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Lansoprazole

    DEA Class; Rx, OTC

    Common Brand Names; Prevacid, Prevacid Solu Tab, Prevacid 24HR

    • Proton Pump Inhibitors

    Proton-pump inhibitor (PPI), gastric antisecretory agent
    Used for treatment of duodenal and gastric ulcers, erosive esophagitis, GERD, heartburn, ZE syndrome, and NSAID-induced ulcers; combined with antibiotics for eradication of H. pylori
    Associated with increased risk of Clostridium difficile-associated diarrhea

     Indicated for

    • Duodenal Ulcer
    • Gastric Ulcer
    • NSAID-associated GU
    • Gastroesophageal Reflux Disease
    • Erosive Esophagitis
    • Hypersecretory Condition (eg, Zollinger-Ellison Syndrome)
    • Helicobacter Pylori Infection
    • Heartbur

    Hypersensitivity to lansoprazole or other proton pump inhibitors

    Coadministration with rilpivirine-containing products

    • Headache (3-7%)
    • Diarrhea (1-5%)
    • Constipation (1-5%)
    • Nausea (1-3%)
    • Abdominal pain (1-3%)
    • Anxiety
    • Angina
    • Palpitations
    • Syncope
    • Edema
    • Anorexia
    • Dry mouth
    • Tenesmus
    • Flatulence
    • Melena
    • Myalgia
    • Tinnitus
    • Allergic reaction

    Proton pump inhibitors (PPIs) are possibly associated with increased incidence of Clostridium difficile-associated diarrhea (CDAD); consider diagnosis of CDAD for patients taking PPIs who have diarrhea that does not improve

    Liver disease may require dosage reduction

    May cause severe skin reactions; symptoms may include skin reddening, blisters, rash; if allergic reaction occurs, stop use and seek medical help right away

    Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) reported with PPIs; avoid using for longer than medically indicated; discontinue if signs or symptoms consistent with CLE or SLE are observed and refer patient to specialist

    Severe cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) reported in association with use of PPIs; discontinue therapy at first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation

    Published observational studies suggest that PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine, particularly with prolonged (>1 yr), high-dose therapy

    Decreased gastric acidity increases serum chromogranin A (CgA) levels and may cause false-positive diagnostic results for neuroendocrine tumors; temporarily discontinue PPIs before assessing CgA levels

    PPIs may decrease the efficacy of clopidogrel by reducing the formation of the active metabolite

    Relief of symptoms does not eliminate the possibility of a gastric malignancy

    Therapy increases risk of Salmonella, Campylobacter, and other infections

    Acute interstitial nephritis reported in patients taking proton pump inhibitors; discontinue therapy if interstitial nephritis develops

    Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin

    May elevate and/or prolong serum concentrations of methotrexate and/or its metabolite when administered concomitantly with PPIs, possibly leading to toxicity; consider a temporary withdrawal of PPI therapy with high dose methotrexate administration

    SoluTab dosage form contains phenylalanine, a component of aspartame, which can be harmful to patients with phenylketonuria (PKU); before prescribing lansoprazole to a patient with PKU, consider the combined daily amount of phenylalanine from all sources, including the SoluTab dosage form

    Some dosage forms contain benzyl alcohol, which has been associated with gasping syndrome in the neonate; avoid or use dosage forms containing benzyl alcohol with caution in neonates

    Available data from published observational studies overall do not indicate an association of adverse pregnancy outcomes with lansoprazole treatment; estimated background risk of major birth defects and miscarriage for the indicated populations are unknown

    There is no information regarding presence of lansoprazole in human milk, effects on breastfed infant, or on milk production

    Adults

    30 mg/day PO for most indications; 90 mg/day PO is FDA-approved maximum for eradication of H. pylori; however, up to 120 mg/day PO is used off-label; up to 180 mg/day PO for Zollinger-Ellison syndrome.

    Geriatric

    30 mg/day PO for most indications; 90 mg/day PO is FDA-approved maximum for eradication of H. pylori; however, up to 120 mg/day PO is used off-label; up to 180 mg/day PO for Zollinger-Ellison syndrome.

    Adolescents

    30 mg/day PO for most indications; up to 60 mg/day PO has been used off-label for eradication of H. pylori.

    Children

    12 years: 30 mg/day PO for most indications; up to 60 mg/day PO has been used off-label for eradication of H. pylori.
    1 to 11 years weighing more than 30 kg: 30 mg/day PO for GERD or erosive esophagitis, up to 60 mg/day PO has been used off-label for refractory cases and for eradication of H. pylori.
    1 to 11 years weighing 30 kg or less: 15 mg/day PO for GERD or erosive esophagitis, occasionally higher doses used for refractory cases; up to 2.5 mg/kg/day (Max: 60 mg/day) PO has been used off-label for eradication of H. pylori.

    Infants

    Safety and efficacy have not been established; doses up to 2 mg/kg/day PO have been used off-label for GERD.

    Neonates

    Safety and efficacy have not been established; doses up to 1.5 mg/kg/day have been used off-label for GERD.

    Lansoprazole

    capsule delayed release

    • 15mg

    • 30mg

    tablet, oral-disintegrating

    • 15mg

    • 30mg

    oral suspension

    • 3 mg/mL