Dinovo 375 mg+20 mg (Tablet (Delayed Release))

Unit Price: ৳ 12.00 (5 x 10: ৳ 600.00)
Strip Price: ৳ 120.00

Medicine Details

Category Details
Generic Naproxen sodium esomeprazole magnesium
Company Beximco pharmaceuticals ltd
Also available as
Dinovo 500 mg tablet

Title and Categories

  • Naproxen & Esomeprazole Tablet
  • 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

  • Consists of an immediate release Esomeprazole Magnesium layer & an enteric-coated Naproxen core
  • Esomeprazole is released first into the stomach, prior to the dissolution of Naproxen in the small intestine
  • Naproxen is a NSAID with analgesic & antipyretic properties
  • Mechanism of action of Naproxen is to inhibit prostaglandin synthesis
  • Esomeprazole is a proton pump inhibitor that 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
  • 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 & Older: 375 mg or 500 mg naproxen/20 mg of esomeprazole based on weight

Administration

  • Do not split, chew, crush or dissolve the tablet
  • Take at least 30 minutes before meals

Interactions

  • Concomitant use of NSAIDs may reduce the antihypertensive effect of ACE inhibitors, diuretics & beta-blockers
  • Concomitant use of this tablet and warfarin may result in an increased risk of a bleeding complication
  • Inhibition of gastric acid secretion by Esomeprazole may interfere with the absorption of certain drugs (eg. Ketoconazole, iron salts and digoxin)
  • Administration with high-fat food in healthy volunteers does not affect the extent of absorption of naproxen but significantly prolongs tmax by 10 hours and decreases peak plasma concentration (Cmax) by about 12%

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

  • Decreased occurrence of gastric ulcers & NSAID-associated upper gastrointestinal adverse events compared to Naproxen alone
  • Possible small increased risk of arterial thrombotic events, particularly at high doses and in long-term treatment
  • Gastrointestinal adverse events such as nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, and more

Pregnancy & Lactation

  • Not recommended during the first and second trimester of pregnancy unless the potential benefit to the patient outweighs the potential risk to the foetus
  • Contraindicated during the third trimester of pregnancy
  • Not recommended during breastfeeding

Precautions & Warnings

  • Avoid the combination with NSAIDs including cyclooxygenase-2 selective inhibitors
  • Use with caution in older people due to increased frequency of adverse reactions
  • Risk-factors to develop NSAID related gastro-intestinal complications include high age, concomitant use of anticoagulants, corticosteroids, other NSAIDs, debilitating cardiovascular disease, Helicobacter pylori infection, and a history of gastric and/or duodenal ulcers and upper gastrointestinal bleeding

Use in Special Populations

  • Use caution and possible dosage adjustment in elderly patients
  • Not recommended for use in patients with moderate to severe or severe renal impairment (creatinine clearance <30 ml/min)
  • Monitor patients with mild to moderate hepatic impairment closely & consider a possible dose reduction based on the Naproxen component of this tablet

Overdose Effects

  • Symptoms related to Naproxen overdose may include lethargy, dizziness, drowsiness, epigastric pain, abdominal discomfort, heartburn, indigestion, nausea, and more
  • There are no specific antidotes for Naproxen overdose
  • Symptoms related to Esomeprazole overdose are transient and single doses of 80 mg esomeprazole were uneventful
  • No specific antidote is known for Esomeprazole overdose

Storage Conditions

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

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