Osteoarthritis, rheumatoid arthritis, ankylosing spondylitis: to improve symptoms and reduce risk of gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers.
Swallow whole. Take at least 30min before meals. ≥18yrs: One 375/20 or 500/20 tab twice daily. Use lowest effective dose for the shortest duration. Consider dose reduction in mild to moderate hepatic impairment.
<18yrs: not established.
NSAID + proton pump inhibitor.
Aspirin allergy/triad. Coronary artery bypass surgery. Late pregnancy (≥30 weeks gestation).
Increased risk of serious cardiovascular thrombotic events, MI, stroke, gastrointestinal adverse events (bleeding, ulceration, perforation); may be fatal. Moderate to severe renal impairment (CrCl <30mL/min) or severe hepatic impairment: not recommended. History of ulcer disease, GI bleeding, or inflammatory bowel disease (eg, ulcerative colitis, Crohn’s disease). Hypertension; monitor BP. CHF. Edema. Bleeding disorders. Pre-existing asthma. Impaired renal or hepatic function. Monitor blood, liver, and renal function in chronic use. Discontinue if liver or renal dysfunction, bleeding, or serious rash occurs. Increased risk of osteoporosis-related fractures of the hip, wrist or spine with long-term and multiple daily dose PPI therapy. Monitor magnesium levels with long-term therapy. Elderly. Debilitated. Pregnancy (Cat.C <30 weeks gestation, Cat.D ≥30 weeks gestation). Labor & delivery, nursing mothers: not recommended.
Concomitant St. John's wort, rifampin, atazanavir, nelfinavir: not recommended. Avoid concomitant non-aspirin NSAIDs. May potentiate saquinavir (monitor; consider reducing saquinavir dose), protein-bound drugs (eg, hydantoins, sulfonamides, sulfonylureas). Increases lithium and tacrolimus levels. Antagonizes clopidogrel; consider alternative anti-platelet therapy. Methotrexate excretion reduced (caution w. high doses). May antagonize diuretics, beta-blockers (eg, propranolol), ACE inhibitors. Increased renal toxicity with cyclosporine and ACE inhibitors. Increased risk of GI bleed with oral corticosteroids, smoking, alcohol, SSRIs. Monitor aspirin and oral anticoagulants. May affect CYP2C19 substrates (eg, diazepam, cilostazol). May affect absorption of pH-dependent drugs (eg, ketoconazole, digoxin, iron salts). Probenecid increases plasma levels and delays elimination. Delayed absorption with concomitant cholestyramine. May interfere with neuroendocrine diagnostic tests.
Erosive gastritis, dyspepsia, gastritis, diarrhea, gastric ulcer, upper abdominal pain, nausea; renal papillary necrosis; rare: hypomagnesemia (w. prolonged PPI therapy); see literature re: risk of cardiovascular events, serious gastrointestinal events, possible C. difficile associated diarrhea.
Hepatic (CYP2C9, 1A2, 2C19, 3A4); 99% protein bound.
Renal (primarily), fecal.