It is indicated for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID associated gastric ulcers. Esomeprazole & Naproxen combination is not recommended for initial treatment of acute pain because the absorption of naproxen is delayed compared to absorption from other naproxencontaining products. Controlled studies do not extend beyond 6 months.
Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs
This consists of an immediate release Esomeprazole Magnesium layer & an enteric-coated Naproxen core. As a result, 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. The mechanism of action of Naproxen is to inhibit the 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 by acting specifically on the proton pump, Esomeprazole blocks the final step in acid production, thus reducing gastric acidity.
Rheumatoid Arthritis, Osteoarthritis and Ankylosing Spondylitis: The dosage is one tablet twice daily of 375 mg naproxen and 20 mg of esomeprazole or 500 mg naproxen and 20 mg of esomeprazole. The tablets are to be swallowed whole with liquid. Do not split, chew, crush or dissolve the tablet. This is to be taken at least 30 minutes before meals.
With medicine:
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.
Esomeprazole inhibits gastric acid secretion & may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (eg. Ketoconazole, iron salts and digoxin).
With food & others: Administration of Naproxen & Esomeprazole together 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%
Contraindicated in known hypersensitivity to any component of Progesic or substituted benzimidazoles, history of asthma, 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, late pregnancy. Patients with known CV disease/risk factors may be at greater risk. Progesic should be used with caution in patients with fluid retention or heart failure.
The adverse effects reported with this combination may include gastrointestinal disorders like dyspepsia, diarrhea, nausea, flatulence, abdominal pain etc.
Naproxen & Esomeprazole both are pregnancy category B drug. This combination should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. Naproxen & Esomeprazole are likely to be excreted in human milk, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Symptoms: Related to Naproxen overdose- Significant Naproxen overdosage may be characterized by lethargy, dizziness, drowsiness, epigastric pain, abdominal discomfort, heartburn, indigestion, nausea, transient alterations in liver function, hypoprothrombinemia, renal dysfunction, metabolic acidosis, apnea, disorientation or vomiting. Gastrointestinal bleeding can occur. Hypertension, acute renal failure, respiratory depression, and coma may occur, but are rare. Anaphylactoid reactions have been reported with therapeutic ingestion of NSAIDs, and may occur following an overdose. It is not known what dose of the drug would be life-threatening.
Related to esomeprazole overdose- The symptoms described in connection with deliberate esomeprazole overdose (limited experience of doses in excess of 240 mg/day) are transient. Single doses of 80 mg esomeprazole were uneventful.
Management: Related to Naproxen- Patients should be managed by symptomatic and supportive care following a NSAID overdose, particularly with respect to GI effects and renal damage. There are no specific antidotes. Hemodialysis does not decrease the plasma concentration of Naproxen because of the high degree of its protein binding. Emesis and/or activated charcoal (60 to 100 g in adults, 1 to 2 g/kg in children) and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose. Forced diuresis, alkalinization of urine or hemoperfusion may not be useful due to high protein binding.
Related to Esomeprazole- No specific antidote is known. Esomeprazole is extensively plasma protein bound and is therefore not readily dialyzable. As in any case of overdose, treatment should be symptomatic and general supportive measures should be utilised.
Store at temperature of below 30°C, protect from light & moisture. Keep out of reach of children.
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