Nexpro Tablets (Generic Esomeprazole Magnesium Tablets)

1. Nexpro Tablets (Generic Esomeprazole Magnesium Tablets) © The Swiss Pharmacy

2. Nexpro Tablets (Generic Esomeprazole Magnesium Tablets) Nexpro (Generic Esomeprazole Magnesium Tablets) is a proton pump inhibitor used for treatment of gastroesophageal reflux disease (GERD), Risk reduction of NSAID-associated gastric ulcer, H. pylori eradication to reduce the risk of duodenal ulcer recurrence and pathological hypersecretory conditions, including Zollinger- Ellison syndrome. It works by decreasing the amount of acid your stomach makes. It relieves symptoms such as heartburn, difficulty swallowing, and cough. This medication helps heal acid damage to the stomach and esophagus, helps prevent ulcers, and may help prevent cancer of the esophagus. © The Swiss Pharmacy

3. Nexpro Tablets (Generic Esomeprazole Magnesium Tablets) Nexpro Tablets are manufactured by Torrent Pharmaceuticals Limited, India in the strengths of 20 mg and 40 mg. © The Swiss Pharmacy

4. Nexpro Tablets (Generic Esomeprazole Magnesium Tablets) Chemical Structure © The Swiss Pharmacy

5. Nexpro Tablets (Generic Esomeprazole Magnesium Tablets) The active ingredient contained in Nexpro tablets is Esomeprazole Magnesium. Each enteric coated Nexpro tablet contains Esomeprazole Magnesium Trihydrate I.P. equivalent to 20 mg or 40 mg of Esomeprazole. © The Swiss Pharmacy

6. Nexpro Tablets (Generic Esomeprazole Magnesium Tablets) Uses of Nexpro 20 mg and 40 mg Tablets: Nexpro (Generic Esomeprazole Magnesium Tablets) is used to treat conditions where there is too much acid in the stomach. It is used to treat duodenal and gastric ulcers, erosive esophagitis, gastroesophageal reflux disease (GERD), and Zollinger-Ellison syndrome, a condition wherein the stomach produces too much acid. Esomeprazole is also used with antibiotics (eg, Amoxicillin, Clarithromycin) to treat ulcers that are caused by the H. pylori bacteria. This medicine is also used to prevent stomach ulcers and stomach irritation in patients taking NSAIDs (eg, aspirin, ibuprofen) for long periods of time. Esomeprazole is a proton pump inhibitor (PPI). It works by decreasing the amount of acid that is produced by the stomach. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9579_Esomeprazole-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9579_Esomeprazole-Tablets.html © The Swiss Pharmacy

7. Nexpro Tablets (Generic Esomeprazole Magnesium Tablets) Uses of Nexpro 20 mg and 40 mg Tablets: Treatment of Gastroesophageal Reflux Disease (GERD): Healing of Erosive Esophagitis: Nexpro (Generic Esomeprazole Magnesium tablets) is used for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis. For those patients who have not healed after 4 to 8 weeks of treatment, an additional 4 to 8 week course of Esomeprazole Magnesium tablets may be considered. Maintenance of Healing of Erosive Esophagitis: Esomeprazole Magnesium tablets are indicated to maintain symptom resolution and healing of erosive esophagitis. Symptomatic Gastroesophageal Reflux Disease: Esomeprazole Magnesium tablets are used for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults and children 1 year or older. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9579_Esomeprazole-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9579_Esomeprazole-Tablets.html © The Swiss Pharmacy

8. Nexpro Tablets (Generic Esomeprazole Magnesium Tablets) Uses of Nexpro 20 mg and 40 mg Tablets: Risk Reduction of NSAID-Associated Gastric Ulcer: Esomeprazole Magnesium tablets are indicated for the reduction in the occurrence of gastric ulcers associated with continuous NSAID therapy in patients at risk for developing gastric ulcers. Patients are considered to be at risk due to their age ( 60 and above) and/or documented history of gastric ulcers. H. Pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence using Triple Therapy ( Nexpro tablets Plus Amoxicillin and Clarithromycin): Nexpro (Generic Esomeprazole Magnesium tablets), in combination with Amoxicillin and Clarithromycin, are indicated for the treatment of patients with H. Pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori. Eradication of H. Pylori has been shown to reduce the risk of duodenal ulcer recurrence. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9579_Esomeprazole-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9579_Esomeprazole-Tablets.html © The Swiss Pharmacy

9. Nexpro Tablets (Generic Esomeprazole Magnesium Tablets) Uses of Nexpro 20 mg and 40 mg Tablets: Pathological Hypersecretory Conditions Including Zollinger- Ellison Syndrome: Esomeprazole Magnesium tablets (Nexpro) are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9579_Esomeprazole-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9579_Esomeprazole-Tablets.html © The Swiss Pharmacy

10. Nexpro Tablets (Generic Esomeprazole Magnesium Tablets) Recommended Dosage Treatment of Gastroesophageal Reflux Disease (GERD): Treatment of Gastroesophageal Reflux Disease (GERD): For adult patients, the dosage of Nexpro (Generic Esomeprazole Magnesium Tablets) for the is 20 mg or 40 mg once daily for 4 to 8 weeks For patients 12 to 17 years of age, the dosage is 20 mg or 40 mg Once daily for up to 8 weeks For patients 1 to 11 years of age, the dosage is 10 mg or 20 mg Once daily for up to 8 weeks URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9579_Esomeprazole-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9579_Esomeprazole-Tablets.html © The Swiss Pharmacy

