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Lansoprazole

Pronunciation

Pronunciation

(lan SOE pra zole)

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule Delayed Release, Oral:

GoodSense Lansoprazole: 15 mg [gluten free; contains brilliant blue fcf (fd&c blue #1), fd&c yellow #10 (quinoline yellow)]

Heartburn Relief 24 Hour: 15 mg [DSC] [sodium free; contains brilliant blue fcf (fd&c blue #1), fd&c red #40, fd&c yellow #10 (quinoline yellow)]

Heartburn Treatment 24 Hour: 15 mg [sodium free; contains brilliant blue fcf (fd&c blue #1), fd&c yellow #10 (quinoline yellow)]

Prevacid: 15 mg, 30 mg [contains brilliant blue fcf (fd&c blue #1), fd&c red #40]

Prevacid 24HR: 15 mg [sodium free; contains brilliant blue fcf (fd&c blue #1), fd&c red #40]

Generic: 15 mg, 30 mg

Suspension, Oral:

First-Lansoprazole: 3 mg/mL (90 mL, 150 mL, 300 mL) [contains benzyl alcohol, fd&c red #40, saccharin sodium; strawberry flavor]

Tablet Disintegrating, Oral:

Prevacid SoluTab: 15 mg, 30 mg [contains aspartame]

Brand Names: U.S.

  • First-Lansoprazole
  • GoodSense Lansoprazole [OTC]
  • Heartburn Relief 24 Hour [OTC] [DSC]
  • Heartburn Treatment 24 Hour [OTC]
  • Prevacid
  • Prevacid 24HR [OTC]
  • Prevacid SoluTab

Pharmacologic Category

  • Proton Pump Inhibitor
  • Substituted Benzimidazole

Pharmacology

Decreases acid secretion in gastric parietal cells through inhibition of (H+, K+)-ATPase enzyme system, blocking the final step in gastric acid production.

Absorption

Rapid

Distribution

Vd: Children: 0.61 to 0.9 L/kg; Adults: 15.7 ± 1.9 L

Metabolism

Hepatic via CYP2C19 and 3A4 to inactive metabolites, and in parietal cells to two active metabolites that are not present in systemic circulation

Excretion

Excretion: Feces (67%); urine (33%; 14% to 25% as metabolites and <1% as unchanged drug)

Clearance:

Children: 0.57 to 0.71 L/hour/kg

Adults: 11.1 ± 3.8 L/hour; Hepatic impairment: 3.2 to 7.2 hours

Onset of Action

Gastric acid suppression: Oral: 1 to 3 hours

Time to Peak

Plasma: 1.7 hours

Duration of Action

Gastric acid suppression: Oral: >1 day

Half-Life Elimination

Children: 1.2 to 1.5 hours; Adults: 1.5 ± 1 hour; Elderly: 2 to 3 hours; Hepatic impairment: 3 to 7 hours

Protein Binding

97%

Special Populations: Hepatic Function Impairment

Mean t½ prolonged to 3.2 to 7.2 hours and AUC increased up to 500%.

Special Populations: Elderly

Clearance is decreased with t½ increasing ~50% to 100%. Because mean t½ remains between 1.9 to 2.9 hours, repeated once daily dosing does not accumulate; no adjustment needed.

Use: Labeled Indications

Gastroesophageal reflux disease (GERD): Short-term (up to 8 weeks) treatment of symptomatic GERD; short-term (up to 8 weeks) treatment for all grades of erosive esophagitis; to maintain healing of erosive esophagitis.

Hypersecretory conditions: Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

Peptic ulcer disease: Short-term (4 weeks) treatment of active duodenal ulcers; maintenance treatment of healed duodenal ulcers; as part of a multidrug regimen for H. pylori eradication to reduce the risk of duodenal ulcer recurrence; short-term (up to 8 weeks) treatment of active benign gastric ulcer; treatment of NSAID-associated gastric ulcer; to reduce the risk of NSAID-associated gastric ulcer in patients with a history of gastric ulcer who require an NSAID.

OTC labeling: Relief of frequent heartburn (≥2 days/week)

Contraindications

Hypersensitivity (eg, anaphylaxis, angioedema, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, urticaria) to lansoprazole or any component of the formulation

Canadian labeling: Additional contraindications (not in US labeling): Coadministration with rilpivirine.

