OMEPRAZOLE capsule delayed release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Omeprazole (UNII: KG60484QX9) (Omeprazole - UNII:KG60484QX9)

Available from:

St Marys Medical Park Pharmacy

INN (International Name):

Omeprazole

Composition:

Omeprazole 40 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

OMEPRAZOLE - OMEPRAZOLE CAPSULE, DELAYED RELEASE
ST MARYS MEDICAL PARK PHARMACY
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OMEPRAZOLE SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR OMEPRAZOLE.
OMEPRAZOLE DELAYED-RELEASE CAPSULES, USP
INITIAL U.S. APPROVAL: 1989
RECENT MAJOR CHANGES
Warnings and Precautions, Interaction with Clopidogrel (5.4) 10/2012
Warnings and Precautions, _Clostridium difficile_ associated diarrhea
(5.3) 09/2012
Warnings and Precautions, Concomitant use of Omeprazole with
Methotrexate (5.9) 01/2012
INDICATIONS AND USAGE
Omeprazole is a proton pump inhibitor indicated for:
• Treatment in adults of duodenal ulcer (1.1) and gastric ulcer
(1.2)
• Treatment in adults and children of gastroesophageal reflux
disease (GERD) (1.3) and maintenance of healing of erosive
esophagitis (1.4)
The safety and effectiveness of omeprazole in pediatric patients <1
year of age have not been established. (8.4)
DOSAGE AND ADMINISTRATION
INDICATION (2)
OMEPRAZOLE DOSE (2)
(2)
FREQUENCY (2)
TREATMENT OF ACTIVE DUODENAL ULCER
(2.1) (2)
20 mg (2)
(2)
Once daily for 4 weeks. Some patients may require
an additional 4 weeks (2)
(2)
_H. PYLORI_ ERADICATION TO REDUCE THE RISK OF DUODENAL ULCER
RECURRENCE (2.2) (2)
_Triple Therapy:_ (2)
(2)
Ome prazole
Amoxicillin (2)
Clarithromycin (2)
(2)
(2)
20 mg (2)
(2)
1000 mg (2)
(2)
500 mg (2)
(2)
(2)
Each drug twice daily for 10 days (2)
(2)
_Dual Therapy:_ (2)
Ome prazole
Clarithromycin (2)
40 mg (2)
500 mg (2)
Once daily for 14 days (2)
Three times daily for 14 days (2)
GASTRIC ULCER (2.3) (2)
40 mg (2)
(2)
Once daily for 4 to 8 weeks (2)
GERD (2.4) (2)
20 mg (2)
(2)
Once daily for 4 to 8 weeks (2)
MAINTENANCE OF HEALING OF EROSIVE
ESOPHAGITIS (2.5) (2)
20 mg (2)
(2)
Once daily (2)
PATHOLOGICAL HYPERSECRETORY
CONDITIONS (2.6) (2)
60 mg (varies with
individual patient) (2)
(2)
Once daily (2)
PEDIATRIC PATIENTS (2)
(2 TO 16 YEARS OF AGE) (2.7)
GERD AND MAINTENANCE OF HEALING OF
EROSIVE (2)
ESOPHA