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Medication Safety Issues
Sound-alike/look-alike issues:
Prevacid® may be confused with Pravachol®, Prevpac®, Prilosec®, Prinivil®
Pronunciation
(lan SOE pra zole)
U.S. Brand Names
Generic Available
No
Canadian Brand Names
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
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, substituted benzimidazoles (ie, esomeprazole, omeprazole, pantoprazole, rabeprazole), 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.
Disease-related concerns:
• Gastric malignancy: Relief of symptoms does not preclude the presence of a gastric malignancy.
• Hepatic impairment: Patients with severe liver dysfunction may require dosage reductions.
Special populations:
• Pediatrics: Safety and efficacy have not been established in children <1 year of age.
Dosage form specific issues:
• Phenylalanine: Prevacid® SoluTab™ contains phenylalanine.
Adverse Reactions
1% to 10%:
Central nervous system: Headache (children 1-11 years 3%, 12-17 years 7%)
Gastrointestinal: Abdominal pain (children 12-17 years 5%; adults 2%), constipation (children 1-11 years 5%; adults 1%), diarrhea (60 mg/day; adults 7%), nausea (children 12-17 years 3%; adults 1%)
<1%: Abdomen enlarged, abnormal dreams, abnormal menses, abnormal stools, abnormal vision, acne, agitation, albuminuria, allergic reaction, alkaline phosphatase increased, ALT increased, alopecia, amnesia, anemia, angina, anorexia, anxiety, apathy, appetite increased, arrhythmia, AST increased, arthralgia, arthritis, asthma, back pain, bezoar, bilirubinemia, blurred vision, bradycardia, breast enlargement, breast pain, breast tenderness, bronchitis, bone disorder, candidiasis, carcinoma, cardiospasm, cerebrovascular accident, cerebral infarction, chest pain, chills, cholelithiasis, cholesterol increased, cholesterol decreased, colitis, confusion, conjunctivitis, contact dermatitis, convulsion, cough increased, creatinine increased, deafness, dehydration, depersonalization, depression, diabetes mellitus, diplopia, dizziness, dry eyes, dry mouth, dry skin, dyspepsia, dysphagia, dyspnea, dysmenorrhea, dysuria, ear disorder, edema, electrolytes imbalance, emotional lability, enteritis, eosinophilia, epistaxis, eructation, esophageal ulcer, esophagitis, eye pain, fecal discoloration, fever, fixed eruption, flatulence, flu-like syndrome, fundic gland polyps, gastric nodules, gastrin levels increased, gastritis, gastroenteritis, gastrointestinal anomaly, gastrointestinal hemorrhage, GGTP increased, GGTP decreased, glucocorticoid levels increased, globulins increased, glossitis, glycosuria, goiter, gout, gum hemorrhage, gynecomastia, hair disorder, halitosis, hallucinations, hematemesis, hematuria, hemiplegia, hemolysis, hemoptysis, hiccup, hostility aggravated, hyperglycemia, hyperkinesia, hyperlipemia, hypertonia, hypoesthesia, hypoglycemia, hyper-/hypotension, hypothyroidism, impotence, infection, insomnia, joint disorder, kidney calculus, kidney pain, laryngeal neoplasia, LDH increased, leg cramps, leukorrhea, libido decreased, libido increased, liver function test abnormal, lymphadenopathy, maculopapular rash, malaise, melena, menorrhagia, menstrual disorder, migraine, moniliasis (oral), mouth ulceration, musculoskeletal pain, myalgia, myasthenia, MI, nail disorder, neck pain, neck rigidity, nervousness, neurosis, otitis media, pain, palpitation, paresthesia, parosmia, pelvic pain, penis disorder, peripheral edema, pharyngitis, photophobia, platelet abnormalities, pleural disorder, pneumonia, polyuria, pruritus, rash, RBC abnormal, rectal disorder, rectal hemorrhage, respiratory disorder, retinal degeneration, rhinitis, salivation increased, shock, sinusitis, skin carcinoma, sleep disorder, somnolence, stomatitis, stridor, sweating, syncope, synovitis, tachycardia, taste loss, taste perversion, tenesmus, testis disorder, thirst, thinking abnormality, thrombocytopenia, tinnitus, tremor, tongue disorder, ulcerative colitis, ulcerative stomatitis, upper respiratory inflammation, upper respiratory infection, urethral pain, urinary frequency, urination impaired, urticaria, vaginitis, vasodilation, vertigo, visual field defect, vomiting, weakness, WBC abnormal, weight gain/loss