11. Nexpro Tablets (Generic Esomeprazole Magnesium Tablets) Recommended Dosage For risk reduction of NSAID-Associated Gastric Ulcer in adults For risk reduction of NSAID-Associated Gastric Ulcer in adults the dose is 20 mg or 40 mg once daily for up to 6 months. The dose for H. Pylori Eradication (Triple Therapy) in adults: The dose for H. Pylori Eradication (Triple Therapy) in adults: Nexpro 40 mg Once daily for 10 days, Amoxicillin 1000 mg twice daily for 10 days and Clarithromycin 500 mg twice daily for 10 days. The dose to treat Pathological Hypersecretory Conditions in Pathological Hypersecretory Conditions in adults adults is 40 mg twice daily. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9579_Esomeprazole-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9579_Esomeprazole-Tablets.html © The Swiss Pharmacy

12. Nexpro Tablets (Generic Esomeprazole Magnesium Tablets) Contraindications ➔Nexpro tablets are contraindicated in patients with a known hypersensitivity to Esomeprazole, proton pump inhibitors (PPIs), substituted benzimidazoles or any component of the tablet. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticaria. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9579_Esomeprazole-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9579_Esomeprazole-Tablets.html © The Swiss Pharmacy

13. Nexpro Tablets (Generic Esomeprazole Magnesium Tablets) Storage Instructions Nexpro (Generic Esomeprazole Magnesium Tablets) have to be stored at controlled room temperature i.e. from 20°C to 25°C (68°F to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). Keep this as well as all other medicines away from children and pets. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9579_Esomeprazole-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9579_Esomeprazole-Tablets.html © The Swiss Pharmacy

14. Nexpro Tablets (Generic Esomeprazole Magnesium Tablets) Warnings Symptomatic response does not preclude the presence of gastric malignancy. Atrophic gastritis has been noted with long-term Omeprazole therapy. Acute interstitial nephritis has been observedin patients taking PPIs. Cyanocobalamin (vitamin B-12) Deficiency: Daily long-term use (e.g.,longer than 3 years) may lead to malabsorption or a deficiency of Cyanocobalamin. PPI therapy may be associated with increased risk ofClostridium difficile associated diarrhea. Avoid concomitant use of Nexpro (Esomeprazole Magnesium tablets) with Clopidogrel. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9579_Esomeprazole-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9579_Esomeprazole-Tablets.html © The Swiss Pharmacy

15. Nexpro Tablets (Generic Esomeprazole Magnesium Tablets) Warnings Bone Fracture: Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. Hypomagnesemia has been reported rarely with prolonged treatment with PPIs. Avoid concomitant use of Nexpro tablets with St John’s Wort or Rifampin due to the potential reduction in Esomeprazole levels. Interactions with diagnostic investigations for Neuroendocrine Tumors: Increases in intragastric pH may result in hypergastrinemia and enterochromaffin-like cell hyperplasia and increased chromogranin A levels which may interfere with diagnostic investigations for neuroendocrine tumors. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9579_Esomeprazole-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9579_Esomeprazole-Tablets.html © The Swiss Pharmacy

16. Nexpro Tablets (Generic Esomeprazole Magnesium Tablets) Possible Side Effects Most common Esomeprazole Magnesium (Nexpro tablets) side effects in adult patients (18 years or greater) with an incidence rate of greater than or equal to 1% : headache, diarrhea, nausea, flatulence, abdominal pain, constipation, and dry mouth. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9579_Esomeprazole-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9579_Esomeprazole-Tablets.html © The Swiss Pharmacy

17. Nexpro Tablets (Generic Esomeprazole Magnesium Tablets) Overdosage Single doses of 80 mg of Esomeprazole (Nexpro tablets) were uneventful. Reports of overdosage with Omeprazole in humans may also be relevant. Doses ranged up to 2,400 mg (120 times the usual recommended clinical dose). Symptoms were variable, but included confusion, drowsiness, blurred vision, tachycardia, nausea, diaphoresis, flushing, headache, dry mouth, and other adverse reactions similar to those seen in normal clinical experience. No specific antidote for Esomeprazole is known. Since Esomeprazole is extensively protein bound, it is not expected to be removed by dialysis. In the event of Nexpro overdosage, treatment should be symptomatic and supportive. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9579_Esomeprazole-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9579_Esomeprazole-Tablets.html © The Swiss Pharmacy

18. Nexpro Tablets (Generic Esomeprazole Magnesium Tablets) Nexpro Tablets During Pregnancy Esomeprazole Magnesium (Nexpro Tablets) has been classified by the US FDA as Pregnancy Category B. Reproductive studies in rats and rabbits with Esomeprazole (Nexpro) and multiple cohort studies in pregnant women with Omeprazole use during the first trimester do not show an increased risk of congenital anomalies or adverse pregnancy outcomes. There are, however, no adequate and well controlled studies of Esomeprazole use in pregnancy. Because animal reproduction studies are not always predictive of human response, this medication should be used during pregnancy only if clearly needed. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9579_Esomeprazole-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9579_Esomeprazole-Tablets.html © The Swiss Pharmacy

19. Nexpro Tablets (Generic Esomeprazole Magnesium Tablets) Nexpro Tablets Nexpro Tablets (Generic Esomeprazole Magnesium Tablets) are manufactured by Torrent Pharmaceuticals Limited, India. URL: URL: https://www.theswisspharmacy.com/product_info.php?info=p9579_Esomeprazole-Tablets.html https://www.theswisspharmacy.com/product_info.php?info=p9579_Esomeprazole-Tablets.html © The Swiss Pharmacy