Country: United States
Language: English
Source: NLM (National Library of Medicine)
ESOMEPRAZOLE STRONTIUM (UNII: C5N25H3803) (ESOMEPRAZOLE - UNII:N3PA6559FT)
Amneal Pharmaceuticals LLC
ESOMEPRAZOLE STRONTIUM
ESOMEPRAZOLE 20 mg
ORAL
PRESCRIPTION DRUG
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. Esomeprazole strontium is 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 either due to their age (≥60) and/or documented history of gastric ul
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 65162-955-03 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 65162-957-03 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 Authorized Generic
ESOMEPRAZOLE STRONTIUM- ESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE Amneal Pharmaceuticals LLC ---------- MEDICATION GUIDE ESOMEPRAZOLE STRONTIUM (es-o-mep-ra-zol stron-tee-um) delayed-release capsules Read the Medication Guide that comes with esomeprazole strontium before you start taking esomeprazole strontium and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. What is the most important information I should know about esomeprazole strontium? Esomeprazole strontium may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor. Esomeprazole strontium can cause serious side effects, including: • Diarrhea. Esomeprazole strontium may increase your risk of getting severe diarrhea. This diarrhea may be caused by an infection (Clostridium difficile) in your intestines. Call your doctor right away if you have watery stool, stomach pain, and fever that does not go away. • Bone fractures. People who take multiple daily doses of Proton Pump Inhibitor medicines for a long period of time (a year or longer) may have an increased risk of fractures of the hip, wrist, or spine. You should take esomeprazole strontium exactly as prescribed, at the lowest dose possible for your treatment and for the shortest time needed. Talk to your doctor about your risk of bone fracture if you take esomeprazole strontium. Esomeprazole strontium can have other serious side effects. See “What are the possible side effects of esomeprazole strontium?” What is esomeprazole strontium? Esomeprazole strontium is a prescription medicine called a proton pump inhibitor (PPI). Esomeprazole strontium reduces the amount of acid in your stomach. Esomeprazole strontium is used in adults: • for 4 to 8 weeks to treat the symptoms of gastroesophageal reflux disease (GERD). Esomeprazole strontium may also be prescribed to heal acid-related damage to the lining of the esophagus ( Read the complete document
ESOMEPRAZOLE STRONTIUM- ESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED RELEASE AMNEAL PHARMACEUTICALS 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) INDICATIONS AND USAGE Esomeprazole strontium is a proton pump inhibitor indicated for adults for: 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 INDICATION DOSE FREQUENCY GASTROESOPHAGEAL REFLUX DISEASE (GERD) Adults 24.65 or 49.3 mg Once daily for 4-8 weeks RISK REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER Adults 24.65 or 49.3 mg Once daily for up to 6 months _H. PYLORI_ ERADICATION (TRIPLE THERAPY) IN ADULTS: Esomeprazole strontium 49.3 mg Once daily for 10 days Amoxicillin 1000 mg Twice daily for 10 days Clarithromycin 500 mg Twice daily for 10 days PATHOLOGICAL HYPERSECRETORY CONDITIONS Adults 49.3 mg Twice daily See full prescribing information for full dosage and administration (2) Patients with severe liver impairment: do not exceed dose of 24.65 mg (2) DOSAGE FORMS AND STRENGTHS _Delayed-Release Capsules (3):_ 24.65 mg of esomeprazole strontium (equivalent to 20 mg of esomeprazole) 49.3 mg of esomeprazole strontium (equivalent to 40 mg of esomeprazole) CONTRAINDICATIONS Patients with known hypersensitivity to proton pump inhibitors (PPIs) (angioedema and anaphylaxis have occurred) (4) WARNINGS AND PRECAUTIONS Symptomatic response does not preclude the presence of gastric malignancy (5.1) Atrophic gastritis has been noted with long-term omeprazole therapy (5.2) PPI therapy may be associated with increased risk of _Clostridium difficile_ associ Read the complete document