Generic Name and Formulations:
Naproxen, esomeprazole (as magnesium trihydrate); 375mg/20mg, 500mg/20mg; del-rel tabs.
Indications for VIMOVO:
Osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, juvenile idiopathic arthritis (JIA): to relieve signs/symptoms and reduce risk of developing naproxen-associated gastric ulcers.
Limitations Of use:
Not interchangeable with its individual components. Not for initial treatment of acute pain.
Use lowest effective dose for shortest duration. Swallow whole. Take at least 30 mins before meals. ≥18yrs: one 375mg/20mg or 500mg/20mg tab twice daily. Consider dose reduction in mild-to-moderate hepatic impairment.
Use lowest effective dose for shortest duration. Swallow whole. Take at least 30 mins before meals. JIA: <12yrs or <38kg: not established. ≥12yrs (≥38kg–<50kg): one 375mg/20mg tab twice daily; (>50kg): one 375mg/20mg or 500mg/20mg tab twice daily.
Aspirin allergy. Coronary artery bypass graft surgery. Concomitant rilpivirine-containing products.
Risk of serious cardiovascular and gastrointestinal events.
Increased risk of serious cardiovascular events (including MI, stroke). Avoid in recent MI, severe heart failure; if necessary, monitor. Increased risk of serious GI adverse events (including inflammation, bleeding, ulceration, perforation). History of ulcer disease, GI bleeding, or inflammatory bowel disease (eg, ulcerative colitis, Crohn’s disease). Hypertension; monitor BP closely. Moderate-to-severe renal impairment (CrCl <30mL/min) or severe hepatic impairment: not recommended. Discontinue if signs/symptoms of liver disease develop, if abnormal LFTs persist or worsen, or if acute interstitial nephritis, cutaneous/systemic lupus erythematosus, bleeding occurs. Dehydration. Hypovolemia. Hyperkalemia. Coagulation disorders. Monitor CBCs, blood chemistry, hepatic, and renal function in long-term therapy. Pre-existing asthma. May mask signs of infection or fever. Discontinue at 1st sign of rash or any other hypersensitivity. Symptomatic response does not preclude gastric malignancy. Long-term therapy (eg, >3yrs) may lead to malabsorption/deficiency of Vit. B12. Monitor magnesium levels during prolonged therapy. Increased risk of fundic gland polyps with long-term use (esp. >1yr) or osteoporosis-related fractures (hip, wrist or spine) with long-term (>1yr) and multiple daily dose PPI therapy. Elderly. Debilitated. Labor & delivery. Pregnancy (≥30 weeks gestation; avoid). Nursing mothers.
NSAID + proton pump inhibitor.
See Contraindications. Concomitant St. John's wort, rifampin, atazanavir, nelfinavir, voriconazole: not recommended. Avoid concomitant aspirin, salicylates (eg, diflunisal, salsalate) or other NSAIDs. Increased risk of GI bleed with anticoagulants, antiplatelets, oral corticosteroids, SSRIs, SNRIs, smoking, alcohol, or prolonged NSAID therapy; monitor. May antagonize, or increase risk of renal failure with diuretics (eg, loop or thiazides), ACE inhibitors, ARBs, or β-blockers; monitor closely. Potentiates digoxin, saquinavir, tacrolimus, diazepam; monitor. May potentiate lithium, methotrexate, cyclosporine; monitor for toxicity. Concomitant with pemetrexed may increase risk of pemetrexed-associated myelosuppression, renal, and GI toxicity. Consider dose reduction of concomitant cilostazol (50mg twice daily). Antagonizes clopidogrel; consider alternative anti-platelets. May affect absorption of pH-dependent drugs (eg, ketoconazole, erlotinib, mycophenolate mofetil, iron salts). May interfere with neuroendocrine diagnostic tests; discontinue esomeprazole ≥14 days prior to CgA level assessment.
Gastritis, diarrhea; cardiovascular thrombotic events, GI ulcer/bleed, hepatotoxicity, renal toxicity, hypersensitivity reactions, anemia, bone fracture; possible C. difficile-associated diarrhea; rare: hypomagnesemia.
Hepatic (CYP2C9, 1A2, 2C19, 3A4); 99% protein bound.
Renal (primarily), fecal.