ESOMEPRAZOLE MAGNESIUM- esomeprazole magnesium delayed release capsules capsule, coated pellets

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

ESOMEPRAZOLE MAGNESIUM (UNII: R6DXU4WAY9) (ESOMEPRAZOLE - UNII:N3PA6559FT)

Disponible desde:

Proficient Rx LP

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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

Resumen del producto:

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.

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM DELAYED RELEASE
CAPSULES CAPSULE, COATED PELLETS
PROFICIENT RX LP
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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:
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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