Rabeprazole

Rabeprazole
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rabin Bista, M.B.B.S. [2]

Disclaimer

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.

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

There is limited information regarding Off-Label Guideline-Supported Use of Rabeprazole in adult patients.

Non–Guideline-Supported Use

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

There is limited information regarding Off-Label Guideline-Supported Use of Rabeprazole in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Rabeprazole in pediatric patients.

Contraindications

• Rabeprazole is contraindicated in patients with known hypersensitivity to rabeprazole, substituted benzimidazoles, or to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, and urticaria

Warnings

Presence of Gastric Malignancy

• Symptomatic response to therapy with rabeprazole does not preclude the presence of gastric malignancy.
• Patients with healed GERD were treated for up to 40 months with rabeprazole and monitored with serial gastric biopsies. Patients without H. pylori infection (221 of 326 patients) had no clinically important pathologic changes in the gastric mucosa. Patients with H. pylori infection at baseline (105 of 326 patients) had mild or moderate inflammation in the gastric body or mild inflammation in the gastric antrum. Patients with mild grades of infection or inflammation in the gastric body tended to change to moderate, whereas those graded moderate at baseline tended to remain stable. Patients with mild grades of infection or inflammation in the gastric antrum tended to remain stable. At baseline, 8% of patients had atrophy of glands in the gastric body and 15% had atrophy in the gastric antrum. At endpoint, 15% of patients had atrophy of glands in the gastric body and 11% had atrophy in the gastric antrum. Approximately 4% of patients had intestinal metaplasia at some point during follow-up, but no consistent changes were seen.

Concomitant Use with Warfarin

• Steady state interactions of rabeprazole and warfarin have not been adequately evaluated in patients. 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. Patients treated with a proton pump inhibitor and warfarin concomitantly may need to be monitored for increases in INR and prothrombin time.

Acute Interstitial Nephritis

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

Cyanocobalamin (vitamin B-12) Deficiency

• 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 B-12) caused by hypo- or achlorhydria. Rare reports of cyanocobalamin deficiency occurring with acid-suppressing therapy have been reported in the literature. This diagnosis should be considered if clinical symptoms consistent with cyanocobalamin deficiency are observed.

Clostridium difficile Associated Diarrhea

• Published observational studies suggest that PPI therapy like Rabeprazole may be associated with an increased risk of Clostridium difficile associated diarrhea, especially in hospitalized patients. This diagnosis should be considered for diarrhea that does not improve.
• Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.
• Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents. For more information specific to antibacterial agents (clarithromycin and amoxicillin) indicated for use in combination with ACIPHEX, refer to Warnings and Precautions sections of those package inserts.

Bone Fracture=

• 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). Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Patients at risk for osteoporosis-related fractures should be managed according to established treatment guidelines.

Hypomagnesemia=

• 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. In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuation of the PPI.
• For patients expected to be on prolonged treatment or who take PPIs with medications such as digoxin or drugs that may cause hypomagnesemia (e.g., diuretics), healthcare professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically.

Concomitant Use of ACIPHEX with Methotrexate=

• Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. In high-dose methotrexate administration, a temporary withdrawal of the PPI may be considered in some patients

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.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Rabeprazole in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Rabeprazole during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Rabeprazole with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Rabeprazole with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Rabeprazole with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Rabeprazole with respect to specific gender populations.

Race

There is no FDA guidance on the use of Rabeprazole with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Rabeprazole in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Rabeprazole in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Rabeprazole in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Rabeprazole in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Rabeprazole in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Rabeprazole in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Rabeprazole in the drug label.

Pharmacology

There is limited information regarding Rabeprazole Pharmacology in the drug label.

Mechanism of Action

Structure

File:Rabeprazole01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Rabeprazole in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Rabeprazole in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Rabeprazole in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Rabeprazole in the drug label.

How Supplied

Storage

There is limited information regarding Rabeprazole Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Rabeprazole |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Rabeprazole |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Rabeprazole in the drug label.

Precautions with Alcohol

• Alcohol-Rabeprazole interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

{{#subobject:

 |Page Name=Rabeprazole
 |Pill Name=No image.jpg
 |Drug Name=
 |Pill Ingred=|+sep=;
 |Pill Imprint=
 |Pill Dosage={{{dosageValue}}} {{{dosageUnit}}}
 |Pill Color=|+sep=;
 |Pill Shape=
 |Pill Size (mm)=
 |Pill Scoring=
 |Pill Image=
 |Drug Author=
 |NDC=

}}

{{#subobject:

 |Label Page=Rabeprazole
 |Label Name=Rabeprazole11.png

}}

{{#subobject:

 |Label Page=Rabeprazole
 |Label Name=Rabeprazole11.png

}}