Vivlodex Generic Name & Formulations
Legal Class
Rx
General Description
Meloxicam 5mg, 10mg; caps.
Pharmacological Class
NSAID (oxicam).
How Supplied
Caps—30, 90
Manufacturer
Generic Availability
NO
Vivlodex Indications
Indications
Osteoarthritis pain.
Vivlodex Dosage and Administration
Adult
Use lowest effective dose for shortest duration. ≥18yrs: initially 5mg once daily; may increase up to max 10mg/day. Hemodialysis: max 5mg/day.
Children
<18yrs: not established.
Vivlodex Contraindications
Contraindications
Aspirin or other NSAID allergy. Coronary artery bypass graft surgery.
Vivlodex Boxed Warnings
Boxed Warning
Risk of serious cardiovascular and gastrointestinal events.
Vivlodex Warnings/Precautions
Warnings/Precautions
Not interchangeable with other forms of oral meloxicam. Increase risk of serious cardiovascular events (including MI, 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.
Vivlodex Pharmacokinetics
See Literature
Vivlodex Interactions
Interactions
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.
Vivlodex Adverse Reactions
Adverse Reactions
Diarrhea, nausea, abdominal discomfort; elevated ALT/AST, anemia, cardiovascular events, GI bleed/ulcer, edema, hyperkalemia, anaphylactic reactions, rash, hepatotoxicity, renal papillary necrosis.
Vivlodex Clinical Trials
See Literature
Vivlodex Note
Not Applicable
Vivlodex Patient Counseling
See Literature
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