Dosing: Adult

Symptomatic GERD: Oral: Short-term treatment: 15 mg once daily for up to 8 weeks

Erosive esophagitis: Oral: Short-term treatment: 30 mg once daily for up to 8 weeks; continued treatment for an additional 8 weeks may be considered for recurrence or for patients who do not heal after the first 8 weeks of therapy. Maintenance therapy: 15 mg once daily; controlled studies did not extend past 12 months of therapy

Hypersecretory conditions: Oral: Initial: 60 mg once daily; adjust dose based upon patient response and to reduce acid secretion to <10 mEq/hour (5 mEq/hour in patients with prior gastric surgery); doses of 90 mg twice daily have been used; administer doses >120 mg/day in divided doses

Peptic ulcer disease:

Duodenal ulcer: Oral: Short-term treatment: 15 mg once daily for 4 weeks; maintenance therapy: 15 mg once daily

Gastric ulcer: Oral: Short-term treatment: 30 mg once daily for up to 8 weeks. Some clinical trial data suggests a dose of 15 mg once daily for up to 8 weeks may also be effective.

Helicobacter pylori eradication: 30 mg 3 times daily administered with amoxicillin 1,000 mg 3 times daily for 14 days or 30 mg twice daily administered with amoxicillin 1,000 mg and clarithromycin 500 mg twice daily for 10 to 14 days

American College of Gastroenterology guidelines (Chey 2007):

Nonpenicillin allergy: 30 mg twice daily administered with amoxicillin 1,000 mg and clarithromycin 500 mg twice daily for 10 to 14 days

Penicillin allergy: 30 mg twice daily administered with clarithromycin 500 mg and metronidazole 500 mg twice daily for 10 to 14 days or 30 mg once or twice daily administered with bismuth subsalicylate 525 mg and metronidazole 250 mg plus tetracycline 500 mg 4 times daily for 10 to 14 days

NSAID-associated gastric ulcer (healing): Oral: 30 mg once daily for 8 weeks; controlled studies did not extend past 8 weeks

NSAID-associated gastric ulcer (to reduce risk): Oral: 15 mg once daily for up to 12 weeks; controlled studies did not extend past 12 weeks

Heartburn (OTC labeling): Oral: 15 mg once daily for 14 days; may repeat 14 days of therapy every 4 months. Do not take for >14 days or more often than every 4 months, unless instructed by health care provider.

Stress ulcer prophylaxis, ICU patients (off-label use): Oral: 30 mg once daily (Brophy 2010; Olsen 2008). Note: Intended for patients with associated risk factors (eg, coagulopathy, mechanical ventilation for ≥48 hours, severe sepsis); discontinue use once risk factors have resolved (Dellinger 2013).

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

GERD, erosive esophagitis: Children 1 to 11 years: Oral:

≤30 kg: 15 mg once daily for up to 12 weeks

>30 kg: 30 mg once daily for up to 12 weeks

Note: Doses were increased in some pediatric patients if still symptomatic after 2 or more weeks of treatment (maximum dose: 30 mg twice daily)

GERD:

Erosive esophagitis: Children 12 to 17 years: Oral: 30 mg once daily for up to 8 weeks

Nonerosive GERD: Children 12 to 17 years: Oral: 15 mg once daily for up to 8 weeks

Dosing: Renal Impairment

No dosage adjustment necessary.

Dosing: Hepatic Impairment

Mild or moderate impairment: No dosage adjustment necessary.

Severe impairment: There are no dosage adjustments provided in the manufacturer’s labeling; however, bioavailability is increased in hepatic impairment. Consider dose reduction.

Extemporaneously Prepared

A 3 mg/mL oral solution (Simplified Lansoprazole Solution [SLS]) may be made with capsules and sodium bicarbonate. Empty the contents of ten lansoprazole 30 mg capsules into a beaker. Add 100 mL sodium bicarbonate 8.4% and gently stir until dissolved (about 15 minutes). Transfer solution to an amber-colored syringe or bottle. A prior study showed that SLS was stable for 8 hours at room temperature or for 14 days refrigerated (DiGiancinto, 2000). However, a more recent study, demonstrated SLS to be stable for 48 hours at room temperature in oral syringes and for only 7 days when refrigerated (Morrison, 2013).

