ESOMEPRAZOLE MAGNESIUM capsule, delayed release

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Preferred Pharmaceuticals Inc.

INN:

ESOMEPRAZOLE MAGNESIUM

composition:

ESOMEPRAZOLE 40

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

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

leaflet_short:

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: Bottles of 20                                  NDC 68788-6922-2 Bottles of 30                                  NDC 68788-6922-3 Bottles of 60                                  NDC 68788-6922-6 Bottles of 90                                  NDC 68788-6922-9 Bottles of 100                                NDC 68788-6922-1 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.

authorization_status:

Abbreviated New Drug Application

SPC

ESOMEPRAZOLE MAGNESIUM- ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED
RELEASE
PREFERRED PHARMACEUTICALS INC.
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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 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)
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DOSAGE AND ADMINISTRATION
Indication
(2)
Dose
(2)
Fre que ncy
(2)
GASTROESOPHAGEAL REFLUX DISEASE (GERD)
(2)
Adults
(2)
20 mg or 40 mg
(2)
Once daily for 4 to 8 weeks
(2)
12 to 17 years
(2)
20 mg or 40 mg
(2)
Once daily for up to 8 weeks
(2)
1 to 11 years
(2)
10 mg or 20 mg
(2)
Once daily for up to 8 weeks
(2)
RISK REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER
(2)
20 mg or 40 mg
(2)
Once daily for up to 6 months
(2)
_H. PYLORI _ERADICATION _(Triple Therapy_):
(2)
Esomeprazole Magnesium
(2)
40 mg
(2)
Once daily for 10 days
(2)
Amoxicillin
(2)
1000 mg
(2)
Twice daily for 10 days
(2)
Clarithromycin
(2)
500 mg
(2)
Twice daily for 10 Days
(2)
PATHOLOGICAL HYPERSECRETORY CONDITIONS
(2)
40 mg
(2)
Twice daily
(2)
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
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CONTRAINDICATIONS
Patients with known hypersensitivity to proton pump inhibitors (PPIs)
(angioedema and anaphylaxis have occurred) (4) (4)
WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Most common adverse reac