ONCE-DAILY, CONVENIENT DOSING WITH ACIPHEX®

  • 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 tablet strength exceeds the recommended dose for these patients.
  • Use another rabeprazole formulation for pediatric patients 1 year to less than 12 years of age.
  • Recommended dosage and duration of ACIPHEX delayed-release tablets in adults and adolescents 12 years of age and older
  • ADULTS
  • Indication
  • Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD)
  • Dosage of ACIPHEX delayed-release tablet
  • 20 mg once daily
  • Treatment Duration
  • 4 to 8 weeks*
  • Indication
  • Maintenance of Healing of Erosive or Ulcerative GERD
  • Dosage of ACIPHEX delayed-release tablet
  • 20 mg once daily
  • Treatment Duration
  • Controlled studies do not extend beyond 12 months
  • Indication
  • Symptomatic GERD in Adults
  • Dosage of ACIPHEX delayed-release tablet
  • 20 mg once daily
  • Treatment Duration
  • Up to 4 weeks**
  • Indication
  • Healing of Duodenal Ulcers
  • Dosage of ACIPHEX delayed-release tablet
  • 20 mg once daily after the morning meal
  • Treatment Duration
  • Up to 4 weeks***
  • Indication
  • Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence
  • Dosage of ACIPHEX delayed-release tablet
  • 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
  • Treatment Duration
  • 7 days
  • Indication
  • Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome
  • Dosage of ACIPHEX delayed-release tablet

  • 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

  • Treatment Duration
  • 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
  • Indication
  • Symptomatic GERD
  • Dosage of ACIPHEX delayed-release tablet
  • 20 mg once daily
  • Treatment Duration
  • Up to 8 weeks
  • Recommended dosage and duration of ACIPHEX delayed-release tablets in adults and adolescents 12 years of age and older
  • Indication
  • Dosage of ACIPHEX delayed-release tablet
  • Treatment Duration
  • ADULTS
  • 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
  • 7 days
  • 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.

Administration Instructions

  • 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

GERD - Gastroesophageal reflux disease

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Important Safety Information

ACIPHEX (rabeprazole sodium) should not be taken by patients who are allergic to rabeprazole sodium or any of its ingredients. Patients should disclose any medications, such as Methotrexate or Warfarin, that they are taking before taking ACIPHEX, as ACIPHEX can affect how certain oral medications work in the body.

Important Safety Information

ACIPHEX (rabeprazole sodium) should not be taken by patients who are allergic to rabeprazole sodium or any of its ingredients. Patients should disclose any medications, such as Methotrexate or Warfarin, that they are taking before taking ACIPHEX, as ACIPHEX can affect how certain oral medications work in the body.

Indication and Usage

ACIPHEX delayed-release tablets are a proton pump inhibitor (PPI) indicated in adults for:

  • Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD)
  • Maintenance of Healing of Erosive or Ulcerative GERD.
  • Treatment of Symptomatic GERD.
  • Healing of Duodenal Ulcers.
  • Helicobacter pylori Eradication to Reduce Risk of Duodenal Ulcer Recurrence.
  • Treatment of Pathological Hypersecretory Conditions, Including
    • Zollinger-Ellison Syndrome
  • In adolescent patients 12 years of age and older for:
    • Short-term Treatment of Symptomatic GERD.

Side Effects

Common side effects of ACIPHEX may include:

  • Rash or itching
  • Upset stomach
  • Diarrhea
  • Gas
  • Sore throat
  • Headache
  • Insomnia
  • Nervousness

Serious side effects are as follows. Patients taking ACIPHEX are advised to contact their healthcare provider if they experience any of the following symptoms:

  • Hepatitis,
  • Abnormal brain function or structure (encephalopathy),
  • Dizziness,
  • Swelling,
  • Joint pain, and
  • Muscle pains.

Contraindications

  • Patients with a history of hypersensitivity to rabeprazole.
  • PPIs, including ACIPHEX delayed-release tablets, are contraindicated in patients receiving rilpivirine-containing products.
  • Refer to the Contraindications section of the prescribing information for clarithromycin and amoxicillin, when administered in combination with ACIPHEX.

Warnings

  • Symptomatic response to therapy with rabeprazole does not preclude the presence of gastric malignancy.
  • Use with warfarin: Monitor for increases in INR and prothrombin time.
  • Acute interstitial nephritis has been observed in patients taking PPIs.
  • Cyanocobalamin (vitamin B-12) Deficiency: Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin.
  • PPI therapy may be associated with increased risk of Clostridium difficile associated diarrhea.
  • Bone fracture: Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine.
  • Hypomagnesemia has been reported rarely with prolonged treatment with PPIs.

To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

See Full Prescribing Information for ACIPHEX.

Reference:

  1. ACIPHEX [Prescribing information]. Wixom, MI, Woodward Pharma Services LLC, 2021.

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