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Special Alerts
Possible Increased Risk of Clostridium Difficile–Associated Diarrhea (CDAD) with Proton Pump Inhibitor Use: Update
February 2012
The U.S. Food and Drug Administration (FDA) and Health Canada have announced that proton pump inhibitors (PPIs) may be associated with an increased risk of Clostridium difficile–associated diarrhea (CDAD). The FDA reviewed reports of PPI-associated CDAD from the FDA Adverse Event Reporting System and from the medical literature. The association of PPI use and CDAD varied among studies, ranging from a risk of 1.4-2.75 higher in those exposed to a PPI compared to those without PPI exposure. Many of the cases reported involved patients who were elderly, had chronic and/or underlying conditions, or were taking broad-spectrum antibiotics - all of which could have increased the risk of CDAD. Health Canada has also been assessing study data on an ongoing basis. In spite of potential predisposition to CDAD, or other limitations to study design, association with PPI use could not be ruled out and patients with these risk factors may have more serious outcomes from CDAD associated with PPI use. The FDA is working with manufacturers to include information regarding the increased risk of CDAD with use of PPIs in their prescribing information and is also evaluating the risk of CDAD in users of histamine H2 receptor blockers. Health Canada also notes that the possible association between PPIs and CDAD is noted in their PPI product labeling.
The following advice is provided by the FDA and Health Canada to assist healthcare professionals in the management of patients receiving PPIs:
- Consider a diagnosis of CDAD in PPI users that have persistent diarrhea.
- Advise patients to get immediate care from a healthcare professional if they experience persistent watery stools, bloody diarrhea, abdominal pain or tenderness, nausea, loss of appetite, or fever while taking PPIs.
- Use the lowest dose and shortest duration of PPI therapy appropriate for the condition being treated.
For more information, refer to the following websites:
U.S.:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm290838.htm
http://www.fda.gov/Drugs/DrugSafety/ucm290510.htm
Canada: http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/_2012/2012_23-eng.php
Pronunciation
(lan SOE pra zole)
Generic Available (U.S.)
Yes
Brand Names: U.S.
Brand Names: Canada
Pharmacologic Category
Pharmacologic Category Synonyms
Use: Labeled Indications
Short-term 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 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; short-term treatment of symptomatic GERD; short-term treatment for all grades of erosive esophagitis; to maintain healing of erosive esophagitis; long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome
OTC labeling: Relief of frequent heartburn (≥2 days/week)
Pregnancy Risk Factor
B
Pregnancy Considerations
Animal studies have not shown teratogenic effects to the fetus. However, there are no adequate and well-controlled studies in pregnant women; use during pregnancy only if clearly needed.
Lactation
Excretion in breast milk unknown/not recommended
Contraindications
Hypersensitivity to lansoprazole or any component of the formulation
Warnings/Precautions
Concerns related to adverse effects:
• Atrophic gastritis: Long-term omeprazole therapy has caused atrophic gastritis (by biopsy); this may also occur with lansoprazole.
• Carcinoma: No reports of enterochromaffin-like (ECL) cell carcinoids, dysplasia, or neoplasia has occurred.
• 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.
Disease-related concerns:
• Gastric malignancy: Relief of symptoms does not preclude the presence of a gastric malignancy.
• Gastrointestinal infection (eg, Salmonella, Campylobacter): Use of proton pump inhibitors 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 omeprazole or use of a PPI with less potent CYP2C19 inhibition (eg, pantoprazole). Lansoprazole exhibits the most potent CYP2C19 inhibition; given the potency of lansoprazole's CYP2C19 inhibitory activity, avoidance of lansoprazole would appear prudent. 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).
Special populations:
• Pediatrics: Lansoprazole has been shown to be ineffective for the treatment of symptomatic GERD in children 1 month to <1 year.
Dosage form specific issues:
• Phenylalanine: Prevacid® SoluTab™ contains 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 1-4 days for full effect to be seen.
