omeprazole and sodium bicarbonate

FDA Drug Profile — ZEGERID, Konvomep

Drug Details

Generic Name
omeprazole and sodium bicarbonate
Brand Names
ZEGERID, Konvomep
Application Number
NDA021636
Sponsor
Santarus, Inc..
NDC Codes
5
Dosage Forms
POWDER, FOR SUSPENSION, CAPSULE, KIT
Routes
ORAL
Active Ingredients
OMEPRAZOLE, SODIUM BICARBONATE

Indications and Usage

1 INDICATIONS AND USAGE Omeprazole and Sodium Bicarbonate capsules are indicated in adults for the : short-term treatment of active duodenal ulcer. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy. short-term treatment (4 to 8 weeks) of active benign gastric ulcer. treatment of heartburn and other symptoms associated with GERD for up to 4 weeks. short-term treatment (4 to 8 weeks) of EE due to acid-mediated GERD which has been diagnosed by endoscopy in adults. The efficacy of Omeprazole and Sodium Bicarbonate capsules used for longer than 8 weeks in patients with EE has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of EE or GERD symptoms (e.g., heartburn), additional 4 to 8-week courses of Omeprazole and Sodium Bicarbonate capsules may be considered. maintenance of healing of EE due to acid-mediated GERD. Controlled studies do not extend beyond 12 months. Omeprazole and Sodium Bicarbonate capsules are a proton pump inhibitor (PPI). Omeprazole and Sodium Bicarbonate capsules are indicated in adults for: Treatment of active duodenal ulcer ( 1 ) Treatment of active benign gastric ulcer ( 1 ) Treatment of erosive esophagitis (EE) due to acid-mediated gastroesophageal reflux disease (GERD) ( 1 ) Maintenance of healing of EE ( 1 )