Rabeprazole

DEA Class; Rx

Common Brand Names; Aciphex, Aciphex Sprinkle

  • Proton Pump Inhibitors

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

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)

For the treatment of erosive esophagitis (erosive GERD).
For the healing of duodenal ulcer.
For the treatment of pathological hypersecretory conditions including Zollinger-Ellison syndrome.
For Helicobacter pylori (H. pylori) eradication.
For the short-term treatment of frequent dyspepsia or pyrosis (heartburn) that occurs 2 or more times per week.
For the healing of gastric ulcer.
For the treatment of eosinophilic esophagitis (EoE).

Hypersensitivity to rabeprazole or other proton pump inhibitors (PPIs)

Rilpivirine-containing products

  • 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

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

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

Adults

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.

Geriatric

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.

Adolescents

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.

Children

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.

Infants

Safety and efficacy have not been established.

Neonates

Safety and efficacy have not been established.

Rabeprazole sodium

tablet, delayed-release

  • 20mg

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