Country: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT)
Mylan Institutional Inc.
ESOMEPRAZOLE MAGNESIUM
ESOMEPRAZOLE 20 mg
ORAL
PRESCRIPTION DRUG
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. Esomeprazole magnesium delayed-release capsules are indicated to maintain symptom resolution and healing of erosive esophagitis. Controlled studies do not extend beyond 6 months. 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 in patients at risk for developing gastric ulcers. Patients are considered to be at risk due to their age (≥ 60) and/or d
Esomeprazole Magnesium Delayed-Release Capsules, USP are available containing 22.25 mg or 44.50 mg of esomeprazole magnesium, USP equivalent to 20 mg or 40 mg of esomeprazole, respectively. The 20 mg capsules are hard gelatin capsules with a white opaque cap and white opaque body filled with white to off-white colored pellets. The capsules are axially printed with M150 in black ink on the cap and body. They are available as follows: NDC 42292-009-16 – Unit dose blister packages of 60 (10 cards of 6 capsules each). The 40 mg capsules are hard gelatin capsules with a white opaque cap and white opaque body filled with white to off-white colored pellets. The capsules are axially printed with M151 in black ink on the cap and body. They are available as follows: NDC 42292-010-16 – Unit dose blister packages of 60 (10 cards of 6 capsules each). Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] PHARMACIST: Dispense a Medication Guide with each prescription.
Abbreviated New Drug Application
ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE PELLETS Mylan Institutional Inc. ---------- MEDICATION GUIDE Esomeprazole Magnesium Delayed-Release Capsules, USP (es″ oh mep′ ra zole mag nee′ zee um) Read the Medication Guide that comes with esomeprazole magnesium delayed-release capsules before you start taking esomeprazole magnesium delayed-release capsules 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? 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 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 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. What are esomeprazole magnesium delayed-release capsules? Esomeprazole magnesium delayed-release capsules are a prescription medicine called a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules reduce the amount of acid in your stomach. Esomeprazole magnesium delayed-release capsules are used in adults: • for 4 to 8 wee Lestu allt skjalið
ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE PELLETS MYLAN INSTITUTIONAL INC. ---------- 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 Warnings and Precautions, Acute Tubulointerstitial Nephritis (5.2) 11/2020 INDICATIONS AND USAGE Esomeprazole magnesium delayed-release capsules are a 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) DOSAGE AND ADMINISTRATION INDICATION DOSE FREQUENCY GASTROESOPHAGEAL REFLUX DISEASE (GERD) Adults 20 mg or 40 mg Once daily for 4 to 8 weeks 12 to 17 years 20 mg or 40 mg Once daily for up to 8 weeks 1 to 11 years 10 mg or 20 mg Once daily for up to 8 weeks RISK REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER 20 mg or 40 mg Once daily for up to 6 months _H. PYLORI_ ERADICATION _(Triple Therapy):_ Esomeprazole Magnesium Delayed-Release Capsules 40 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 40 mg Twice daily See full prescribing information for administration options. ( 2) Patients with severe liver impairment-do not exceed dose of 20 mg. ( 2) DOSAGE FORMS AND STRENGTHS Esomeprazole Magnesium Delayed-Release Capsules: 20 mg and 40 mg. ( 3) CONTRAINDICATIONS Patients with known hypersensitivity to proton pump inhibitors (PPIs) (angioedema and anaphylaxis have occurred). ( 4) WARNINGS AND PRECAUTIONS Gastric Malignancy: In adults, symptomatic res Lestu allt skjalið