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Duration of relief averaged 4 to 5 hours for 200 mg of etodolac and 5 to 6 hours for 400 mg of etodolac as measured by when approximately half of the patients required remedication.

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The use of Lodine with concomitant NSAIDs includingcyclooxygenase-2-selective inhibitors should be avoidedsee section 4.5)

Osteoarthritisimmediate and extended-release formsrheumatoid arthritisimmediate and extended-release formsjuvenile rheumatoid arthritisextended-release formshort-term painimmediate release form)

Frequency not reportedDry mouthulcerative stomatitiseructationpeptic ulcergastrointestinalGIbleedingperforationesophagitisesophageal stricturecardiospasmcolitisGI discomfortburning sensationgastralgiaupper abdominal discomfortglossitishematemesisrectal bleedingheartburnindigestionulcerative colitis exacerbatedCrohn’s disease exacerbated.

In patients with renalcardiac or hepatic impairment especially those taking diuretics and the elderlyrenal function should be monitored in these patientssee also section 4.3Caution is required since the use of NSAIDs may result in a dose dependent reduction in prostaglandin formation and precipitate renal failureThe dose should be kept as low as possibleHoweverimpairment of renal or hepatic functions due to other causes may alter drug metabolismpatients receiving concomitant long term therapyespecially the elderlyshould be observed for potential side effects and their drug doses adjusted as neededor the drug discontinued.

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