Esomeprazole / Naproxen

What it is and how it works

Mechanism of Action Naproxen and esomeprazole magnesium delayed-release tablets consists of an immediate-release esomeprazole magnesium layer and an enteric-coated naproxen core. As a result, esomeprazole is released first in the stomach, prior to the dissolution of naproxen in the small intestine. The enteric coating prevents naproxen release at pH levels below 5.5. The mechanism of action of the naproxen anion, like that of other NSAIDs, is not completely understood but inhibition of cyclooxygenase (COX-1 and COX-2). Naproxen and esomeprazole magnesium delayed-release tablets has analgesic, anti-inflammatory, and antipyretic properties contributed by the naproxen component.

Mechanism class: Cyclooxygenase Inhibitors

Indications

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 tablet with the single-ingredient products of naproxen and esomeprazole magnesium.

Dosage and administration (summary)

Administration • Use the lowest naproxen dose for the shortest duration consistent with individual patient treatment goals. ( 2.1 , 5.1 ). • If a total daily dose of less than 40 mg esomeprazole is more appropriate, a different treatment should be considered. • Swallow naproxen and esomeprazole magnesium delayed-release tablets whole with liquid at least 30 minutes before meals.

Contraindications

Naproxen and esomeprazole magnesium delayed-release tablets are contraindicated in the following patients: • Known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to naproxen, esomeprazole magnesium, substituted benzimidazoles, or to any components of the drug product, including omeprazole. Hypersensitivity reactions to esomeprazole may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria .

Warnings and precautions

Hepatotoxicity : Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop. Hypertension : Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure. ( 5.4 , 7 ) Heart Failure and Edema : Avoid use of naproxen and esomeprazole magnesium delayed-release tablets in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure.

Pregnancy

Pregnancy Risk Summary 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.

Storage and supply

Naproxen and esomeprazole magnesium delayed-release tablets (375 mg naproxen/20 mg esomeprazole magnesium) are off white to yellow colored modified capsule shaped, biconvex, film-coated tablets printed with R 289 in black ink on one side and plain on other side, supplied as: Bottles of 60 NDC 55111-289-60 Naproxen and esomeprazole magnesium delayed…

Source: Naproxen And Esomeprazole Magnesium (Naproxen And Esomeprazole Magnesium) — US FDA prescribing information, 2024-12-20, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.