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.