Generic

Naproxen Sodium + Esomeprazole Magnesium

Indications

Naproxen and Esomeprazole are used to treat the signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, as well as to reduce the risk of gastric ulcers in patients who are at risk of NSAID-related gastric ulcers.

Pharmacology

This is made up of an Esomeprazole Magnesium coating that releases quickly and an enteric-coated Naproxen core. As a consequence, Esomeprazole is released into the stomach first, followed by Naproxen dissolution in the small intestine.

Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) with analgesic and antipyretic effects. The effect of Naproxen is to stop the production of prostaglandins. Esomeprazole is a proton pump inhibitor that inhibits the H+/k+ -ATPase in the gastric parietal cell, suppressing gastric acid output. By working directly on the proton pump, Esomeprazole prevents the final stage in acid generation.

Dosage & Administration

Before opting to take this pill, carefully evaluate the potential advantages and dangers as well as alternative treatment choices. Use the lowest effective dose for the shortest time possible in accordance with the treatment goals of each individual patient. A different therapy should be explored if a dose of Esomeprazole lower than a total daily dose of 40 mg is more appropriate.

Adults with Rheumatoid Arthritis, Osteoarthritis, or Ankylosing Spondylitis: Take one tablet of either 375 mg naproxen/20 mg esomeprazole or 500 mg naproxen/20 mg esomeprazole twice day.

Weight more than 50 kg: 375 mg naproxen/20 mg esomeprazole; or 500 mg naproxen/20 mg esomeprazole

Do not split, chew, crush or dissolve the tablet. This tablet is to be taken at least 30 minutes before meals.

Interaction

Concomitant use of NSAIDs and ACE inhibitors, diuretics, and beta-blockers may diminish their antihypertensive impact. Concomitant use of this pill with warfarin may raise the risk of bleeding complications.

Esomeprazole reduces stomach acid secretion and may interfere with the absorption of medicines whose bioavailability is influenced by gastric pH. (eg. Ketoconazole, iron salts and digoxin).

With food and others: Giving Naproxen and Esomeprazole along with a high-fat meal has little effect on naproxen absorption, but it considerably prolongs tmax by 10 hours and lowers peak plasma concentration (Cmax) by around 12% in healthy volunteers.

Contraindications

Hypersensitivity to any of the tablet’s ingredients or substituted benzimidazoles.

After using aspirin or other NSAIDs, you may get asthmay urticaria or other allergic responses.

In the case of coronary artery bypass graft (CABG) surgery, use during the peri-operative period.

Side Effect

This medication is generally well tolerated. Erosive gastritis, dyspepsia, gastritis, diarrhea, gastric ulcer, upper abdominal discomfort, nausea, and other unpleasant responses were the most prevalent in clinical studies (>5%).

Pregnancy & Lactation

Category C pregnancy. It should be avoided in late pregnancy since it may cause premature closure of the ductus arteriosus. Because of the Naproxen component, this tablet should not be taken by nursing mothers.

Precautions & Warnings

Patients having a history of cardiovascular disease or risk factors may be at higher risk. In patients with fluid retention or heart failure, this pill should be taken with care.

Therapeutic Class

Non-steroidal anti-inflammatory drugs, drugs for osteoarthritis, drugs for rheumatoid arthritis (NSAIDs)

Storage Conditions

Store in a cool and dry place, below 30°C and away from light. Keep out of reach of children.

Pharmaceutical Name

Eskayef Pharmaceuticals Ltd.