Classes
DEA Class; Rx
Common Brand Names; Aciphex, Aciphex Sprinkle
- Proton Pump Inhibitors
Description
Proton pump inhibitor (PPI); gastric antisecretory agent
Used for GERD, peptic ulcer disease, in combination with antibiotics for the eradication of H. pylori, and for hypersecretory conditions such as ZE syndrome
May have less potential for drug interactions compared to other PPIs
Indications
Indicated for short-term (up to 4 weeks) treatment in healing and symptomatic relief of duodenal ulcers
In combination with amoxicillin and clarithromycin for treatment of H pylori infection and duodenal ulcer disease (active or history within past 5 yr)
Contraindications
Hypersensitivity to rabeprazole or other proton pump inhibitors (PPIs)
Rilpivirine-containing products
Adverse Effects
- Headache (2-10%)
- Constipation (2%)
- Diarrhea (2-5%)
- Flatulence (3%)
- Pain (3%)
- Pharyngitis (3%)
- Abdominal pain (4%)
- Agitation
- Agranulocytosis
- Alopecia
- Anemia
- Angioedema
- Chest pain
- Delirium
- Erythema multiforme
- Hypokalemia
- Hypomagnesemia
- Hyponatremia
- Jaundice
- Leukocytosis
- Leukopenia
- Migraine
- Osteoporosis related fracture
- Rhabdomyolysis
Warnings
PPIs are possibly associated with increased incidence of Clostridium difficile-associated diarrhea (CDAD); consider diagnosis of CDAD for patients taking PPIs with diarrhea that does not improve
In liver disease may require dosage reduction
Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) reported with PPIs; avoid using for longer than medically indicated; discontinue if signs or symptoms consistent with CLE or SLE are observed and refer patient to specialist; most patients improve with discontinuation of PPI alone in 4-12 weeks; serological testing (e.g. ANA) may be positive and elevated serological test results may take longer to resolve than clinical manifestations
Severe cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) reported in association with use of PPIs; discontinue therapy at first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation
Use of proton pump inhibitors may increase risk of salmonella and campylobacter infection
Reduce of symptoms does not eliminate presence of gastric malignancy; consider additional follow-up and diagnostic testing in adult patients who have suboptimal response or early symptomatic relapse after completing treatment with a PPI
Published observational studies suggest that PPI therapy may be associated with an increased risk of osteoporosis-related fractures of the hip, wrist, or spine; particularly with prolonged (>1 yr), high-dose therapy
Decreased gastric acidity increases serum chromogranin A (CgA) levels and may cause false positive diagnostic results for neuroendocrine tumors; temporarily discontinue PPIs before assessing CgA levels
Monitor for increases in INR and prothombin time when coadministered with warfarin
Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin
Acute interstitial nephritis reported in patients taking proton pump inhibitors
Concomitant use of proton pump inhibitors with methotrexate, primarily at high dose, may elevate and prolong serum concentrations 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
PPI therapy is associated with increased risk of fundic gland polyp; risk increases with long-term use >1 year; patient may be asymptomatic; problem usually identified incidentally on endoscopy; use shortest duration of therapy appropriate to condition being treated
Pregnancy and Lactation
There are no available human data in pregnant women to inform drug associated risk; background risk of major birth defects and miscarriage for indicated populations are unknown
Lactation studies have not been conducted to assess presence in human milk, effects on breastfed infant, or effects on milk production; drug is present in rat milk
Maximum Dosage
40 mg/day PO for most indications; up to 80 mg/day PO has been used off-label for H. pylori eradication; 120 mg/day PO for Zollinger-Ellison syndrome.
40 mg/day PO for most indications; up to 80 mg/day PO has been used off-label for H. pylori eradication; 120 mg/day PO for Zollinger-Ellison syndrome.
20 mg/day PO is the FDA-approved maximum; however, up to 40 mg/day PO has been used off-label for H. pylori eradication.
12 years: 20 mg/day PO is the FDA-approved maximum; however, up to 40 mg/day PO has been used off-label for H. pylori eradication.
1 to 11 years: 10 mg/day PO (delayed-release capsules) is the FDA-approved maximum; however, up to 2.5 mg/kg/day PO (Max: 40 mg/day) has been used off-label for H. pylori eradication.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Rabeprazole sodium
tablet, delayed-release
- 20mg