Generic Name and Formulations:
Indomethacin 20mg, 40mg; hard gel caps.
Iroko Pharmaceuticals, LLC
Indications for TIVORBEX:
Mild-to-moderate acute pain.
Use lowest effective dose for shortest duration. >17yrs: 20mg 3 times daily or 40mg 2–3 times daily.
≤17yrs: not established.
Aspirin allergy. Coronary artery bypass graft surgery.
Not interchangeable with other forms of indomethacin. 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 or GI bleeding. 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: not recommended. Hyperkalemia. Coagulation disorders. Monitor CBCs, blood chemistry, hepatic, renal, and ocular function in long-term therapy. Pre-existing asthma. Depression or other psychiatric disturbances. Epilepsy. Parkinsonism. May mask signs of infection or fever. Discontinue if severe CNS effects, rash or other signs of hypersensitivity occur. Elderly. Debilitated. Labor & delivery. Pregnancy (Cat.C: <30 weeks gestation; Cat.D: ≥30 weeks gestation; 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. 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 potentiate lithium, methotrexate, cyclosporine; monitor for toxicity. Concomitant with pemetrexed may increase risk of pemetrexed-associated myelosuppression, renal, and GI toxicity. Potentiated by probenecid.
NSAID (indole deriv.).
Nausea, post procedural edema, headache, dizziness, vomiting, post procedural hemorrhage, constipation, pruritus, diarrhea, dyspepsia, post procedural swelling, rash, abdominal pain, somnolence, hyperhidrosis, decreased appetite, hot flush, syncope; cardiovascular thrombotic events, GI ulcer/bleed, hepatotoxicity, renal toxicity, anaphylaxis, anemia.
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