naproxen 375 mg esomeprazole magnesium 20 mg
1 INDICATIONS AND USAGE Naproxen and esomeprazole magnesium delayed-release tablets, a combination of naproxen and esomeprazole magnesium, are 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 naproxen and esomeprazole magnesium delayed-release tablets 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 naproxen and esomeprazole magnesium delayed-release tablets is indicated to decrease the risk of developing naproxen-associated gastric ulcers. Limitations of Use: • Do not substitute naproxen and esomeprazole magnesium delayed-release tablets 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) ] . 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 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 naproxen and esomeprazole magnesium delayed-release tablets 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 naproxen and esomeprazole magnesium delayed-release tablets 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 )
mylan pharmaceuticals inc.
OVAL YELLOW NE1
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naproxen 500 mg esomeprazole magnesium 20 mg
mylan pharmaceuticals inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING Naproxen and Esomeprazole Magnesium Delayed-Release Tablets are available containing 375 mg or 500 mg of naproxen, USP and 22.25 mg of esomeprazole magnesium, USP (amorphous) equivalent to 20 mg of esomeprazole providing for the following combinations: 375 mg/20 mg and 500 mg/20 mg. The 375 mg/20 mg tablets are yellow, film-coated, oval, unscored tablets imprinted with NE1 in black ink on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-4385-91 bottles of 60 tablets The 500 mg/20 mg tablets are yellow, film-coated, oval, unscored tablets imprinted with NE2 in black ink on one side of the tablet and blank on the other side. They are available as follows: NDC 0378-4386-91 bottles of 60 tablets Storage: Store at 20° to 25°C (68° to 77°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, light-resistant container as defined in the USP using a child-resistant closure if package is subdivided. PHARMACIST: Dispense a Medication Guide with each prescription.
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