Xenole™ 375 Tablet: Each tablet contains delayed release Naproxen USP 375 mg and immediate release Esomeprazole Magnesium Trihydrate USP equivalent to Esomeprazole 20 mg.
Xenole™ 500 Tablet: Each tablet contains delayed release Naproxen USP 500 mg and immediate release Esomeprazole Magnesium Trihydrate USP equivalent to Esomeprazole 20 mg.
Xenole™ consists of an immediate release Esomeprazole magnesium layer and 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 an NSAID with analgesic and antipyretic properties. Naproxen inhibits the synthesis of prostaglandin. 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 reduces gastric acidity.
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.
One Xenole™ 375 or Xenole™ 500 tablet twice daily. The tablets are to be swallowed whole with liquid. Do not split, chew, crush or dissolve the tablet. The tablet is to be taken at least 30 minutes before meals.
Concomitant use of NSAIDs may reduce the antihypertensive effect of ACE inhibitors, diuretics, and beta-blockers. Concomitant use of Xenole™ and Warfarin may result in increased risk of bleeding complications. Esomeprazole inhibits gastric acid secretion and may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (eg. Ketoconazole, iron salts and Digoxin).
Overdose *Overdose of Naproxen:* Significant Naproxen overdosage may be characterized by lethargy, drowsiness, epigastric pain, abdominal discomfort, heartburn, indigestion, nausea, transient alterations in liver function, hypoprothrombinemia, renal dysfunction, metabolic acidosis, apnea, vomiting etc. *Overdose of Esomeprazole:* The major signs of acute toxicity were reduced motor activity change in respiratory frequency, tremor and intermittent clonic convulsions etc.
Pregnancy Category C: * In late pregnancy, it should be avoided because it may cause premature closure of the ductus arteriosus. *In lactation:* Should not be used in nursing mothers due to the Naproxen component.
Patients with known CV disease/risk factors may be at greater risk. Xenole™ should be used with caution in patients with fluid retention or heart failure.
Store in a cool and dry place, away from light and moisture. Keep the medicine out of the reach of children.