Note: A more palatable lansoprazole (3 mg/mL) suspension is commercially available as a compounding kit (First-Lansoprazole).

DiGiancinto JL, Olsen KM, Bergman KL, et al, “Stability of Suspension Formulations of Lansoprazole and Omeprazole Stored in Amber-Colored Plastic Oral Syringes,” Ann Pharmacother, 2000, 34(5):600-5 10852086Morrison JT, Lugo RA, Thigpen JC, et al, “Stability of Extemporaneously Prepared Lansoprazole Suspension at Two Temperatures,” J Pediatr Pharmacol Ther, 2013, 18(2):122-7.Sharma V, “Comparison of 24-hour Intragastric pH Using Four Liquid Formulations of Lansoprazole and Omeprazole,” Am J Health Syst Pharm, 1999, 56(Suppl 4):18-21. 10597120Sharma VK, Vasudeva R, and Howden CW, “Simplified Lansoprazole Suspension - Liquid Formulations of Lansoprazole - Effectively Suppresses Intragastric Acidity When Administered Through a Gastrostomy,” Am J Gastroenterol, 1999, 94(7):1813-7.10406240

Administration

Oral: Administer before food; best if taken before breakfast. The intact granules should not be chewed or crushed; however, several options are available for those patients unable to swallow capsules:

Capsules may be opened and the intact granules sprinkled on 1 tablespoon of applesauce, Ensure pudding, cottage cheese, yogurt, or strained pears. The granules should then be swallowed immediately.

Capsules may be opened and emptied into ~60 mL orange juice, apple juice, or tomato juice; mix and swallow immediately. Rinse the glass with 2 or more volumes of juice and swallow immediately to assure complete delivery of the dose.

Orally disintegrating tablets: Should not be swallowed whole, broken, cut, or chewed. Place tablet on tongue; allow to dissolve (with or without water) until particles can be swallowed. Orally-disintegrating tablets may also be administered via an oral syringe: Place the 15 mg tablet in an oral syringe and draw up ~4 mL water, or place the 30 mg tablet in an oral syringe and draw up ~10 mL water. After tablet has dispersed, administer within 15 minutes. Refill the syringe with water (2 mL for the 15 mg tablet; 5 mL for the 30 mg tablet), shake gently, then administer any remaining contents.

Nasogastric tube administration:

Capsule: Capsule can be opened, the granules mixed (not crushed) with 40 mL of apple juice and then administered through the NG tube into the stomach, then flush tube with additional apple juice. Do not mix with other liquids. Thirty milligrams has also been suspended in 10 mL of 8.4% sodium bicarbonate solution (or apple juice) or divided into 4 equal parts and flushed with water and administered via NG tube (Brophy 2010; Tsai 2000).

Orally-disintegrating tablet: Nasogastric tube ≥8 French: Place a 15 mg tablet in a syringe and draw up ~4 mL water, or place the 30 mg tablet in a syringe and draw up ~10 mL water. After tablet has dispersed, administer within 15 minutes. Refill the syringe with ~5 mL water, shake gently, and then flush the nasogastric tube.

Dietary Considerations

Should be taken before eating; best if taken before breakfast. Some products may contain phenylalanine.

Storage

Capsules, orally disintegrating tablets: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light and moisture.

Powder for suspension (First Lansoprazole compounding kit): Prior to compounding, store at 15°C to 30°C (59°F to 86°F). Once compounded, the product is stable for 30 days at 2°C to 8°C (36°F to 46°F); protect from freezing. Protect from light.

Drug Interactions

Amphetamine: Proton Pump Inhibitors may increase the absorption of Amphetamine. Monitor therapy

Atazanavir: Proton Pump Inhibitors may decrease the serum concentration of Atazanavir. Management: See full drug interaction monograph for details. Consider therapy modification

Bisphosphonate Derivatives: Proton Pump Inhibitors may diminish the therapeutic effect of Bisphosphonate Derivatives. Monitor therapy

Bosentan: May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

Bosutinib: Proton Pump Inhibitors may decrease the serum concentration of Bosutinib. Management: Consider alternatives to proton pump inhibitors, such as antacids or H2 receptor antagonists. Administer alternative agents more than 2 hours before or after bosutinib. Consider therapy modification

Capecitabine: Proton Pump Inhibitors may diminish the therapeutic effect of Capecitabine. Monitor therapy

