Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease GERD)

ACIPHEX® is 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 ACIPHEX® may be considered.

Maintenance of Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD)

ACIPHEX® is 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.

Treatment of Symptomatic Gastroesophageal Reflux Disease (GERD)

ACIPHEX® is indicated for the treatment of daytime and nighttime heartburn and other symptoms associated with GERD.

Healing of Duodenal Ulcers

ACIPHEX® is indicated for short-term (up to four weeks) treatment in the healing and symptomatic relief of duodenal ulcers. Most patients heal within four weeks.

Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence

ACIPHEX® 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 and DOSAGE AND ADMINISTRATION.)

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, Microbiology and the clarithromycin package insert, CLINICAL PHARMACOLOGY, Microbiology.)

Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome

ACIPHEX® is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (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). For those patients who have not healed after 8 weeks of treatment, an additional 8-week course of ACIPHEX® may be considered.

Maintenance of Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD Maintenance)

The recommended adult oral dose is one ACIPHEX® 20 mg delayed-release tablet to be taken once daily. (See INDICATIONS AND USAGE).

Treatment of Symptomatic Gastroesophageal Reflux Disease (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). If symptoms do not resolve completely after 4 weeks, an additional course of treatment may be considered.

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). Most patients with duodenal ulcer heal within four weeks. A few patients may require additional therapy to achieve healing.

Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
Three Drug Regimen^a:

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.

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.

ACIPHEX® tablets should be swallowed whole. The tablets should not be chewed, crushed, or split. ACIPHEX® can be taken with or without food.

ACIPHEX® 20 mg is supplied as delayed-release light yellow enteric-coated tablets. The name and strength, in mg, (ACIPHEX 20) is imprinted on one side.

Bottles of 30 (NDC#62856-243-30)

Bottles of 90 (NDC#62856-243-90)

Unit Dose Blisters Package of 100 (10 x 10) (NDC#62856-243-41)

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Protect from moisture.

ACIPHEX® is a registered trademark of Eisai Co., Ltd., Tokyo, Japan.
Manufactured and Marketed by Eisai Inc., Woodcliff Lake, NJ 07677 Marketed by PriCara, Unit of Ortho-McNeil, Inc., Raritan, NJ 08869
Revised February, 2007 FDA rev date: 6/3/2005

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