INDICATIONS

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).

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.

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.

DOSAGE AND ADMINISTRATION

Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD)

The recommended adult oral dose is one ACIPHEXTM 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).

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.

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 ACIPHEXTM 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.

HOW SUPPLIED

ACIPHEX™ 20 mg is supplied as delayed-release light yellow enteric-coated tablets.

The medication code number (E243) is imprinted on one side.

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

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.