Naxsil E 375 mg+20 mg (Tablet (Delayed Release))
Unit Price: ৳ 10.00 (5 x 6: ৳ 300.00)
Strip Price: ৳ 60.00
Medicine Details
Category | Details |
---|---|
Generic | Naproxen sodium esomeprazole magnesium |
Company | Silco pharmaceutical ltd |
Also available as |
Therapeutic Class
- Drugs for Osteoarthritis
- Drugs used for Rheumatoid Arthritis
- Non-steroidal Anti-inflammatory Drugs (NSAIDs)
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
- Immediate release Esomeprazole Magnesium layer
- Enteric-coated Naproxen core
- NSAID with analgesic and antipyretic properties
- Inhibition of prostaglandin synthesis
- Specific inhibition of the H+/k+ -ATPase in the gastric parietal cell
- Reduction of gastric acidity
Dosage
- Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals
- Adult dosage: One tablet twice daily of either: 375 mg naproxen/20 mg of esomeprazole; or 500 mg naproxen/20 mg of esomeprazole
- Adolescent dosage: 375 mg naproxen/20 mg of esomeprazole; or 500 mg naproxen/20 mg of esomeprazole for weight greater than 50 kg
- One tablet twice daily of 375 mg naproxen/20 mg of esomeprazole for weight 38 kg to less than 50 kg
Administration
- Tablet is to be taken at least 30 minutes before meals
- Do not split, chew, crush or dissolve the tablet
Interaction
- Concomitant use of NSAIDs may reduce the antihypertensive effect of ACE inhibitors, diuretics, and beta-blockers
- Increased risk of bleeding complication with warfarin
- Inhibition of gastric acid secretion may interfere with the absorption of certain drugs where gastric pH is an important determinant of bioavailability
- Effect of high-fat food on absorption of naproxen
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
- Decrease in occurrence of gastric ulcers and NSAID associated upper gastrointestinal adverse events compared to Naproxen alone
- Increased risk of arterial thrombotic events at high doses and in long-term treatment
- Gastrointestinal side effects include peptic ulcers, perforation or GI bleeding, nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease
- Less frequently observed side effects include gastritis, oedema, hypertension, and cardiac failure
Pregnancy & Lactation
- Use during the first and second trimester should be carefully considered
- Contraindicated during the third trimester of pregnancy
- Not recommended during breastfeeding
- NSAIDs like Naproxen may impair female fertility
Precautions & Warnings
- Avoid using with other NSAIDs and cyclooxygenase-2 selective inhibitors
- Minimize undesirable effects by using the lowest effective dose for the shortest duration necessary to control symptoms
- Risk-factors for developing NSAID related gastro-intestinal complications
- Increased frequency of adverse reactions in older people especially gastro-intestinal bleeding and perforation
- Increased risk of GI bleeding, ulceration or perforation, particularly in older people
- Appropriate monitoring and advice required for patients with a history of hypertension and/or mild to moderate congestive heart failure
- Long-term administration of NSAIDs can result in renal injury
Use in Special Populations
- Caution and possible dosage adjustment in elderly patients due to changes in unbound plasma fraction of naproxen
- Not recommended in patients with moderate to severe or severe renal impairment
- Close monitoring and possible dose reduction in patients with mild to moderate hepatic impairment
Overdose Effects
- Symptoms related to Naproxen overdose including lethargy, dizziness, drowsiness, epigastric pain, abdominal discomfort, heartburn, indigestion, nausea, disorientation, vomiting, and rare occurrences of hypertension, acute renal failure, respiratory depression, and coma
- Symptoms related to esomeprazole overdose are transient
- Management includes symptomatic and supportive care following a NSAID overdose, particularly with respect to GI effects and renal damage, and no specific antidote is known for esomeprazole overdose
Storage Conditions
- Store at temperature of below 30°C
- Protect from light and moisture
- Keep out of reach of children
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