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HIGHLIGHTS OF PRESCRIBING INFORMATION |
These highlights do not include all the information needed to use ACIPHEX safely and effectively. See full prescribing information for ACIPHEX.
ACIPHEX® (rabeprazole sodium) Delayed-Release Tablets
Initial U.S. Approval: 1999
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RECENT MAJOR CHANGES
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Warnings and Precautions, Bone Fracture (5.6)08/2010
Warnings and Precautions, Hypomagnesemia (5.7)05/2011
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INDICATIONS AND USAGE
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ACIPHEX is a proton-pump inhibitor (PPI) indicated in adults for:
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Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD) (1.1)
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Maintenance of Healing of Erosive or Ulcerative GERD (1.2)
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Treatment of Symptomatic GERD (1.3)
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Healing of Duodenal Ulcers (1.4)
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Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence (1.5)
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Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome (1.6)
ACIPHEX is a proton-pump inhibitor indicated for adolescent patients 12years of age and above for:
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Short-term treatment of Symptomatic GERD (1.3)
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DOSAGE AND ADMINISTRATION
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ACIPHEX tablets should be swallowed whole. The tablets should not be chewed, crushed or split.
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Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD) (2.1) |
20mg once daily |
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Maintenance of Healing of Erosive or Ulcerative GERD (2.2) |
20mg once daily |
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Treatment of Symptomatic GERD (2.3) |
20mg once daily |
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Healing of Duodenal Ulcers (2.4) |
20mg once daily after morning meal |
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Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence (2.5) |
Three Drug Regimen:
ACIPHEX 20mg
Amoxicillin 1000mg
Clarithromycin 500mg |
All three medications should be taken twice daily with morning and evening meals for 7days |
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Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome (2.6) |
Starting dose 60mg once daily then adjust to patient needs |
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DOSAGE FORMS AND STRENGTHS
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