Esomeprazole 20 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, 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.
Mylan Institutional Inc.
CAPSULE WHITE M150 M150
Related Pills
Esomeprazole 40 MG Delayed Release Oral Capsule
Mylan Institutional Inc.
DISCLAIMER:
"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."
"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."
"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."
PillSync may earn a commission via links on our site
16 HOW SUPPLIED/STORAGE AND HANDLING Esomeprazole Magnesium Delayed-Release capsules, USP are available containing 22.25 mg or 44.50 mg of esomeprazole magnesium, USP equivalent to 20 mg or 40 mg of esomeprazole, respectively. The 20 mg capsules are hard gelatin capsules with a white opaque cap and white opaque body filled with white to off-white colored pellets. The capsules are axially printed with M150 in black ink on the cap and body. They are available as follows: NDC 42292-009-16 – Unit dose blister packages of 60 (10 cards of 6 capsules each). The 40 mg capsules are hard gelatin capsules with a white opaque cap and white opaque body filled with white to off-white colored pellets. The capsules are axially printed with M151 in black ink on the cap and body. They are available as follows: NDC 42292-010-16 – Unit dose blister packages of 60 (10 cards of 6 capsules each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] PHARMACIST: Dispense a Medication Guide with each prescription.
More pills like CAPSULE M150 M150