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Class: Proton-pump Inhibitors
- Antiulcer Agents
- Gastric Antisecretory Agents
- Acid-pump Inhibitors
VA Class: GA900
Chemical Name: 2-[[[4-(3-Methoxypropoxy)-3-methyl-2-pyridyl]methyl]sulfinyl]-benzimidazole sodium
Molecular Formula: C18H20N3NaO3S
CAS Number: 117976-90-6
Brands: AcipHex
Acid- or proton-pump inhibitor; gastric antisecretory agent.
Short-term treatment of symptomatic GERD (e.g., heartburn) in patients without erosive esophagitis.
Short-term treatment of erosive esophagitis in patients with GERD.
Maintain healing and decrease recurrence of erosive esophagitis.
Short-term treatment of active duodenal ulcer.
Treatment of Helicobacter pylori infection and duodenal ulcer disease. Used in conjunction with amoxicillin and clarithromycin (triple therapy).
Long-term treatment of pathologic GI hypersecretory conditions (e.g., Zollinger-Ellison syndrome).
Some evidence for use of proton-pump inhibitors (e.g., omeprazole) for gastric acid suppressive therapy as an adjunct in the management of upper GI Crohn’s disease†, including esophageal†, gastroduodenal†, and jejunoileal† disease.
Administer orally; may give without regard to meals, but manufacturer recommends administration after morning meal in patients with duodenal ulcer.
When used in combination with clarithromycin and amoxicillin for treatment of H. pylori infection and duodenal ulcer disease, take all 3 drugs twice daily with morning and evening meals.
Swallow tablets intact; do not chew, crush, or split.
Antacids may be used concomitantly as needed for pain relief.
Available as rabeprazole sodium; dosage expressed in terms of the salt.
Adolescents ≥12 years of age: 20 mg once daily for up to 8 weeks.
20 mg once daily for 4 weeks; may give additional 4 weeks if symptoms are not completely resolved.
20 mg once daily for 4–8 weeks. If not healed after 8 weeks, consider additional 8 weeks of therapy (up to 16 weeks for a single course).
20 mg once daily. Chronic, lifelong therapy may be appropriate.
20 mg once daily for up to 4 weeks; some patients may require additional therapy.
Triple therapy: 20 mg twice daily for 7 days in conjunction with amoxicillin and clarithromycin.
60 mg once daily. Dosages up to 100 mg once daily or 60 mg twice daily have been used. Divided doses may be required. Adjust dosage as needed, continue treatment as long as necessary. Has been used continuously for up to 1 year.
Known hypersensitivity to rabeprazole, any ingredient in the formulation, or other substituted benzimidazoles (e.g., esomeprazole, lansoprazole, pantoprazole, omeprazole).
Response to rabeprazole does not preclude presence of occult gastric neoplasm.
Proton-pump inhibitors associated with possible increased (1.4–2.75 times) risk of Clostridium difficile infection, including C. difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis). Many patients also had other risk factors for CDAD. May be severe; colectomy and, rarely, death reported.
Use the lowest effective dosage and shortest duration of therapy appropriate for the patient's clinical condition.
Consider CDAD if persistent diarrhea develops and manage accordingly; initiate supportive therapy (e.g., fluid and electrolyte management), anti-infective therapy directed against C. difficile (e.g., metronidazole, vancomycin), and surgical evaluation as clinically indicated.
Administration of proton-pump inhibitors has been associated with an increased risk for developing certain infections (e.g., community-acquired pneumonia).
Several observational studies suggest that use of proton-pump inhibitors, particularly in high dosages (i.e., multiple daily doses) and/or for prolonged periods of time (i.e., ≥1 year), may be associated with increased risk of osteoporosis-related fractures of the hip, wrist, or spine. Magnitude of risk is unclear; causality not established. FDA is continuing to evaluate this safety concern.
Use the lowest effective dosage and shortest duration of therapy appropriate for the patient’s clinical condition.
