Generic Name and Formulations:
Naproxen, esomeprazole (as magnesium trihydrate); 375mg/20mg, 500mg/20mg; delayed-release tabs.
- SAFETY ALERT: FDA Warns of C. Difficile-Associated Diarrhea Risk with Proton Pump Inhibitors
- FDA Warns That PPIs May Cause Hypomagnesemia
- Proton pump inhibitors (PPIs) class labeling change to include fracture risk
Indications for VIMOVO:
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, acute interstitial nephritis, bleeding, or serious rash occurs. Gastric malignancy. Long-term therapy may lead to malabsorption/deficiency of Vit. B12 or atrophic gastritis. 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, infertility: not recommended. Nursing mothers.
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). May affect other 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), ACEIs, ARBs. Increased renal toxicity with cyclosporine, ACEIs, ARBs, 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, erlotinib, mycophenolate mofetil, 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; discontinue esomeprazole 14 days prior to CgA level assessment.
Gastritis, diarrhea, GI ulcers, upper abdominal pain, nausea, dyspepsia; renal papillary necrosis; rare: hypomagnesemia or Vit. B12 deficiency (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.
- 500mg/20mg tablets (Qty:60)
- appx. price $1524.00