Naprozol 500

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 and to reduce the risk of stomach ulcers in individuals 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 gastric acid secretion by inhibiting the H+/k+ -ATPase in the gastric parietal cell. By working directly on the proton pump, Esomeprazole reduces stomach acidity by blocking the last stage in acid generation.

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

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

Interaction

• NSAIDs may decrease the antihypertensive impact of ACE inhibitors, diuretics, and beta-blockers when used together.
• When this pill is used with warfarin, the chance of a bleeding problem is raised.
• 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 regard to food and others: In healthy adults, taking naproxen and esomeprazole combined with a high-fat meal has no effect on naproxen absorption, but it considerably prolongs tmax by 10 hours and lowers peak plasma concentration (Cmax) by around 12%.

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

Concomitant use of NSAIDs and diuretics may decrease the antihypertensive impact of ACE inhibitors, diuretics, and other blood pressure medications. 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

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

General Pharmaceuticals Ltd.