OMEPRAZOLE capsule, delayed release

Country: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9)

থেকে পাওয়া:

STAT Rx USA LLC

INN (International Name):

OMEPRAZOLE

রচনা:

OMEPRAZOLE 40 mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Omeprazole delayed-release capsules are indicated for short-term treatment of active duodenal ulcer in adults. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy. Omeprazole delayed-release capsules in combination with clarithromycin and amoxicillin, is indicated for treatment of patients with H. pylori infection and duodenal ulcer disease (active or up to 1-year history) to eradicate H. pylori in adults. Omeprazole delayed-release capsules, in combination with clarithromycin is indicated for treatment of patients with H. pylori infection and duodenal ulcer disease to eradicate H. pylori in adults. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see Clinical Studies (14.1) and Dosage and Administration (2) ]. Among patients who fail therapy, Omeprazole delayed-release capsules with clarithromycin is more likely to be associated with the development of clarithromycin resistance as compared with triple therapy. In pa

পণ্য সারাংশ:

Omeprazole delayed-release capsules, USP 40 mg are off-white to pale yellow, elliptical to spherical pellets filled in size ‘Oel’ hard gelatin capsules with opaque yellow colored cap and opaque lavender colored body, imprinted on cap ‘OMEPRAZOLE’  40 mg and body ‘R159’ with black ink. The capsules are supplied in bottles of 30, 60 and 90.                                                                                       Bottles of 30                                                                  NDC 42549-658-30 Bottles of 60                                                                  NDC 42549-658-60 Bottles of 90                                                                  NDC 42549-658-90 Storage         Store  delayed-release capsules in a tight container protected from light and moisture. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Relabeling and Repackaging by: STAT Rx USA LLC Gainesville, GA.  30501

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

OMEPRAZOLE - OMEPRAZOLE CAPSULE, DELAYED RELEASE
STAT RX USA LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
OMEPRAZOLE DELAYED-RELEASE CAPSULES
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE.
SEE FULL PRESCRIBING INFORMATION FOR.
INITIAL U.S. APPROVAL:
RECENT MAJOR CHANGES
Indications and Usage, Treatment of Gastroesophageal Reflux Disease
(1.3) 03/2008
Dosage and Administration, Pediatric Patients (2.7) 03/2008
INDICATIONS AND USAGE
Omeprazole is a proton pump inhibitor indicated for: (1)
Treatment of duodenal ulcer in adults (1.1) (1)
Treatment of gastric ulcer in adults (1.2) (1)
Treatment of gastroesophageal reflux disease (GERD) in pediatric
patients and adults (1.3) (1)
Maintenance of healing of erosive esophagitis in pediatric patients
and adults (1.4) (1)
Treatment of pathological hypersecretory conditions in adults (1.5)
(1)
The safety and effectiveness of omeprazole in pediatric patients < 1
year of age have not been established. (8.4) (1)
DOSAGE AND ADMINISTRATION
INDICATION (2)
OMEPRAZOLE DOSE (2)
FREQUENCY (2)
SHORT-TERM TREATMENT OF ACTIVE
DUODENAL ULCER (2.1) (2)
20 mg (2)
Once daily for 4 weeks. Some patients may require
an additional 4 weeks (2)
_H. PYLORI_ ERADICATION TO REDUCE THE RISK OF DUODENAL ULCER
RECURRENCE (2.2) (2)
_Triple Therapy:_ (2)
Omeprazole (2)
20 mg (2)
Each drug twice daily for 10 days (2)
Amoxicillin (2)
1000 mg (2)
Clarithromycin (2)
500 mg (2)
_Dual Therapy:_ (2)
Omeprazole (2)
40 mg (2)
Once daily for 14 days (2)
Clarithromycin (2)
500 mg (2)
Three times daily for 14 days (2)
GASTRIC ULCER (2.3) (2)
40 mg (2)
Once daily for 4 to 8 weeks (2)
GERD (2.4) (2)
20 mg (2)
Once daily for 4 to 8 weeks (2)
MAINTENANCE OF HEALING OF EROSIVE
ESOPHAGITIS (2.5) (2)
20 mg (2)
Once daily (2)
PATHOLOGICAL HYPERSECRETORY
CONDITIONS (2.6) (2)
60 mg (varies with
individual patient) (2)
Once daily (2)
PEDIATRIC PATIENTS (2 TO 16 YEARS OF
AGE) (2.7) (2)
GERD (2)
Weight (2)
10 < 20 kg (2)
> 20 kg (2)
Dose (2)
10 mg (2)
20 mg (2)
Once daily (2)
AND MAINTENANCE OF HEALING