Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Fannin (UK) Limited, 42-46 Booth Drive, Park Farm South, Wellingborough, Northamptonshire, NN8 6GT
Nabumetone is a non-acidic non-steroidal anti-inflammatory agent which is a relatively weak inhibitor of prostaglandin synthesis. However, following absorption from the gastrointestinal tract it is rapidly metabolised in the liver to the principal active metabolite, 6-methoxy-2-naphthylacetic acid (6-MNA), a potent inhibitor of prostaglandin synthesis.
For use in osteoarthritis and rheumatoid arthritis requiring anti-inflammatory and analgesic treatment.
For oral administration.
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4).
500 mg film-coated tablets should be taken preferably with or after food.
The recommended daily dose is two tablets (1 g) taken as a single dose at bedtime.
For severe or persistent symptoms, or during acute exacerbations, an additional one or two tablets (500 mg – 1 g) may be given as a morning dose.
In common with many drugs, blood levels may be higher in elderly patients. The recommended daily dose of 1 g should not be exceeded in this age group and in some cases 500 mg may give satisfactory relief.
The elderly are at increased risk of the serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest dose should be used and for the shortest duration. The patient should be monitored regularly for gastrointestinal bleeding during NSAID therapy.
There are no clinical data to recommend use of Nabumetone 500mg Tablets in children.
Symptoms include headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, rarely diarrhoea, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, fainting and occasionally convulsions.
In cases of significant poisoning acute renal failure and liver damage are possible.
There is no specific antidote and the active metabolite 6-MNA is not dialysable. Patients should be treated symptomatically as required.
Within one hour of ingestion of a potentially toxic amount, activated charcoal should be considered (up to 60g dose given divided doses orally) with appropriate supportive therapy.
Alternatively, in adults, gastric lavage should be considered within one hour of ingestion of a potentially life-threatening overdose. Good urine output should be ensured. Renal and liver function should be closely monitored.
Patients should be observed for at least four hours after ingestion of potentially toxic amounts.
Frequent or prolonged convulsions should be treated with intravenous diazepam. Other measures may be indicated by patient’s clinical condition.
3 years.
Do not store above 25°C. Store in the original package.
Blisters of PVC/PVdC/aluminium.
Pack sizes of 8, 56 and 100 tablets.
Not applicable.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
