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Proton pump inhibitor (PPI)
Treatment Including Zollinger-Ellison Syndrome:
Initial: 60mg qdTitrate: Individualize doseDoses up to 90mg bid have been administeredDivide dose if >120mg/day
Treatment: 15mg qd for 4 weeks
Maint of Healing of Duodenal Ulcer:15mg qd
Healing: 30mg qd for 8 weeksRisk Reduction: 15mg qd for up to 12 weeks
W/ Duodenal Ulcer Disease to Reduce the Risk of Duodenal Ulcer Recurrence:
Triple Therapy:30mg cap + clarithromycin 500mg + amoxicillin 1000mg, all bid for 10 or 14 days
Dual Therapy:Allergic/Intolerant/Resistant to Clarithromycin:30mg cap + amoxicillin 1000mg, all tid w/ for 14 days
Symptomatic GERD: 15mg qd for up to 8 weeks
Treatment of Erosive Esophagitis:30mg qd for up to 8 weeks; may give for 8 more weeks if healing does not occurMay consider an additional 8-week course if there is a recurrence of erosive esophagitis
Maint of Healing of Erosive Esophagitis:15mg qd
Benign:30mg qd for up to 8 weeks
Symptomatic GERD:1-11 Years:≤30kg: 15mg qd for up to 12 weeks; may increase up to 30mg bid after ≥2 weeks if still symptomatic>30kg: 30mg qd for up to 12 weeks; may increase up to 30mg bid after ≥2 weeks if still symptomatic
Symptomatic Nonerosive GERD: 12-17 Years:15mg qd for up to 8 weeksTreatment of Erosive Esophagitis:1-11 Years:≤30kg: 15mg qd for up to 12 weeks; may increase up to 30mg bid after ≥2 weeks if still symptomatic>30kg: 30mg qd for up to 12 weeks; may increase up to 30mg bid after ≥2 weeks if still symptomatic12-17 Years:30mg qd for up to 8 weeks
Hepatic ImpairmentSevere: Consider dose adjustment
Take ac.CapSwallow whole; do not crush or chew.If trouble swallowing, may sprinkle intact granules on 1 tbsp of either applesauce, Ensure pudding, cottage cheese, yogurt or strained pears, or into 60mL of either apple juice, orange juice, or tomato juice and swallow immediately.NG Tube (≥16 French):Mix intact granules into 40mL of apple juice; do not use other liquids.Inject through the NG tube into the stomach.Flush w/ additional apple juice to clear the tube.Disintegrating SoluTabDo not break, crush, chew, or cut.Allow tab to disintegrate on tongue, w/ or w/o water, until particles can be swallowed.Oral Syringe:Place a 15mg tab in oral syringe and draw up 4mL of water, or place a 30mg tab w/ 10mL of water.Shake gently to allow for a quick dispersal.After the tab has dispersed, administer w/in 15 min.Refill the syringe w/ approx 2mL (5mL for the 30mg tab) of water, shake gently, and administer any remaining contents.NG Tube (≥8 French):Place a 15mg tab in a syringe and draw up 4mL of water, or place a 30mg tab w/ 10mL of water.Shake gently to allow for a quick dispersal.After the tab has dispersed, inject through the NG tube into the stomach w/in 15 min.Refill the syringe w/ approx 5mL of water, shake gently, and flush the NG tube.
Cap, Delayed-Release: 15mg, 30mg; Tab, Disintegrating (SoluTab): 15mg, 30mg
Known severe hypersensitivity to any component of the formulation. When used w/ clarithromycin and/or amoxicillin, refer to the individual PIs.
Symptomatic response does not preclude the presence of gastric malignancy. Acute interstitial nephritis reported; d/c if this develops. Cyanocobalamin (vitamin B12) deficiency may occur due to malabsorption with daily long-term treatment (eg, >3 yrs) with any acid-suppressing medications. May increase risk for Clostridium difficile-associated diarrhea (CDAD), especially in hospitalized patients. May increase risk for osteoporosis-related fractures of the hip, wrist, or spine, especially with high-dose and long-term therapy. Use lowest dose and shortest duration appropriate to the condition being treated. Hypomagnesemia reported; Mg2+ replacement and discontinuation of therapy may be required. (Tab, Disintegrating) Contains phenylalanine.
Abdominal pain, constipation, diarrhea, nausea, dizziness, headache.
May reduce the absorption of drugs where gastric pH is an important determinant of bioavailability; ampicillin esters, ketoconazole, atazanavir, nelfinavir, iron salts, erlotinib and mycophenolate mofetil (MMF) absorption may decrease, while digoxin absorption may increase. May substantially decrease concentrations of HIV protease inhibitors (eg, atazanavir, nelfinavir); avoid coadministration. Caution in transplant patients receiving MMF. May increase theophylline clearance; may require theophylline dose titration when lansoprazole is started or stopped. Monitor for increases in INR and PT with warfarin. May increase tacrolimus levels. May elevate and prolong levels of MTX leading to toxicities; consider temporary withdrawal of therapy with high-dose MTX. Caution with digoxin or other drugs that may cause hypomagnesemia (eg, diuretics).
Pregnancy: Category B. Lactation: Not for use in nursing.
Proton pump inhibitor; suppresses gastric acid secretion by specific inhibition of the (H+/K+)-ATPase enzyme system at the secretory surface of the gastric parietal cell. Blocks the final step of acid production.
Absorption: Rapid; absolute bioavailability (>80%); Tmax=1.7 hrs. Distribution: Plasma protein binding (97%). Metabolism: Liver (extensive). Elimination: Urine (1/3), feces (2/3); T1/2<2 hrs.
Assess for hepatic insufficiency, risk for osteoporosis, phenylketonuria, previous hypersensitivity to the drug, pregnancy/nursing status, and possible drug interactions. Obtain baseline Mg2+ levels in patients expected to be on prolonged treatment.
Monitor for signs/symptoms of acute interstitial nephritis, cyanocobalamin deficiency, bone fractures, CDAD, hypersensitivity reactions, and other adverse reactions. Monitor Mg2+ levels periodically in patients expected to be on prolonged treatment.
Advise to seek immediate medical attention if diarrhea does not improve or cardiovascular/neurological symptoms (eg, palpitations, dizziness, seizures, tetany) develop. Instruct to take exactly ud. Inform of alternative methods of administration if patient has swallowing difficulties.
25°C (77°F); excursions permitted to 15-30°C (59-86°F).