rabeprazole (Rx)

Brand and Other Names:Aciphex, Aciphex Sprinkle
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Dosing & Uses

AdultPediatric

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
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Interactions

Interaction Checker

and rabeprazole

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    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 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

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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

            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

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            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.

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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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            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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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            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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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.