Mode of Action:
Nabumetone is a nonsteroidal anti-inflammatory drug (NSAID) that exhibits anti-inflammatory, analgesic and antipyretic properties in pharmacologic studies. As with other nonsteroidal anti-inflammatory agents, its mode of action is not known. However, the ability to inhibit prostaglandin synthesis may be involved in the anti-inflammatory effect.
Drug Label Information | Brands:
Nabumetone is indicated:
- For relief of the signs and symptoms of rheumatoid arthritis.
- For relief of the signs and symptoms of osteoarthritis.
- Nabumetone is contraindicated in patients with known hypersensitivity to nabumetone or its excipients.
- Nabumetone should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients
- In the setting of coronary artery bypass graft (CABG) surgery
ADVERSE DRUG REACTIONS:
Blood and lymphatic system disorders
Very Rare: Thrombocytopenia,
Not known: Neutropenia, agranulocytosis, aplastic anaemia, leucopenia and haemolytic anaemia
Immune system disorders
Very rare: Anaphylaxis, anaphylactoid reaction
Uncommon: Confusion, nervousness, insomnia
Not known: Depression, hallucinations
Nervous system disorders
Uncommon: Somnolence, dizziness, headache, paresthesia, anxiety
Not known: Aseptic meningitis (especially in patients with existing autoimmune disorders such as systemic lupus erythematosus, mixed connective tissue disease, with symptoms such as stiff neck, headache, nausea, vomiting, fever or disorientation , vertigo, drowsiness
Uncommon: Abnormal vision, eye disorders
Not known: Optic neuritis
Ear and labyrinth disorders
Common: Tinnitus, ear disorder
Common: Increases in blood pressure
Respiratory, thoracic and mediastinal disorders
Uncommon: Dyspnoea, respiratory disorder, epistaxis
Very rare: Interstitial pneumonitis
Not known: Asthma, aggravated asthma, bronchospasm
Common: Diarrhoea, constipation, dyspepsia, gastritis, nausea, abdominal pain, flatulence
Uncommon: Duodenal ulcer, GI bleeding, gastric ulcer, GI disorder, melaena, vomiting, stomatitis, dry mouth
Very rare: Pancreatitis
Gastrointestinal: The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly, may occur Nausea vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn’s disease have been reported following administration. Less frequently, gastritis has been reported.
Very rare: Hepatic failure, jaundice
Skin and subcutaneous tissue disorders
Common: Rash, pruritus
Uncommon: Photosensitivity, urticaria, sweating
Very rare: Bullous reactions including toxic epidermal necrolysis, Stevens Johnson syndrome, erythema multiforme, angioedema, pseudoporphyria, alopecia
Not known: Purpura
Musculoskeletal and connective tissue disorders
Renal and urinary disorders
Uncommon: Urinary tract disorder
Very rare: Renal failure, nephrotic syndrome
Not known: Interstitial nephritis
Reproductive system and breast disorders
Very rare: Menorrhagia
General disorders and administration site conditions
Uncommon: Asthenia, fatigue
Not known: Malaise
Uncommon: Elevated liver function tests
Hypersensitivity reactions have been reported following treatment with NSAIDs. These may consist of (a) non-specific allergic reactions and anaphylaxis (b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea, or (c) assorted skin disorders, including rashes of various type, pruritus, urticaria, purpura, angioedema and, more rarely exfoliative and bullous dermatoses (including epidermal necroylsis and erythema multiforme).
Other adverse reactions reported include:
Neurological and special senses: Optic neuritis, reports of aseptic meningitis (especially in patients with existing auto-immune disorders, such as systemic lupus erythematosus, mixed connective tissue disease), with symptoms such as a stiff neck, headache, nausea, vomiting, fever or disorientation, depression, confusion, hallucinations, tinnitus, vertigo, dizziness, malaise, fatigue and drowsiness.
Renal: Nephrotoxicity in various forms, including interstitial nephritis,
Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment.
Clinical trial and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with an increased risk of arterial thrombotic events (for example myocardial infarction, stroke and death)
In clinical trials, increases in doses above 1 g did not lead to an increase in the incidence of side effects. However, the lowest effective dose should always be used.
Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE-inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE-inhibitors.
When nabumetone is administered with aspirin, its protein binding is reduced, although the clearance of free nabumetone is not altered. The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of nabumetone and aspirin is not generally recommended because of the potential of increased adverse effects.
Clinical studies, as well as post-marketing observations, have shown that nabumetone can reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis. During concomitant therapy with NSAIDs, the patient should be observed closely for signs of renal failure, as well as to assure diuretic efficacy.
NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance. The mean minimum lithium concentration increased 15% and the renal clearance was decreased by approximately 20%. These effects have been attributed to inhibition of renal prostaglandin synthesis by the NSAID. Thus, when NSAIDs and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity.
NSAIDs have been reported to competitively inhibit methotrexate accumulation in rabbit kidney slices. This may indicate that they could enhance the toxicity of methotrexate. Caution should be used when NSAIDs are administered concomitantly with methotrexate.
The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious GI bleeding higher than users of either drug alone.
Routes of Administration:
Elimination Half life:
Routes of Administration:
Elimination Half life: