Classes
DEA Class; Rx, OTC
Common Brand Names; Prevacid, Prevacid Solu Tab, Prevacid 24HR
- Proton Pump Inhibitors
Description
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
Indications
Indicated for
- Duodenal Ulcer
- Gastric Ulcer
- NSAID-associated GU
- Gastroesophageal Reflux Disease
- Erosive Esophagitis
- Hypersecretory Condition (eg, Zollinger-Ellison Syndrome)
- Helicobacter Pylori Infection
- Heartbur
Contraindications
Hypersensitivity to lansoprazole or other proton pump inhibitors
Coadministration with rilpivirine-containing products
Adverse Effects
- 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
Warnings
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
Pregnancy and Lactation
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
Maximum Dosage
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.
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.
30 mg/day PO for most indications; up to 60 mg/day PO has been used off-label for eradication of H. pylori.
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.
Safety and efficacy have not been established; doses up to 2 mg/kg/day PO have been used off-label for GERD.
Safety and efficacy have not been established; doses up to 1.5 mg/kg/day have been used off-label for GERD.
How supplied
Lansoprazole
capsule delayed release
15mg
30mg
tablet, oral-disintegrating
15mg
30mg
oral suspension
3 mg/mL