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  • Prevacid
    (Lansoprazole) - Takeda

    OTHER BRAND NAMES

    Prevacid SoluTab (Takeda)

    THERAPEUTIC CLASS

    Proton pump inhibitor

    DEA CLASS

    RX

    INDICATIONS

    Short-term treatment of active duodenal ulcer (DU), active benign gastric ulcer (GU), and erosive esophagitis (EE). Maint of healing of DU and EE. Treatment and risk reduction of NSAID-associated GU. Treatment of heartburn and other symptoms associated with gastroesophageal reflux disease (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

    Adults: Take before eating. DU: Short-Term Treatment: 15mg qd for 4 weeks. Maint of Healing of DU: 15mg qd. Short-Term Treatment of Benign GU: 30mg qd for up to 8 weeks. NSAID-associated GU: Healing: 30mg qd for 8 weeks. Risk Reduction: 15mg qd for up to 12 weeks. GERD: Short-Term Treatment of Symptomatic GERD: 15mg qd for up to 8 weeks. Short-Term Treatment of EE: 30mg qd for up to 8 weeks. May give for 8 more weeks if healing does not occur. If there is recurrence of EE, an additional 8-week course may be considered. Maint of Healing of EE: 15mg qd. Pathological Hypersecretory Conditions: Initial: 60mg qd. Titrate: Individualize dose. Max: 90mg bid. Divide dose if >120mg/day. H. pylori Eradication to Reduce Risk of DU Recurrence: Triple Therapy: 30mg + amoxicillin 1000mg + clarithromycin 500mg, all bid (q12h) for 10 or 14 days. Dual Therapy: 30mg + amoxicillin 1000mg, both tid (q8h) for 14 days. Severe Hepatic Impairment: Consider dose adjustment.

    PEDIATRIC DOSAGE

    Pediatrics: Take before eating. 12-17 yrs: Short-Term Treatment of Symptomatic GERD: Nonerosive GERD: 15mg qd for up to 8 weeks. EE: 30mg qd for up to 8 weeks. 1-11 yrs: Short-Term Treatment of Symptomatic GERD/EE: >30kg: 30mg qd for up to 12 weeks; may increase up to 30mg bid after ≥2 weeks if symptomatic. ≤30kg: 15mg qd for up to 12 weeks; may increase up to 30mg bid after ≥2 weeks if symptomatic. Severe Hepatic Impairment: Consider dose adjustment.

    HOW SUPPLIED

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

    WARNINGS/PRECAUTIONS

    Symptomatic response does not preclude the presence of gastric malignancy. 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; magnesium replacement and d/c of therapy may be required. (Tab, Disintegrating) Contains phenylalanine.

    ADVERSE REACTIONS

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

    DRUG INTERACTIONS

    Substantially decreases atazanavir concentrations; concomitant use is not recommended. May alter absorption of other drugs where gastric pH is an important determinant of oral bioavailability (eg, ampicillin esters, digoxin, iron salts, ketoconazole). Delayed absorption and reduced bioavailability with sucralfate; give at least 30 mins prior to sucralfate. 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 methotrexate leading to toxicities; consider temporary withdrawal of therapy with high-dose methotrexate. Caution with digoxin or other drugs that may cause hypomagnesemia (eg, diuretics).

    PREGNANCY

    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.

    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 magnesium levels.

    MONITORING

    Monitor for signs/symptoms of bone fractures, CDAD, hypersensitivity reactions, and other adverse reactions. Monitor magnesium levels periodically.

    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 as directed. Inform of alternative methods of administration if patient has swallowing difficulties.

    ADMINISTRATION/STORAGE

    Administration: Oral route. Take before eating. May also be administered via NG tube. Do not crush, break, cut, or chew. Swallow caps whole. Allow tab to disintegrate on tongue until particles can be swallowed. Refer to PI for additional administration instructions. Storage: 25°C (77°F); excursions permitted to 15-30°C (59-86°F).