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, Prevacid NapraPAC, Prevpac
Special Alerts:
[Posted 03/02/2011] ISSUE: FDA notified healthcare professionals and the public that prescription proton pump inhibitor (PPI) drugs may cause low serum magnesium levels (hypomagnesemia) if taken for prolonged periods of time (in most cases, longer than one year). Low serum magnesium levels can result in serious adverse events including muscle spasm (tetany), irregular heartbeat (arrhythmias), and convulsions (seizures); however, patients do not always have these symptoms. Treatment of hypomagnesemia generally requires magnesium supplements. In approximately one-quarter of the cases reviewed, magnesium supplementation alone did not improve low serum magnesium levels and the PPI had to be discontinued.
BACKGROUND: PPIs work by reducing the amount of acid in the stomach and are used to treat conditions such as gastroesophageal reflux disease (GERD), stomach and small intestine ulcers, and inflammation of the esophagus.
RECOMMENDATION: Healthcare professionals should consider obtaining serum magnesium levels prior to initiation of prescription PPI treatment in patients expected to be on these drugs for long periods of time, as well as patients who take PPIs with medications such as digoxin, diuretics or drugs that may cause hypomagnesemia. For patients taking digoxin, a heart medicine, this is especially important because low magnesium can increase the likelihood of serious side effects. Healthcare professionals should consider obtaining magnesium levels periodically in these patients. For additional information, refer to the Data Summary section of the FDA Drug Safety Communication. For more information visit the FDA website at: and .
[Posted 05/25/2010] FDA notified healthcare professionals and patients of revisions to the prescription and over-the-counter [OTC] labels for proton pump inhibitors, which work by reducing the amount of acid in the stomach, to include new safety information about a possible increased risk of fractures of the hip, wrist, and spine with the use of these medications.
The new safety information is based on FDA's review of several epidemiological studies that found those at greatest risk for these fractures received high doses of proton pump inhibitors or used them for one year or more. The majority of the studies evaluated individuals 50 years of age or older and the increased risk of fracture primarily was observed in this age group. While the greatest increased risk for fractures in these studies involved people who had been taking prescription proton pump inhibitors for at least one year or who had been taking high doses of the prescription medications (not available over-the-counter), as a precaution, the “Drug Facts” label on the OTC proton pump inhibitors (indicated for 14 days of continuous use) also is being revised to include information about this risk. FDA recommends healthcare professionals, when prescribing proton pump inhibitors, should consider whether a lower dose or shorter duration of therapy would adequately treat the patient's condition.
The safety communication includes a data summary with a table and references which support the epidemiological studies reviewed for this communication. For more information visit the FDA website at: and .
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
IV as short-term (up to 7 days) alternative to oral therapy for the treatment of erosive esophagitis in adults unable to continue taking the drug orally; safety and efficacy of IV lansoprazole not established for initial treatment.170
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.1 171
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
Pathologic GI Hypersecretory Conditions
Long-term treatment of pathologic hypersecretory conditions (e.g., Zollinger-Ellison syndrome with or without multiple endocrine adenoma).1
Lansoprazole Dosage and Administration
Administration
Oral Administration
Administer orally before a meal.1 3 43 171 191
Antacids may be used concomitantly as needed for pain relief.1 2 3 4
Capsules
Swallow capsules intact; do not chew or crush.1 171 191
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
Place orally disintegrating 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
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
Place 15- or 30-mg orally disintegrating 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
IV Administration
For solution compatibility and storage information, see Stability.
