Esomeprazole + Naproxen is indicated for the following conditions-

• osteoarthritis
• rheumatoid arthritis
• ankylosing spondylitis

Osteoarthritis

Rheumatoid Arthritis

Ankylosing Spondylitis

• Rheumatoid Arthritis, Osteoarthritis and Ankylosing Spondylitis: The dosage is one tablet twice daily of Esomeprazole + Naproxen 375 mg naproxen and 20 mg of esomeprazole or 500 mg naproxen and 20 mg of esomeprazole.
• Geriatric Patients: Use caution when high doses are required and some adjustment of dosage may be required in elderly patients.
• Patients With Moderate to Severe Renal Impairment: Naproxen-containing products are not recommended for use in patients with moderate to severe or severe renal impairment (creatinine clearance <30 mL/min).
• Hepatic impairment: Patients with mild to moderate hepatic impairment should be continuously monitored, and a possible dose reduction based on the naproxen component of Esomeprazole + Naproxen may be considered.
• Esomeprazole + Naproxen is not recommended for use in children.
• The tablets are to be swallowed whole with liquid. Do not split, chew, crush or dissolve the tablet. Esomeprazole + Naproxen should be taken at least 30 minutes before meals.

The most common adverse reactions associated with the medication include-

• dyspepsia
• gastritis
• diarrhea
• gastric ulcer
• abdominal pain
• nausea

Dyspepsia

Diarrhea

Gastric Ulcer

Nausea

• Serious and potentially fatal cardiovascular (CV) thrombotic events, myocardial infarction, and stroke. Patients with known CV disease/risk factors may be at greater risk.
• New onset or worsening of pre-existing hypertension. Blood pressure should be monitored closely during treatment with Esomeprazole + Naproxen
• Esomeprazole + Naproxen should be used with caution in patients with fluid retention or heart failure
• Serious gastrointestinal (GI) adverse events, which can be fatal. The risk is greater in patients with a prior history of ulcer disease or GI bleeding, and in patients at high risk for GI events, especially the elderly. Esomeprazole + Naproxen should be used with caution in these patients
• Symptomatic response to esomeprazole does not preclude the presence of gastric malignancy
• Atrophic gastritis has been noted on biopsy with long-term omeprazole therapy
• Treatment should be withdrawn when active and clinically significant bleeding from any source occurs
• Renal papillary necrosis and other renal injury with long-term use. Use Esomeprazole + Naproxen with caution in the elderly, those with impaired renal function, hypovolemia, salt depletion, heart failure, liver dysfunction, and those taking diuretics, ACE-inhibitors or angiotensin II receptor antagonists.
• Acute interstitial nephritis has been observed in patients taking PPIs. Not recommended for patients with moderate or severe renal impairment
• Esomeprazole + Naproxen should not be used in aspirin hypersensitive patients
• Serious skin adverse reactions such as exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, which can be fatal and can occur without warning. Discontinue Esomeprazole + Naproxen at first appearance of skin rash or any other sign of hypersensitivity
• Elevated liver enzymes and, rarely, severe hepatic reactions. Discontinue use immediately if abnormal liver enzymes persist or worsen
• Should be avoided in patients with severe hepatic impairment
• Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin.
• Proton pump inhibitor (PPI) therapy may be associated with increased risk of Clostridium difficile associated diarrhea.
• Avoid concomitant use of esomeprazole with clopidogrel
• Long-term and multiple daily dose PPI therapy is associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine
• Interactions with diagnostic investigations for Neuroendocrine Tumors: Increases in intragastric pH may result in hypergastrinemia, enterochromaffin-like cell hyperplasia, and increased Chromogranin A levels which may interfere with diagnostic investigations for neuroendocrine tumors.
• Hypomagnesemia has been reported rarely with prolonged treatment with PPIs
• Fetal toxicity: avoid drug starting at 30 weeks gestation