国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9)
STAT Rx USA LLC
OMEPRAZOLE
OMEPRAZOLE 40 mg
ORAL
PRESCRIPTION DRUG
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
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
Abbreviated New Drug Application
OMEPRAZOLE - OMEPRAZOLE CAPSULE, DELAYED RELEASE STAT RX USA LLC ---------- 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 阅读完整的文件