Adverse Reactions
1% to 10%:
Central nervous system: Headache (children 1-11 years 3%, 12-17 years 7%), dizziness (children 12-17 years 3%; adults <1%)
Gastrointestinal: Diarrhea (1% to 5%; 60 mg/day: 7%), abdominal pain (children 12-17 years 5%; adults 2%), constipation (children 1-11 years 5%; adults 1%), nausea (children 12-17 years 3%; adults 1%)
<1%, postmarketing, and/or case reports (limited to important or life-threatening): Abdomen enlarged, abnormal dreams, abnormal menses, abnormal stools, abnormal vision, agitation, agranulocytosis, albuminuria, allergic reaction, alkaline phosphatase increased, ALT increased, alopecia, amblyopia, amnesia, anaphylactoid reaction, anemia, angina, anorexia, anxiety, aplastic anemia, appetite increased, arrhythmia, AST increased, arthralgia, arthritis, asthma, avitaminosis, bezoar, bilirubinemia, blepharitis, blurred vision, bradycardia, breast enlargement, breast pain, breast tenderness, bronchitis, candidiasis, carcinoma, cardiospasm, cataract, cerebrovascular accident, cerebral infarction, chest pain, chills, cholelithiasis, cholesterol increased/decreased, colitis, confusion, conjunctivitis, cough increased, creatinine increased, deafness, dehydration, dementia, depersonalization, depression, diabetes mellitus, diaphoresis, diplopia, dry eyes, dry skin, dyspepsia, dysphagia, dyspnea, dysmenorrhea, dysuria, edema, electrolyte imbalance, emotional lability, enteritis, eosinophilia, epistaxis, eructation, erythema multiforme, esophageal stenosis, esophageal ulcer, esophagitis, fecal discoloration, fever, fixed eruption, flatulence, flu-like syndrome, fracture, fundic gland polyps, gastric nodules, gastrin levels increased, gastritis, gastroenteritis, gastrointestinal anomaly, gastrointestinal hemorrhage, GGTP increased/decreased, glaucoma, glucocorticoid levels increased, glossitis, glycosuria, goiter, gout, gum hemorrhage, gynecomastia, halitosis, hallucinations, hematemesis, hematuria, hemiplegia, hemolysis, hemolytic anemia, hemoptysis, hepatotoxicity, hostility aggravated, hyper-/hypoglycemia, hyperkinesia, hyperlipemia, hypertonia, hypoesthesia, hyper-/hypotension, hypomagnesemia, hypothyroidism, impotence, infection, insomnia, interstitial nephritis, kidney calculus, laryngeal neoplasia, LDH increased, leg cramps, leukopenia, leukorrhea, libido decreased/increased, liver function test abnormal, lung fibrosis, lymphadenopathy, maculopapular rash, malaise, melena, menorrhagia, migraine, moniliasis (oral), mouth ulceration, musculoskeletal pain, myalgia, myasthenia, myositis, MI, nervousness, neurosis, neutropenia, pain, palpitation, pancreatitis, pancytopenia, paresthesia, parosmia, pelvic pain, peripheral edema, pharyngitis, photophobia, platelet abnormalities, pneumonia, polyuria, pruritus, ptosis, rash, rectal hemorrhage, retinal degeneration, rhinitis, salivation increased, seizure, shock, sinusitis, skin carcinoma, sleep disorder, somnolence, speech disorder, Stevens-Johnson syndrome, stomatitis, stridor, syncope, synovitis, tachycardia, taste loss, taste perversion, tenesmus, thirst, thrombocytopenia, thrombotic thrombocytopenic purpura, tinnitus, tremor, tongue disorder, toxic epidermal necrolysis, ulcerative colitis, ulcerative stomatitis, upper respiratory inflammation, upper respiratory infection, urethral pain, urinary frequency/urgency, urination impaired, urinary retention, urinary tract infection, urticaria, vaginitis, vasodilation, vertigo, visual field defect, vomiting, weakness, WBC abnormal, weight gain/loss, xerostomia
Metabolism/Transport Effects
Substrate of CYP2C19 (major), CYP2C9 (minor), CYP3A4 (major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential; Inhibits CYP2C19 (moderate), CYP2C9 (weak), CYP2D6 (weak), CYP3A4 (weak); Induces CYP1A2 (weak/moderate)