Administer by IV infusion over 30 minutes.170
Use inline filter provided by manufacturer to remove precipitates that may form when lansoprazole is mixed with IV solutions; follow manufacturer's instructions for priming the filter and precautions regarding its use.170
Flush the IV line with ≥5 mL of 5% dextrose, lactated Ringer's, or 0.9% sodium chloride injection before administration; then attach the administration set and inline filter to the IV port and infuse the drug.170 After administering the dose, remove and discard the administration set, including filter, and flush the IV line with ≥5 mL of 5% dextrose, lactated Ringer's, or 0.9% sodium chloride injection.170
Failure to flush the IV line or discard the administration set may result in degradation of lansoprazole and formation of black or brown precipitate in the IV tubing or inline filter.170
Do not administer with any other drugs or diluents because of potential incompatibilities.170
Reconstitution and Dilution
Reconstitute vial containing 30 mg of lansoprazole with 5 mL of sterile water for injection to provide a solution containing 6 mg/mL.170 Dilute reconstituted solution in 50 mL of 5% dextrose, lactated Ringer's, or 0.9% sodium chloride injection prior to administration.170
Alternatively, connect vial containing 30 mg of lansoprazole powder for injection to a Mini-Bag Plus Container containing 50 mL of 5% dextrose or 0.9% sodium chloride injection and reconstitute according to manufacturer's directions.170 181
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
IV
30 mg once daily for up to 7 days.170 Discontinue IV administration as soon as patient can resume oral lansoprazole therapy.170
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 36 134 170 171
Renal Impairment
Lansoprazole dosage adjustment not necessary.1 24 36 170 171 Kit containing lansoprazole, amoxicillin, and clarithromycin (Prevpac) or lansoprazole and naproxen (PrevacidNapraPAC) not recommended for use in patients with Clcr <30 mL/minute.134 171
Geriatric Patients
Lansoprazole dosage adjustment not necessary.1 33 34 170 171
Cautions for Lansoprazole
Contraindications
Known severe hypersensitivity to lansoprazole, any ingredient in the formulation, or to other substituted benzimidazoles (e.g., esomeprazole, omeprazole, pantoprazole, rabeprazole).1 170 171 191 b
Warnings/Precautions
GI Effects
Response to lansoprazole therapy does not preclude presence of occult gastric neoplasm.1 134 170 171
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
Hip 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.178 300 301 302 303 304 305 309 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.178 301 303 305 307 309
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.178 303 305 307 309
Use of Combination Preparations
When kits containing lansoprazole and other agents (NSAIAs, anti-infectives) are used, consider the cautions, precautions, and contraindications associated with the concomitant agent(s).134 171
Specific Populations
Pregnancy
Category B.1 170
Lactation
Distributed into milk in rats; not known whether distributed into human milk.1 134 170 171 Discontinue nursing or the drug.1 134 170 171
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
Safety and efficacy of IV lansoprazole not established in pediatric patients.170
Geriatric Use
No substantial differences in efficacy and safety of oral lansoprazole in geriatric patients relative to younger adults.1 170 171 Clinical data regarding use of IV lansoprazole in geriatric patients are limited.170
Hepatic Impairment
Increased systemic exposure (AUC) and decreased clearance.1 134 170 171 Consider dosage reduction in patients with severe hepatic impairment.1 22 24 36 134 170 171
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.1 134 170 171 In adults receiving IV lansoprazole, headache, injection site pain, injection site reaction, nausea.170
Interactions for Lansoprazole
Metabolized by CYP2C19 and CYP3A.1 134 170 171 189 190
Drugs Metabolized by Hepatic Microsomal Enzymes
Unlikely to have clinically important interaction with drugs metabolized by CYP3A, 1A2, 2C9, 2C19, 2D6.1 134 170 171
Specific Drugs
Drug | Interaction | Comments |
|---|---|---|
Amoxicillin | No evidence of clinically important interaction 1 134 171 | |
Antacids | Administered concomitantly with lansoprazole in clinical studies1 134 171 | |
Antipyrine | No evidence of clinically important interaction 1 134 170 171 | |
Atazanavir | Possible altered oral absorption of atazanavir, resulting in decreased plasma atazanavir concentrations;1 134 171 possible loss of virologic response180 | Manufacturer of lansoprazole states that concomitant administration with atazanavir is not recommended1 134 171 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 1 134 170 171 | |
