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

Unit Price: ৳ 13.00 (5 x 4: ৳ 260.00)
Strip Price: ৳ 52.00

Medicine Details

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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