Novoxen 500 mg+20 mg (Tablet (Delayed Release))
Unit Price: ৳ 13.00 (5 x 4: ৳ 260.00)
Strip Price: ৳ 52.00
Medicine Details
Category | Details |
---|---|
Generic | Naproxen sodium esomeprazole magnesium |
Company | Orion pharma ltd |
Also available as |
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 NSAID-associated gastric ulcers
Pharmacology
- Consists of an immediate release Esomeprazole Magnesium layer
- Consists of an enteric-coated Naproxen core
- Mechanism of action of Naproxen is to inhibit prostaglandin synthesis
- Esomeprazole suppresses gastric acid secretion by specific inhibition of the H+/k+ -ATPase in the gastric parietal cell
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
- Adolescent dosage: 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
Interaction
- Concomitant use of NSAIDs may reduce the antihypertensive effect of ACE inhibitors, diuretics, and beta-blockers
- Concomitant use with warfarin may result in an increased risk of a bleeding complication
- Esomeprazole may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability
Contraindications
- Known hypersensitivity to any component of the 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
- Naproxen and Esomeprazole tablet has been shown to decrease the occurrence of gastric ulcers and NSAID-associated upper gastrointestinal adverse events compared to Naproxen alone
- Clinical trial and epidemiological data suggest that use of coxibs and some NSAIDs may be associated with a small increased risk of arterial thrombotic events
- Oedema, hypertension, and cardiac failure have been reported in association with NSAID treatment
- Peptic ulcers, perforation, or GI bleeding, sometimes fatal, particularly in older people, may occur
- Other adverse events include nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis, and Crohn’s disease
Pregnancy & Lactation
- Not recommended during the first and second trimester of pregnancy
- Contraindicated during the third trimester of pregnancy
- Not recommended during breastfeeding
- Use of NSAIDs like Naproxen may impair female fertility
Precautions & Warnings
- Avoid combination with NSAIDs including cyclooxygenase-2 selective inhibitors
- Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms
- Risk-factors to develop NSAID related gastro-intestinal complications include high age, concomitant use of anticoagulants, and corticosteroids
Use in Special Populations
- Elderly patients: use caution when high doses are required, and some adjustment of dosage may be required
- Patients with Moderate to Severe Renal impairment: not recommended for use
- Hepatic insufficiency: monitor patients with mild to moderate hepatic impairment closely
Overdose Effects
- Symptoms include lethargy, dizziness, drowsiness, epigastric pain, abdominal discomfort, heartburn, indigestion, and nausea
- Management involves symptomatic and supportive care, including emesis and/or activated charcoal
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
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