rabeprazole (Rx)Brand and Other Names:Aciphex, Aciphex Sprinkle

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet, delayed-release

  • 20mg
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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

Administration

Administer with or without meals

Swallow tablet whole; do not chew or crush

Dosing 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
more...

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
  • 1-12 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
  • 1-12 years (≥15 kg): 10 mg PO qDay 30 minutes before a meal, for up to 12 weeks

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
  • Granules should not be chewed or crushed; 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)
  • The whole dose should be taken within 15 minutes of preparation
  • Food or liquid should be at or below room temperature; do not store mixture for future use
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Interactions

Interaction Checker

rabeprazole and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            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

            Hypokalemia

            Hypomagnesemia

            Hyponatremia

            Jaundice

            Leukocytosis

            Leukopenia

            Migraine

            Osteoporosis related fracture

            Rhabdomyolysis

            Stevens-Johnson syndrome

            Sudden death

            Toxic epidermal necrolysis

            Abnormal taste

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            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

            Liver disease: May require dosage reduction

            Atrophic gastritis may occur as has occurred with omeprazole

            Contains enteric coated granules (acid labile); do not chew or crush

            Use of proton pump inhibitors may increase risk of salmonella and campylobacter infection

            Reduce of symptoms does not eliminate presence of gastric malignancy

            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

            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

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            Pregnancy & Lactation

            Pregnancy category: C

            Lactation: Unknown whether rabeprazole is distributed into breast milk; use caution

            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.

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            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%)

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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