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

Indications

• Relief of signs & symptoms of Osteoarthritis
• Relief of signs & symptoms of Rheumatoid arthritis
• Relief of signs & 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 and an enteric-coated Naproxen core
• Naproxen - NSAID with analgesic and antipyretic properties, inhibits prostaglandin synthesis
• Esomeprazole - Proton pump inhibitor, suppresses gastric acid secretion by inhibition of the H+/k+ -ATPase

Dosage

• Use 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
• Juvenile Idiopathic Arthritis in Adolescent Patients 12 Years of Age and Older - Varying 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 and beta-blockers
• Concomitant use with warfarin may result in increased risk of a bleeding complication
• Esomeprazole may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability
• Administration with high-fat food may affect absorption of naproxen

Contraindications

• Known hypersensitivity to any component of the tablet or substituted benzimidazoles
• History of hypersensitivity 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
• Possible association with arterial thrombotic events, oedema, hypertension, cardiac failure, gastrointestinal adverse events

Pregnancy & Lactation

• Use not recommended during the first and second trimester of pregnancy
• Contraindicated during the third trimester of pregnancy
• Not recommended during breastfeeding
• Possible impairment of female fertility

Precautions & Warnings

• Avoid combination with NSAIDs including cyclooxygenase-2 selective inhibitors
• Use with low dose acetylsalicylic acid may minimize undesirable effects
• Increased risk factors for developing NSAID-related complications in certain patients

Use in Special Populations

• Caution and possible dosage adjustments in elderly patients
• Not recommended in patients with moderate to severe renal impairment
• Close monitoring and possible dose reduction in patients with mild to moderate hepatic impairment

Overdose Effects

• Symptoms of Naproxen overdose may include lethargy, dizziness, drowsiness, gastrointestinal discomfort, and renal dysfunction
• Management includes symptomatic and supportive care, emesis, activated charcoal, and osmotic cathartic

Therapeutic Class

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

Storage Conditions

• Store at temperature below 30°C
• Protect from light and moisture
• Keep out of reach of children

Related Brands

• Duofix 500 mg+20 mg (Tablet (Delayed Release)) - osl-pharma-limited
• Duofix 375 mg+20 mg (Tablet (Delayed Release)) - osl-pharma-limited
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• Xenole 375 mg+20 mg (Tablet (Delayed Release)) - square-pharmaceuticals-plc
• Twist 500 mg+20 mg (Tablet (Delayed Release)) - chemist-laboratories-ltd