Zegerid

Product manufactured by Santarus, Inc..

Application Nr Approved Date Route Status External Links
NDA021636 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Zegerid ® For Oral Suspension And Zegerid 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. O The Efficacy Of Zegerid 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 Zegerid May Be Considered. • Maintenance Of Healing Of Ee Due To Acid-Mediated Gerd. Controlled Studies Do Not Extend Beyond 12 Months. Zegerid For Oral Suspension Is Indicated In Adults For The : • Reduction Of Risk Of Upper Gi Bleeding In Critically Ill Adult Patients. Zegerid Is A Proton Pump Inhibitor (Ppi). Zegerid For Oral Suspension And Zegerid Capsules Are Indicated In Adults For: • Treatment Of Active Duodenal Ulcer ( 1 ) • Treatment Of Active Benign Gastric Ulcer ( 1 ) • Treatment Of Erosive Esophagitis (Ee) Due To Acid-Mediated Gastroesophageal Reflux Disease (Gerd) ( 1 ) • Maintenance Of Healing Of Ee ( 1 ) Zegerid For Oral Suspension Is Indicated In Adults For: • Reduction Of Risk Of Upper Gastrointestinal (Gi) Bleeding In Critically Ill Patients ( 1 )

All Formulated Excipients (0 Total)

None

Active Ingredients ( 2 Total)

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