Paincare 500

Generic

Naproxen Sodium + Esomeprazole Magnesium

Indications

It is indicated for the relief of sign and symptoms of osteoarthritis, rheumatic arthritis and ankylosingspondylities and 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 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

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.

Interaction

Use with medication: 
Concurrent use of NSAID may reduce the antihypertensive effects of ACEI, diuretics, and beta blockers. 
Simultaneous use of this tablet and warfarin may increase the risk of bleeding complications. 
Esomeprazole inhibits gastric acid secretion and may interfere with the absorption of drugs, where gastric pH is an important determinant of bioavailability (for example, ketoconazole, iron salts, and digoxin). 
and food and others: taking naproxen, esomeprazole and high-fat foods in healthy volunteers will not affect the absorption of naproxen, but significantly prolong tmax by 10 hours and increase the maximum plasma concentration (Cmax ) Decrease by about 1 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. is used in the perioperative period of coronary artery bypass graft (CABG) surgery.

Side Effects

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

Pregnancy & Lactation

Pregnancy category C. It should be avoided in the third trimester because it can cause the arterial duct to close prematurely. Because it contains naproxen, breast-feeding mothers should not use the pill.

Precautions & Warnings

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 Conditions

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

Pharmaceutical Name

Labaid Pharma Ltd.