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Lansoprazole


Pronunciation

 (lan SOE pra zole)


U.S. Brand Names

 Prevacid®; Prevacid® SoluTab™


Generic Available

 No


Canadian Brand Names

 Prevacid®


Use

Oral: 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

I.V.: Short-term treatment ( 7 days) of erosive esophagitis in adults unable to take oral medications


Use - Unlabeled/Investigational

 Active ulcer bleeding (parenteral formulation)


Pregnancy Risk Factor

 B


Pregnancy Implications

 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

 Severe liver dysfunction may require dosage reductions. Symptomatic response does not exclude malignancy. Safety and efficacy have not been established in children <1 year of age.


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 (4%; 4% to 7% at doses of 30-60 mg/day), 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, asthenia, 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 disorder, gastrointestinal hemorrhage, GGTP increased, GGTP decreased, glucocorticoids increased, globulins increased, glossitis, glycosuria, goiter, gout, gum hemorrhage, gynocomastia, hair disorder, halitosis, hallucinations, hematemesis, hematuria, hemiplegia, hemolysis, hemoptysis, hiccup, hostility aggravated, hyperglycemia, hyperkinesia, hyperlipemia, hypertonia, hypesthesia, 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, WBC abnormal, weight gain/loss

Postmarketing and/or case reports: Agranulocytosis, anaphylactoid reaction, aplastic anemia, dizziness, erythema multiforme, hemolytic anemia, hepatotoxicity, leukopenia, neutropenia, pancreatitis, pancytopenia, speech disorder, Stevens-Johnson syndrome, thrombocytopenia, thrombotic thrombocytopenic purpura, toxic epidermal necrolysis (some fatal), urinary retention


Overdosage/Toxicology

 No symptoms of toxicity were observed in animal studies; limited human experience in overdose. Treatment is symptomatic and supportive. Lansoprazole is not removed by hemodialysis.


Drug Interactions

 Substrate of CYP2C8/9 (minor), 2C19 (major), 3A4 (major); Inhibits CYP2C8/9 (weak), 2C19 (moderate), 2D6 (weak), 3A4 (weak); Induces CYP1A2 (weak)

CYP2C19 inducers: May decrease the levels/effects of lansoprazole. Example inducers include aminoglutethimide, carbamazepine, phenytoin, and rifampin.

CYP2C19 substrates: Lansoprazole may increase the levels/effects of CYP2C19 substrates. Example substrates include citalopram, diazepam, methsuximide, phenytoin, propranolol, and sertraline.

CYP3A4 inducers: CYP3A4 inducers may decrease the levels/effects of lansoprazole. Example inducers include aminoglutethimide, carbamazepine, nafcillin, nevirapine, phenobarbital, phenytoin, and rifamycins.

Itraconazole and ketoconazole: Proton pump inhibitors may decrease the absorption of itraconazole and ketoconazole.

Protease inhibitors: Proton pump inhibitors may decrease absorption of some protease inhibitors (atazanavir and indinavir).


Ethanol/Nutrition/Herb Interactions

Ethanol: Avoid ethanol (may cause gastric mucosal irritation).

Food: Lansoprazole serum concentrations may be decreased if taken with food.


Stability

 Store at 15°C to 30°C (59°F to 86°F); protect from light and moisture.

Oral suspension: Empty packet into container with 2 tablespoons of water. Do not mix with other liquids or food. Stir well and drink immediately.

Powder for injection: Reconstitute with sterile water 5 mL; mix gently until dissolved. Prior to administration, further dilute with 50 mL of NS, LR, or D5W. After reconstitution, the solution may be stored for up to 1 hour at room temperature prior to final dilution. Following final dilution, solutions mixed with NS or LR are stable at room temperature for 24 hours; solutions mixed with D5W are stable for 12 hours


Mechanism of Action

 A proton pump inhibitor which decreases acid secretion in gastric parietal cells


Pharmacodynamics/Kinetics

Duration: >1 day

Absorption: Rapid

Protein binding: 97%

Metabolism: Hepatic via CYP2C19 and 3A4, and in parietal cells to two inactive metabolites

Bioavailability: 80%; decreased 50% to 70% if given 30 minutes after food

Half-life elimination: 2 hours; Elderly: 2-3 hours; Hepatic impairment: 7 hours

Time to peak, plasma: 1.7 hours

Excretion: Feces (67%); urine (33%)


Dosage

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

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: Oral:

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: 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

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

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 of therapy

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 that do not heal after the first 8 weeks of therapy; maintenance therapy: 15 mg once daily

I.V.: 30 mg once daily for up to 7 days; patients should be switched to an oral formulation as soon as they can take oral medications

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

Helicobacter pylori eradication: Oral: 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

Prevention of rebleeding in peptic ulcer bleed (unlabeled use): I.V.: 60 mg, followed by 6 mg/hour infusion for 72 hours

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.

I.V.: Administer over 30 minutes. Use of an in-line filter is required. Before and after administration, flush I.V. line with NS, LR, or D5W. Do not administer with other medications.

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.

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.


