Indicated for:

Healing of Erosive or Ulcerative GERD in Adults:

• 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 GERD in Adults:

• 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 GERD in Adults:

• Treatment of daytime and nighttime heartburn and other symptoms associated with GERD in adults for up to 4 weeks.

Healing of Duodenal Ulcers in Adults:

• 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 in Adults:

• ACIPHEX delayed-release tablets in combination with amoxicillin and clarithromycin as a three drug regimen, are 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.

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.

Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome in Adults:

• ACIPHEX delayed-release tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

Treatment of Symptomatic GERD in Adolescent Patients 12 Years of Age and Older:

• ACIPHEX delayed-release tablets are indicated for the treatment of symptomatic GERD in adolescents 12 years of age and above for up to 8 weeks.

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.

Published observational studies suggest that PPI therapy like ACIPHEX may be associated with an increased risk of Clostridium difficile-associated diarrhea, especially in hospitalized patients.

Several published observational studies in adults suggest that PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. The risk of fracture was increased in patients who received high dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer).

Acute tubulointerstitial nephritis (TIN) has been observed in patients taking PPIs and may occur at any point during PPI therapy.

Acute interstitial nephritis has been observed in patients taking PPIs including ACIPHEX. Acute interstitial nephritis may occur at any point during PPI therapy and is generally attributed to an idiopathic hypersensitivity reaction.

Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs, including rabeprazole.

PPI use is associated with an increased risk of fundic gland polyps that increases with long-term use, especially beyond one year. Most PPI users who developed fundic gland polyps were asymptomatic and fundic gland polyps were identified incidentally on endoscopy.

Daily treatment with any acid-suppressing medications over a long period of time (e.g., longer than 3 years) may lead to malabsorption of cyanocobalamin (vitamin B12) caused by hypo- or achlorhydria. 

Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs for at least three months, in most cases after a year of therapy. Serious adverse events include tetany, arrhythmias, and seizures.

PPIs, including ACIPHEX, are contraindicated with rilpivirine-containing products. ACIPHEX is also contraindicated with Nelfinavir, clarithromycin and amoxicillin.

There have been reports of increased INR and prothrombin time in patients receiving a proton pump inhibitor and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death.

Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate and prolong serum concentrations of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities.

There are no available human data on ACIPHEX use in pregnant women to inform the drug associated risk. Animal studies: changes in bone morphology were observed.

Lactation studies have not been conducted to assess the presence of rabeprazole in human milk, the effects of rabeprazole on the breastfed infant, or the effects of rabeprazole on milk production. Rabeprazole is present in rat milk.

GoToSource

• Adult dosage greater than 20 mg once daily for healing of erosive or ulcerative GERD, maintenance or healing of GERD, treatment of symptomatic GERD or healing of duodenal ulcers. GoToSource

• Use in patients under the age of 12 for short-term treatment of symptomatic GERD. GoToSource

• Use in patients under the age of 18 for healing of erosive or ulcerative GERD, maintenance or healing of erosive or ulcerative GERD, treatment of symptomatic GERD, healing of duodenal ulcers, helicobacter pylori eradication to reduce the risk of duodenal ulcer recurrence and treatment of pathological hypersecretory conditions. GoToSource

• Use with risedronate to treat osteoporosis. GoToSource

• Refractory gastric tube ulcer after esophagectomy. GoToSource

• Use as an antiparasitic agent. GoToSource

• Reduction of strictures, dysplasia and adenocarcinoma in barrett’s oesophagus. GoToSource

• Reduction of aspirin associated esophageal injury. GoToSource

• Bile reflux gastritis after cholecystectomy. GoToSource

• Type II diabetes. GoToSource

Increased risk of myocardial infarction. GoToSource

Hypomagnesemia (low magnesium). GoToSource

Interstitial nephritis (kidney disorder). GoToSource

Community-acquired pneumonia. GoToSource

Bilateral blurred vision. GoToSource

Birth defects. GoToSource

Fractures, C. diff infection, thrombocytopenia and rhabdomyolysis. GoToSource

Dissociative disorder when combined with clarithromycin. GoToSource

Anxiety and panic attacks. GoToSource

Use with clopidogrel increases risk of adverse cardiovascular events and death. GoToSource

Cutaneous reactions. GoToSource

Myopathy including polymyositis. GoToSource 

Subacute cutaneous lupus erythematosus (skin lesions). GoToSource

Lawsuits filed for birth defects, hip, wrist and spine fractures, heart attacks, hypomagnesemia and strokes.