Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT)
Proficient Rx LP
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 may be considered. Pediatric Patients 12 Years to 17 Years of Age Esomeprazole magnesium delayed-release capsules 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 capsules are indicated for sh
Esomeprazole magnesium delayed-release capsules, USP 20 mg, are light yellow to brown colored enteric coated pellets filled in size "4" hard gelatin capsule, opaque dark blue cap & opaque dark blue body printed "ESOM" on cap and "20" on the body in white ink. They are supplied as follows: NDC 71205-706-30 bottles of 30 NDC 71205-706-60 bottles of 60 NDC 71205-706-90 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, USP 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 DELAYED RELEASE CAPSULES CAPSULE, COATED PELLETS 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, Severe Cutaneous Adverse Reactions (5.5) 03/2022 Hypomagnesemia and Mineral Metabolism (5.9) 03/2022 INDICATIONS AND USAGE Esomeprazole magnesium is a proton pump inhibitor (PPI). Esomeprazole magnesium delayed-release capsules are indicated for the: • • • • • • DOSAGE AND ADMINISTRATION POPULATION RECOMMENDED ADULT (2.1) AND PEDIATRIC DOSAGE (2.2) HEALING OF EE (1 YEAR AND OLDER) 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 MAINTENANCE OF HEALING OF EE Adults 20 mg once daily. Controlled studies do not extend beyond 6 months TREATMENT OF SYMPTOMATIC GERD Adults 20 mg once daily once daily for 4 weeks some patients may require an additional 4 weeks 12 years to 17 years 20 mg once daily for 4 weeks RISK REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER Adults 20 mg or 40 mg once daily for up to 6 months _H. PYLORI _ERADICATION TO REDUCE THE RISK OF DUODENAL ULCER RECURRENCE Adults 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 INCLUDING ZOLLINGER-ELLISON SYNDROME Adults Starting dosage is 40 mg twice daily (varies with the individual patient) as long as clinically indicated. 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 Belgenin tamamını okuyun