Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
Esomeprazole Magnesium (UNII: R6DXU4WAY9) (Esomeprazole - UNII:N3PA6559FT)
Proficient Rx LP
Esomeprazole Magnesium
Esomeprazole 20 mg
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. In infants 1 month to less than 1 year, esomeprazole magnesium delayed-release capsules are indicated for short-term treatment (up to 6 weeks) of erosive esophagitis due to acid-mediated GERD. 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 GER
Esomeprazole magnesium delayed-release capsules USP, 20 mg are pale yellow to brown colored pellets filled in size ‘4’ empty hard gelatin capsule shell with light blue cap and dark blue body imprinted with ‘RDY’ on cap and ‘492’ on body with black ink and are supplied in bottles of 30’s, 60's, and 90's. Bottles of 30 NDC 63187-964-30 Bottles of 60 NDC 63187-964-60 Bottles of 90 NDC 63187-964-90 Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature]. Keep esomeprazole magnesium delayed-release capsules USP container tightly closed. Dispense in a tight container if the esomeprazole magnesium delayed-release capsules USP product package is subdivided.
Abbreviated New Drug Application
ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE Proficient Rx LP ---------- 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: 1. A type of kidney problem (acute interstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including esomeprazole magnesium delayed-release capsules, may develop a kidney problem called acute interstitial 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. 2. 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. 1. 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 exactly as prescribed, at the lowest dose possible for your treatment and for the shortest time needed. Talk to your doctor about your risk of bone fracture Soma hati kamili
ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE PROFICIENT RX LP ---------- 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, Atrophic Gastritis (5.2) removed. 10/2016 Warnings and Precautions, Cutaneous and Systemic 10/2016 Lupus Erythematosus (5.5) INDICATIONS AND USAGE Esomeprazole magnesium delayed-release capsule USP is a proton pump inhibitor indicated for the following: 1. 2. 3. DOSAGE AND ADMINISTRATION INDICATION DOSE FREQUENCY GASTROESOPHAGEAL REFLUX DISEASE (GERD) Adults 12 to 17 years 1 to 11 years 20 mg or 40mg 20 mg or 40 mg 10 mg or 20 mg Once daily for 4 to 8 weeks Once daily for up to 8 weeks Once daily for up to 8 weeks 1 month to less than 1 year: 2.5 mg, 5 mg or 10 mg (based on weight). Once daily, up to 6 weeks for erosive esophagitis (EE) due to acid-mediated GERD only. RISK REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER 20 mg or 40 mg Once daily for up to 6 months 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 2. CONTRAINDICATIONS Patients with known hypersensitivity to proton pump inhibitors (PPIs) (angioedema and anaphylaxis have occurred) (4) WARNINGS AND PRECAUTIONS 1. 2. 3. 4. 5. Treatment of gastroesophageal reflux disease (GERD) (1.1) Risk reduction of NSAID-associated gastric ulcer (1.2) Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (1.4) Esomeprazole magnesium Delayed-Release Capsules: 20 mg and 40 mg (3) Gastric Malignancy:In adults, symptomatic response does not preclude the presence of gastric malignancy. Soma hati kamili