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1 Indications And Usage Omeprazole/sodium Bicarbonate Powder For Oral Suspension And Capsules Is A Proton Pump Inhibitor 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 ) • Reduction Of Risk Of Upper Gi Bleeding In Critically Ill Patients ( 1.5 ) The Safety And Effectiveness Of Omeprazole/sodium Bicarbonate Powder For Oral Suspension And Capsules In Pediatric Patients (<18 Years Of Age) Have Not Been Established. ( 8.4 ) 1.1 Duodenal Ulcer Omeprazole/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/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/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/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/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), Additional 4-8 Week Courses Of Omeprazole/sodium Bicarbonate May Be Considered. [See Clinical Studies ( 14.3 )] 1.4 Maintenance Of Healing Of Erosive Esophagitis Omeprazole/sodium Bicarbonate Is Indicated To Maintain Healing Of Erosive Esophagitis. Controlled Studies Do Not Extend Beyond 12 Months. [See Clinical Studies ( 14.4 )] 1.5 Reduction Of Risk Of Upper Gastrointestinal Bleeding In Critically Ill Patients (40mg Oral Suspension Only) Omeprazole/sodium Bicarbonate Powder For Oral Suspension 40 Mg/1680 Mg Is Indicated For The Reduction Of Risk Of Upper Gi Bleeding In Critically Ill Patients. [See Clinical Studies, Reduction Of Risk Of Upper Gastrointestinal Bleeding In Critically Ill Patients ( 14.5 )]
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