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, advanced renal disease; 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. 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. May be associated with a reversible delay in ovulation in females of reproductive potential. Pregnancy (avoid during ≥30 weeks gestation): increased risk of premature closure of the fetal ductus arteriosus; (20–30 weeks gestation): may cause fetal renal dysfunction/oligohydramnios; if treatment needed, limit dose and duration of use. Nursing mothers.
NSAID + H2 blocker.
Concomitant aspirin, salicylates (eg, diflunisal, salsalate) or other NSAIDs: not recommended. Increased risk of GI bleed with anticoagulants, antiplatelets, oral corticosteroids, SSRIs, SNRIs, smoking, alcohol, or prolonged NSAID therapy; monitor. Potentiates digoxin; monitor levels. May potentiate lithium, methotrexate, cyclosporine, tizanidine (avoid); monitor for toxicity. May antagonize, or increase risk of renal failure with diuretics (eg, loop or thiazides), ACE inhibitors, ARBs, or β-blockers; monitor closely. May antagonize pH-dependent drugs (see full labeling). Avoid dasatinib, delavirdine, cefditoren, fosamprenavir. 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, serious skin reactions (eg, Stevens-Johnson Syndrome, toxic epidermal necrolysis), Drug Reaction with Eosinophilia and Systemic Symptoms (discontinue if occurs), edema, anemia, active bleeding (discontinue if occurs); rare: aseptic meningitis.
Generic Drug Availability: