Dosing & Uses
Dosage Forms & Strengths
tablet, delayed-release
- 20mg
Duodenal Ulcer
Indicated for short-term (up to 4 weeks) treatment in healing and symptomatic relief of duodenal ulcers
20 mg PO qDay after morning meal for up to 4 weeks; to achieve healing, some patients may require additional therapy
Helicobacter Pylori Eradication
In combination with amoxicillin and clarithromycin for treatment of H pylori infection and duodenal ulcer disease (active or history within past 5 yr)
20 mg PO BID for 7 days with morning and evening meals; take with amoxicillin 1000 mg PO BID and clarithromycin 500 mg BID
Gastroesophageal Reflux Disease
Healing or erosive or ulcerative GERD
- 20 mg PO qDay for 4-8 weeks; if not healed after 8 weeks, an additional 8-week course may be considered
- Maintenance dosing (20 mg/day for up to 12 months) shown to reduce relapse rates
Symptomatic GERD
- Treatment of daytime and nighttime heartburn and other symptoms associated with GERD
- 20 mg PO qDay for 4 weeks; if symptoms not completely resolved after 4 weeks, an additional course may be considered
Hypersecretory Conditions
Long-term treatment of pathologic hypersecretory conditions, including Zollinger-Ellison syndrome
60 mg PO qDay initially; may increase to 100 mg PO qDay or 60 mg PO q12hr
Dosing considerations
- Continue use as long as clinically needed; some patients with SE have been treated continuously for up to 1 yr
Dosage Modifications
Renal impairment: Dose adjustment not necessary
Hepatic impairment
- Mild to moderate: Dose adjustment not necessary
- Severe: Not studied
Dosage Forms & Strengths
tablet, delayed-release
- 20mg
capsule, sprinkle
- 5mg
- 10mg
Gastroesophageal Reflux Disease
Delayed-release tablet
- Indicated for short-term treatment of symptomatic GERD in adolescents
- <12 years: Safety and efficacy not established
- ≥12 years: 20 mg PO qDay for up to 8 weeks
Delayed-release capsule (sprinkles)
- <1 year: Safety and efficacy not established
- 1-11 years (<15 kg): 5 mg PO qDay 30 minutes before a meal, for up to 12 weeks; may increase to 10 mg/day if inadequate response
- 1-11 years (≥15 kg): 10 mg PO qDay 30 minutes before a meal, for up to 12 weeks
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Adverse Effects
1-10%
Headache (2-10%)
Constipation (2%)
Diarrhea (2-5%)
Flatulence (3%)
Pain (3%)
Pharyngitis (3%)
Abdominal pain (4%)
<1%
Agitation
Agranulocytosis
Alopecia
Anemia
Angioedema
Chest pain
Delirium
Erythema multiforme
Hypokalemia
Hypomagnesemia
Hyponatremia
Jaundice
Leukocytosis
Leukopenia
Migraine
Osteoporosis related fracture
Rhabdomyolysis
Stevens-Johnson syndrome
Sudden death
Toxic epidermal necrolysis
Abnormal taste
Postmarketing Reports
Cutaneous and systemic lupus erythematosus
Cyanocobalamin (vitamin B-12) deficiency
Blood and lymphatic system disorders: Hemolytic anemia, pancytopenia, thrombocytopenia
Ear and labyrinth disorders: Vertigo
Eye disorders: Blurred vision
Immune system disorders: Anaphylaxis, toxic epidermal necrolysis (some fatal)
Infections and ifestations: Clostridium difficile-associated diarrhea
Investigations: Increases in prothrombin time/INR (in patients treated with concomitant warfarin), TSH elevations
Metabolism and nutrition disorders: Hyperammonemia
Musculoskeletal system disorders: Bone fracture
Nervous system disorders: Coma
Psychiatric disorders: Disorientation
Renal and urinary disorders: Interstitial nephritis
Respiratory, thoracic and mediastinal disorders: Interstitial pneumonia
Skin and subcutaneous tissue disorders: Severe dermatologic reactions including bullous and other drug eruptions of the skin
Gastrointestinal: Fundic gland polyps
Warnings
Contraindications
Hypersensitivity to rabeprazole or other proton pump inhibitors (PPIs)
Rilpivirine-containing products
Cautions
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
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
Hypomagnesemia may occur with prolonged use (ie, >1 yr); adverse effects, such as tetany, arrhythmias, or seizures, may result; in 25% of cases reviewed, magnesium supplementation alone did not improve low serum magnesium levels, and the PPI had to be discontinued; consider monitoring magnesium levels prior to initiation of PPI treatment and periodically
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 & Lactation
Pregnancy
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; however, background risk in U.S. general population of major birth defects is 2-4% and of miscarriage is 15- 20% of clinically recognized pregnancies; no evidence of adverse developmental effects were seen in animal reproduction studies with rabeprazole administered during organogenesis at 13 and 8 times human area under plasma concentration-time curve (AUC) at recommended dose for GERD, in rats and rabbits, respectively; changes in bone morphology were observed in offspring of rats treated with oral doses of different PPI through most of pregnancy and lactation; when maternal administration was confined to gestation only, there were no effects on bone physeal morphology in offspring at any age
Lactation
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; development and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed infant from drug or from underlying maternal condition
Pregnancy Categories
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Pharmacology
Mechanism of Action
Proton pump inhibitor (PPI); binds to H+/K+-exchanging ATPase (proton pump) in gastric parietal cells, blocking acid secretion
Absorption
Bioavailability: 52%
Onset: Within 1 hr
Duration: 24 hr
Peak plasma time: 2-5 hr (tablet); 1-6.5 hr (capsule)
Distribution
Protein bound: 95-98%
Metabolism
Metabolism: Liver; extensively by hepatic P450 enzyme CYP2C19; second pathway through CYP3A4; also by non-enzymatic reduction
Metabolites (presumed inactive): Rabeprazole thioether, sulfone metabolite, desmethyl metabolite, desmethyl thioether, thioether carboxylic acid
CYP2C19 substrate (minor)
Elimination
Half-life elimination: 1-2 hr, depending on dose
Dialyzable: No
Total body clearance: 4-8 mL/min/kg
Excretion: Urine (90%); feces (10%)
Administration
Oral Administration
Delayed-release tablet
- Administer with or without meals
- Swallow tablet whole; do not chew or crush
Delayed-release capsule
- Take 30 minutes before a meal
- Contains enteric coated granules (acid labile); do not chew or crush
- Do not swallow capsule whole
- Open capsule and sprinkle entire contents on small amount of soft food (eg, applesauce, fruit- or vegetable-based baby food, or yogurt) or empty contents into a small amount of liquid (eg, infant formula, apple juice, or pediatric electrolyte solution)
- Take entire dose within 15 minutes of preparation
- Food or liquid should be at or below room temperature; do not store mixture for future use
Missed dose
- Administer a missed dose as soon as possible
- If administration time is close to the following dose, skip missed dose and take current dose
- Do not take 2 doses at the same time
Storage
Delayed release tablet and capsule: Store at room temperature at 77°F (25°C); excursions permitted to 59-86°F (15-30°C)
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Patient Handout
Formulary
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