Postmarketing and/or case reports: Agranulocytosis, anaphylactoid reaction, aplastic anemia, erythema multiforme, hemolytic anemia, hepatotoxicity, interstitial nephritis, leukopenia, myositis, neutropenia, pancreatitis, pancytopenia, speech disorder, Stevens-Johnson syndrome, thrombotic thrombocytopenic purpura, toxic epidermal necrolysis, urinary retention
Metabolism/Transport Effects
Substrate of CYP2C9 (minor), 2C19 (major), 3A4 (major); Inhibits CYP2C9 (weak), 2C19 (moderate), 2D6 (weak), 3A4 (weak); Induces CYP1A2 (weak)
Drug Interactions
Antifungal Agents (Azole Derivatives, Systemic): Proton Pump Inhibitors may decrease the absorption of Antifungal Agents (Azole Derivatives, Systemic). Exceptions: Miconazole. Risk D: Consider therapy modification
Atazanavir: Proton Pump Inhibitors may decrease the absorption of Atazanavir. Risk D: Consider therapy modification
Clopidogrel: Proton Pump Inhibitors may diminish the therapeutic effect of Clopidogrel. This appears to be due to reduced formation of the active clopidogrel metabolite. 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
Dasatinib: Proton Pump Inhibitors may decrease the absorption of Dasatinib. Risk D: Consider therapy modification
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 absorption of Indinavir. Risk C: Monitor therapy
Iron Salts: Proton Pump Inhibitors may decrease the absorption of Iron Salts. Exceptions: Ferric Gluconate; Iron Dextran Complex; Iron Sucrose. Risk C: Monitor therapy
Methotrexate: Proton Pump Inhibitors may decrease the excretion of Methotrexate. Antirheumatic doses of methotrexate probably hold minimal risk. Risk C: Monitor therapy
Saquinavir: Proton Pump Inhibitors may increase the serum concentration of Saquinavir. Risk C: Monitor therapy
Tipranavir: May decrease the serum concentration of Proton Pump Inhibitors. These data are derived from studies with Ritonavir-boosted Tipranavir. 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 15°C to 30°C (59°F to 86°F). Protect from light and moisture.
Reconstitution
Oral suspension: Empty packet into container with 2 tablespoons of water. Do not mix with other liquids or food. Stir well and drink immediately.
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
Duration: >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: 1-2 hours; Elderly: 2-3 hours; Hepatic impairment: ?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
>30 kg: 30 mg once daily
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: Currently accepted recommendations (may differ from product labeling): Dose varies with regimen: 30 mg once daily or 60 mg/day in 2 divided doses; requires combination therapy with antibiotics
Elderly: No dosage adjustment is needed in elderly patients with normal hepatic function
Dosage adjustment in renal impairment: No dosage adjustment is needed
Dosing adjustment in hepatic impairment: Dose reduction is necessary for severe hepatic impairment
Administration: Oral
Administer before food; best if taken before breakfast. The intact granules should not be chewed or crushed; however, in addition to oral suspension, 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.
Capsule granules may be mixed with apple, cranberry, grape, orange, pineapple, prune, tomato and V-8® juice and stored for up to 30 minutes.
Delayed release oral suspension granules should be mixed with 2 tablespoonfuls (30 mL) of water; no other liquid should be used. Stir well and drink immediately. Should not be administered through enteral administration tubes.
