Arthritis/rheumatic disorders:
Indications for: Nabumetone
Rheumatoid arthritis. Osteoarthritis.
Clinical Trials:
Osteoarthritis
The use of nabumetone in relieving the signs and symptoms of osteoarthritis (OA) was assessed in double-blind, controlled trials in which 1,047 patients were treated for 6 weeks to 6 months. In these trials, nabumetone in a dose of 1000 mg/day administered at night was comparable to naproxen 500 mg/day and to aspirin 3600 mg/day.
Rheumatoid Arthritis
The use of nabumetone in relieving the signs and symptoms of rheumatoid arthritis (RA) was assessed in double-blind, randomized, controlled trials in which 770 patients were treated for 3 weeks to 6 months. Nabumetone, in a dose of 1000 mg/day administered at night was comparable to naproxen 500 mg/day and to aspirin 3600 mg/day.
In controlled clinical trials of rheumatoid arthritis patients, nabumetone has been used in combination with gold, d-penicillamine and corticosteroids.
Adult Dosage:
Individualize. Initially 1g once daily; max 2g/day in 1 or 2 divided doses. Renal insufficiency (CrCl 30–49mL/min): initial max 750mg once daily, may increase to 1.5g/day; (CrCl <30mL/min): initial max 500mg once daily, may increase to 1g/day.
Children Dosage:
Not established.
Nabumetone Contraindications:
Aspirin allergy. 3rd trimester pregnancy. Coronary artery bypass graft surgery.
Boxed Warning:
Increased risk of cardiovascular thrombotic events. Increased risk of serious GI adverse events.
Nabumetone Warnings/Precautions:
Advanced renal disease: not recommended. History of upper GI disease or other ulcer risk. Cardiovascular disease. Renal or severe hepatic impairment. Fluid retention. Heart failure. Hypertension. Asthma. Monitor BP, renal and hepatic function. Discontinue if hepatic dysfunction or skin rash occurs. Monitor hemoglobin or hematocrit if signs of anemia occur. Avoid sun, UV light. Elderly. Debilitated. Labor & delivery. Pregnancy (Cat.C). Nursing mothers: not recommended.
Nabumetone Classification:
NSAID (naphthylalkanone).
Nabumetone Interactions:
Increased risk of GI toxicity with aspirin, other NSAIDs, alcohol, smoking.
Renal toxicity potentiated with diuretics. May potentiate lithium levels. May antagonize ACE inhibitors. Monitor oral anticoagulants (eg, warfarin). Caution with methotrexate.
Adverse Reactions:
GI bleeding, diarrhea, dyspepsia, abdominal pain, constipation, flatulence, nausea, positive stool guaiac, edema, photosensitivity, dizziness, headache, fatigue, sweating, insomnia, nervousness, somnolence, rash (discontinue if occurs), pruritus, tinnitus. Risk of cardiovascular events: see full labeling.
Note:
Formerly known under the brand name Relafen.
Drug Elimination:
Approximately 75% of a radiolabeled dose was recovered in urine in 48 hours. Approximately 80% was recovered in 168 hours. A further 9% appeared in the feces.
Following oral administration of dosages of 1000 mg to 2000 mg to steady state, the mean plasma clearance of 6MNA is 20-30 mL/min and the elimination half-life is approximately 24 hours.
How Supplied:
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