Cefditoren: Proton Pump Inhibitors may decrease the serum concentration of Cefditoren. Management: If possible, avoid use of cefditoren with proton pump inhibitors (PPIs). Consider alternative methods to minimize/control acid reflux (eg, diet modification) or alternative antimicrobial therapy if use of PPIs can not be avoided. Consider therapy modification

Clopidogrel: Lansoprazole may decrease serum concentrations of the active metabolite(s) of Clopidogrel. Management: Due to the possible risk for impaired clopidogrel effectiveness, clinicians should carefully consider the need for proton pump inhibitor therapy in patients receiving clopidogrel. Other acid-lowering therapies do not appear to share this interaction. Consider therapy modification

CYP2C19 Inducers (Strong): May increase the metabolism of CYP2C19 Substrates. Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. Consider therapy modification

CYP3A4 Inducers (Moderate): May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

CYP3A4 Inducers (Strong): May increase the metabolism of CYP3A4 Substrates. Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. Consider therapy modification

Cysteamine (Systemic): Proton Pump Inhibitors may diminish the therapeutic effect of Cysteamine (Systemic). Monitor therapy

Dabigatran Etexilate: Proton Pump Inhibitors may decrease serum concentrations of the active metabolite(s) of Dabigatran Etexilate. Monitor therapy

Dabrafenib: May decrease the serum concentration of CYP3A4 Substrates. Management: Seek alternatives to the CYP3A4 substrate when possible. If concomitant therapy cannot be avoided, monitor clinical effects of the substrate closely (particularly therapeutic effects). Consider therapy modification

Dabrafenib: May decrease the serum concentration of CYP2C19 Substrates. Management: Seek alternatives to the CYP2C19 substrate when possible. If concomitant therapy cannot be avoided, monitor clinical effects of the substrate closely (particularly therapeutic effects). Consider therapy modification

Dabrafenib: Proton Pump Inhibitors may decrease the serum concentration of Dabrafenib. Dabrafenib may decrease the serum concentration of Proton Pump Inhibitors. Management: Seek alternatives to the proton pump inhibitor when possible. If concomitant therapy cannot be avoided, monitor for diminished effects of both drugs. Consider therapy modification

Dasatinib: Proton Pump Inhibitors may decrease the serum concentration of Dasatinib. Management: Antacids (taken 2 hours before or after dasatinib administration) can be used in place of the proton pump inhibitor if some acid-reducing therapy is needed. Avoid combination

Deferasirox: May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

Delavirdine: Proton Pump Inhibitors may decrease the serum concentration of Delavirdine. Management: Chronic therapy with proton pump inhibitors (PPIs) should be avoided in patients treated with delavirdine. The clinical significance of short-term PPI therapy with delavirdine is uncertain, but such therapy should be undertaken with caution. Avoid combination

Dexmethylphenidate: Proton Pump Inhibitors may increase the absorption of Dexmethylphenidate. Specifically, proton pump inhibitors may interfere with the normal release of drug from the extended-release capsules (Focalin XR brand), which could result in both increased absorption (early) and decreased delayed absorption. Monitor therapy

Dextroamphetamine: Proton Pump Inhibitors may increase the absorption of Dextroamphetamine. Specifically, the dextroamphetamine absorption rate from mixed amphetamine salt extended release (XR) capsules may be increased in the first hours after dosing. Monitor therapy

Enzalutamide: May decrease the serum concentration of CYP3A4 Substrates. Management: Concurrent use of enzalutamide with CYP3A4 substrates that have a narrow therapeutic index should be avoided. Use of enzalutamide and any other CYP3A4 substrate should be performed with caution and close monitoring. Consider therapy modification

Enzalutamide: May decrease the serum concentration of CYP2C19 Substrates. Conversely, concentrations of active metabolites may be increased for those drugs activated by CYP2C19. Management: Concurrent use of enzalutamide with CYP2C19 substrates that have a narrow therapeutic index should be avoided. Use of enzalutamide and any other CYP2C19 substrate should be performed with caution and close monitoring. Consider therapy modification

Erlotinib: Proton Pump Inhibitors may decrease the serum concentration of Erlotinib. Avoid combination

Fluconazole: May increase the serum concentration of Proton Pump Inhibitors. Monitor therapy

