البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: NLM (National Library of Medicine)
OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9)
DOH CENTRAL PHARMACY
OMEPRAZOLE
OMEPRAZOLE 20 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 are more likely to be associated with the development of clarithromycin resistance as compared with triple ther
Omeprazole delayed-release capsules USP 10 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 010” is imprinted on each capsule in black ink. Omeprazole delayed-release capsules USP 20 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 020” is imprinted on each capsule in black ink. Omeprazole delayed-release capsules USP 40 mg are available for oral administration as hard gelatin capsules with a pink opaque body and a reddish brown opaque cap. “APO 040” is imprinted on each capsule in black ink. They are supplied by State of Florida DOH Central Pharmacy as follows: Storage Store omeprazole delayed-release capsules in a tight container protected from light and moisture. 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].
Abbreviated New Drug Application
OMEPRAZOLE DELAYED-RELEASE - OMEPRAZOLE CAPSULE, DELAYED RELEASE DOH CENTRAL PHARMACY ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE OMEPRAZOLE DELAYED-RELEASE . SEE FULL PRESCRIBING INFORMATION FOR OMEPRAZOLE DELAYED-RELEASE . INITIAL U.S. APPROVAL 1989 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: • Treatment of duodenal ulcer in adults (1.1) • Treatment of gastric ulcer in adults (1.2) • Treatment of gastroesophageal reflux disease (GERD) in pediatric patients and adults (1.3) • Maintenance of healing of erosive esophagitis in pediatric patients and adults (1.4) • Treatment of pathological hypersecretory conditions in adults (1.5) 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 (1 TO 16 YEARS OF AGE) (2.7) (2) GERD (2) AND MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS (2) Weight (2) 5 < 1 اقرأ الوثيقة كاملة