Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT)
Cipla USA Inc.
ORAL
PRESCRIPTION DRUG
Adults Esomeprazole magnesium for delayed release oral suspension is indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed EE in adults. For those patients who have not healed after 4 to 8 weeks of treatment, an additional 4- to 8- week course of esomeprazole magnesium for delayed release oral suspension may be considered. Pediatric Patients 12 Years to 17 Years of Age Esomeprazole magnesium for delayed release oral suspension is indicated for the short-term treatment (4 to 8 weeks) for the healing of EE in pediatric patients 12 years to 17 years of age. Pediatric Patients 1 Year to 11 Years of Age Esomeprazole magnesium for delayed release oral suspension is indicated for the short-term treatment (8 weeks) for the healing of EE in pediatric patients 1 year to 11 years of age. Pediatric Patients 1 Month to Less Than 1 Year of Age Esomeprazole magnesium for delayed release oral suspension is indicated for short-term treatment (up to 6 week
Esomeprazole magnesium For Delayed Release Oral Suspension is supplied as a unit dose packet containing a fine yellow powder, consisting of white to pale brownish esomeprazole granules and pale yellow inactive granules. Esomeprazole magnesium for delayed release oral suspension unit dose packets are supplied as follows: NDC 69097-527-34 unit dose packages of 30: 10 mg esomeprazole packets Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature].
Abbreviated New Drug Application
ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM GRANULE, FOR SUSPENSION, EXTENDED RELEASE Cipla USA Inc. ---------- MEDICATION GUIDE Esomeprazole magnesium (es-oh-MEP-ra-zole mag-NEE-zee-um) For Delayed Release Oral Suspension What is the most important information I should know about Esomeprazole magnesium For Delayed Release Oral Suspension? Esomeprazole magnesium For Delayed Release Oral Suspension may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor. Esomeprazole magnesium For Delayed Release Oral Suspension can cause serious side effects, including: • A type of kidney problem (acute tubulointerstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including Esomeprazole magnesium For Delayed Release Oral Suspension, may develop a kidney problem called acute tubulointerstitial nephritis that can happen at any time during treatment with Esomeprazole magnesium For Delayed Release Oral Suspension. Call your doctor right away if you have a decrease in the amount that you urinate or if you have blood in your urine. • Diarrheacaused by an infection (Clostridium difficile)in your intestines. Call your doctor right away if you have watery stools or stomach pain that does not go away. You may or may not have a fever. • Bone fractures (hip, wrist, or spine). Bone fractures in the hip, wrist, or spine may happen in people who take multiple daily doses of PPI medicines and for a long period of time (a year or longer). Tell your doctor if you have a bone fracture, especially in the hip, wrist, or spine. • Certain types of lupus erythematosus. Lupus erythematosus is an autoimmune disorder (the body’s immune cells attack other cells or organs in the body). Some people who take PPI medicines, including Esomeprazole magnesium For Delayed Release Oral Suspension, may develop certain types of lupus erythematosus or have worsening of the lupus they already have. Call your doctor right away if you have new or worsening joint pain or a rash Baca dokumen lengkapnya
ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM GRANULE, FOR SUSPENSION, EXTENDED RELEASE CIPLA USA INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ESOMEPRAZOLE MAGNESIUM FOR DELAYED RELEASE ORAL SUSPENSION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ESOMEPRAZOLE MAGNESIUM FOR DELAYED RELEASE ORAL SUSPENSION. ESOMEPRAZOLE MAGNESIUM FOR DELAYED RELEASE ORAL SUSPENSION INITIAL U.S. APPROVAL: 1989 (OMEPRAZOLE) INDICATIONS AND USAGE Esomeprazole magnesium for delayed release oral suspension is a proton pump inhibitor (PPI). Esomeprazole magnesium for delayed release oral suspension is indicated for the: Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 1 year to 17 years of age and of EE due to acid-mediated GERD in pediatric patients 1 month to less than 1 year of age. (1.1) Maintenance of healing of EE in adults. (1.2) Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 1 year to 17 years of age. (1.3) Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 years and older) and/or documented history of gastric ulcers. (1.4) Helicobacter pylori eradication in adult patients to reduce the risk of duodenal ulcer recurrence in combination with amoxicillin and clarithromycin. (1.5) Long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome in adults. (1.6) DOSAGE AND ADMINISTRATION POPULATION RECOMMENDED ADULT (2.1) AND PEDIATRIC DOSAGE (2.2) HEALING OF EE (1 YEAR AND OLDER) EE DUE TO ACID-MEDIATED GERD (1 MONTH TO LESS THAN 1 YEAR) Adults 20 mg or 40 mg once daily for 4 to 8 weeks; some patients may require an additional 4 to 8 weeks 12 years to 17 years 20 mg or 40 mg once daily for 4 to 8 weeks 1 month to 11 years see full prescribing information for weight-based dosing and duration of treatment (2.2) Baca dokumen lengkapnya