Drug Interactions
Amphetamines: Proton Pump Inhibitors may increase the serum concentration of Amphetamines. Specifically, data indicate that Proton Pump Inhibitors may increase the rate at which Amphetamines are absorbed. Total exposure to Amphetamines is not significantly changed. Risk C: Monitor therapy
ARIPiprazole: CYP3A4 Inhibitors (Weak) may increase the serum concentration of ARIPiprazole. Management: Monitor for increased aripiprazole systemic exposure/affects with concomitant use of a weak CYP3A4 inhibitor. Decrease aripiprazole dose to 25% of the usual dose in patients receiving both a CYP3A4 and a CYP2D6 inhibitor (regardless of potencies). Risk C: Monitor therapy
ARIPiprazole: CYP2D6 Inhibitors (Weak) may increase the serum concentration of ARIPiprazole. Management: Monitor for increased aripiprazole pharmacologic effects. Aripiprazole dose adjustments may or may not be required based on concomitant therapy and/or indication. Consult product labeling for specific recommendations. Risk C: Monitor therapy
Atazanavir: Proton Pump Inhibitors may decrease the serum concentration of Atazanavir. Management: Avoid concurrent PPI in HIV treatment-experienced patients. For treatment-naive patients, atazanavir/ritonavir dose should be given approximately 12 hours after the PPI, and the PPI should not exceed the equivalent of 20 mg omeprazole. Risk D: Consider therapy modification
Bisphosphonate Derivatives: Proton Pump Inhibitors may diminish the therapeutic effect of Bisphosphonate Derivatives. Risk C: 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. Risk D: Consider therapy modification
Citalopram: CYP2C19 Inhibitors (Moderate) may increase the serum concentration of Citalopram. Management: Limit citalopram dose to a maximum of 20 mg/day if used with a moderate CYP2C19 inhibitor. Patients using this combination should be monitored closely for evidence of citalopram toxicity (e.g., serotonin syndrome, QT prolongation, etc.). Risk D: 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. Risk D: Consider therapy modification
Conivaptan: May increase the serum concentration of CYP3A4 Substrates (Low risk). Risk C: Monitor therapy
CYP2C19 Inducers (Strong): May increase the metabolism of CYP2C19 Substrates. Risk C: Monitor therapy
CYP2C19 Substrates: CYP2C19 Inhibitors (Moderate) may decrease the metabolism of CYP2C19 Substrates. Risk C: Monitor therapy
CYP3A4 Inducers (Strong): May increase the metabolism of CYP3A4 Substrates. Risk C: Monitor therapy
Dabigatran Etexilate: Proton Pump Inhibitors may decrease serum concentrations of the active metabolite(s) of Dabigatran Etexilate. Risk C: Monitor therapy
Dasatinib: Proton Pump Inhibitors may decrease the serum concentration of Dasatinib. Management: Avoid concurrent use of proton pump inhibitors with dasatinib. Antacids (taken 2 hours before or after dasatinib administration) should be used in place of these agents if some acid-reducing therapy is needed. Risk D: Consider therapy modification
Deferasirox: May decrease the serum concentration of CYP3A4 Substrates. Risk C: 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. Risk X: 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. Risk C: Monitor therapy
Erlotinib: Proton Pump Inhibitors may decrease the serum concentration of Erlotinib. Risk X: Avoid combination
Fluconazole: May increase the serum concentration of Proton Pump Inhibitors. Risk C: Monitor therapy
Gefitinib: Proton Pump Inhibitors may decrease the serum concentration of Gefitinib. Risk C: Monitor therapy
