ACIPHEX tablets should be swallowed whole. The tablets should not be chewed, crushed, or split. ACIPHEX can be taken with or without food.
2.1. Healing of Erosive or Ulcerative GERD
The recommended adult oral dose is one ACIPHEX 20 mg delayed-release tablet to be taken once daily for four to eight weeks. {See INDICATIONS AND USAGE (1.1)}. For those patients who have not healed after 8 weeks of treatment, an additional 8-week course of ACIPHEX may be considered.
2.2. Maintenance of Healing of Erosive or Ulcerative GERD
The recommended adult oral dose is one ACIPHEX 20 mg delayed-release tablet to be taken once daily. {See INDICATIONS AND USAGE (1.2)}.
2.3. Treatment of Symptomatic GERD
The recommended adult oral dose is one ACIPHEX 20 mg delayed-release tablet to be taken once daily for 4 weeks. {See INDICATIONS AND USAGE (1.3)}. If symptoms do not resolve completely after 4 weeks, an additional course of treatment may be considered. The recommended adolescent dosing is listed in Section 2.7.
2.4. Healing of Duodenal Ulcers
The recommended adult oral dose is one ACIPHEX 20 mg delayed-release tablet to be taken once daily after the morning meal for a period up to four weeks. {See INDICATIONS AND USAGE (1.4)}. Most patients with duodenal ulcer heal within four weeks. A few patients may require additional therapy to achieve healing.
2.5. Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
TABLE 1 THREE DRUG REGIMENa
All three medications should be taken twice daily with the morning and evening meals.a It is important that patients comply with the full 7-day regimen. {See CLINICAL STUDIES section (14.5)}.
ACIPHEX
20 mg
Twice Daily for 7 Days
Amoxicillin
1000 mg
Twice Daily for 7 Days
Clarithromycin
500 mg
Twice Daily for 7 Days
2.6. Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome
The dosage of ACIPHEX in patients with pathologic hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once a day. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Some patients may require divided doses. Doses up to 100 mg QD and 60 mg BID have been administered. Some patients with Zollinger-Ellison syndrome have been treated continuously with ACIPHEX for up to one year.
2.7. Short-term Treatment of GERD in Adolescent Patients 12 Years of Age and Above
The recommended oral dose for adolescents 12 years of age and above is 20 mg once daily for up to 8 weeks {See Pediatric Use (8.4)}.
2.8. Elderly, Renal and Hepatic Impaired Patients
No dosage adjustment is necessary in elderly patients, in patients with renal disease or in patients with mild to moderate hepatic impairment. Administration of rabeprazole to patients with mild to moderate liver impairment resulted in increased exposure and decreased elimination. Due to the lack of clinical data on rabeprazole in patients with severe hepatic impairment, caution should be exercised in those patients.