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1 Indications And Usage Omeprazole And Sodium Bicarbonate Is A Proton Pump Inhibitor (Ppi) Indicated For: Short-Term Treatment Of Active Duodenal Ulcer ( 1.1 ) Short-Term Treatment Of Active Benign Gastric Ulcer ( 1.2 ) Treatment Of Gastroesophageal Reflux Disease (Gerd) ( 1.3 ) Maintenance Of Healing Of Erosive Esophagitis ( 1.4 ) The Safety And Effectiveness Of Omeprazole And Sodium Bicarbonate Capsules In Pediatric Patients (<18 Years Of Age) Have Not Been Established. ( 8.4 ) 1.1 Duodenal Ulcer Omeprazole And Sodium Bicarbonate Is Indicated For Short-Term Treatment Of Active Duodenal Ulcer. Most Patients Heal Within Four Weeks. Some Patients May Require An Additional Four Weeks Of Therapy. [See Clinical Studies ( 14.1 ).] 1.2 Gastric Ulcer Omeprazole And Sodium Bicarbonate Is Indicated For Short-Term Treatment (4-8 Weeks) Of Active Benign Gastric Ulcer. [See Clinical Studies ( 14.2 ).] 1.3 Treatment Of Gastroesophageal Reflux Disease (Gerd) Symptomatic Gerd Omeprazole And Sodium Bicarbonate Is Indicated For The Treatment Of Heartburn And Other Symptoms Associated With Gerd For Up To 4 Weeks. [See Clinical Studies ( 14.3 ).] Erosive Esophagitis Omeprazole And Sodium Bicarbonate Is Indicated For The Short-Term Treatment (4-8 Weeks) Of Erosive Esophagitis Which Has Been Diagnosed By Endoscopy. The Efficacy Of Omeprazole And Sodium Bicarbonate Used For Longer Than 8 Weeks In These Patients Has Not Been Established. If A Patient Does Not Respond To 8 Weeks Of Treatment, It May Be Helpful To Give Up To An Additional 4 Weeks Of Treatment. If There Is Recurrence Of Erosive Esophagitis Or Gerd Symptoms (E.g., Heartburn), An Additional 4-8 Week Courses Of Omeprazole And Sodium Bicarbonate May Be Considered. [See Clinical Studies ( 14.3 ).] 1.4 Maintenance Of Healing Of Erosive Esophagitis Omeprazole And Sodium Bicarbonate Is Indicated To Maintain Healing Of Erosive Esophagitis. Controlled Studies Do Not Extend Beyond 12 Months. [See Clinical Studies ( 14.4 ).]
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