Inpiduals at risk for osteoporosis-related fractures should receive an adequate intake of calcium and vitamin D; assess and manage these patients’ bone health according to current standards of care.
Hypomagnesemia, symptomatic and asymptomatic, reported rarely in patients receiving long-term therapy (≥3 months or, in most cases, >1 year) with proton-pump inhibitors, including rabeprazole. Serious adverse effects include tetany, seizures, tremors, carpopedal spasm, arrhythmias (e.g., atrial fibrillation, supraventricular tachycardia), and abnormal QT interval. Paresthesia, muscle weakness, muscle cramps, lethargy, fatigue, and unsteadiness may occur. Most patients required magnesium replacement and discontinuance of the proton-pump inhibitor. Hypomagnesemia resolved within 1 week (median) following discontinuance and recurred within 2 weeks (median) of rechallenge.
In patients expected to receive long-term proton-pump inhibitor therapy or in patients currently receiving digoxin or drugs that may cause hypomagnesemia (e.g., diuretics), consider measuring serum magnesium concentrations prior to initiation of prescription proton-pump inhibitor therapy and periodically thereafter.
Category B.
Not known whether rabeprazole is distributed into milk; discontinue nursing or the drug.
Safety and efficacy for short-term treatment of symptomatic GERD established in adolescents 12–16 years of age. Pharmacokinetic and adverse effect profiles similar to those in adults.
Safety and efficacy not established in children <12 years of age.
No substantial differences in safety or efficacy relative to younger adults, but increased sensitivity cannot be ruled out.
Use with caution in patients with severe impairment.
Pain, pharyngitis, flatulence, infection, constipation.
Metabolized in the liver, principally by CYP3A and 2C19 isoenzymes.
No clinically important interactions with some drugs that are metabolized by CYP isoenzymes under single dose conditions; effects of rabeprazole have not been studied under steady-state conditions.
Potential pharmacologic interaction (possible increased risk of hypomagnesemia). Consider monitoring magnesium concentrations prior to initiation of prescription proton-pump inhibitor therapy and periodically thereafter. (See Hypomagnesemia under Cautions.)
Drug
Interaction
Comments
Amoxicillin
Increased rabeprazole and 14-hydroxyclarithromycin AUC and plasma concentrations when administered with amoxicillin and clarithromycin
Not expected to result in toxicity
Antacids
No clinically important effects on rabeprazole pharmacokinetics
Atazanavir
Possible altered oral absorption of atazanavir, resulting in decreased plasma atazanavir concentrations; possible loss of virologic response
Manufacturer of rabeprazole states that concomitant administration with atazanavir is not recommended
Antiretroviral treatment-naive patients: If a proton-pump inhibitor is used concomitantly with atazanavir, administer ritonavir-boosted atazanavir (atazanavir 300 mg and ritonavir 100 mg once daily with food); administer the proton-pump inhibitor approximately 12 hours before ritonavir-boosted atazanavir
For treatment-naive patients, dosage of proton-pump inhibitor should not exceed omeprazole 20 mg daily (or equivalent)
Antiretroviral treatment-experienced patients: Concomitant use of proton-pump inhibitors with atazanavir not recommended
Clarithromycin
Increased rabeprazole and 14-hydroxyclarithromycin AUC and plasma concentrations when administered with amoxicillin and clarithromycin
Not expected to result in toxicity
Clopidogrel
Certain CYP2C19 inhibitors (e.g., omeprazole, esomeprazole) reduce exposure to clopidogrel’s active metabolite and decrease platelet inhibitory effect; potentially may reduce clopidogrel’s clinical efficacy
Dexlansoprazole, lansoprazole, or pantoprazole had less effect on clopidogrel's antiplatelet activity than did omeprazole or esomeprazole
Assess risks and benefits of concomitant proton-pump inhibitor and clopidogrel use in inpidual patients
American College of Cardiology Foundation/American College of Gastroenterology/American Heart Association (ACCF/ACG/AHA) states that GI bleeding risk reduction with concomitant proton-pump inhibitor in patients with risk factors for GI bleeding (e.g., advanced age; concomitant use of warfarin, corticosteroids, or NSAIAs; H. pylori infection) may outweigh potential reduction in cardiovascular efficacy of antiplatelet treatment associated with a drug-drug interaction. In patients without such risk factors, ACCF/ACG/AHA states that risk/benefit balance may favor use of antiplatelet therapy without a proton-pump inhibitor.
