Xenole 500

Generic

Naproxen Sodium + Esomeprazole Magnesium

 

Indications

Naproxen and Esomeprazole are used to treat the signs and 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

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

Naproxen is a nonsteroidal anti-inflammatory drug (NSAID) with analgesic and antipyretic effects. Naproxen's method of action is to suppress prostaglandin production. Esomeprazole is a proton pump inhibitor that inhibits stomach acid secretion by selectively inhibiting the H+/k+ -ATPase in the gastric parietal cell. By working specifically on the proton pump, Esomeprazole inhibits the last step in acid generation; as a result, stomach acidity is reduced.

 

Dosage  

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 esomeprazole
• Weight 38 kg to less than 50 kg: One tablet twice daily of 375 mg naproxen/20 mg of esomeprazole.

 

Administration

The pill should not be broken, chewed, crushed, or dissolved. This pill should be taken 30 minutes before meals.

 

Interaction

When it comes to medicine:

• The use of NSAIDs concurrently may decrease the antihypertensive impact of ACE inhibitors, diuretics, and beta-blockers.
• Concurrent use of this pill with warfarin may raise the risk of a bleeding problem.
• Esomeprazole reduces stomach acid secretion and may interfere with medication absorption in cases where gastric pH is a significant factor of bioavailability (eg. Ketoconazole, iron salts and digoxin).

With food and others: Administration of Naproxen and Esomeprazole along with high-fat meal has no effect on naproxen absorption but considerably prolongs tmax by 10 hours and reduces peak plasma concentration (Cmax) by around 12% in healthy individuals.

 

Contraindications

• Any known hypersensitivity to this tablet's components or substituted benzimidazoles.
• Aspirin or other NSAIDs have caused asthmatic urticaria or other allergic-type responses in the past.
• In the setting of coronary artery bypass graft (CABG) surgery, use during the peri-operative phase.

 

Side Effects

This medication is generally well tolerated. The following are the most common adverse responses in clinical trials (>5%): erosive gastritis, dyspepsia, gastritis, diarrhea, gastric ulcer, upper abdominal discomfort, nausea, and so on.

 

Pregnancy & Lactation

C is the pregnancy category. 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 who have a history of CV disease or risk factors may be at a higher risk. In patients with fluid retention or heart failure, this pill should be taken with care.

 

Therapeutic Class

Rheumatoid Arthritis Drugs, Osteoarthritis Drugs, Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

 

Storage Conditions

Store at temperatures below 30°C and keep away from light and moisture. Keep out of children's reach.

 

Pharmaceutical Name

Square Pharmaceuticals Ltd.