Naproxen and esomeprazole magnesium

NAPROXEN AND ESOMEPRAZOLE MAGNESIUM

Manufacturer: Ajanta Pharma USA Inc.

Score: 148.0

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