.1
Maintenance of Duodenal Ulcer HealingOral
Benign Gastric UlcerOral
NSAIA-induced Gastric Ulcer
30 mg once daily for 8 weeks.1
Pathologic GI Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome)
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
Cautions for Lansoprazole
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
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
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
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, 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
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
No substantial differences in efficacy and safety of oral lansoprazole in geriatric patients relative to younger adults.1
Common Adverse Effects
Interactions for Lansoprazole
Drugs Metabolized by Hepatic Microsomal Enzymes
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.)
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
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
Manufacturer of lansoprazole states clopidogrel dosage adjustment not required if used with recommended lansoprazole dosages1
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
See table entry for gastric pH-dependent drugs
Diuretics (i.e., loop or thiazide diuretics)
Possible increased risk of hypomagnesemia327
Use of esomeprazole with fosamprenavir (with or without ritonavir) did not substantially affect concentrations of amprenavir (active metabolite of fosamprenavir)345
Gastric pH-dependent drugs (e.g., ampicillin esters, digoxin, iron salts, ketoconazole)
No dosage adjustment required when proton-pump inhibitors used with lopinavir/ritonavir179
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
Possible increased concentrations of tacrolimus, particularly in transplant patients who are intermediate or poor metabolizers of CYP2C19 substrates1
Prolonged binding to gastric parietal proton pump enzyme.1
Plasma Protein Binding
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
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
For information on systemic interactions resulting from concomitant use, see Interactions.
Immediately use extemporaneous mixtures of capsule contents and food or juice.1 (See Oral Administration under Dosage and Administration.)
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
Advice to Patients
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
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 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
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Capsules, delayed-release (containing enteric-coated granules)
Lansoprazole Delayed-Release Capsules
Lansoprazole Delayed-Release Capsules
Tablets, delayed-release (containing enteric-coated microgranules), orally disintegrating
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)
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Amoxicillin 250MG Capsules (TEVA PHARMACEUTICALS USA): 90/$17.99 or 180/$25.97
Amoxicillin 500MG Capsules (SANDOZ): 30/$15.99 or 60/$20.97
Biaxin 250MG Tablets (ABBOTT): 60/$361.00 or 180/$1,025.97
Biaxin 500MG Tablets (ABBOTT): 20/$129.98 or 60/$369.98
Clarithromycin 250MG Tablets (SANDOZ): 30/$148.99 or 90/$426.99
Clarithromycin 500MG Tablets (TEVA PHARMACEUTICALS USA): 30/$125.99 or 90/$355.96
Lansoprazole 15MG Delayed-release Capsules (SANDOZ): 30/$105.99 or 90/$263.97
Lansoprazole 15MG Dispersible Tablets (SANDOZ): 30/$162.98 or 90/$466.95
Lansoprazole 30MG Delayed-release Capsules (SANDOZ): 30/$99.99 or 90/$245.97
Lansoprazole 30MG Dispersible Tablets (SANDOZ): 30/$162.98 or 90/$466.95
Prevacid 15MG Delayed-release Capsules (TAKEDA PHARMACEUTICALS): 30/$213.98 or 90/$617.99
Prevacid SoluTab 15MG Dispersible Tablets (TAKEDA PHARMACEUTICALS): 100/$631.98 or 300/$1,850.93
Prevacid SoluTab 30MG Dispersible Tablets (TAKEDA PHARMACEUTICALS): 30/$198.99 or 90/$567.94
AHFS DI Essentials. © Copyright, 2004-2016, Selected Revisions January 31, 2013. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
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