Generic Name and Formulations:
Naproxen, esomeprazole (as magnesium trihydrate); 375mg/20mg, 500mg/20mg; delayed-release tabs.
Osteoarthritis, rheumatoid arthritis, ankylosing spondylitis: to improve signs/symptoms and reduce risk of gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers.
Swallow whole. Take at least 30 mins before meals. ≥18yrs: One 375mg/20mg or 500mg/20mg 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.
Increased risk of serious cardiovascular thrombotic events, MI, stroke, GI 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. Volume depleted. 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. Gastric malignancy. Atrophic gastritis (w. long-term therapy). Increased risk of osteoporosis-related fractures (hip, wrist or spine) with long-term and multiple daily dose PPI therapy. Monitor magnesium levels with long-term therapy. May mask inflammation and fever. Elderly. Debilitated. Pregnancy (Cat.C <30 weeks gestation, Cat.D ≥30 weeks gestation; avoid). Labor & delivery, nursing mothers, infertility: not recommended.
Concomitant St. John's wort, rifampin, atazanavir, nelfinavir: not recommended. Avoid concomitant non-aspirin NSAIDs or other naproxen-containing drugs. 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-platelets. Methotrexate excretion reduced (caution w. high doses). May antagonize diuretics, beta-blockers (eg, propranolol), ACE inhibitors. Increased renal toxicity with cyclosporine, ACE inhibitors, angiotensin II receptor antagonists, diuretics. Increased risk of GI bleed with oral corticosteroids, smoking, alcohol, SSRIs. Monitor aspirin and oral anticoagulants. May affect CYP2C19 substrates (eg, diazepam), cilostazol (consider reducing dose), voriconazole. 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 5HIAA urinary assays and neuroendocrine diagnostic tests.
Erosive gastritis, dyspepsia, gastritis, diarrhea, gastric ulcer, upper abdominal pain, nausea; renal papillary necrosis; rare: hypomagnesemia (w. prolonged PPI therapy); see full labeling re: risk of cardiovascular events, serious GI events, possible C. difficile-associated diarrhea.
Hepatic (CYP2C9, 1A2, 2C19, 3A4); 99% protein bound.
Renal (primarily), fecal.