Herbs (CYP3A4 Inducers): May increase the metabolism of CYP3A4 Substrates. Risk C: Monitor therapy
Imatinib: Lansoprazole may enhance the dermatologic adverse effect of Imatinib. Risk C: Monitor therapy
Indinavir: Proton Pump Inhibitors may decrease the serum concentration of Indinavir. Risk C: Monitor therapy
Iron Salts: Proton Pump Inhibitors may decrease the absorption of Iron Salts. Exceptions: Ferric Gluconate; Ferumoxytol; Iron Dextran Complex; Iron Sucrose. Risk C: Monitor therapy
Itraconazole: Proton Pump Inhibitors may decrease the serum concentration of Itraconazole. Risk D: Consider therapy modification
Ketoconazole: May increase the serum concentration of Proton Pump Inhibitors. Proton Pump Inhibitors may decrease the serum concentration of Ketoconazole. Risk D: Consider therapy modification
Ketoconazole (Systemic): May increase the serum concentration of Proton Pump Inhibitors. Proton Pump Inhibitors may decrease the serum concentration of Ketoconazole (Systemic). Risk D: 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. Risk D: Consider therapy modification
Methotrexate: Proton Pump Inhibitors may increase the serum concentration of Methotrexate. Risk C: 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. Risk C: Monitor therapy
Mycophenolate: Proton Pump Inhibitors may decrease the serum concentration of Mycophenolate. Specifically, concentrations of the active mycophenolic acid may be reduced. Risk C: 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. Risk X: Avoid combination
Pimozide: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Pimozide. Risk X: Avoid combination
Posaconazole: Proton Pump Inhibitors may decrease the serum concentration of Posaconazole. Risk X: Avoid combination
Raltegravir: Proton Pump Inhibitors may increase the serum concentration of Raltegravir. Risk C: Monitor therapy
Rilpivirine: Proton Pump Inhibitors may decrease the serum concentration of Rilpivirine. Risk X: Avoid combination
Saquinavir: Proton Pump Inhibitors may increase the serum concentration of Saquinavir. Risk C: Monitor therapy
Tacrolimus: Proton Pump Inhibitors may increase the serum concentration of Tacrolimus. 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. Risk D: 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. Risk D: Consider therapy modification
Tipranavir: May decrease the serum concentration of Proton Pump Inhibitors. These data are derived from studies with Ritonavir-boosted Tipranavir. Risk C: Monitor therapy
Tocilizumab: May decrease the serum concentration of CYP3A4 Substrates. Risk C: Monitor therapy
Vismodegib: Proton Pump Inhibitors may decrease the serum concentration of Vismodegib. Management: Carefully consider the need for any medication that increases the pH of the upper GI tract (PPIs, H2RAs, antacids), as these could significantly reduce vismodegib systemic exposure. Vismodegib dose increases are unlikely to compensate for this effect. Risk D: Consider therapy modification
Vitamin K Antagonists (eg, warfarin): Lansoprazole may increase the serum concentration of Vitamin K Antagonists. Risk C: Monitor therapy
Voriconazole: Proton Pump Inhibitors may increase the serum concentration of Voriconazole. Risk C: Monitor therapy
Ethanol/Nutrition/Herb Interactions
Ethanol: Avoid ethanol (may cause gastric mucosal irritation).
Food: Lansoprazole serum concentrations may be decreased if taken with food.
Herb/Nutraceutical: Avoid St John's wort (may decrease the levels/effect of lansoprazole).
Storage
Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).
Mechanism of Action
Decreases acid secretion in gastric parietal cells through inhibition of (H+, K+)-ATPase enzyme system, blocking the final step in gastric acid production.
