Generic Name and Formulations:
Ibuprofen, famotidine 800mg/26.6mg; tabs.
Indications for DUEXIS:
Relief of signs/symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper GI ulcers (eg, gastric and/or duodenal ulcer), in patients who are taking ibuprofen for those indications.
Do not substitute with single-ingredient ibuprofen and famotidine products. Use lowest effective dose for shortest duration. Swallow whole. 1 tab three times daily.
Aspirin allergy. Coronary artery bypass graft 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 and/or GI bleeding. Inflammatory bowel disease (eg, ulcerative colitis, Crohn’s disease). Hypertension; monitor BP closely. Hepatic or renal impairment. Discontinue if signs/symptoms of liver disease develop, or if abnormal LFTs persist or worsen. Dehydration. Hypovolemia. Advanced renal disease or CrCl <50mL/min: not recommended. Hyperkalemia. Coagulation disorders. Seizures. Monitor CBCs, blood chemistry, hepatic, renal, and ocular 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. Elderly. Debilitated. Labor & delivery. Pregnancy (3rd trimester: avoid). Nursing mothers.
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. Concomitant dasatinib, delavirdine, cefditoren, fosamprenavir: not recommended. May antagonize, or increase risk of renal failure with diuretics (eg, loop or thiazides), ACE inhibitors, ARBs, or β-blockers; monitor closely. Potentiates digoxin; monitor levels. May antagonize pH-dependent drugs (see full labeling). May potentiate lithium, methotrexate, cyclosporine, tizanidine (avoid); monitor for toxicity. Concomitant with pemetrexed may increase risk of pemetrexed-associated myelosuppression, renal, and GI toxicity.
NSAID + H2 blocker.
Nausea, diarrhea, constipation, upper abdominal pain, headache; cardiovascular thrombotic events, GI ulcer/bleed, hepatotoxicity, renal toxicity, hypertension, hypersensitivity reactions, edema, anemia; rare: aseptic meningitis.
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