País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT)
A-S Medication Solutions
ORAL
PRESCRIPTION DRUG
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. Esomeprazole magnesium delayed-release capsules are indicated for the reduction in the occurrence of gastric ulcers associated with continuous NSAID therapy
Product: 50090-5365 NDC: 50090-5365-0 30 CAPSULE, DELAYED RELEASE in a BOTTLE NDC: 50090-5365-1 90 CAPSULE, DELAYED RELEASE in a BOTTLE
Abbreviated New Drug Application
ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE A-S Medication Solutions ---------- MEDICATION GUIDE Esomeprazole Magnesium (ES-oh-MEP-ra-zole mag-NEE-zee-um) Delayed-Release Capsules, USP Rx only Read the Medication Guide that comes with esomeprazole magnesium delayed-release capsules, USP before you start taking esomeprazole magnesium delayed-release capsules, USP 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 magnesium delayed-release capsules, USP? Esomeprazole magnesium delayed-release capsules, USP may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor. Esomeprazole magnesium delayed-release capsules, USP can cause serious side effects, including: • A type of kidney problem (acute interstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including esomeprazole magnesium delayed-release capsules, USP, may develop a kidney problem called acute interstitial nephritis that can happen at any time during treatment with esomeprazole magnesium delayed-release capsules, USP. Call your doctor if you have a decrease in the amount that you urinate or if you have blood in your urine. • Diarrhea. Esomeprazole magnesium delayed-release capsules, USP 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 PPI 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 magnesium delayed-release capsules, USP exactly as prescribed, at the lowest dose possible for your treatment and for Leer el documento completo
ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE A-S MEDICATION SOLUTIONS ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES. ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES, FOR ORAL USE INITIAL U.S. APPROVAL: 1989 (OMEPRAZOLE) RECENT MAJOR CHANGES INDICATIONS AND USAGE • • • • DOSAGE AND ADMINISTRATION GASTROESOPHAGEAL REFLUX DISEASE (GERD) (2) Adults (2) 20 mg or 40 mg (2) Once daily for 4 to 8 weeks (2) 12 to 17 years (2) 20 mg or 40 mg (2) Once daily for up to 8 weeks (2) 1 to 11 years (2) 10 mg or 20 mg (2) Once daily for up to 8 weeks (2) RISK REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER (2) 20 mg or 40 mg (2) Once daily for up to 6 months (2) _H. PYLORI _ERADICATION _(Triple Therapy):_ (2) Esomeprazole magnesium delayed-release capsules (2) 40 mg (2) Once daily for 10 days (2) Amoxicillin (2) 1000 mg (2) Twice daily for 10 days (2) Clarithromycin (2) 500 mg (2) Twice daily for 10 days (2) PATHOLOGICAL HYPERSECRETORY CONDITIONS (2) 40 mg (2) Twice daily (2) See full prescribing information for administration options. (2) (2) Patients with severe liver impairment-do not exceed dose of 20 mg. (2) (2) DOSAGE FORMS AND STRENGTHS • CONTRAINDICATIONS Patients with known hypersensitivity to proton pump inhibitors (PPIs) (angioedema and anaphylaxis have occurred). (4) (4) WARNINGS AND PRECAUTIONS Warnings and Precautions, Fundic Gland Polyps (5.12) 06/2018 Esomeprazole magnesium delayed-release capsules are 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) INDICATION DOSE FREQUENCY Esomeprazo Leer el documento completo