Pharmacodynamics/Kinetics
Onset of action: Gastric acid suppression: Oral: 1-3 hours
Duration: Gastric acid suppression: Oral: >1 day
Absorption: Rapid
Distribution: Vd: 14-18 L
Protein binding: 97%
Metabolism: Hepatic via CYP2C19 and 3A4, and in parietal cells to two active metabolites that are not present in systemic circulation
Bioavailability: ≥80%; decreased 50% to 70% if given 30 minutes after food
Half-life elimination: 1.5 ± 1 hours; Elderly: 2-3 hours; Hepatic impairment: 3-7 hours
Time to peak, plasma: 1.7 hours
Excretion: Feces (67%); urine (33%)
Dosage
Oral:
Children 1-11 years: GERD, erosive esophagitis:
≤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)
Children 12-17 years:
Nonerosive GERD: 15 mg once daily for up to 8 weeks
Erosive esophagitis: 30 mg once daily for up to 8 weeks
Adults:
Duodenal ulcer: Short-term treatment: 15 mg once daily for 4 weeks; maintenance therapy: 15 mg once daily
Gastric ulcer: Short-term treatment: 30 mg once daily for up to 8 weeks
NSAID-associated gastric ulcer (healing): 30 mg once daily for 8 weeks; controlled studies did not extend past 8 weeks of therapy
NSAID-associated gastric ulcer (to reduce risk): 15 mg once daily for up to 12 weeks; controlled studies did not extend past 12 weeks of therapy
Symptomatic GERD: Short-term treatment: 15 mg once daily for up to 8 weeks
Erosive esophagitis: 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
Hypersecretory conditions: 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
Helicobacter pylori eradication:
Manufacturer labeling: 30 mg 3 times/day administered with amoxicillin 1000 mg 3 times/day for 14 days or 30 mg twice daily administered with amoxicillin 1000 mg and clarithromycin 500 mg twice daily for 10-14 days
American College of Gastroenterology guidelines (Chey, 2007):
Nonpenicillin allergy: 30 mg twice daily administered with amoxicillin 1000 mg and clarithromycin 500 mg twice daily for 10-14 days
Penicillin allergy: 30 mg twice daily administered with clarithromycin 500 mg and metronidazole 500 mg twice daily for 10-14 days or 30 mg once or twice daily administered with bismuth subsalicylate 525 mg and metronidazole 250 mg plus tetracycline 500 mg 4 times/day for 10-14 days
Heartburn: OTC labeling: 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 healthcare provider.
Dosage adjustment in renal impairment: No dosage adjustment is needed
Dosing adjustment in hepatic impairment: Severe hepatic impairment: Consider dose reduction
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 additional juice and swallow 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.
Administration: Other
Nasogastric tube administration:
Capsule: Capsule can be opened, the granules mixed (not crushed) with 40 mL of apple juice and then injected through the NG tube into the stomach, then flush tube with additional apple juice. Do not mix with other liquids.
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.
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
Dietary Considerations
Should be taken before eating; best if taken before breakfast. Some products may contain phenylalanine.
Patient Education
Take before eating. Do not crush or chew granules. Patients who may have difficulty swallowing capsules may open the delayed-release capsules and sprinkle the contents on applesauce, pudding, cottage cheese, or yogurt. Avoid alcohol. Report unresolved diarrhea, persistent heartburn, or abdominal pain.
Geriatric Considerations
The clearance of lansoprazole is decreased in the elderly; however, the half-life is only increased by 50% to 100%, resulting in a continued short half-life with no accumulation in the elderly. No dosage adjustment is required with normal hepatic function. The rate of healing and side effects are similar to younger adults.
An increased risk of fractures of the hip, spine, or wrist has been observed in epidemiologic studies with proton pump inhibitor (PPI) use, primarily in older adults ≥50 years of age. The greatest risk was seen in patients receiving high doses or on long-term therapy (≥1 year). Calcium and vitamin D supplementation and close monitoring are recommended to reduce the risk of fracture in high-risk patients.
