ESOMEPRAZOLE MAGNESIUM capsule delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bryant Ranch Prepack

INN (International Name):

ESOMEPRAZOLE MAGNESIUM

Composition:

ESOMEPRAZOLE 40 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED
RELEASE
BRYANT RANCH PREPACK
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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, 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:
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)
DOSAGE AND ADMINISTRATION INDICATION
DO SE
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
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 response does not preclude
the presence of gastric malignancy. Consider
additional