Xenmep 500 mg+20 mg (Tablet (Delayed Release))

Indications

• Relief of signs and symptoms of osteoarthritis
• Relief of signs and symptoms of rheumatoid arthritis
• Relief of signs and symptoms of ankylosing spondylitis
• Decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers

Pharmacology

• Consists of an immediate release Esomeprazole Magnesium layer & an enteric-coated Naproxen core
• Naproxen is a NSAID with analgesic & antipyretic properties
• Esomeprazole is a proton pump inhibitor that suppresses gastric acid secretion by specific inhibition of the H+/k+-ATPase in the gastric parietal cell by acting specifically on the proton pump

Dosage

• Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals
• Adults: One tablet twice daily of either: 375 mg naproxen/20 mg of esomeprazole; or 500 mg naproxen/20 mg of esomeprazole
• Adolescent Patients 12 Years of Age & Older: Dosage based on weight

Administration

• Do not split, chew, crush or dissolve the tablet
• Take at least 30 minutes before meals

Interaction

• 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 (e.g. Ketoconazole, iron salts and digoxin)

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

• Decreased occurrence of gastric ulcers and NSAID associated upper gastrointestinal adverse events compared to Naproxen alone
• Gastrointestinal side effects from Naproxen
• Elevated risk of arterial thrombotic events with high doses and long-term treatment
• Gastrointestinal adverse events like nausea, vomiting, diarrhea, etc.

Pregnancy & Lactation

• Naproxen and Esomeprazole tablet should not be given unless the potential benefit to the patient outweighs the potential risk to the fetus
• Not recommended during breastfeeding or in women attempting to conceive

Precautions & Warnings

• Avoid combination with other NSAIDs, especially cyclooxygenase-2 selective inhibitors
• Use the lowest effective dose for the shortest duration necessary to control symptoms
• Monitoring required for patients with hypertension, congestive heart failure, renal impairment, etc.

Use in Special Populations

• Use caution when high doses are required in elderly patients
• Not recommended for use in patients with moderate to severe or severe renal impairment
• Monitor patients with mild to moderate hepatic impairment closely

Overdose Effects

• Symptoms related to Naproxen overdose include gastrointestinal issues, renal dysfunction, and neurological symptoms
• Management includes symptomatic and supportive care, emesis, activated charcoal, etc.

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

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