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.
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 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.
NSAID + H2 blocker.
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.
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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