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  • Prevacid
    (lansoprazole)

    OTHER BRAND NAMES

    Prevacid SoluTab

    THERAPEUTIC CLASS

    Proton pump inhibitor (PPI)

    DEA CLASS

    RX

    INDICATIONS

    Short-term treatment of active duodenal ulcer (DU), active benign gastric ulcer (GU), and erosive esophagitis (EE). Maintenance of healing of DU and EE. Treatment and risk reduction of NSAID-associated GU. Treatment of heartburn and other symptoms associated with GERD. Long-term treatment of pathological hypersecretory conditions (eg, Zollinger-Ellison syndrome). Combination therapy with amoxicillin +/- clarithromycin for Helicobacter pylori eradication to reduce the risk of DU recurrence.

    ADULT DOSAGE

    Pathological Hypersecretory Conditions

    Treatment Including Zollinger-Ellison Syndrome:

    Initial: 60mg qd
    Titrate: Individualize dose

    Doses up to 90mg bid have been administered
    Divide dose if >120mg/day

    Active Duodenal Ulcer

    Treatment:
    15mg qd for 4 weeks

    Maint of Healing of Duodenal Ulcer:
    15mg qd

    NSAID-Associated Gastric Ulcer

    Healing:
    30mg qd for 8 weeks

    Risk Reduction:

    15mg qd for up to 12 weeks

    Helicobacter pylori Eradication

    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

    Gastroesophageal Reflux Disease

    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 occur
    May consider an additional 8-week course if there is a recurrence of erosive esophagitis

    Maint of Healing of Erosive Esophagitis:
    15mg qd

    Gastric Ulcers

    Benign:
    30mg qd for up to 8 weeks

    PEDIATRIC DOSAGE

    Gastroesophageal Reflux Disease

    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 weeks

    Treatment 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 symptomatic
    12-17 Years:
    30mg qd for up to 8 weeks

    DOSING CONSIDERATIONS

    Hepatic Impairment
    Severe: Consider dose adjustment

    ADMINISTRATION

    Oral route

    Take ac

    Cap
    Swallow 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 SoluTab
    Do 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

    HOW SUPPLIED

    Cap, Delayed-Release: 15mg, 30mg; Tab, Disintegrating (SoluTab): 15mg, 30mg

    WARNINGS/PRECAUTIONS

    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.

    ADVERSE REACTIONS

    Abdominal pain, constipation, diarrhea, nausea, dizziness, headache.

    DRUG INTERACTIONS

    May reduce the absorption of drugs where gastric pH is an important determinant of bioavailability; ampicillin esters, ketoconazole, atazanavir, iron salts, erlonitib and mycophenolate mofetil (MMF) absorption may decrease, while digoxin absorption may increase. May substantially decrease atazanavir concentrations; 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 AND LACTATION

    Category B, not for use in nursing.

    MECHANISM OF ACTION

    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.

    PHARMACOKINETICS

    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.

    ASSESSMENT

    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.

    MONITORING

    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.

    PATIENT COUNSELING

    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.

    STORAGE

    25°C (77°F); excursions permitted to 15-30°C (59-86°F).