1 INDICATIONS AND USAGE Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor indicated for the following: Treatment of gastroesophageal reflux disease (GERD). ( 1.1 ) Risk reduction of NSAID-associated gastric ulcer. ( 1.2 ) H. pylori eradication to reduce the risk of duodenal ulcer recurrence. (1.3) Pathological hypersecretory conditions, including Zollinger-Ellison syndrome. ( 1.4 ) 1.1 Treatment of Gastroesophageal Reflux Disease (GERD) Healing of Erosive Esophagitis Esomeprazole magnesium delayed-release capsules are indicated 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 delayed-release capsules may be considered. Maintenance of Healing of Erosive Esophagitis Esomeprazole magnesium delayed-release capsules are indicated to maintain symptom resolution and healing of erosive esophagitis. Controlled studies do not extend beyond 6 months. Symptomatic Gastroesophageal Reflux Disease Esomeprazole magnesium delayed-release capsules are indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults and children 1 year or older. 1.2 Risk Reduction of NSAID-Associated Gastric Ulcer Esomeprazole magnesium delayed-release capsules 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/or documented history of gastric ulcers. Controlled studies do not extend beyond 6 months. 1.3 H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Triple Therapy (esomeprazole magnesium plus amoxicillin and clarithromycin): Esomeprazole magnesium, in combination with amoxicillin and clarithromycin, is 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 [see Dosage and Administration (2) and Clinical Studies (14) ] . In patients who fail therapy, susceptibility testing should be done. If resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted [see Clinical Pharmacology (12.4 ) and the prescribing information for clarithromycin] . 1.4 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome Esomeprazole magnesium delayed-release capsules are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison Syndrome.
Amneal Pharmaceuticals LLC
16 HOW SUPPLIED/STORAGE AND HANDLING
ESOMEPRAZOLE MAGNESIUM Delayed-release Capsules USP, 20 mg are supplied as hard gelatin capsules, 'AMNEAL 644' printed on white opaque body and two parallel bands on white opaque cap with blue ink. They are available as follows: Bottles of 30: NDC 65162-644-03 Bottles of 90: NDC 65162-644-09 Bottles of 500: NDC 65162-644-50 Bottles of 1000: NDC 65162-644-11
ESOMEPRAZOLE MAGNESIUM Delayed-release Capsules USP, 40 mg are supplied as hard gelatin capsules, 'AMNEAL 645' printed on white opaque body and three parallel bands on white opaque cap with blue ink. They are available as follows: Bottles of 30: NDC 65162-645-03 Bottles of 90: NDC 65162-645-09 Bottles of 500: NDC 65162-645-50 Bottles of 1000: NDC 65162-645-11 Store at 20Â° to 25Â°C (68Â° to 77Â°F); excursions permitted between 15Â° to 30Â°C (59Â° to 86Â°F) [see USP Controlled Room Temperature]. Keep
ESOMEPRAZOLE MAGNESIUM delayed-release capsules container tightly closed. Dispense in a tight container if the
ESOMEPRAZOLE MAGNESIUM delayed-release capsules product package is subdivided.
Amneal Pharmaceuticals LLC
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