esomeprazole magnesium capsule delayed release
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, 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 [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.
cspc ouyi pharmaceutical co., ltd.
CAPSULE BLUE OE A97 20mg
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esomeprazole magnesium capsule delayed release
cspc ouyi pharmaceutical co., ltd.
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16 HOW SUPPLIED/STORAGE AND HANDLING Esomeprazole magnesium delayed-release capsules USP, 20 mg, are blue capsules, imprinted with two “20mg” on the body and two “OE A97” on the cap in black ink, and the contents are white to light yellow pellets without adhesion. They are supplied as follows: NDC 24075-0700-3 bottles of 30 with child-resistant closure NDC 24075-0700-1 bottles of 1,000 Esomeprazole magnesium delayed-release capsules USP, 40 mg, are blue capsules, imprinted with two “40mg” on the body and two “OE A96” on the cap in black ink, and the contents are white to light yellow pellets without adhesion. They are supplied as follows: NDC 24075-1701-3 bottles of 30 with child-resistant closure NDC 24075-1701-1 bottles of 1,000 Store at 25°C (77°F); excursions permitted from 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. Keep esomeprazole magnesium delayed-release capsules,USP container tightly closed. Dispense in a tight container if the esomeprazole magnesium delayed-release capsules, USP product package is subdivided.
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