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Rabeprazole

Brand Name: Aciphex, Aciphex Sprinkle

Generic Name: Rabeprazole

Drug Class: Proton Pump Inhibitors

What Is Rabeprazole and How Does It Work?

Rabeprazole is a proton pump inhibitor (PPI) to reduce stomach acid and is used for the treatment of gastroesophageal reflux disease (GERD), duodenal ulcers, and used in combination with antibiotics to treat Helicobacter pylori (H. pylori) bacterial infections in the stomach.

Rabeprazole is available under the following different brand names: Aciphex and Aciphex Sprinkle.

Dosages of Rabeprazole

Dosage Forms and Strengths

Tablet, delayed-release

Capsule, sprinkle

  • 5 mg
  • 10 mg

Dosage Considerations – Should be Given as Follows:

sprinkle

  • Indicated for short-term (up to 4 weeks) treatment in healing and symptomatic relief of duodenal ulcers
  • 20 mg orally once/day 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 years)
  • 20 mg orally twice daily for 7 days with morning and evening meals; take with amoxicillin 1000 mg orally twice daily and clarithromycin 500 mg twice daily

Gastroesophageal Reflux Disease (GERD)

Adult:

Healing or erosive or ulcerative GERD

  • 20 mg orally once/day 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 orally once/day for 4 weeks; if symptoms not completely resolved after 4 weeks, an additional course may be considered

Pediatric:

Delayed-release tablet

  • Indicated for short-term treatment of symptomatic GERD in adolescents
  • Children 12 years and older: 20 mg orally once/day for up to 8 weeks
  • Children under 12 years: Safety and efficacy not established

Delayed-release capsule (sprinkles)

  • Children 1-12 years (less than 15 kg): 5 mg orally once/day 30 minutes before a meal, for up to 12 weeks; may increase to 10 mg/day if inadequate response
  • Children 1-12 years (15 kg or greater): 10 mg orally once/day 30 minutes before a meal, for up to 12 weeks
  • Children under 1 year: Safety and efficacy not established

Hypersecretory Conditions

Long-term treatment of pathologic hypersecretory conditions, including Zollinger-Ellison syndrome

60 mg orally once/day initially; may increase to 100 mg orally once/day or 60 mg orally every 12 hours

Dosing considerations

  • Continue use as long as clinically needed; some patients with SE have been treated continuously for up to 1 year

Dosage Modifications

Renal impairment: Dose adjustment not necessary

Hepatic impairment

  • Mild to moderate: Dose adjustment not necessary
  • Severe: Not studied

SLIDESHOW

Digestive Disorders: Common Misconceptions See Slideshow

What Are Side Effects Associated with Using Rabeprazole?

Common side effects of Rabeprazole include:

Less common side effects of rabeprazole include:

Postmarketing side effects of rabeprazole reported include:

This is not a complete list of side effects and other serious side effects may occur. Call your doctor for information and medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What Other Drugs Interact with Rabeprazole?

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

Severe interactions of rabeprazole include:

  • erlotinib
  • nelfinavir
  • rilpivirine

Serious interactions of rabeprazole include:

Rabeprazole has moderate interactions with at least 49 different drugs.

Rabeprazole has mild interactions with at least 59 different drugs.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. Check with your physician if you have health questions or concerns.

What Are Warnings and Precautions for Rabeprazole?

Warnings

This medication contains rabeprazole. Do not take Aciphex or Aciphex Sprinkle if you are allergic to rabeprazole or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

  • Hypersensitivity to rabeprazole or other proton pump inhibitors (PPIs)
  • Rilpivirine-containing products

Effects of Drug Abuse

  • No information available

Short-Term Effects

  • See "What Are Side Effects Associated with Using Rabeprazole?"

Long-Term Effects

  • 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 (greater than 1 year), high-dose therapy.
  • Hypomagnesemia may occur with prolonged use (i.e., greater than 1 year); 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.
  • Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin.
  • See "What Are Side Effects Associated with Using Rabeprazole?"

Cautions

  • Proton pump inhibitors (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 (greater than 1 year), 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 (i.e., greater than 1 year); 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.

Pregnancy and Lactation

  • Use rabeprazole with caution during pregnancy if benefits outweigh risks. Animal studies show risk and human studies are not available or neither animal nor human studies were done.
  • It is unknown whether rabeprazole is distributed into breast milk; use caution if breastfeeding.
References

Medscape. Rabeprazole.
https://reference.medscape.com/drug/aciphex-rabeprazole-342002
RxList. Aciphex.
https://www.rxlist.com/aciphex-side-effects-drug-center.htm
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