Anesthesia and Critical Care Concerns/Other Considerations

 Intravenous omeprazole has been studied in prevention of rebleeding in ulcer patients who are at high risk for rebleeding (endoscopic findings of active bleeding or nonbleeding visible vessel) after successful hemostasis (Lin HJ, 1998; Lau JY, 2000). Lin and his group treated 100 ulcer patients (actively bleeding ulcers or ulcers with nonbleeding visible vessels) endoscopically and then randomized them to cimetidine (300 mg bolus followed by 50 mg/hour infusion) or omeprazole (40 mg bolus, ~7 mg/hour infusion) for 72 hours. Patients were discharged on the oral form of the drug arm they were assigned to. The omeprazole group maintained an intragastric pH >6 for about 84% of the infusion duration, while the cimetidine group maintained their pH >6 only about 50% of the time. Rebleeding occurred significantly more often in the cimetidine group. Lau and his colleagues treated patients with actively bleeding ulcers or ulcers with nonbleeding visible vessels with an epinephrine infusion followed by thermocoagulation. They were then randomized to omeprazole (80 mg bolus followed by a continuous infusion of 8 mg/hour for 72 hours) or placebo. All patients were discharged on oral omeprazole (20 mg/day) for 8 weeks and received H. pylori treatment if indicated. The primary goal was to evaluate the rate of rebleeding during the first 30 days after endoscopy. Two hundred and forty patients were enrolled with randomization of 120 into each group. Bleeding recurred in significantly more patients receiving placebo than omeprazole infusion. The authors concluded that after endoscopic therapy, omeprazole reduces the risk of rebleeding in patients with actively bleeding ulcers or ulcers with nonbleeding visible vessels.


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


Dosage Forms

Capsule, delayed release (Prevacid®): 15 mg, 30 mg

Granules, for oral suspension, delayed release (Prevacid®): 15 mg/packet (30s), 30 mg/packet (30s) [strawberry flavor]

Injection, powder for reconstitution (Prevacid®): 30 mg

Tablet, orally-disintegrating (Prevacid® SoluTab™): 15 mg [contains phenylalanine 2.5 mg; strawberry flavor]; 30 mg [contains phenylalanine 5.1 mg; strawberry flavor]


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

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.

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.

Jung R and MacLaren R, "Proton-Pump Inhibitors for Stress Ulcer Prophylaxis in Critically Ill Patients," Ann Pharmacother , 2002, 36(12):1929-37.

Lau JY, Sung JJ, Lee KK, et al, "Effect of Intravenous Omeprazole on Recurrent Bleeding After Endoscopic Treatment of Bleeding Peptic Ulcers," N Engl J Med , 2000, 343(5):310-6.

Lin HJ, Lo WC, Lee FY, et al, "A Prospective Randomized Comparative Trial Showing That Omeprazole Prevents Rebleeding in Patients With Bleeding Peptic Ulcer After Successful Endoscopic Therapy," Arch Intern Med , 1998, 158(1):54-8.

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

 Agopton® (AT, CH, DE); Alexin® (PT); Amarin® (YU); Aprazol® (TR); Bamalite® (ES); Betalans® (ID); Blason® (AR); Blosel® (GT); Compraz® (ID); Dakar® (BE, LU); Degastrol® (TR); Digest® (ID); Diprox® (BR); Estomil® (ES); Gastrex® (PT); Gastroliber® (PT); HeliClear® (GB); Helicol® (TR); Helicopac® (BR); Heliklar® (BR); HeliMet® (GB); Ilsatec® (AR, BR, MX); Lacopen® (CO); Lanfast® (EC); Lanproton® (CO); Lansokrazol® (GT); Lansone® (CZ, HU, PL); Lansopep® (CO); Lansoprazol® (BR, CL); Lansoprazol Calox® (CR, PA); Lansoprazol Genfar® (EC); Lansoprol® (TR); Lansoptol® (RU); Lansor® (TR); Lansox® (IT); Lanvell® (ID); Lanximed® (CO); Lanzap® (RO, RU); Lanzedin® (TR); Lanzo® (DK, FI, NO, SE); Lanzol® (BR, IN); Lanzopral® (AR, CL); Lanzor® (DE, FR, ZA); Lanzul® (HR, PL, RO, SI); Lapraz® (ID); Laproton® (ID); Lasoprol® (CY, RO, YU); Laz® (ID); Limpidex® (IT); Lizul® (PT); Lopral® (CO); Mesactol® (AR); Monolitum® (CR, ES, GT, PA, PT, SV); Neutron® (CO); Ogast® (FR); Ogasto® (CL); Ogastro® (BR, CO, CR, DO, GT, HN, MX, PA, SV, TR); Opiren® (ES); Pampe® (PT); Pepzol® (PT); Prazolax® (DO); Prazol® (BR); Prazotec® (ID); Prevacid® (CA, JP, SG, TH); Prezal® (NL); Prolanz® (ID); Prosogan® (ID); Pro Ulco® (ES); Pylobac® (DO); Pyloripac® (BR); Pysolan® (ID); Takepron® (BG, JP, KW, LB, MA, MY, SY); Ulcertec® (PT); Ulfine® (PT); Ulpax® (MX); Unival® (CL); Zolt® (FI); Zopral® (DO); Zoprol® (TR); Zoton® (AU, GB, IE, IL, IT, NZ)


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