ESOMEPRAZOLE MAGNESIUM- esomeprazole magnesium capsule, delayed release

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

American Health Packaging

INN（国际名称）:

ESOMEPRAZOLE MAGNESIUM

组成:

ESOMEPRAZOLE 20 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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. In infants 1 month to less than 1 year, esomeprazole magnesium delayed-release capsules are indicated for short-term treatment (up to 6 weeks) of erosive esophagitis due to acid-mediated GERD. 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

產品總結:

Esomeprazole magnesium delayed-release capsules USP, 20 mg are pale yellow to yellow colored pellets filled in size ‘4’ empty hard gelatin capsule shell with light blue cap and dark blue body imprinted with ‘RDY’ on cap and ‘492’ on body with black ink. Unit dose packages of 100 (10 x 10) NDC 60687-235-01. Esomeprazole magnesium delayed-release capsules USP, 40 mg are pale yellow to yellow colored pellets filled in size ‘3’ empty hard gelatin capsule shell with light blue cap and dark blue body imprinted with ‘RDY’ on cap and ‘493’ on body with black ink. Unit dose packages of 100 (10 x 10) NDC 60687-246-01. Store at 20°-25°C (68°-77°F). [See USP Controlled Room Temperature]. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

授权状态:

Abbreviated New Drug Application

资料单张

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)

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ESOMEPRAZOLE MAGNESIUM-
esomeprazole magnesium capsule, delayed
release  American Health Packaging
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MEDICATION GUIDE
8423501/0417
Esomeprazole Magnesium Delayed-Release Capsules, USP
(es" oh mep' ra zole mag nee' zee um)
Read the Medication Guide that comes with esomeprazole
magnesium delayed-release capsules before you start taking
esomeprazole magnesium delayed-release capsules and each time you
get a refill. There may be new information. This information does
not take the place of talking with your doctor about your medical
condition or your treatment.
What is the most important informat

阅读完整的文件

产品特点

ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED
RELEASE
AMERICAN HEALTH PACKAGING
----------
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 Lupus Erythematosus
(5.5)
10/2016
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)
Pathological hypersecretory conditions, including Zollinger-Ellison
syndrome ( 1.4)
DOSAGE AND ADMINISTRATION
INDIC ATIO N
DO SE
FREQUENCY
GASTROESOPHAGEAL REFLUX DISEASE (GERD)
Adults
20 mg or 40mg
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
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