Omeprazole/Sodiium Bicarbonate

FDA Drug Profile — Omeprazole/Sodiium Bicarbonate

Drug Details

Generic Name
Omeprazole/Sodiium Bicarbonate
Brand Names
Omeprazole/Sodiium Bicarbonate
Application Number
ANDA204228
Sponsor
Direct_rx
NDC Codes
1
Dosage Forms
CAPSULE
Routes
ORAL
Active Ingredients
OMEPRAZOLE, SODIUM BICARBONATE

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.