esomeprazole magnesium
esomeprazole magnesium is listed in the FDA National Drug Code directory with 35 NDC codes, marketed under brand names including esomeprazole magnesium, 24 HOUR Esomeprazole Magnesium, Esomeprazole Magnesium. Available dosage forms: capsule, delayed release, capsule, tablet.
Drug Details
- Generic Name
- esomeprazole magnesium
- Brand Names
- esomeprazole magnesium, 24 HOUR Esomeprazole Magnesium, Esomeprazole Magnesium, Nexium 24HR, Nexium 24HR ClearMinis, topcare esomeprazole magnesium, Esomeprazole magnesium, Esomeprazole, Up and Up Esomeprazole Magnesium
- Application Number
- ANDA206296
- Sponsor
- Bryant Ranch Prepack
- NDC Codes
- 35
- Dosage Forms
- CAPSULE, DELAYED RELEASE, CAPSULE, TABLET
- Routes
- ORAL
- Active Ingredients
- ESOMEPRAZOLE MAGNESIUM DIHYDRATE, ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM TRIHYDRATE
Indications and Usage
1 INDICATIONS AND USAGE Naproxen and esomeprazole magnesium delayed-release tablets, 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 naproxen and esomeprazole magnesium delayed-release tablet 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 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 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 tablet 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 naproxen and esomeprazole magnesium delayed-release tablet 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 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 )