Gefitinib: Proton Pump Inhibitors may decrease the serum concentration of Gefitinib. Management: Avoid use of proton pump inhibitors (PPIs) with gefitinib when possible. If required, administer gefitinib 12 hours after administration of the PPI or 12 hours before the next dose of the PPI. Consider therapy modification

Imatinib: Lansoprazole may enhance the dermatologic adverse effect of Imatinib. Monitor therapy

Indinavir: Proton Pump Inhibitors may decrease the serum concentration of Indinavir. Monitor therapy

Iron Salts: Proton Pump Inhibitors may decrease the absorption of Iron Salts. Exceptions: Ferric Carboxymaltose; Ferric Citrate; Ferric Gluconate; Ferric Hydroxide Polymaltose Complex; Ferric Pyrophosphate Citrate; Ferumoxytol; Iron Dextran Complex; Iron Sucrose. Monitor therapy

Itraconazole: Proton Pump Inhibitors may decrease the serum concentration of Itraconazole. Consider therapy modification

Ketoconazole (Systemic): Proton Pump Inhibitors may decrease the serum concentration of Ketoconazole (Systemic). Ketoconazole (Systemic) may increase the serum concentration of Proton Pump Inhibitors. Consider therapy modification

Ledipasvir: Proton Pump Inhibitors may decrease the serum concentration of Ledipasvir. Management: PPI doses equivalent to omeprazole 20 mg or lower may be given with ledipasvir under fasted conditions. Administration with higher doses of PPIs, 2 hours after a PPI, or in combination with food and PPIs may reduce ledipasvir bioavailability. Consider therapy modification

Mesalamine: Proton Pump Inhibitors may diminish the therapeutic effect of Mesalamine. Proton pump inhibitor-mediated increases in gastrointestinal pH may cause the premature release of mesalamine from specific sustained-release mesalamine products. Management: Consider avoiding concurrent administration of high-dose proton pump inhibitors (PPIs) with sustained-release mesalamine products. Consider therapy modification

Methotrexate: Proton Pump Inhibitors may increase the serum concentration of Methotrexate. Monitor therapy

Methylphenidate: Proton Pump Inhibitors may increase the absorption of Methylphenidate. Specifically, proton pump inhibitors may interfere with the normal release of drug from the extended-release capsules (Ritalin LA brand), which could result in both increased absorption (early) and decreased delayed absorption. Monitor therapy

Mitotane: May decrease the serum concentration of CYP3A4 Substrates. Management: Doses of CYP3A4 substrates may need to be adjusted substantially when used in patients being treated with mitotane. Consider therapy modification

Multivitamins/Minerals (with ADEK, Folate, Iron): Proton Pump Inhibitors may decrease the serum concentration of Multivitamins/Minerals (with ADEK, Folate, Iron). Specifically, the absorption of iron may be decreased. Monitor therapy

Mycophenolate: Proton Pump Inhibitors may decrease the serum concentration of Mycophenolate. Specifically, concentrations of the active mycophenolic acid may be reduced. Monitor therapy

Nelfinavir: Proton Pump Inhibitors may decrease serum concentrations of the active metabolite(s) of Nelfinavir. Proton Pump Inhibitors may decrease the serum concentration of Nelfinavir. Avoid combination

Nilotinib: Proton Pump Inhibitors may decrease the serum concentration of Nilotinib. Management: Avoid this combination when possible since separation of doses is not likely to be an adequate method of minimizing the interaction. Consider therapy modification

PAZOPanib: Proton Pump Inhibitors may decrease the serum concentration of PAZOPanib. Avoid combination

Posaconazole: Proton Pump Inhibitors may decrease the serum concentration of Posaconazole. Consider therapy modification

Raltegravir: Proton Pump Inhibitors may increase the serum concentration of Raltegravir. Monitor therapy

Rilpivirine: Proton Pump Inhibitors may decrease the serum concentration of Rilpivirine. Avoid combination

Riociguat: Proton Pump Inhibitors may decrease the serum concentration of Riociguat. Monitor therapy

Risedronate: Proton Pump Inhibitors may diminish the therapeutic effect of Risedronate. Proton Pump Inhibitors may increase the serum concentration of Risedronate. This applies specifically to use of delayed-release risedronate. Avoid combination

