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How PDUFA Dates Work Day 160: Filing Decision - The FDA reviews the application for completeness

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If oral ibuprofen is necessary , consider these risk-reduction strategies: Use the lowest effective dose (200-400 mg) for the shortest duration possible Take ibuprofen with or after food to minimise gastric irritation (ensuring this is at least 30 minutes after taking Rybelsus) Consider gastroprotection with a proton pump inhibitor (PPI) if you have risk factors for gastric complications, including: age 65, history of peptic ulcer or GI bleeding, concurrent use of anticoagulants, antiplatelets, SSRIs/SNRIs, or corticosteroids [13] [14] Avoid prolonged courses without medical supervision Do not take ibuprofen if you are dehydrated or experiencing vomiting or diarrhoea Alternative analgesics may include codeine-based preparations for more severe pain, though these can cause constipation and nausea, potentially compounding Rybelsus side effects

2014;9(11):e111925