Arthritis/rheumatic disorders:
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.
Adult Dosage:
Do not substitute with single-ingredient ibuprofen and famotidine products. Use lowest effective dose for shortest duration. Swallow whole. 1 tab three times daily.
Children Dosage:
Not established.
DUEXIS Contraindications:
Aspirin allergy. Coronary artery bypass graft surgery.
Boxed Warning:
Risk of serious cardiovascular and gastrointestinal events.
DUEXIS Warnings/Precautions:
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.
DUEXIS Classification:
NSAID + H2 blocker.
DUEXIS Interactions:
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.
Adverse Reactions:
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:
NO
How Supplied:
Tabs—90