Saquinavir: Proton Pump Inhibitors may increase the serum concentration of Saquinavir. Monitor therapy

Sarilumab: May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

Siltuximab: May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

St John's Wort: May decrease the serum concentration of CYP3A4 Substrates. Management: Consider an alternative for one of the interacting drugs. Some combinations may be specifically contraindicated. Consult appropriate manufacturer labeling. Consider therapy modification

Tacrolimus (Systemic): Proton Pump Inhibitors may increase the serum concentration of Tacrolimus (Systemic). Management: Tacrolimus dose adjustment may be required. Rabeprazole, pantoprazole, or selected H2-receptor antagonists (i.e., ranitidine or famotidine) may be less likely to interact. Genetic testing may predict patients at highest risk. Consider therapy modification

Tipranavir: May decrease the serum concentration of Proton Pump Inhibitors. These data are derived from studies with Ritonavir-boosted Tipranavir. Monitor therapy

Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates. Monitor therapy

Velpatasvir: Proton Pump Inhibitors may decrease the serum concentration of Velpatasvir. Avoid combination

Vitamin K Antagonists (eg, warfarin): Lansoprazole may increase the serum concentration of Vitamin K Antagonists. Monitor therapy

Voriconazole: May increase the serum concentration of Proton Pump Inhibitors. Proton Pump Inhibitors may increase the serum concentration of Voriconazole. Management: In patients receiving omeprazole 40 mg/day or greater, reduce omeprazole dose by half when initiating voriconazole. Monitor therapy

Adverse Reactions

1% to 10%:

Central nervous system: Headache (children: 3%; adolescents: 7%), dizziness (adolescents: 3%; adults: <1%)

Gastrointestinal: Diarrhea (1% to 5%; 60 mg/day: 7%), abdominal pain (adolescents: 5%; adults: 2%), constipation (children: 5%; adults 1%), nausea (adolescents: 3%; adults 1%)

<1% (Limited to important or life-threatening): Abnormal dreams, abnormal hepatic function tests, abnormal stools, ageusia, agitation, agranulocytosis, albuminuria, alopecia, altered sense of smell, amblyopia, amnesia, anaphylactoid reaction, anemia, angina pectoris, anorexia, anxiety, aphthous stomatitis, aplastic anemia, arthralgia, arthritis, asthma, bezoar formation, blepharitis, blepharoptosis, blood platelet disorder, blurred vision, bone fracture, bradycardia, breast hypertrophy, breast tenderness, bronchitis, candidiasis, carcinoma, cardiac arrhythmia, cataract, cerebral infarction, cerebrovascular accident, change in WBC count, chest pain, chills, cholelithiasis, Clostridium difficile-associated diarrhea, colitis, confusion, conjunctivitis, cough, deafness, decreased gamma-glutamyl transferase, decreased libido, decreased serum cholesterol, dehydration, dementia, depersonalization, depression, diabetes mellitus, diaphoresis, difficulty in micturition, diplopia, drowsiness, dry eye syndrome, dysgeusia, dysmenorrhea, dyspepsia, dysphagia, dyspnea, dysuria, edema, electrolyte disturbance, emotional lability, enlargement of abdomen, enteritis, eosinophilia, epistaxis, eructation, erythema multiforme, esophageal achalasia, esophageal stenosis, esophageal ulcer, esophagitis, fecal discoloration, fever, fixed drug eruption, flatulence, flu-like symptoms, gastric polyp (fundic gland), gastritis, gastroenteritis, gastrointestinal disease, gastrointestinal hemorrhage, gingival hemorrhage, glaucoma, glossitis, glycosuria, goiter, gout, gynecomastia, halitosis, hallucination, hematemesis, hematuria, hemiplegia, hemolysis, hemolytic anemia, hemoptysis, hepatotoxicity, hostility, hyperbilirubinemia, hyperglycemia hyperkinesia, hyperlipidemia, hypermenorrhea, hypersensitivity reaction, hypertension, hypertonia, hypoesthesia, hypoglycemia, hypomagnesemia, hypotension, hypothyroidism, impotence, increased appetite, increased gamma-glutamyl transferase, increased gastrin, increased lactate dehydrogenase, increased libido, increased serum alkaline phosphatase, increased serum ALT, increased serum AST, increased serum cholesterol, increased serum creatinine, increased serum glucocorticoids, increased thirst, infection, insomnia, interstitial nephritis, leg cramps, leukopenia, leukorrhea, lymphadenopathy, maculopapular rash, malaise, mastalgia, melena, menstrual disease, migraine, musculoskeletal pain, myalgia, myasthenia, myocardial infarction, myositis, neoplasm (laryngeal), nephrolithiasis, nervousness, neutropenia, nodule (gastric), oral candidiasis, oral mucosa ulcer, pain, palpitations, pancreatitis, pancytopenia, paresthesia, pelvic pain, peripheral edema, pharyngitis, photophobia, pneumonia, polyuria, pruritus, psychoneurosis, pulmonary fibrosis, rectal hemorrhage, renal disease (chronic: Lazarus 2016), retinal degeneration, rhinitis, seizure, shock, sialorrhea, sinusitis, skin carcinoma, skin rash, sleep disorder, speech disturbance, Stevens-Johnson syndrome, stomatitis, stridor, syncope, synovitis, tachycardia, tenesmus, thrombocytopenia, thrombotic thrombocytopenic purpura, tinnitus, tremor, tongue disease, toxic epidermal necrolysis, ulcerative colitis, upper respiratory tract inflammation, upper respiratory tract infection, urethral pain, urinary frequency, urinary retention, urinary tract infection, urinary urgency, urticaria, vaginitis, vasodilatation, vertigo, visual disturbance, visual field defect, vitamin deficiency, vomiting, weakness, weight gain, weight loss, xeroderma, xerostomia

