ESOMEPRAZOLE MAGNESIUM- esomeprazole magnesium capsule, delayed release

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

NuCare Pharmaceuticals,Inc.

INN（国際名）:

ESOMEPRAZOLE MAGNESIUM

構図:

ESOMEPRAZOLE 40

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

Healing of Erosive Esophagitis Esomeprazole magnesium delayed-release capsules, USP 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, USP may be considered.             Maintenance of Healing of Erosive Esophagitis Esomeprazole magnesium delayed-release capsules, USP 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, USP are indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults. Esomeprazole magnesium delayed-release capsules, USP are indicated for the reduction in the occurrence of gastric ulcers associated with continuous NSAID

製品概要:

Esomeprazole Magnesium Delayed-Release Capsules, USP 40 mg, are size 2 hard gelatin capsule having pink cap and body, imprinted as 40 mg on the body and 1155 on the cap with white ink, containing off white to cream colored granules. They are supplied as follows: NDC 68071-3179-3 Bottles of 30 Store at 20° to 25°C (68° to 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 with a child-resistant closure.

認証ステータス:

Abbreviated New Drug Application

製品の特徴

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 USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1989 (OMEPRAZOLE)
RECENT MAJOR CHANGES
Warnings and Precautions, Interactions with Diagnostic
Investigations for Neuroendocrine Tumors (5.10) 03/2014
Contraindications (4) 12/2014
Warnings and Precautions, Acute Interstitial Nephritis (5.3) 12/2014
Warnings and Precautions, Cyanocobalamin (vitamin B-12)
Deficiency (5.4) 12/2014
INDICATIONS AND USAGE
Esomeprazole magnesium is a proton pump inhibitor indicated for the
following: (1)
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
20 mg or 40 mg
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
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 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
40 mg
Twice daily
See full prescribing information for administration options (2) (2)
Patients with severe liver impairment-do not exceed dose of 20 mg (2)
(2)
DOSAGE FORMS AND STRENGTHS
Esomeprazole Magnesium Delayed-Release Capsules: 20 mg and 40 mg (3)
CONTRAINDICATIONS
Patients with known hypers