Esona 500

Generic

Naproxen Sodium + Esomeprazole Magnesium

 

Indications

Naproxen and esomeprazole are indicated to relieve the signs and symptoms of 

• osteoarthritis 
• rheumatoid arthritis 
• ankylosing spondylitis and 
• reduce the risk of gastric ulcer in patients at risk of NSAID-related gastric ulcer.

 

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. It acts specifically on the proton pump 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.

 

 Administration

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

 

Interactions

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 formulation is well tolerated. The most frequent adverse reactions in clinical trials (> 5%): erosive gastritis, dyspepsia, gastritis, diarrhea, gastric ulcer, epigastric 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.

 

Precautions & Warnings

Patients with known cardiovascular disease / risk factors may be at increased risk. Patients with fluid retention or heart failure should use this product with caution.

 

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

NAVANA PHARMACEUTICALS LTD