Warnings/Precautions

Concerns related to adverse effects:

• Carcinoma: No reports of enterochromaffin-like (ECL) cell carcinoids, dysplasia, or neoplasia has occurred.

Clostridium difficile-associated diarrhea (CDAD): Use of proton pump inhibitors (PPIs) may increase risk of CDAD, especially in hospitalized patients; consider CDAD diagnosis in patients with persistent diarrhea that does not improve. Use the lowest dose and shortest duration of PPI therapy appropriate for the condition being treated.

• Cutaneous and systemic lupus erythematosus: Has been reported as new onset or exacerbation of existing autoimmune disease; most cases were cutaneous lupus erythematosus (CLE), most commonly, subacute CLE (occurring within weeks to years after continuous therapy). Systemic lupus erythematosus (SLE) is less common (typically occurs within days to years after initiating treatment) and occurred primarily in young adults up to elderly patients. Discontinue therapy if signs or symptoms of CLE or SLE occur and refer to a specialist for evaluation; most patients improve 4 to 12 weeks after discontinuation of lansoprazole.

• Fractures: Increased incidence of osteoporosis-related bone fractures of the hip, spine, or wrist may occur with proton pump inhibitor (PPI) therapy. Patients on high-dose or long-term therapy should be monitored. Use the lowest effective dose for the shortest duration of time, use vitamin D and calcium supplementation, and follow appropriate guidelines to reduce risk of fractures in patients at risk.

• Hypomagnesemia: Reported rarely, usually with prolonged PPI use of ≥3 months (most cases >1 year of therapy). May be symptomatic or asymptomatic; severe cases may cause tetany, seizures, and cardiac arrhythmias. Consider obtaining serum magnesium concentrations prior to beginning long-term therapy, especially if taking concomitant digoxin, diuretics, or other drugs known to cause hypomagnesemia; and periodically thereafter. Hypomagnesemia may be corrected by magnesium supplementation, although discontinuation of lansoprazole may be necessary; magnesium levels typically return to normal within 1 week of stopping.

• Interstitial nephritis: Acute interstitial nephritis has been observed in patients taking PPIs; may occur at any time during therapy and is generally due to an idiopathic hypersensitivity reaction. Discontinue if acute interstitial nephritis develops.

• Vitamin B12 deficiency: Prolonged treatment (≥2 years) may lead to vitamin B12 malabsorption and subsequent vitamin B12 deficiency. The magnitude of the deficiency is dose-related and the association is stronger in females and those younger in age (<30 years); prevalence is decreased after discontinuation of therapy (Lam 2013).

Disease-related concerns:

• Gastric malignancy: Relief of symptoms does not preclude the presence of a gastric malignancy.

• Gastrointestinal infection (eg, Salmonella, Campylobacter): Use of PPIs may increase risk of these infections.