Orally-disintegrating tablets: Should not be swallowed whole 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; 4 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. Granules for oral suspension should not be administered through enteral administration tubes.
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. Prevacid® SoluTab™ contains phenylalanine 2.5 mg per 15 mg tablet; phenylalanine 5.1 mg per 30 mg tablet.
Patient Education
Take as directed, 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. Breast-feeding precaution: Breast-feeding is not recommended.
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 short half-life and 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.
Anesthesia and Critical Care Concerns/Other Considerations
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 assess 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. [DSC] = Discontinued product
Capsule, delayed release:
Prevacid®: 15 mg, 30 mg
Granules, for oral suspension, delayed release:
Prevacid®: 15 mg/packet (30s) [strawberry flavor], 30 mg/packet (30s) [strawberry flavor] [DSC]
Tablet, delayed release, orally disintegrating:
Prevacid® SoluTab™: 15 mg [contains phenylalanine 2.5 mg; strawberry flavor]; 30 mg [contains phenylalanine 5.1 mg; strawberry flavor]
Pricing: U.S. (www.drugstore.com)
Capsule, delayed release (Prevacid)
15 mg (30): $160.66
30 mg (30): $154.31
Tablet, orally-disintegrating (Prevacid SoluTab)
15 mg (30): $121.99
15 mg (100): $507.23
30 mg (30): $125.99
Extemporaneously Prepared
A 3 mg/mL lansoprazole oral solution (Simplified Lansoprazole Solution) can be prepared with ten lansoprazole 30 mg capsules and 100 mL 8.4% sodium bicarbonate. Empty capsules into beaker. Add sodium bicarbonate solution. Gently stir (about 15 minutes) until dissolved. Transfer to amber-colored syringe or bottle. Stable for 8 hours at room temperature or for 14 days under refrigeration.
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, 34:600-5
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):S18-21.
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
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.
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.
Dellinger RP, Levy MM, Carlet JM, et al, “Surviving Sepsis Campaign: International Guidelines for Management of Severe Sepsis and Septic Shock: 2008,” Intensive Care Med, 2008, 34(1): 17-60. Available at http://www.survivingsepsis.org/system/files/images/2008_20International_20SSC_20Guidelines_1_.pdf
DeVault KR and Castell DO, “Practice Guidelines. Updated Guidelines for the Diagnosis and Treatment of Gastroesophageal Reflux Disease”, Am J Gastroenterol, 2005,100(1):190-200.
Frazzoni M, De Micheli E, Grisendi A, et al, "Effective Intra-Oesophageal Acid Suppression in Patients With Gastro-Oesophageal Reflux Disease: Lansoprazole vs. Pantoprazole," Aliment Pharmacol Ther, 2003, 17(2):235-41.
Howden CW and Hunt RH, “Guidelines for the Management of Helicobacter pylori Infection. Ad Hoc Committee on Practice Parameters of the American College of Gastroenterology,” Am J Gastroenterol, 1998, 93(12):2336-8.
Huang JQ, Goldwater DR, Thomson AB, et al, "Acid Suppression in Healthy Subjects Following Lansoprazole or Pantoprazole," Aliment Pharmacol Ther, 2002, 16(3):425-33.
Jung R and MacLaren R, “Proton-Pump Inhibitors for Stress Ulcer Prophylaxis in Critically Ill Patients,” Ann Pharmacother, 2002, 36(12):1929-37.
Natsch S, Vinks MH, Voogt AK, et al, “Anaphylactic Reactions to Proton-Pump Inhibitors,” Ann Pharmacother, 2000, 34(4):474-6.
Wolfe MM and Sachs G, “Acid Suppression: Optimizing Therapy for Gastroduodenal Ulcer Healing, Gastroesophageal Reflux Disease, and Stress-Related Erosive Syndrome,” Gastroenterology, 2000,118(2 Suppl 1):9-31.
International Brand Names
Lexi-Comp.com
Last full review/revision August 2008
Content last modified August 2008
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