Rabeprazole DR

Class
Acid suppression agents
Subclass
Proton pump inhibitors
Substance name
RABEprazole sodium DR
Brand names
Aciphex®
Common formulations
Tablet
Dosage and administration
Adults patients
Symptomatic relief
GERD
20 mg PO daily for up to 4 weeks
Consider administering an additional course of treatment if the symptoms do not resolve completely after 4 weeks.
Treatment
Duodenal ulcer
20 mg PO qAM for up to 4 weeks
Taken after the morning meal.
GERDErosive or ulcerative
Start at: 20 mg PO daily for 4-8 weeks
Maintenance: 20 mg PO daily for up to 12 months
Consider administering an additional 8-week course if the ulcer is not healed after 8 weeks of treatment.
H. pylori infectionTriple therapy
20 mg PO BID for 7 days
Taken with morning and evening meals. Administered in combination with amoxicillin orally 1,000 mg BID and clarithromycin 500 mg orally twice daily.
Pathological hypersecretory gastrointestinal conditions
Start at: 60 mg PO daily
Maintenance: 60-100 mg PO daily, in a single or divided doses
Barrett's esophagusOff-label
20 mg PO daily
Eosinophilic esophagitisOff-label
20 mg PO BID for 8 weeks
Functional dyspepsiaOff-label
20 mg PO daily
H. pylori infectionOff-label
20 mg PO BID as part of an eradication regimen
Taken 30-60 minutes before meals.
Other off-label uses
Treatment of peptic ulcer disease (bleeding)
Prevention of NSAID-induced peptic ulcer
Prevention of aspiration, during general anesthesia
Indications for use
Labeled indications
Adults
Symptomatic relief of GERD
Treatment of H. pylori infection (triple therapy)
Treatment of duodenal ulcer
Treatment of GERD (erosive or ulcerative)
Treatment of pathological hypersecretory gastrointestinal conditions
Off-label indications
Adults
Treatment of Barrett's esophagus
Treatment of H. pylori infection
Treatment of eosinophilic esophagitis
Treatment of functional dyspepsia
Treatment of peptic ulcer disease (bleeding)
Prevention of NSAID-induced peptic ulcer
Prevention of aspiration, in patients undergoing general anesthesia
Safety risks
Contraindications
Hypersensitivity to rabeprazole or its components or to other substituted benzimidazoles
Concomitant use of rilpivirine
Warnings and precautions
Acute interstitial nephritis
Maintain a high level of suspicion, as PPIs have been associated with an increased risk of acute interstitial nephritis.
Bone fracture
Maintain a high level of suspicion, as PPIs have been associated with an increased risk of osteoporosis-related fractures, especially with high-dose (multiple daily doses) or long-term (≥ 1 year) treatment.
C. difficile infection
Maintain a high level of suspicion, as PPIs have been associated with an increased risk of C. difficile-associated diarrhea, especially in hospitalized patients.
Cutaneous lupus erythematosus, SLE
Maintain a high level of suspicion, as PPIs have been associated with an increased risk of systemic and cutaneous lupus erythematosus.
Decreased serum calcium
Use caution in patients at risk of hypocalcemia, such as with hypoparathyroidism.
Decreased serum magnesium
Maintain a high level of suspicion, as long-term (≥ 3 months) treatment with PPIs has been associated with an increased risk of hypomagnesemia, leading to hypocalcemia and/or hypokalemia and exacerbation of underlying hypocalcemia. Consider monitoring magnesium levels before initiating PPIs and periodically during treatment in patients expected to receive prolonged treatment or taking concomitant drugs (such as digoxin) or agents causing hypomagnesemia (such as diuretics).
Fundic gland polyps
Maintain a high level of suspicion, as long-term treatment with PPIs has been associated with an increased risk of funds gland polyps.
Gastric cancer
Maintain a high level of suspicion, as long-term treatment with PPIs has been associated with an increased risk of rare types of gastrointestinal tumors in animal studies.
Increased serum methotrexate levels
Use caution in patients receiving high-dose methotrexate. Consider withdrawing proton pump inibitors temporarily.
Mask symptoms of gastric cancer
Maintain a high level of suspicion, as symptomatic response to PPIs does not preclude the presence of gastric malignancy. Consider obtaining diagnostic testing in adult patients with a suboptimal response or early symptomatic relapse after completing treatment.
Prolonged PT, increased INR
Use caution in patients taking warfarin. Monitor for increases in INR and PT.
Severe cutaneous adverse reactions
Maintain a high level of suspicion, as rabeprazole has been associated with an increased risk of severe cutaneous adverse reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS syndrome, and acute generalized exanthematous pustulosis.
Vitamin B12 deficiency
Maintain a high level of suspicion, as long-term (≥ 3 years) treatment with PPIs has been associated with an increased risk of vitamin B12 deficiency.
Specific populations
Renal impairment
eGFR 0-90 mL/min/1.73 m²
Use acceptable. No dose adjustment required.
Renal replacement therapy
Any modality
Use acceptable. No dose adjustment required.
Hepatic impairment
Child-Pugh A (mild)
Use acceptable. No dose adjustment required.
Child-Pugh B (moderate)
Use acceptable. No dose adjustment required.
Child-Pugh C (severe)
Avoid use. Monitor for adverse reactions.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: B1
Use only if clearly needed. Evidence of fetal harm in animals. Advise against self-medication with PPIs (OTC formulations) during pregnancy.
Breastfeeding
Use only if benefits outweigh potential risks.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Some adverse effects on lactation reported.
Adverse reactions
Common 1-10%
Hepatitis, hepatic encephalopathy, infections, constipation, headache, abdominal pain, diarrhea, dry mouth, dizziness, peripheral edema, ↑ liver enzymes, myalgia, arthralgia, pain, pharyngitis, flatulence
Unknown frequency
Agranulocytosis, ↓ WBC count, ↓ platelet count, pancytopenia, vertigo, blurred vision, jaundice, angioedema, ↑PT, ↑ INR, ↑ serum TSH, ↑ blood ammonia, ↓ serum magnesium, ↓ serum calcium, ↓ serum potassium, ↓ serum sodium, rhabdomyolysis, coma, delirium, disorientation, erectile dysfunction, erythema multiforme, hemolytic anemia, fundic gland polyps, anaphylaxis, systemic lupus erythematosus, Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS syndrome, acute generalized exanthematous pustulosis, Clostridioides difficile infection, bone fracture, interstitial nephritis, interstitial lung disease, cutaneous lupus erythematosus
Interactions
Drug(s)
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