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Naproxen and esomeprazole magnesium

NAPROXEN AND ESOMEPRAZOLE MAGNESIUM

Manufacturer: Dr. Reddy's Laboratories Limited

Score: 144.0

Quick Summary

Naproxen and esomeprazole magnesium delayed-release tablets are a combination of naproxen, a nonsteroidal anti-inflammatory drug (NSAID), and esomeprazole magnesium, a proton pump inhibitor (PPI), used for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis in adults, and juvenile idiopathic arthritis (JIA) in adolescent patients. The esomeprazole component is used to decrease the risk of developing naproxen-associated gastric ulcers.

Key Clinical Findings and Indications

  • Relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis in adults
  • Relief of signs and symptoms of juvenile idiopathic arthritis (JIA) in adolescent patients
  • Decrease the risk of developing naproxen-associated gastric ulcers

Important Safety Information

Warning

Cardiovascular thrombotic events, GI bleeding, ulceration, and perforation

Contraindications

  • Known hypersensitivity to naproxen, esomeprazole magnesium, or any components of the drug product
  • History of asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs
  • In the setting of coronary artery bypass graft (CABG) surgery
  • Patients receiving rilpivirine-containing products

Adverse Reactions

  • Gastritis
  • Diarrhea
  • Upper respiratory tract infection
  • Flatulence
  • Headache
  • Urinary tract infection
  • Dysgeusia

Dosing Recommendations

General Guidance

Avoid in moderate/severe renal impairment or severe hepatic impairment. Consider dose reduction in mild/moderate hepatic impairment.

Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Spondylitis

Adult Dose

One naproxen and esomeprazole magnesium delayed-release tablet twice daily of either 375 mg naproxen/20 mg of esomeprazole or 500 mg of naproxen/20 mg of esomeprazole

Pediatric Dose

Not applicable

Juvenile Idiopathic Arthritis (JIA) in Adolescent Patients

Adult Dose

Not applicable

Pediatric Dose

One naproxen and esomeprazole magnesium delayed-release tablet twice daily of 375 mg naproxen/20 mg of esomeprazole for patients weighing 38 kg to less than 50 kg

Special Population Considerations

Pregnancy

  • Use of NSAIDs, including naproxen and esomeprazole magnesium delayed-release tablets, can cause premature closure of the fetal ductus arteriosus and fetal and renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment

Nursing Mothers

  • Naproxen is excreted in human milk, and it is not known whether esomeprazole is excreted in human milk

Pediatric Use

  • The safety and effectiveness of naproxen and esomeprazole magnesium delayed-release tablets have been established in adolescent patients 12 years of age and older weighing at least 38 kg for the symptomatic relief of JIA and to decrease the risk of developing naproxen-associated gastric ulcers

Geriatric Use

  • Elderly patients, compared to younger patients, are at greater risk for NSAID-associated serious cardiovascular, gastrointestinal, and/or renal adverse reactions

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