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1 Indications And Usage • Rabeprazole Sodium Delayed-Release Tablets Are A Proton-Pump Inhibitor (Ppi) Indicated In Adults For: • Healing Of Erosive Or Ulcerative Gastroesophageal Reflux Disease (Gerd) ( 1.1 ) • Maintenance Of Healing Of Erosive Or Ulcerative Gerd ( 1.2 ) • Treatment Of Symptomatic Gerd ( 1.3 ) • Healing Of Duodenal Ulcers ( 1.4 ) • Helicobacter Pylori Eradication To Reduce The Risk Of Duodenal Ulcer Recurrence ( 1.5 ) • Treatment Of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome ( 1.6 ) • In Adolescent Patients 12 Years Of Age And Older For: • Short-Term Treatment Of Symptomatic Gerd ( 1.7 ) 1.1healing Of Erosive Or Ulcerative Gerd In Adults Rabeprazole Sodium Delayed-Release Tablets Are Indicated For Short-Term (4 To 8 Weeks) Treatment In The Healing And Symptomatic Relief Of Erosive Or Ulcerative Gastroesophageal Reflux Disease (Gerd). For Those Patients Who Have Not Healed After 8 Weeks Of Treatment, An Additional 8-Week Course Of Rabeprazole Sodium Delayed-Release Tablets May Be Considered. 1.2maintenance Of Healing Of Erosive Or Ulcerative Gerd In Adults Rabeprazole Sodium Delayed-Release Tablets Are Indicated For Maintaining Healing And Reduction In Relapse Rates Of Heartburn Symptoms In Patients With Erosive Or Ulcerative Gastroesophageal Reflux Disease (Gerd Maintenance). Controlled Studies Do Not Extend Beyond 12 Months. 1.3treatment Of Symptomatic Gerd In Adults Rabeprazole Sodium Delayed-Release Tablets Are Indicated For The Treatment Of Daytime And Nighttime Heartburn And Other Symptoms Associated With Gerd In Adults. 1.4healing Of Duodenal Ulcers In Adults Rabeprazole Sodium Delayed-Release Tablets Are Indicated For Short-Term (Up To 4 Weeks) Treatment In The Healing And Symptomatic Relief Of Duodenal Ulcers. Most Patients Heal Within 4 Weeks. 1.5 Helicobacter Pylori Eradication To Reduce The Risk Of Duodenal Ulcer Recurrence In Adults Rabeprazole Sodium Delayed-Release Tablets In Combination With Amoxicillin And Clarithromycin As A Three Drug Regimen, Is Indicated For The Treatment Of Patients With H. Pylori Infection And Duodenal Ulcer Disease (Active Or History Within The Past 5 Years) To Eradicate H. Pylori . Eradication Of H. Pylori Has Been Shown To Reduce The Risk Of Duodenal Ulcer Recurrence [See Clinical Studies (14.5) And Dosage And Administration (2.5) ] . In Patients Who Fail Therapy, Susceptibility Testing Should Be Done. If Resistance To Clarithromycin Is Demonstrated Or Susceptibility Testing Is Not Possible, Alternative Antimicrobial Therapy Should Be Instituted [See Clinical Pharmacology (12.2) And The Clarithromycin Package Insert, Clinical Pharmacology (12.2)] . 1.6treatment Of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome In Adults Rabeprazole Sodium Delayed-Release Tablets Are Indicated For The Long-Term Treatment Of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome. 1.7short-Term Treatment Of Symptomatic Gerd In Adolescent Patients 12 Years Of Age And Older Rabeprazole Sodium Delayed-Release Tablets Are Indicated For The Treatment Of Symptomatic Gerd In Adolescents 12 Years Of Age And Above For Up To 8 Weeks.
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