Country: Ամերիկայի Միացյալ Նահանգներ
language: անգլերեն
source: NLM (National Library of Medicine)
ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT)
NuCare Pharmaceuticals,Inc.
ESOMEPRAZOLE MAGNESIUM
ESOMEPRAZOLE 40
ORAL
PRESCRIPTION DRUG
Healing of Erosive Esophagitis Esomeprazole magnesium delayed-release capsules, USP 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, USP may be considered. Maintenance of Healing of Erosive Esophagitis Esomeprazole magnesium delayed-release capsules, USP 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, USP are indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults. Esomeprazole magnesium delayed-release capsules, USP are indicated for the reduction in the occurrence of gastric ulcers associated with continuous NSAID
Esomeprazole Magnesium Delayed-Release Capsules, USP 40 mg, are size 2 hard gelatin capsule having pink cap and body, imprinted as 40 mg on the body and 1155 on the cap with white ink, containing off white to cream colored granules. They are supplied as follows: NDC 68071-3179-3 Bottles of 30 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep Esomeprazole Magnesium Delayed-Release Capsules, USP container tightly closed. Dispense in a tight container with a child-resistant closure.
Abbreviated New Drug Application
ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE NUCARE PHARMACEUTICALS,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 USP, FOR ORAL USE INITIAL U.S. APPROVAL: 1989 (OMEPRAZOLE) RECENT MAJOR CHANGES Warnings and Precautions, Interactions with Diagnostic Investigations for Neuroendocrine Tumors (5.10) 03/2014 Contraindications (4) 12/2014 Warnings and Precautions, Acute Interstitial Nephritis (5.3) 12/2014 Warnings and Precautions, Cyanocobalamin (vitamin B-12) Deficiency (5.4) 12/2014 INDICATIONS AND USAGE Esomeprazole magnesium is a proton pump inhibitor indicated for the following: (1) 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 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) (2) Patients with severe liver impairment-do not exceed dose of 20 mg (2) (2) DOSAGE FORMS AND STRENGTHS Esomeprazole Magnesium Delayed-Release Capsules: 20 mg and 40 mg (3) CONTRAINDICATIONS Patients with known hypers read_full_document