If concomitant therapy with a proton-pump inhibitor and clopidogrel is deemed necessary, consider using an agent with little or no CYP2C19-inhibitory activity; alternatively, consider using a histamine H2-receptor antagonist (ranitidine, famotidine, nizatidine) but not cimetidine (also a potent CYP2C19 inhibitor)
Cyclosporine
Rabeprazole inhibited cyclosporine metabolism in vitro
Diazepam
No pharmacokinetic interaction observed after single doses
Digoxin
Hypomagnesemia (e.g., resulting from long-term use of proton-pump inhibitors) sensitizes the myocardium to digoxin and, thus, may increase risk of digoxin-induced cardiotoxic effects
See table entry for gastric pH-dependent drugs
Consider monitoring magnesium concentrations prior to initiation of prescription proton-pump inhibitor therapy and periodically thereafter
Diuretics (i.e., loop or thiazide diuretics)
Possible increased risk of hypomagnesemia
Consider monitoring magnesium concentrations prior to initiation of prescription proton-pump inhibitor therapy and periodically thereafter
Fosamprenavir
Use of esomeprazole with fosamprenavir (with or without ritonavir) did not substantially affect concentrations of amprenavir (active metabolite of fosamprenavir)
No dosage adjustment required when proton-pump inhibitors used with fosamprenavir (with or without ritonavir)
Gastric pH-dependent drugs (e.g., digoxin, ketoconazole)
Rabeprazole may alter drug absorption
Monitor if used concomitantly
Lopinavir
Lopinavir/ritonavir: Omeprazole had no clinically important effect on plasma concentrations or AUC of lopinavir
No dosage adjustment required when proton-pump inhibitors used with lopinavir/ritonavir
Methotrexate (high-dose)
Possible delayed clearance and increased serum concentrations of methotrexate and/or its metabolite hydroxymethotrexate; possible methotrexate toxicity
Reported mainly with high-dose methotrexate (300 mg/m2 to 12 g/m2), but also reported with low dosages (e.g., 15 mg per week)
Manufacturer of rabeprazole recommends considering temporary discontinuance of proton-pump inhibitor therapy in some patients receiving high-dose methotrexate
Some clinicians recommend withholding the proton-pump inhibitor for several days before and after administration of either high-dose or low-dose methotrexate or, alternatively, substituting a histamine H2-receptor antagonist for the proton-pump inhibitor
Phenytoin
No pharmacokinetic interaction observed after single doses
Raltegravir
Omeprazole increased peak plasma concentration and AUC of raltegravir
No dosage adjustment recommended when proton-pump inhibitors used with raltegravir
Rilpivirine
Omeprazole decreased plasma concentrations and AUC of rilpivirine
Concomitant use of rilpivirine and proton-pump inhibitors contraindicated
Saquinavir
Ritonavir-boosted saquinavir: Omeprazole increased peak plasma concentration and AUC of saquinavir
Caution advised if proton-pump inhibitor used with ritonavir-boosted saquinavir; monitor for saquinavir toxicity
Sucralfate
Possible delayed proton-pump inhibitor absorption and decreased bioavailability
Administer proton-pump inhibitor at least 30 minutes before sucralfate
Theophylline
No pharmacokinetic interaction observed after single doses
Warfarin
Potential for increased INR and PT
Monitor PT and INR
Absolute bioavailability with 20 mg dose is about 52%. Repeated dosing does not affect pharmacokinetics.
Within 1 hour. Median inhibition of 24-hour gastric acidity is 88% of maximum after first dose.
