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Indications

Naproxen and esomeprazole are indicated to relieve the signs and symptoms of osteoarthritis

• Rheumatoid arthritis
• Ankylosing spondylitis
• Reduce the risk of gastric ulcer in patients at risk of NSAID-related gastric ulcer.

Pharmacology

It consists of an immediate-release esomeprazole magnesium layer and an enteric-coated naproxen core. Therefore, esomeprazole is first released in the stomach, and then naproxen is dissolved in the small intestine. 

Naproxen is a non-steroidal anti-inflammatory drug with analgesic and antipyretic properties. Naproxen's mechanism of action is to inhibit the synthesis of prostaglandins. Esomeprazole is a proton pump inhibitor that specifically acts on proton pumps and inhibits gastric acid secretion by specifically inhibiting ATPase H + / k + in parietal cells. Esomeprazole blocks acid production. The last passage, thereby reducing gastric acid.

Dosage & Administration

Before deciding to use this tablet, carefully consider the potential benefits and risks of this tablet and other treatment options. Use the lowest effective dose for the shortest duration that meets each patient's treatment goals. If the esomeprazole dose is less than the total daily dose of 40 mg, a different treatment should be considered. 

Rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis 
 Adults: One capsule twice daily: 375 mg naproxen / 20 mg esomeprazole; o Naproxen 500 mg/esomeprazole 20 mg 

Juvenile idiopathic arthritis in adolescent patients 12 years and older weighing more than 50 kg: Naproxen 375 mg/esomeprazole 20 mg; or 500 mg naproxen / 20 mg angstrom Someprazole 

weighing 38 kg to less than 50 kg: Take 375 mg naproxen / 20 mg esomeprazole tablets twice a day.

Do not split, chew, crush, or dissolve the tablet. The tablet should be taken at least 30 minutes before meals.

Interaction

Combined use with drugs: 

combined with non-steroidal anti-inflammatory drugs may reduce the antihypertensive effects of ACE inhibitors, diuretics, and beta-blockers. 
combined with this tablet and warfarin may increase the risk of bleeding complications.  

Esomeprazole inhibits gastric acid secretion and may interfere with the absorption of drugs, in which gastric acidity is an important determinant of bioavailability (such as ketoconazole, iron salts, and digoxin). 

and food and others: the intake of naproxen, esomeprazole, and high-fat foods in healthy volunteers will not affect the absorption of naproxen, but can significantly prolong the tmax by 10 hours and increase the maximum plasma concentration (Cmax) reduced by approximately 12 %

Contraindications

• You are known to be allergic to any component of the tablet or substituted benzimidazole medications. 
• History of asthmatic urticaria or other allergic reactions after taking aspirin or other non-steroidal anti-inflammatory drugs. 
• It is used in the perioperative period of coronary artery bypass graft (CABG) surgery.

Side-Effects

• Headache
• Nausea
• Vomiting
• Diarrhea
• Indigestion
• Flatulence
• Stomach pain
• Flu-like symptoms

Pregnancy & Lactation

Pregnancy category C. Should be avoided in the third trimester as it can cause the ductus arteriosus to close prematurely. Due to the naproxen content, the tablet should not be used for breastfeeding mothers.

Precautions & Warnings

Patients with known cardiovascular disease/risk factors may be at increased risk. Patients with fluid retention or heart failure should use this product with caution.

Storage Conditions

Store at a temperature of below 30°C, and protect from light & moisture. Keep out of reach of children.