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Arthritis/rheumatic disorders
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Generic Name and Formulations:

Naproxen, esomeprazole (as magnesium trihydrate); 375mg/20mg, 500mg/20mg; del-rel tabs.


Horizon Pharma

Select therapeutic use:

Indications for VIMOVO:

Osteoarthritis, rheumatoid arthritis, ankylosing spondylitis: to relieve signs/symptoms and reduce risk of gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers.


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.


<18yrs: not recommended.


Aspirin allergy. Coronary artery bypass surgery.


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, 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. Gastric malignancy. Long-term therapy may lead to malabsorption/deficiency of Vit. B12, atrophic gastritis, or hypomagnesemia (monitor Mg+ levels). Increased risk of osteoporosis-related fractures (hip, wrist or spine) with long-term and multiple daily dose PPI therapy. Elderly. Debilitated. Labor & delivery. Pregnancy (≥30 weeks gestation; avoid). Nursing mothers.


Concomitant St. John's wort, rifampin, atazanavir, nelfinavir: 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.

Pharmacological Class:

NSAID + proton pump inhibitor.

Adverse Reactions:

Gastritis, diarrhea; cardiovascular thrombotic events, GI ulcer/bleed, hepatotoxicity, renal toxicity, hypersensitivity reactions, anemia, bone fracture, possible C. difficile-associated diarrhea.


Hepatic (CYP2C9, 1A2, 2C19, 3A4); 99% protein bound.


Renal (primarily), fecal.

Generic Availability:


How Supplied:


VIMOVO 500mg/20mg tablets (Qty:60)

appx. price $2116.00