• Hepatic impairment: Patients with severe liver dysfunction may require dosage reductions.

Concurrent drug therapy issues:

• Clopidogrel: Proton pump inhibitors (PPIs) may diminish the therapeutic effect of clopidogrel thought to be due to reduced formation of the active metabolite of clopidogrel. The manufacturer of clopidogrel recommends either avoidance of both omeprazole (even when scheduled 12 hours apart) and esomeprazole or use of a PPI with comparatively less effect on the active metabolite of clopidogrel (eg, pantoprazole). Although lansoprazole exhibits the most potent CYP2C19 inhibition in vitro (Li 2004; Ogilvie 2011), an in vivo study of extensive CYP2C19 metabolizers showed less reduction of the active metabolite of clopidogrel by lansoprazole/dexlansoprazole compared to esomeprazole/omeprazole (Frelinger, 2012). The manufacturer of lansoprazole states that no dosage adjustment is necessary for clopidogrel when used concurrently. In contrast to these warnings, others have recommended the continued use of PPIs, regardless of the degree of inhibition, in patients with a history of GI bleeding or multiple risk factors for GI bleeding who are also receiving clopidogrel since no evidence has established clinically meaningful differences in outcome; however, a clinically-significant interaction cannot be excluded in those who are poor metabolizers of clopidogrel (Abraham 2010; Levine 2011).

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol with caution in neonates. See manufacturer’s labeling.

• Phenylalanine: Some products may contain phenylalanine.

Other warnings/precautions:

• Appropriate use: Helicobacter pylori eradication: Short-term combination therapy (≤7 days) has been associated with a higher incidence of treatment failure. The American College of Gastroenterology recommends 10-14 days of therapy (triple or quadruple) for eradication of H. pylori (Chey 2007).

• Self-medication (OTC use): When used for self-medication, patients should be instructed not to use if they have difficulty swallowing, are vomiting blood, or have bloody or black stools. Prior to use, patients should contact healthcare provider if they have liver disease, heartburn for >3 months, heartburn with dizziness, lightheadedness, or sweating, MI symptoms, frequent chest pain, frequent wheezing (especially with heartburn), unexplained weight loss, nausea/vomiting, stomach pain, or are taking antifungals, atazanavir, digoxin, tacrolimus, theophylline, or warfarin. Patients should stop use and consult a healthcare provider if heartburn continues or worsens, or if they need to take for >14 days or more often than every 4 months. Patients should be informed that it may take 1 to 4 days for full effect to be seen.

Monitoring Parameters

Patients with Zollinger-Ellison syndrome should be monitored for gastric acid output, which should be maintained at ≤10 mEq/hour during the last hour before the next lansoprazole dose; lab monitoring should include CBC, liver function, renal function, and serum gastrin levels

Pregnancy Risk Factor

B

Pregnancy Considerations

Adverse events have not been observed in animal reproduction studies. An increased risk of hypospadias was reported following maternal use of proton pump inhibitors (PPIs) during pregnancy (Anderka 2012), but this was based on a small number of exposures and the same association was not found in another study (Erichsen 2012). Most available studies have not shown an increased risk of major birth defects following maternal use of PPIs during pregnancy (Diav-Citrin 2005; Matok 2012; Pasternak 2010). When treating GERD in pregnancy, PPIs may be used when clinically indicated (Katz 2013).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience headache, abdominal pain, nausea, diarrhea, or constipation. Have patient report immediately to prescriber signs of low magnesium (mood changes; muscle pain or weakness; muscle cramps or spasms; seizures; tremors; lack of appetite; severe nausea or vomiting; or an abnormal heartbeat), signs of kidney problems (urinary retention, hematuria, change in amount of urine passed, or weight gain), signs of lupus (rash on the cheeks or other body parts, sunburn easy, muscle or joint pain, angina or shortness of breath, or swelling in the arms or legs), severe dizziness, passing out, tachycardia, bone pain, signs of Clostridium difficile (C. diff)-associated diarrhea (abdominal pain or cramps, severe diarrhea or watery stools, or bloody stools), or signs of Stevens-Johnson syndrome/toxic epidermal necrolysis (red, swollen, blistered, or peeling skin [with or without fever]; red or irritated eyes; or sores in mouth, throat, nose, or eyes) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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