High-fat meal may delay absorption but does not affect extent.
AUC increased 50–60% in Japanese males receiving a different rabeprazole formulation.
AUC doubled in patients with mild to moderate compensated cirrhosis. Peak plasma concentrations and AUCs increased 20% in patients with mild to moderate hepatic impairment.
In geriatric patients, peak plasma concentration increased by 60% and AUCs doubled.
Not known whether rabeprazole crosses the placenta or is distributed into milk.
Prolonged binding to gastric parietal proton pump enzyme.
Approximately 96%.
Metabolized in the liver, principally by CYP3A and CYP2C19. Principal thioether and sulphone metabolites found in plasma are inactive.
Excreted as metabolites in urine (90%); remainder in feces.
1–2 hours.
In patients with mild to moderate compensated cirrhosis, elimination half-life was 2–3 times greater, and clearance decreased to less than one-half.
In patients with poor CYP2C19 metabolizer phenotype, metabolism is slower than in those with extensive (or rapid) metabolizer phenotype.
25°C (may be exposed to 15–30°C). Protect from moisture.
Inhibits basal and stimulated gastric acid secretion.
Concentrates in acid conditions of parietal cell secretory canaliculi; forms active sulfenamide metabolite that binds to and inactivates hydrogen-potassium ATPase (proton- or acid-pump), blocking final step in secretion of hydrochloric acid. Sustained inactivation of hydrogen-potassium ATPase results in prolonged duration of action.
Suppresses gastric H. pylori in patients with duodenal ulcer and/or reflux esophagitis infected with the organism. Combined therapy with rabeprazole and one or more appropriate anti-infectives (e.g., amoxicillin, clarithromycin) can effectively eradicate H. pylori gastric infection.
Importance of swallowing tablets whole, without crushing or chewing.
Importance of advising patients that use of multiple daily doses of the drug for an extended period of time may increase the risk of fractures of the hip, wrist, or spine.
Risk of hypomagnesemia; importance of immediately reporting and seeking care for any cardiovascular or neurologic manifestations (e.g., palpitations, dizziness, seizures, tetany).
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs. Antacids may be used concomitantly as needed for pain relief.
Possible increased risk of Clostridium difficile infection; importance of contacting clinician if persistent watery stools, abdominal pain, and fever occur.
Importance of women informing their clinicians if they are or plan to become pregnant or plan to breast-feed.
Importance of informing patients of other important precautionary information. (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some inpiduals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
Routes
Dosage Forms
Strengths
Brand Names
Manufacturer
Oral
Tablets, delayed-release (enteric-coated)
20 mg
AcipHex
Eisai (also promoted by Janssen [formerly Ortho-McNeil-Janssen])
AHFS DI Essentials™. © Copyright 2020, Selected Revisions February 15, 2013. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.
† Use is not currently included in the labeling approved by the US Food and Drug Administration.
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Medical Disclaimer
Other brands: Aciphex, Aciphex Sprinkle
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/27/2021.
Source: Drugs.com Rabeprazole Sodium (www.drugs.com/rabeprazole.html).
Commonly reported side effects of rabeprazole include: atrophic gastritis. See below for a comprehensive list of adverse effects.
For the ConsumerApplies to rabeprazole: oral capsule delayed release, oral tablet enteric coated
Along with its needed effects, rabeprazole may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking rabeprazole:
Less common
Rare
Incidence not known
Some side effects of rabeprazole may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Less common
For Healthcare Professionals
Applies to rabeprazole: oral delayed release capsule, oral delayed release tablet, oral tablet extended release
GeneralThe most commonly reported side effects are headache, diarrhea, and abdominal pain.
