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Esomeprazole 40 MG Delayed Release Oral Capsule

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 Delayed-Release Capsules plus amoxicillin and clarithromycin): Esomeprazole Magnesium Delayed-Release Capsules, 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.

Teva Pharmaceuticals USA, Inc.


1 year ago CAPSULE TURQUOISE 6451 40 mg Esomeprazole 40 MG Delayed Release Oral Capsule

CAPSULE TURQUOISE 6451 40 mg

1 year ago CAPSULE TURQUOISE 6451 40 mg Esomeprazole 40 MG Delayed Release Oral Capsule

6451 40 mg CAPSULE TURQUOISE

16 HOW SUPPLIED/STORAGE AND HANDLING

ESOMEPRAZOLE MAGNESIUM Delayed-Release Capsules USP, 20 mg, are available as off-white to pale yellow granule-filled, light turquoise blue, opaque, hard-gelatin capsules, spin-printed “ ” and “6450” on the cap and “20 mg” on the body in gold ink containing 20 mg esomeprazole packaged in bottles of 30 and 90 capsules. NDC 0093- 6450 -56 bottle of 30 NDC 0093- 6450 -98 bottle of 90

ESOMEPRAZOLE MAGNESIUM Delayed-Release Capsules USP, 40 mg, are available as off-white to pale yellow granule-filled, light turquoise blue, opaque, hard-gelatin capsules, spin-printed “ ” and “6451” on the cap and “40 mg” on the body in gold ink containing 40 mg esomeprazole packaged in bottles of 30 and 90 capsules. NDC 0093- 6451 -56 bottle of 30 NDC 0093- 6451 -98 bottle of 90 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP, with a child-resistant closure (as required). KEEP CONTAINER TIGHTLY CLOSED. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. logo logo

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