国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9)
Lake Erie Medical DBA Quality Care Products 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, are 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 are 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 p
Omeprazole Delayed-Release Capsules, 10 mg, are opaque white cap and opaque white body capsules imprinted with "KU" and "114" in black ink. They are supplied as follows: Bottles of 30 NDC 62175-114-32 Bottles of 100 NDC 62175-114-37 Omeprazole Delayed-Release Capsules, 20 mg, are opaque white cap and opaque gold body capsules imprinted with "KU" and "118" in black ink. They are supplied as follows: Bottles of 30 NDC 62175-118-32 Bottles of 100 NDC 62175-118-37 Bottles of 1000 NDC 62175-118-43 Omeprazole Delayed-Release Capsules, 40 mg, are opaque gold cap and opaque gold body capsules imprinted with "KU" and "136" in black ink. They are supplied as follows: Bottles of 30 NDC 62175-136-32 Bottles of 100 NDC 62175-136-37 Bottles of 1000 NDC 62175-136-43 Storage Store Omeprazole Delayed-Release Capsules in a tight container protected from light and moisture. Store at 20°-25°C (68°-77°F) (See USP Controlled Room Temperature). Dispense in a tight and light-resistant container.
Abbreviated New Drug Application
OMEPRAZOLE- OMEPRAZOLE CAPSULE, DELAYED RELEASE LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE OMEPRAZOLE DELAYED-RELEASE CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OMEPRAZOLE DELAYED-RELEASE CAPSULES USP. INITIAL U.S. APPROVAL: 1989 RECENT MAJOR CHANGES WARNINGS AND PRECAUTIONS Bone Fracture (5.3) 09/2010 WARNINGS AND PRECAUTIONS Diminished anti-platelet activity of clopidogrel (5.4) 01/2011 WARNINGS AND PRECAUTIONS Hypomagnesemia (5.7) 06/2011 WARNINGS AND PRECAUTIONS Concomitant Use of Omeprazole Delayed-Release Capsules with St. John's Wort or rifampin (5.8) Interactions with Diagnostic Investigations for Neuroendocrine Tumors (5.9) 06/2011 INDICATIONS AND USAGE Omeprazole Delayed-Release Capsules are 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 Delayed-Release Capsules in pediatric patients < 1 year of age have not been established (8.4). DOSAGE AND ADMINISTRATION INDIC ATIO N OMEPRAZOLE DOSE FREQUENCY TREATMENT OF AC TIVE DUODENAL ULCER (2.1) 20 mg (2) Once daily for 4 weeks. Some patients may require an additional 4 weeks _H. PYLORI_ ERADICATION TO REDUCE THE RISK OF DUODENAL ULCER RECURRENCE (2.2) _Triple Therapy:_ Ome prazole De laye d-Re le ase Capsule s 20 mg Each drug twice daily for 10 days Amoxicillin 1000 mg Clarithromycin 500 mg _Dual Therapy:_ Ome prazole De laye d-Re le ase Capsule s 40 mg Once daily for 14 days Clarithromycin 500 mg Three times daily for 14 days GASTRIC ULCER (2.3) 40 mg Once daily for 4 to 8 weeks GERD (2.4) 20 mg Once daily for 4 to 8 weeks MAINTENANCE OF MAINTENANCE OF HEALING OF ERO SIVE ESO PHAG ITIS (2.5) 20 mg Once daily PATHO LO G IC AL HYPE RSE C RE TO RY CO NDITIO NS (2.6 ) 60 mg (varies 完全なドキュメントを読む