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Esomeprazole 40 MG Delayed Release Oral Capsule

1 INDICATIONS AND USAGE Esomeprazole Magnesium Delayed-release Capsules is a proton pump inhibitor (PPI). Esomeprazole Magnesium Delayed-release Capsules are indicated for the: Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. ( 1.1 ) Maintenance of healing of EE in adults. ( 1.2 ) Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. ( 1.3 ) Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. ( 1.4 ) Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. ( 1.5 ) Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. ( 1.6 ) 1.1 Healing of Erosive Esophagitis (EE) Adults 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 EE in adults. 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. Pediatric Patients 12 Years to 17 Years of Age Esomeprazole Magnesium Delayed-release Capsules are indicated for the short-term treatment (4 to 8 weeks) for the healing of EE in pediatric patients 12 years to 17 years of age. Pediatric Patients 1 Year to 11 Years of Age Esomeprazole Magnesium is indicated for the short-term treatment (8 weeks) for the healing of EE in pediatric patients 1 year to 11 years of age. 1.2 Maintenance of Healing of EE Esomeprazole Magnesium Delayed-release Capsules are indicated for the maintenance of healing of EE in adults. Controlled studies do not extend beyond 6 months. 1.3 Treatment of Symptomatic GERD Adults 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. Pediatric Patients 12 Years to 17 Years of Age Esomeprazole Magnesium Delayed-release Capsules are indicated for short-term treatment (4 weeks) of heartburn and other symptoms associated with GERD in pediatric patients 12 years to 17 years of age. Pediatric Patients 1 Year to 11 Years of Age Esomeprazole Magnesium is indicated for short-term treatment (up to 8 weeks) of heartburn and other symptoms associated with GERD in pediatric patients 1 year to 11 years of age. 1.4 Risk Reduction of Nonsteroidal Anti-Inflammatory Drugs (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 adult patients at risk for developing gastric ulcers. Patients are considered to be at risk due to their age (60 years and older) and/or documented history of gastric ulcers. Controlled studies do not extend beyond 6 months. 1.5 Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Triple Therapy Esomeprazole Magnesium Delayed-release Capsules in combination with amoxicillin and clarithromycin is indicated for the treatment of adult patients with H. pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori . 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] . 1.6 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, in adults.

lannett company, inc.


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11 months ago CAPSULE BLUE KU 840 Esomeprazole 40 MG Delayed Release Oral Capsule

CAPSULE BLUE KU 840

16 HOW SUPPLIED/STORAGE AND HANDLING

ESOMEPRAZOLE MAGNESIUM Delayed-release Capsules, USP, 20 mg, are opaque dark blue cap and opaque white body imprinted with “KU” and “820” in gray and filled with pellets. They are supplied as follows: NDC 62175-820-32 unit of use bottles of 30 NDC 62175-820-46 unit of use bottles of 90 NDC 62175-820-43 bottles of 1000

ESOMEPRAZOLE MAGNESIUM Delayed-release Capsules, USP, 40 mg, are opaque light blue cap and opaque white body imprinted with “KU” and “840” in black and filled with pellets. They are supplied as follows: NDC 62175-840-32 unit of use bottles of 30 NDC 62175-840-46 unit of use bottles of 90 NDC 62175-840-43 bottles of 1000 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°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.

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