Anesthesia and Critical Care Concerns/Other Considerations
Evidence-Based Information:
Stress Ulcer Prophylaxis: The 2008 Surviving Sepsis Campaign guidelines recommend that stress ulcer prophylaxis using an H2 blocker (Grade 1A) or proton pump inhibitor (Grade 1B) be given to patients with severe sepsis to prevent upper GI bleed. Benefit of prevention of upper GI bleed must be weighed against potential effect of increased stomach pH on development of ventilator-associated pneumonia.
Dental Health: Effects on Dental Treatment
No significant effects or complications reported
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
No information available to require special precautions
Mental Health: Effects on Mental Status
May cause drowsiness or dizziness
Mental Health: Effects on Psychiatric Treatment
None reported
Nursing: Physical Assessment/Monitoring
Assess periodic laboratory results and effectiveness of medications that require an acid medium for absorption (eg, ketoconazole, itraconazole). Monitor effectiveness of ulcer symptom relief.
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule, delayed release, oral: 15 mg, 30 mg
Prevacid®: 15 mg, 30 mg
Prevacid® 24 HR: 15 mg
Powder for suspension, oral [compounding kit]:
First®-Lansoprazole: 3 mg/mL (90 mL, 150 mL, 300 mL) [contains benzyl alcohol]
Tablet, delayed release, orally disintegrating, oral: 15 mg, 30 mg
Prevacid® SoluTab™: 15 mg [contains phenylalanine 2.5 mg/tablet; strawberry flavor]
Prevacid® SoluTab™: 30 mg [contains phenylalanine 5.1 mg/tablet; strawberry flavor]
Pricing: U.S. (www.drugstore.com)
Capsule, delayed release (Lansoprazole)
15 mg (30): $105.99
30 mg (30): $99.99
Capsule, delayed release (Prevacid)
15 mg (30): $195.99
Tablet, orally-disintegrating (Lansoprazole)
15 mg (30): $162.98
30 mg (30): $162.98
Tablet, orally-disintegrating (Prevacid SoluTab)
15 mg (100): $631.98
30 mg (30): $198.99
Extemporaneously Prepared
A 3 mg/mL oral solution (Simplified Lansoprazole Solution) 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. Stable for 8 hours at room temperature or for 14 days refrigerated.
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
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.
Sharma 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.
References
Abraham NS, Hlatky MA, Antman EM, et al, “ACCF/ACG/AHA 2010 Expert Consensus Document on the Concomitant Use of Proton Pump Inhibitors and Thienopyridines: A Focused Update of the ACCF/ACG/AHA 2008 Expert Consensus Document on Reducing the Gastrointestinal Risks of Antiplatelet Therapy and NSAID Use: A Report of the American College of Cardiology Foundation Task Force on Expert Consensus Documents,” Circulation, 2010, 122(24):2619-33.
Bell AD, Roussin A, Cartier R, et al, “The Use of Antiplatelet Therapy in the Outpatient Setting: Canadian Cardiovascular Society Guidelines,” Can J Cardiol, 2011, 27(Suppl A):1-59.
Brunner G, Luna P, Hartmann M, et al, “Optimizing the Intragastric pH as a Supportive Therapy in Upper GI Bleeding,” Yale J Biol Med, 1996, 69(3):225-31.
Chey WD, Wong BC, and Practice Parameters Committee of the American College of Gastroenterology, “American College of Gastroenterology, Guideline on the Management of Helicobacter pylori Infection,” Am J Gastroenterol, 2007, 102(8):1808-25.
Chun AH, Eason CJ, Shi HH, et al, “Lansoprazole: An Alternative Method of Administration of a Capsule Dosage Formulation,” Clin Ther, 1995, 17(3):441-7.
Cockayne SE, Glet RJ, Gawkrodger DJ, et al, “Severe Erythrodermic Reactions to the Proton Pump Inhibitors Omeprazole and Lansoprazole,” Br J Dermatol,1999, 141(1):173-5.
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Last full review/revision February 2012
Content last modified February 2012
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