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Overview
Rabeprazole is a proton-pump inhibitor (PPI) that is FDA approved for the treatment of Gastroesophageal Reflux Disease (GERD), Duodenal Ulcers, Helicobacter pylori Eradication, Pathological Hypersecretory Conditions including Zollinger-Ellison Syndrome.. Common adverse reactions include pain, flatulence, infection, constipation..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indications
Healing of Erosive or Ulcerative GERD in Adults
Rabeprazole 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 Rabeprazole may be considered.
Maintenance of Healing of Erosive or Ulcerative GERD in Adults
Rabeprazole 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 GERD in Adults
Rabeprazole is indicated for the 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
Rabeprazole 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 in Adults
Rabeprazole, 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.
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
Rabeprazole is indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.
Short-term Treatment of Symptomatic GERD in Adolescent Patients 12 Years of Age and Older
Rabeprazole is indicated for the treatment of symptomatic GERD in adolescents 12 years of age and above for up to 8 weeks.
Dosage
Healing of Erosive or Ulcerative GERD in Adults
The recommended adult oral dose is one Rabeprazole 20 mg Delayed-Release tablet to be taken once daily for four to eight weeks. For those patients who have not healed after 8 weeks of treatment, an additional 8-week course of Rabeprazole may be considered.
Maintenance of Healing of Erosive or Ulcerative GERD in Adults
The recommended adult oral dose is one Rabeprazole 20 mg Delayed-Release tablet to be taken once daily. Controlled studies do not extend beyond 12 months.
Treatment of Symptomatic GERD in Adults
The recommended adult oral dose is one Rabeprazole 20 mg Delayed-Release tablet to be taken once daily for 4 weeks. If symptoms do not resolve completely after 4 weeks, an additional course of treatment may be considered.
Healing of Duodenal Ulcers in Adults
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 (1.5)]. 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 in Adults
Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome in Adults
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 daily. 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 Rabeprazole for up to one year.
Short-term Treatment of Symptomatic GERD in Adolescent Patients 12 Years of Age and Older
The recommended oral dose for adolescents 12 years of age and older is one 20 mg Delayed-Release Tablet once daily for up to 8 weeks
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.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
Condition1
Developed by:
Class of Recommendation:
Strength of Evidence:
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Rabeprazole in adult patients.
Non–Guideline-Supported Use
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Rabeprazole in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Indications
Treatment of GERD in Pediatric Patients 1 to 11 Years of Age
Rabeprazole is indicated for treatment of GERD in children 1 to 11 years of age for up to 12 weeks.
Dosage
Treatment of GERD in Pediatric Patients 1 to 11 Years of Age
The recommended dosage of Rabeprazole for pediatric patients 1 to 11 years of age by body weight is:
:* Less than 15 kg: 5 mg once daily for up to 12 weeks with the option to increase to 10 mg if inadequate response.
:* 15 kg or more: 10 mg once daily for up to 12 weeks
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
Condition1
Developed by:
Class of Recommendation:
Strength of Evidence:
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Rabeprazole in pediatric patients.
Non–Guideline-Supported Use
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Rabeprazole in pediatric patients.
Contraindications
Condition1
Warnings
Description
Precautions
Description
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Rabeprazole in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Rabeprazole in the drug label.