Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Almirall, S.A., Ronda General Mitre 151, 08022, Barcelona, Spain
Lodine (etodolac) is indicated for acute or long-term use in rheumatoid arthritis and osteoarthritis.
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4)
One tablet daily. If a lower dose is sufficient, conventional Lodine capsules or tablets may be used.
The safety of doses in excess of 600mg per day has not been established.
No occurrence of tolerance or tachyphylaxis has been reported.
No change in initial dosage is generally required in the elderly (see precautions).
The elderly are at increased risk of the serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy.
Not recommended.
For oral administration.
To be taken preferably with or after food. Swallow the tablet whole with a tumblerful of water.
Symptoms include headache, nausea, vomiting, epigastric pain, gastrointaestinal bleeding, rarely diarrhoea, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, fainting, occasionally convulsions. In cases of significant poisoning acute renal failure and liver damage are possible.
Patients should be treated symptomatically as required.
Within one hour of ingestion of a potentially toxic amount, activated charcoal should be considered. Alternatively, in adults, gastric lavage should be considered within one hour of indigestion 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 the patient’s clinical condition.
The standard practices of gastric lavage, activated charcoal administration and general supportive therapy should be undertaken.
Shelf life: Lodine SR Tablets may be stored for up to 3 years.
Store at room temperature, below 25°C.
Vinyl Aclar or PVdC/PVC/Aluminium foil blister packs of 2, 28 or 30 tablets.
HDPE bottle with child resistant closures of 28 or 30 tablets.
Polypropylene securitainers with polyethylene caps of 28 or 30 tablets.
None.
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