Clopidogrel | Certain CYP2C19 inhibitors (e.g., omeprazole) 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 Extent to which other proton-pump inhibitors (which may differ in CYP2C19-inhibitory potency) may interfere with clopidogrel's effects is unknown182 183 184 224 232 317 | 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 |
Diazepam | No evidence of clinically important interaction 1 134 170 171 | |
Gastric pH-dependent drugs (e.g., ampicillin esters, digoxin, iron salts, ketoconazole) | Lansoprazole may alter drug absorption1 134 170 171 | |
Ibuprofen | No evidence of clinically important interaction 1 134 170 171 | |
Indomethacin | No evidence of clinically important interaction 1 134 170 171 | |
Phenytoin | No evidence of clinically important interaction 1 134 170 171 | |
Prednisone | No evidence of clinically important interaction 1 134 170 171 | |
Propranolol | No evidence of clinically important interaction 1 134 170 171 | |
Sucralfate | Lansoprazole absorption delayed, bioavailability decreased1 134 171 | Administer at least 30 minutes before sucralfate1 134 171 |
Theophylline | Minor increase in theophylline clearance1 134 170 171 | Usually not clinically important; may require theophylline dosage adjustment when lansoprazole is initiated or discontinued1 134 170 171 |
Warfarin | May increase PT and INR1 134 170 171 | May need to monitor PT and INR1 134 170 171 |
Lansoprazole Pharmacokinetics
Absorption
Bioavailability
Well absorbed from GI tract (absolute bioavailability >80%).1 134 171 Peak plasma concentrations attained about 1.7 hours after oral administration.1 134 171
Onset
Increased gastric pH occurred within 1–2 or 2–3 hours after a single 30- or 15-mg oral dose, respectively.1 134 171
Duration
Gastric acid secretion normalized over 2–4 days after discontinuance; no apparent rebound.1 134 171
Food
Absorption (peak plasma concentration, AUC) decreased by 50–70% when administered 30 minutes after food.1 134 171 No substantial food effect when administered before meals.1 134 171
Special Populations
Peak plasma concentration and time to peak plasma concentration in patients with renal impairment similar to healthy individuals.1 134 171
Peak plasma concentrations were comparable in patients in Asian and US studies.1 134 171
Distribution
Extent
Distributed into milk in rats; not known whether distributed into human milk.1 134 171
Prolonged binding to gastric parietal proton pump enzyme.1
Plasma Protein Binding
97%.1 170 171
Special Populations
Severe renal impairment decreased plasma protein binding by 1–1.5% after administration of 60 mg dose.1 134 170 171
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 33 134 170 171 Also metabolized in the liver by CYP3A and CYP2C19.1 134 170 171 189 190 Metabolites found in plasma are inactive.1 134 170 171
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.1 134 170 171
Half-life
<2 hours.1 134 170 171
Special Populations
Hepatic impairment increased plasma half-life to 3.2–7.2 hours.1 134 170 171
Renal impairment decreased elimination half-life.1 134 170 171
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
Prevacid NapraPAC Kit
25°C (may be exposed to 15–30°C).171 Protect from light and moisture.171 Store and dispense in original container.171
Prevpac Kit
20–25°C.134 Protect from light and moisture.134
Parenteral
Powder for IV Infusion
Powder: 25°C (may be exposed to 15–30°C).170 Protect from light.170
Reconstituted 6-mg/mL solution: 25°C for up to 1 hour before further dilution.170 Following dilution, 25°C for up to 12 hours (in 50 mL of 5% dextrose injection) or 24 hours (in 50 mL of lactated Ringer's or 0.9% sodium chloride injection).170
In Mini-Bag Plus Container: 25°C for up to 8 hours (in 50 mL of 5% dextrose injection) or 24 hours (in 50 mL of 0.9% sodium chloride injection).170
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.)
Parenteral
Solution Compatibility
Reconstitute powder with sterile water for injection; use of other diluents may result in precipitate or particulate formation.170 Further dilution in 5% dextrose, lactated Ringer's, or 0.9% sodium chloride injection recommended by manufacturer.170
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.1 171 191
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.305 309
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.1 134 170 171 191 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.1 134 170 171 191
Importance of informing patients with phenylketonuria that orally disintegrating tablets contain aspartame.1
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
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.1 134 170 171 (See Cautions.)
Preparations
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
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 |
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