vimovo naproxen and esomeprazole magnesium tablet delayed release
1 INDICATIONS AND USAGE VIMOVO, a combination of naproxen and esomeprazole magnesium, is indicated in adult and adolescent patients 12 years of age and older weighing at least 38 kg, requiring naproxen for symptomatic relief of arthritis and esomeprazole magnesium to decrease the risk for developing naproxen-associated gastric ulcers. The naproxen component of VIMOVO is indicated for relief of signs and symptoms of: osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in adults. juvenile idiopathic arthritis (JIA) in adolescent patients. The esomeprazole magnesium component of VIMOVO is indicated to decrease the risk of developing naproxen-associated gastric ulcers. VIMOVO is a combination of naproxen, a non-steroidal anti-inflammatory drug (NSAID), and esomeprazole magnesium, a proton pump inhibitor (PPI) indicated in adult and adolescent patients 12 years of age and older weighing at least 38 kg, requiring naproxen for symptomatic relief of arthritis and esomeprazole magnesium to decrease the risk of developing naproxen- associated gastric ulcers. The naproxen component of VIMOVO is indicated for relief of signs and symptoms of: osteoarthritis, rheumatoid arthritis and ankylosing spondylitis in adults. juvenile idiopathic arthritis (JIA) in adolescent patients. The esomeprazole magnesium component of VIMOVO is indicated to decrease the risk of developing naproxen-associated gastric ulcers. ( 1 ) Limitations of Use : Do not substitute VIMOVO with the single-ingredient products of naproxen and esomeprazole magnesium. ( 1 ) VIMOVO is 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 ) Limitations of Use: Do not substitute VIMOVO with the single-ingredient products of naproxen and esomeprazole magnesium. VIMOVO is 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) ] .
horizon pharma inc.
OVAL YELLOW 500 20
500 20 OVAL YELLOW
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16 HOW SUPPLIED/STORAGE AND HANDLING VIMOVO (375 mg naproxen /20 mg esomeprazole magnesium) delayed-release tablets are oval, yellow film-coated tablets printed with 375/20 in black ink, supplied as: NDC 75987-031-04 Bottles of 60 tablets VIMOVO (500 mg naproxen /20 mg esomeprazole magnesium) delayed-release tablets are oval, yellow film-coated tablets printed with 500/20 in black ink, supplied as: NDC 75987-030-04 Bottles of 60 tablets Storage : Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Store in the original container and keep the bottle tightly closed to protect from moisture. Dispense in a tight container if package is subdivided.
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