Anaflex Max 375 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

Pharmacology

• Consists of immediate release esomeprazole magnesium layer
• Enteric-coated naproxen core
• Naproxen is a NSAID with analgesic and antipyretic properties
• Inhibits prostaglandin synthesis
• Esomeprazole is a proton pump inhibitor
• Suppresses gastric acid secretion

Dosage

• Use lowest effective dose
• Adult dosage: 375 mg naproxen/20 mg esomeprazole or 500 mg naproxen/20 mg esomeprazole twice daily
• Adolescent dosage: 375 mg naproxen/20 mg esomeprazole or 500 mg naproxen/20 mg esomeprazole for weight >50 kg, 375 mg naproxen/20 mg esomeprazole for weight 38-50 kg

Administration

• Tablet to be taken at least 30 minutes before meals

Interaction

• Concomitant use of NSAIDs may reduce antihypertensive effect of ACE inhibitors, diuretics, and beta-blockers
• Concomitant use with warfarin may increase risk of bleeding
• Inhibits absorption of drugs where gastric pH is important determinant of bioavailability
• Administration with high-fat food prolongs tmax and decreases Cmax

Contraindications

• Known hypersensitivity to any component of the tablet
• 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
• Increased risk of arterial thrombotic events at high doses
• Gastrointestinal side effects such as peptic ulcers, perforation, GI bleeding, nausea, vomiting, diarrhea, flatulence, constipation, etc.

Pregnancy & Lactation

• Contraindicated during third trimester of pregnancy
• Not recommended during breastfeeding
• Use may impair female fertility

Precautions & Warnings

• Avoid concomitant use with NSAIDs including COX-2 selective inhibitors
• Minimize undesirable effects with lowest effective dose for shortest duration necessary
• Risk factors for NSAID related gastro-intestinal complications
• Increased frequency of adverse reactions in older people
• Effects on cardiovascular, cerebrovascular, and renal systems

Use in Special Populations

• Use caution and possible dosage adjustment in elderly patients
• Not recommended for patients with moderate to severe renal impairment
• Monitor and consider dose reduction in patients with mild to moderate hepatic impairment

Overdose Effects

• Symptoms related to naproxen overdose
• Symptoms related to esomeprazole overdose
• Management includes symptomatic and supportive care, no specific antidotes

Therapeutic Class

• Drugs for osteoarthritis
• Drugs used for rheumatoid arthritis
• Non-steroidal anti-inflammatory drugs (NSAIDs)

Storage Conditions

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

Related Brands

• Ultranax Plus 500 mg+20 mg (Tablet (Delayed Release)) - ad-din-pharmaceuticals-ltd