ESOMEPRAZOLE STRONTIUM capsule, delayed release

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

ESOMEPRAZOLE STRONTIUM (UNII: C5N25H3803) (ESOMEPRAZOLE - UNII:N3PA6559FT)

Verfügbar ab:

R2 Pharma, LLC

INN (Internationale Bezeichnung):

ESOMEPRAZOLE STRONTIUM

Zusammensetzung:

ESOMEPRAZOLE 40 mg

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

1.1 Treatment of Gastroesophageal Reflux Disease (GERD) in Adults Healing of Erosive Esophagitis Esomeprazole strontium is 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 strontium may be considered. Maintenance of Healing of Erosive Esophagitis Esomeprazole strontium is indicated to maintain symptom resolution and healing of erosive esophagitis. Controlled studies do not extend beyond 6 months. Symptomatic Gastroesophageal Reflux Disease Esomeprazole strontium is indicated for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults. 1.2 Risk Reduction of NSAID-Associated Gastric Ulcer in Adults Esomeprazole strontium is indicated for the reduction in the occurrence of gastric ulcers associated with continuous NSAID therapy in patients at risk for devel

Produktbesonderheiten:

Esomeprazole strontium delayed-release capsules, 24.65 mg (equivalent to 20 mg of esomeprazole), are hard capsules with light pink cap and body containing off-white to pale brown granules with HMP 20 printed in black ink. They are available as follows: Unit of use bottles of 30 NDC 70849-200-30 Esomeprazole strontium delayed-release capsules, 49.3 mg (equivalent to 40 mg of esomeprazole), are hard capsules with dark pink cap and body containing off-white to pale brown granules with HMP 40 printed in black ink. They are available as follows: Unit of use bottles of 30 NDC 70849-400-30 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 strontium delayed-release capsules container tightly closed. Dispense in a tight container if the esomeprazole strontium delayed-release capsules product package is subdivided.

Berechtigungsstatus:

New Drug Application

Gebrauchsinformation

R2 Pharma, LLC
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MEDICATION GUIDE
Revised: 9/2016
Document Id: 3d19523d-7cb5-2f2f-e054-00144ff88e88
Set id: 3c916d32-f9e9-1d15-e054-00144ff88e88
Version: 2
Effective Time: 20160922
R2 Pharma, LLC

Fachinformation

ESOMEPRAZOLE STRONTIUM- ESOMEPRAZOLE STRONTIUM CAPSULE, DELAYED
RELEASE
R2 PHARMA, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ESOMEPRAZOLE STRONTIUM SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ESOMEPRAZOLE
STRONTIUM.
ESOMEPRAZOLE STRONTIUM DELAYED-RELEASE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1989 (OMEPRAZOLE)
RECENT MAJOR CHANGES
These highlights do not include all the information needed to use
ESOMEPRAZOLE STRONTIUM safely and effectively.
See full prescribing information for ESOMEPRAZOLE STRONTIUM.
ESOMEPRAZOLE STRONTIUM delayed-release capsules, for oral use
Initial U.S. Approval: 1989 (omeprazole)
RECENT MAJOR CHANGES
Warning and Precautions, Atropic Gastritis (5.2) removed 06/2016
Warning and Precautions, Cutaneous and Systemic Lupus Erythematosus
(5.5) 06/2016
INDICATIONS AND USAGE
(1)
Esomeprazole strontium is a proton pump inhibitor indicated for adults
for: (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
(2)
(2)
(2)
INDIC ATIO N
DO SE
FREQUENCY
GASTROESOPHAGEAL REFLUX DISEASE (GERD)*
Adults
24.63 or 49.3 mg
Once daily for 4-8 weeks
RISK REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER
Adults
24.63 or 49.3mg
Once daily for up to 6 months
_H.PYLORI_ ERADICATION (TRIPLE THERAPY) IN ADULTS:
Esomeprazole strontium
49.3mg
Once daily for 10 days
Amoxicillin
1000mg
Twice daily for 10 days
Clarithromycin
500mg
Twice daily for 10 days
PATHOLOGICAL HYPERSECRETORY CONDITIONS
Adults
49.3mg
Twice daily
*Studied for 12 months for Maintenance of Healing of Erosive
Esophagitis (2)
See full prescribing information for full dosage and administration
(2)
Patients with severe liver impairment: do not exceed dose of 24.65 mg
(2) (2)
(2)
(2)
(2)
(2)
DOSAGE FORMS AND STRENGTHS
Delaye