Generic Name and Formulations:
Meloxicam 5mg, 10mg; caps.
Iroko Pharmaceuticals, LLC
Indications for VIVLODEX:
Use lowest effective dose for shortest duration. ≥18yrs: initially 5mg once daily; may increase up to max 10mg/day. Hemodialysis: max 5mg/day.
<18yrs: not established.
Aspirin or other NSAID allergy. Coronary artery bypass graft surgery.
Risk of serious cardiovascular and gastrointestinal events.
Not interchangeable with other forms of oral meloxicam. Increase risk of serious cardiovascular events, MI, and stroke. Avoid in recent MI or severe HF; if used, monitor for cardiac ischemia or worsening HF. Hypertension; monitor BP. Increased risk of serious GI adverse events (eg, inflammation, bleeding, ulceration, perforation). History of ulcer disease and/or GI bleeding. Advanced liver disease and/or coagulopathy. Discontinue if signs/symptoms of liver disease develops. Hepatic or renal impairment; monitor. Dehydration. Hypovolemia; correct volume status prior to starting. Avoid in advanced renal disease; if used, monitor for worsening renal function. Pre-existing asthma. Discontinue if rash or other signs of hypersensitivity occur. Hematologic toxicity. Monitor CBCs, blood chemistry, hepatic and renal function in long-term therapy. May mask signs of infection. Elderly. Debilitated. Labor & delivery. Women with infertility: not recommended. Pregnancy (≥30 weeks gestation; avoid). Nursing mothers.
Avoid concomitant aspirin (at analgesic doses), other NSAIDs, or salicylates. Increased risk of GI bleed with anticoagulants (monitor), oral corticosteroids, SSRIs, SNRIs, smoking, alcohol, or prolonged NSAID therapy. May antagonize or increase risk of acute renal failure (esp. in elderly, volume-depleted, or have renal impairment) with ACE inhibitors, ARBs, β-blockers, diuretics; monitor. Potentiates digoxin, lithium; monitor levels. Caution with methotrexate; monitor for toxicity. Increased nephrotoxicity with cyclosporine; monitor. Concomitant pemetrexed may increase pemetrexed-associated myelosuppression, renal, and GI toxicity.
Diarrhea, nausea, abdominal discomfort; elevated ALT/AST, anemia, cardiovascular events, GI bleed/ulcer, edema, hyperkalemia, anaphylactic reactions, rash, hepatotoxicity, renal papillary necrosis.