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1 Indications And Usage Naproxen And Esomeprazole Magnesium Delayed-Release Tablets, A Combination Of Naproxen And Esomeprazole Magnesium, Is Indicated In Adult Patients, Requiring Naproxen For Symptomatic Relief Of Arthritis And Esomeprazole Magnesium To Decrease The Risk For Developing Naproxen-Associated Gastric Ulcers. The Naproxen Component Of Naproxen And Esomeprazole Magnesium Delayed-Release Tablet Is Indicated For Relief Of Signs And Symptoms Of: • Osteoarthritis, Rheumatoid Arthritis And Ankylosing Spondylitis In Adults. The Esomeprazole Magnesium Component Of Naproxen And Esomeprazole Magnesium Delayed-Release Tablet Is Indicated To Decrease The Risk Of Developing Naproxen-Associated Gastric Ulcers. Limitations Of Use : • Do Not Substitute Naproxen And Esomeprazole Magnesium Delayed-Release Tablet With The Single-Ingredient Products Of Naproxen And Esomeprazole Magnesium. • Naproxen And Esomeprazole Magnesium Delayed-Release Tablets Are Not Recommended For Initial Treatment Of Acute Pain Because The Absorption Of Naproxen Is Delayed Compared To Absorption From Other Naproxen-Containing Products. • Controlled Studies Do Not Extend Beyond 6 Months [See Use In Specific Populations ( 8.4 ), Clinical Studies ( 14 )] . Pediatric Use Information Is Approved For Horizon Pharma Usa, Inc.’s Vimovo ® (Naproxen And Esomeprazole Magnesium) Delayed-Release Tablets. However, Due To Horizon Pharma Usa, Inc.’s Marketing Exclusivity Rights, This Drug Product Is Not Labeled With That Pediatric Information. Naproxen And Esomeprazole Magnesium Delayed-Release Tablets Are A Combination Of Naproxen, A Non-Steroidal Anti-Inflammatory Drug (Nsaid), And Esomeprazole Magnesium, A Proton Pump Inhibitor (Ppi) Indicated In Adult Patients, Requiring Naproxen For Symptomatic Relief Of Arthritis And Esomeprazole Magnesium To Decrease The Risk Of Developing Naproxen associated Gastric Ulcers. The Naproxen Component Of Naproxen And Esomeprazole Magnesium Delayed-Release Tablet Is Indicated For Relief Of Signs And Symptoms Of: • Osteoarthritis, Rheumatoid Arthritis And Ankylosing Spondylitis In Adults. The Esomeprazole Magnesium Component Of Naproxen And Esomeprazole Magnesium Delayed-Release Tablet Is Indicated To Decrease The Risk Of Developing Naproxen-Associated Gastric Ulcers. ( 1 ) Limitations Of Use: • Do Not Substitute Naproxen And Esomeprazole Magnesium Delayed-Release Tablets With The Single-Ingredient Products Of Naproxen And Esomeprazole Magnesium. ( 1 ) • Naproxen And Esomeprazole Magnesium Delayed-Release Tablets Are Not Recommended For Initial Treatment Of Acute Pain Because The Absorption Of Naproxen Is Delayed Compared To Absorption From Other Naproxen-Containing Products. ( 1 ) • Controlled Studies Do Not Extend Beyond 6 Months. ( 1 )
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