GastrointestinalVery common (10% or more): Diarrhea (up to 21%), abdominal pain (up to 16%), vomiting (up to 14%)
Common (1% to 10%): Benign fundic gland polyps, constipation, flatulence, nausea
Uncommon (0.1% to 1%): Dry mouth, dyspepsia, eructation
Rare (0.01% to 0.1%): Gastritis, stomatitis
Frequency not reported: Microscopic colitis
Postmarketing reports: Clostridium difficile-associated diarrhea
OtherCommon (1% to 10%): Asthenia, non-specific pain, pain
Uncommon (0.1% to 1%): Chills, pyrexia/fever
Postmarketing reports: Sudden death
RespiratoryCommon (1% to 10%): Cough, pharyngitis, rhinitis
Uncommon (0.1% to 1%): Bronchitis, sinusitis
Postmarketing reports: Dyspnea, interstitial pneumonia
Nervous systemCommon (1% to 10%): Dizziness, headache, taste disturbance/perversion
Uncommon (0.1% to 1%): Somnolence
Rare (0.01% to 0.1%): Hepatic encephalopathy
Postmarketing reports: Coma, vertigo
Hepatic encephalopathy occurred in patients with underlying cirrhosis.
ImmunologicCommon (1% to 10%): Flu-like syndrome/ influenza-like illness, infection
MusculoskeletalCommon (1% to 10%): Back pain, myalgia
Uncommon (0.1% to 1%): Arthralgia, fracture of hip/wrist/spine, leg cramps
Postmarketing reports: Bone fractures, rhabdomyolysis
DermatologicCommon (1% to 10%): Rash
Uncommon (0.1% to 1%): Erythema
Rare (0.01% to 0.1%): Bullous reactions, pruritus, sweating
Very rare (less than 0.01%): Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN)
Frequency not reported: Facial swelling, subacute cutaneous lupus erythematosus
Postmarketing reports: fatal TEN, other drug eruptions, severe dermatological reactions, systemic lupus erythematosus, urticarial skin eruptions
Erythema and bullous reactions usually resolved after discontinuation.
PsychiatricCommon (1% to 10%): Insomnia
Uncommon (0.1% to 1%): Nervousness
Rare (0.01% to 0.1%): Depression
Frequency not reported: Confusion
Postmarketing reports: Delirium, disorientation
CardiovascularCommon (1% to 10%): Chest pain
Uncommon (0.1% to 1%): Peripheral edema
Postmarketing reports: Hypotension
HepaticUncommon (0.1% to 1%): Increased hepatic enzymes
Rare (0.01% to 0.1%): Hepatitis, jaundice, serious hepatic dysfunction
Increased hepatic enzymes occurred in patients with underlying cirrhosis.
GenitourinaryUncommon (0.1% to 1%): Urinary tract infection
HematologicRare (0.01% to 0.1%): Leukocytosis, leukopenia, neutropenia, thrombocytopenia
Postmarketing reports: Agranulocytosis, bicytopenia, blood dyscrasias, hemolytic anemia, increase in prothrombin time/INR, pancytopenia
Increased prothrombin time/INR occurred in patients taking warfarin concomitantly.
MetabolicRare (0.01% to 0.1%): Anorexia, weight gain
Frequency not reported: Cyanocobalamin (Vitamin B-12) deficiency, hypomagnesemia, hyponatremia
Postmarketing reports: Hyperammonemia
RenalRare (0.01% to 0.1%): Interstitial nephritis
OcularRare (0.01% to 0.1%): Visual disturbance
Postmarketing reports: Blurred vision
EndocrineFrequency not reported: Gynecomastia
Postmarketing reports: Thyroid stimulating hormone (TSH) elevations
HypersensitivityHypersensitivity reactions included facial swelling, hypotension, dyspnea, erythema, and bullous reactions; these reactions typically resolved after discontinuation.
Rare (0.01% to 0.1%): Hypersensitivity
Postmarketing reports: Acute systemic allergic reactions, anaphylaxis/anaphylactic reactions, angioedema, potential allergic reactions
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/27/2021.
Source: Drugs.com Rabeprazole Sodium (www.drugs.com/rabeprazole.html).
August 31, 2020
August 1, 2020
August 2, 2021
August 2, 2021
August 2, 2021
August 2, 2021
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