Generic

Naproxen Sodium + Esomeprazole Magnesium

Indications

Naproxen and Esomeprazole are used to treat the signs and symptoms of-

Osteoarthritis
Rheumatoid arthritis is a kind of arthritis that affects the joints.
Ankylosing spondylitis (AS) and
To reduce the risk of developing gastric ulcers in individuals who are at high risk of developing NSAID-related 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 gastric acid secretion by inhibiting the H+/k+ -ATPase in the gastric parietal cell. By working directly on the proton pump, Esomeprazole prevents the final stage in acid generation, decreasing stomach acidity.

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

Do not split, chew, crush or dissolve the tablet. This tablet is to be taken at least 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 situations where gastric pH is a key 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

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

Storage Conditions

Protect from light and moisture by storing at a temperature below 30°C. Keep out of children's reach.

Pharmaceutical Name

Ibn Sina Pharmaceuticals Ltd.

Nupralgin Plus 500