מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
ESOMEPRAZOLE STRONTIUM (UNII: C5N25H3803) (ESOMEPRAZOLE - UNII:N3PA6559FT)
R2 Pharma, LLC
ESOMEPRAZOLE STRONTIUM
ESOMEPRAZOLE 40 mg
ORAL
PRESCRIPTION DRUG
1.1 Treatment of Gastroesophageal Reflux Disease (GERD) in Adults Healing of Erosive Esophagitis Esomeprazole strontium is 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 strontium may be considered. Maintenance of Healing of Erosive Esophagitis Esomeprazole strontium is indicated to maintain symptom resolution and healing of erosive esophagitis. Controlled studies do not extend beyond 6 months. Symptomatic Gastroesophageal Reflux Disease Esomeprazole strontium is indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults. 1.2 Risk Reduction of NSAID-Associated Gastric Ulcer in Adults Esomeprazole strontium is indicated for the reduction in the occurrence of gastric ulcers associated with continuous NSAID therapy in patients at risk for devel
Esomeprazole strontium delayed-release capsules, 24.65 mg (equivalent to 20 mg of esomeprazole), are hard capsules with light pink cap and body containing off-white to pale brown granules with HMP 20 printed in black ink. They are available as follows: Unit of use bottles of 30 NDC 70849-200-30 Esomeprazole strontium delayed-release capsules, 49.3 mg (equivalent to 40 mg of esomeprazole), are hard capsules with dark pink cap and body containing off-white to pale brown granules with HMP 40 printed in black ink. They are available as follows: Unit of use bottles of 30 NDC 70849-400-30 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Keep esomeprazole strontium delayed-release capsules container tightly closed. Dispense in a tight container if the esomeprazole strontium delayed-release capsules product package is subdivided.
New Drug Application
R2 Pharma, LLC ---------- MEDICATION GUIDE Revised: 9/2016 Document Id: 3d19523d-7cb5-2f2f-e054-00144ff88e88 Set id: 3c916d32-f9e9-1d15-e054-00144ff88e88 Version: 2 Effective Time: 20160922 R2 Pharma, LLC קרא את המסמך השלם
ESOMEPRAZOLE STRONTIUM- ESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE R2 PHARMA, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ESOMEPRAZOLE STRONTIUM SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ESOMEPRAZOLE STRONTIUM. ESOMEPRAZOLE STRONTIUM DELAYED-RELEASE CAPSULES, FOR ORAL USE INITIAL U.S. APPROVAL: 1989 (OMEPRAZOLE) RECENT MAJOR CHANGES These highlights do not include all the information needed to use ESOMEPRAZOLE STRONTIUM safely and effectively. See full prescribing information for ESOMEPRAZOLE STRONTIUM. ESOMEPRAZOLE STRONTIUM delayed-release capsules, for oral use Initial U.S. Approval: 1989 (omeprazole) RECENT MAJOR CHANGES Warning and Precautions, Atropic Gastritis (5.2) removed 06/2016 Warning and Precautions, Cutaneous and Systemic Lupus Erythematosus (5.5) 06/2016 INDICATIONS AND USAGE (1) Esomeprazole strontium is a proton pump inhibitor indicated for adults for: (1) 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) DOSAGE AND ADMINISTRATION (2) (2) (2) INDIC ATIO N DO SE FREQUENCY GASTROESOPHAGEAL REFLUX DISEASE (GERD)* Adults 24.63 or 49.3 mg Once daily for 4-8 weeks RISK REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER Adults 24.63 or 49.3mg Once daily for up to 6 months _H.PYLORI_ ERADICATION (TRIPLE THERAPY) IN ADULTS: Esomeprazole strontium 49.3mg Once daily for 10 days Amoxicillin 1000mg Twice daily for 10 days Clarithromycin 500mg Twice daily for 10 days PATHOLOGICAL HYPERSECRETORY CONDITIONS Adults 49.3mg Twice daily *Studied for 12 months for Maintenance of Healing of Erosive Esophagitis (2) See full prescribing information for full dosage and administration (2) Patients with severe liver impairment: do not exceed dose of 24.65 mg (2) (2) (2) (2) (2) (2) DOSAGE FORMS AND STRENGTHS Delaye קרא את המסמך השלם