Generic name: RABEPRAZOLE SODIUM 20mg
Dosage form: tablet, delayed release
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Table 1 shows the recommended dosage of ACIPHEX delayed-release tablets in adults and adolescent patients 12 years of age and older. The use of ACIPHEX delayed-release tablets is not recommended for use in pediatric patients 1 year to less than 12 years of age because the lowest available tablet strength (20 mg) exceeds the recommended dose for these patients. Use another rabeprazole formulation for pediatric patients 1 year to less than 12 years of age.
|Indication||Dosage of ACIPHEX delayed-release tablets||Treatment Duration|
|Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD)||20 mg once daily||4 to 8 weeks*|
|Maintenance of Healing of Erosive or Ulcerative GERD||20 mg once daily||Controlled studies do not extend beyond 12 months|
|Symptomatic GERD in Adults||20 mg once daily||Up to 4 weeks**|
|Healing of Duodenal Ulcers||20 mg once daily after the morning meal||Up to 4 weeks***|
|Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence||ACIPHEX 20 mg
Amoxicillin 1000 mg
Clarithromycin 500 mg
Take all three medications twice daily with morning and evening meals; it is important that patients comply with the full 7-day regimen [see Clinical Studies (14.5)]
|Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome||Starting dose 60 mg once daily then adjust to patient needs; some patients require divided doses
Dosages of 100 mg once daily and 60 mg twice daily have been administered
|As long as clinically indicated
Some patients with Zollinger-Ellison syndrome have been treated continuously for up to one year
|Adolescents 12 Years of Age and Older|
|Symptomatic GERD||20 mg once daily||Up to 8 weeks|
* For those patients who have not healed after 8 weeks of treatment, an additional 8-week course of ACIPHEX may be considered.
** If symptoms do not resolve completely after 4 weeks, an additional course of treatment may be considered.
*** Most patients heal within 4 weeks; some patients may require additional therapy to achieve healing.
- Swallow ACIPHEX delayed-release tablets whole. Do not chew, crush, or split tablets.
- For the treatment of duodenal ulcers take ACIPHEX delayed-release tablets after a meal.
- For Helicobacter pylori eradication take ACIPHEX delayed-release tablets with food.
- For all other indications ACIPHEX delayed-release tablets can be taken with or without food.
- Take a missed dose as soon as possible. If it is almost time for the next dose, skip the missed dose and go back to the normal schedule. Do not take two doses at the same time.
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- Drug class: proton pump inhibitors
Other brands: Aciphex Sprinkle