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

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