Nesotem 500

Generic

Naproxen Sodium + Esomeprazole Magnesium

Indication

Naproxen & Esomeprazole is indicated for the relief of signs & symptoms of-

• Osteoarthritis
• Rheumatoid arthritis
• Ankylosing spondylitis &
• To decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers.

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 dissolves 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 prostaglandin synthesis. Esomeprazole is a proton pump inhibitor that specifically acts on the proton pump and inhibits gastric acid secretion by specifically inhibiting ATPase H + / k + in gastric parietal cells. Esomeprazole blocks final acid production. One step, thus reducing stomach acid.

Dosage and Administration

Carefully consider the potential benefits & risks of this tablet & other treatment options before deciding to use this tablet. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. If a dose of Esomeprazole lower than a total daily dose of 40 mg is more appropriate, a different treatment should be considered. Rheumatoid Arthritis, Osteoarthritis and Ankylosing Spondylitis-

Adults: One tablet twice daily of either: 375 mg naproxen/20 mg of esomeprazole; or 500 mg naproxen/20 mg of esomeprazole Juvenile Idiopathic Arthritis in Adolescent Patients 12 Years of Age & Older-Weight greater than 50 kg: 375 mg naproxen/20 mg of esomeprazole; or 500 mg naproxen/20 mg of esomeprazoleWeight 38 kg to less than 50 kg: One tablet twice daily of 375 mg naproxen/20 mg of esomeprazole.

Interaction

With medicine:

• Concomitant use of NSAIDs may reduce the antihypertensive effect of ACE inhibitors, diuretics & beta-blockers
• Concomitant use of this tablet and warfarin may result in an increased risk of a bleeding complication.
• Esomeprazole inhibits gastric acid secretion & may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (eg. Ketoconazole, iron salts and digoxin).

With food & others: Administration of Naproxen & Esomeprazole together with high-fat food in healthy volunteers does not affect the extent of absorption of naproxen but significantly prolongs t_max by 10 hours and decreases peak plasma concentration (C_max) by about 12%.

Contraindications

• Known hypersensitivity to any component of this tablet or substituted benzimidazoles.
• History of asthmay urticaria or other allergic-type reactions after taking aspirin or other NSAIDs.
• Use during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery.

Side Effects

In general, this preparation is well tolerated. The most common adverse reactions in clinical trials (>5%): erosive gastritis, dyspepsia, gastritis, diarrhea, gastric ulcer, upper abdominal pain, nausea etc.

Pregnancy & Lactation

Pregnancy category C. In late pregnancy, it should be avoided because it may cause premature closure of the ductus arteriosus. This tablet should not be used in nursing mothers due to the Naproxen component.

Pregnancy & Warning

Patients with known CV disease/risk factors may be at greater risk. This tablet should be used with caution in patients with fluid retention or heart failure.

Therapeutic Class

Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs).

Storage Condition

Protect from light, store bellow 30°C and keep away from children.

Pharmaceutical Name

Team Pharmaceuticals Ltd.