Country: United States
Language: English
Source: NLM (National Library of Medicine)
ESOMEPRAZOLE MAGNESIUM DIHYDRATE (UNII: 36H71644EQ) (ESOMEPRAZOLE - UNII:N3PA6559FT)
Aurobindo Pharma Limited
ESOMEPRAZOLE MAGNESIUM DIHYDRATE
ESOMEPRAZOLE 20 mg
ORAL
PRESCRIPTION DRUG
Adults 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 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 delayed-release capsules may be considered. Pediatric Patients 12 Years to 17 Years of Age Esomeprazole magnesium delayed-release capsules are 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 are indicated for the maintenance of healing of EE in adults. Controlled studies do not extend beyond 6 months. Adults 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. Pediatric Patients 12 Years to 17 Years of Age Esomeprazole magnesium delayed-release capsu
Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg are white/white size ‘4’ hard gelatin capsules filled with white to off white spherical to oval pellets and imprinted with “I81” on body with gold tek ink. They are supplied as follows: Bottles of 30 NDC 65862-783-30 Bottles of 90 NDC 65862-783-90 Bottles of 100 NDC 65862-783-01 Bottles of 1,000 NDC 65862-783-99 10 x 10 Unit-dose Capsules NDC 65862-783-78 Esomeprazole Magnesium Delayed-Release Capsules USP, 40 mg are white/white size ‘2’ hard gelatin capsules filled with white to off white spherical to oval pellets and imprinted with "I82" on body with gold tek ink. They are supplied as follows: Bottles of 30 NDC 65862-784-30 Bottles of 90 NDC 65862-784-90 Bottles of 100 NDC 65862-784-01 Bottles of 1,000 NDC 65862-784-99 10 x 10 Unit-dose Capsules NDC 65862-784-78 Store at 20° to 25°C (68° to 77°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
Aurobindo Pharma Limited ---------- Dispense with Medication Guide available at: www.aurobindousa.com/medication-guides MEDICATION GUIDE Esomeprazole Magnesium Delayed-Release Capsules USP, for oral use (es'' oh mep' ra zole mag nee' zee um) 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 esomeprazole magnesium delayed-release capsules, may develop a kidney problem called acute tubulointerstitial nephritis that can happen at any time during treatment with esomeprazole magnesium delayed-release capsules. 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 esomeprazole magnesium delayed-release capsules, 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 su Read the complete document
ESOMEPRAZOLE MAGNESIUM - ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE AUROBINDO PHARMA LIMITED ---------- 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) INDICATIONS AND USAGE Esomeprazole magnesium delayed-release capsules are a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are 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 A maximum dosage of 20 mg once daily is recommended for patients with severe liver impairment (Child-Pugh Class C). Controlled studies do not extend beyond 6 months. Refer to the amoxicillin and clarithromycin prescribing information for dosage adjustments in elderly and renally-impaired patients. A starting dosage of 20 mg twice daily is recommended for patients with severe liver impairment (Child- Pugh Class C). POPULATION RECOMMENDED ADULT (2.1) AND PEDIATRIC DOSAGE (2.2) HEALING OF EE (12 YEARS AND OLDER) Adults 20 mg or 40 mg once daily for 4 to 8 week Read the complete document