Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT)
Cisen Pharmaceutical Co., Ltd.
ORAL
PRESCRIPTION DRUG
Adults Esomeprazole magnesium delayed-release capsules 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 NEXIUM may be considered. Pediatric Patients 12 Years to 17 Years of Age Esomeprazole magnesium delayed-release capsules 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. Esomeprazole magnesium delayed-release capsules is indicated for the maintenance of healing of EE in adults. Controlled studies do not extend beyond 6 months. Adults Esomeprazole magnesium delayed-release capsules is indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults. Pediatric Patients 12 Years to 17 Years of Age Esomeprazole magnesium delayed-release capsules is indicated for short-term treatment (4
Esomeprazole magnesium delayed-release capsules, USP 20 mg - opaque, hard gelatin, with opaque caramel cap printed “C4” and opaque white body printed “20 mg”. They are supplied as follows: NDC 71256-003-01 unit of use bottles of 30 NDC 71256-003-02 bottles of 90 Esomeprazole magnesium delayed-release capsules, USP 40 mg - opaque, hard gelatin, with opaque caramel cap printed “C3” and opaque white body printed “40 mg”. They are supplied as follows: NDC 71256-004-01 unit of use bottles of 30 NDC 71256-004-02 bottles of 90 Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). [See USP Controlled Room Temperature]. Keep esomeprazole magnesium delayed-release capsules container tightly closed. Dispense in a tight container if the esomeprazole magnesium delayed- release capsules product package is subdivided.
Abbreviated New Drug Application
ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE PELLETS Cisen Pharmaceutical Co., Ltd. ---------- MEDICATION GUIDE MEDICATION GUIDE Esomeprazole Magnesium Delayed-Release Capsules, USP, for oral use What is the most important information I should know about Esomeprazole Magnesium Delayed-Release Capsules? Esomeprazole magnesium delayed-release capsules may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor. Esomeprazole magnesium delayed-release capsules can cause serious side effects, including: • A type of kidney problem (acute tubulointerstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including NEXIUM, may develop a kidney problem called acute tubulointerstitial nephritis that can happen at any time during treatment with NEXIUM. Call your doctor right away if you have a decrease in the amount that you urinate or if you have blood in your urine. • Diarrhea caused 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 NEXIUM, 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 on your cheeks or arms that gets worse in the sun. Talk to your doctor about your risk of these serious side effects. Esomeprazole magnesium delayed-release capsules can have other serious s Belgenin tamamını okuyun
ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE PELLETS CISEN PHARMACEUTICAL CO., LTD. ---------- 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 Contraindications ( 4) 10/2020 Warnings and Precautions, Acute Tubulointerstitial Nephritis (5.2) 11/2020 INDICATIONS AND USAGE Esomeprazole magnesium delayed-release capsules is a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules is indicated for the: • Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years 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 12 years 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 dos Belgenin tamamını okuyun