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:

NuCare Pharmaceuticals,Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. 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 GERD in adults and children 1 year or older. Esomeprazole magnesium delayed-release capsules are indicated for the reduction in the occurren

Product summary:

Esomeprazole magnesium delayed-release capsules USP, 20 mg are White opaque size '4' hard gelatin capsule imprinted with ''H'' on cap and 'E2' on body filled with off white to pale yellow pellets. NDC 31722-664-30 bottles of 30 NDC 31722-664-90 bottles of 90 NDC 31722-664-10 bottles of 1000 Esomeprazole magnesium delayed-release capsules USP, 40 mg are white opaque size '3' hard gelatin capsule imprinted with ''H'' on cap and 'E3' on body filled with off white to pale yellow pellets. NDC 31722-665-30 bottles of 30 NDC 31722-665-90 bottles of 90 NDC 31722-665-10 bottles of 1000 Store at 20° to 25°C (68° to 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

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, FOR ORAL USE
INITIAL U.S. APPROVAL: 1989 (OMEPRAZOLE)
RECENT MAJOR CHANGES
Warnings and Precautions, Fundic Gland Polyps (5.12) 06/2018
INDICATIONS AND USAGE
Esomeprazole magnesium delayed-release capsule, 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)
• _ 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
12 to 17 years
1 to 11 years
20 mg or 40 mg
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
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
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)
Patients with severe liver impairment-do not exceed dose of 20 mg. (2)
DOSAGE FORMS AND STRENGTHS
• Esomeprazole Magnesium Delayed-Release Capsules, USP: 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 presenc