pharmacopeia
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/api/v1/drug/rabeprazole

Mechanism of action

Sourced from openFDA

Rabeprazole belongs to a class of antisecretory compounds (substituted benzimidazole proton-pump inhibitors) that do not exhibit anticholinergic or histamine H 2 -receptor antagonist properties, but suppress gastric acid secretion by inhibiting the gastric H + , K + ATPase at the secretory surface of the gastric parietal cell. Because this enzyme is regarded as the acid (proton) pump within the parietal cell, rabeprazole has been characterized as a gastric proton-pump inhibitor.

Proton Pump

Indications

Sourced from openFDA
  • Rabeprazole sodium delayed-release tablets is a proton pump inhibitor (PPI) indicated in adults for: Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD) ( 1.1 ). Maintenance of Healing of Erosive or Ulcerative GERD ( 1.2 ).ICD-10: K21.9

Contraindications

Sourced from openFDA
  • Patients with a history of hypersensitivity to rabeprazole ( 4 ). PPIs, including rabeprazole sodium delayed-release tablets, are contraindicated in patients receiving rilpivirine-containing products ( 4 , 7 ).contraindicated

Dosage & administration

Sourced from openFDA

Indication Recommended Dosage ( 2 ) Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD) 20 mg once daily for 4 to 8 weeks Maintenance of Healing of Erosive or Ulcerative GERD* studied for 12 months 20 mg once daily* Symptomatic GERD in Adults 20 mg once daily for 4 weeks Healing of Duodenal Ulcers 20 mg once daily after morning meal for up to 4 weeks Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Three Drug Regimen: Rabeprazole sodium delayed-release tablets 20 mg Amoxicillin 1,000 mg Clarithromycin 500 mg All three medications should be taken twice daily with morning and evening meals for 7 days. Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome Starting dose 60 mg once daily then adjust to patient needs Symptomatic GERD in Adolescents 12 Years of Age and Older 20 mg once daily for up to 8 weeks Administration Instructions ( 2 ) : Swallow rabeprazole sodium delayed-release tablets whole. Do not chew, crush or split the tablets. For the treatment of duodenal ulcers take rabeprazole sodium delayed-release tablets after a meal. For Helicobacter pylori eradication take rabeprazole sodium delayed-release tablets with food. For all other indications rabeprazole sodium delayed-release tablets can be taken with or without food. Table 1 shows the recommended dosage of rabeprazole sodium delayed-release tablets in adults and adolescent patients 12 years of age and older.

Warnings & precautions

Sourced from openFDA

Gastric Malignancy : In adults, symptomatic response to therapy with rabeprazole does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing ( 5.1 ). Use with Warfarin : Monitor for increases in INR and prothrombin time ( 5.2 , 7 ). Acute Tubulointerstitial Nephritis : Discontinue treatment and evaluate patients ( 5.3 ). Clostridium difficile- Associated Diarrhea : PPI therapy may be associated with increased risk of ( 5.4 ). Bone Fracture : Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine ( 5.5 ). Severe Cutaneous Adverse Reactions : Discontinue at the first signs or symptoms of severe cutatneous adverse reactions or other signs of hypersensitivity and consider further evaluation ( 5.6 ). Cutaneous and Systemic Lupus Erythematosus : Mostly cutaneous, new onset or exacerbation of existing disease; discontinue rabeprazole sodium delayed-release tablets and refer to specialist for evaluation ( 5.7 ). Cyanocobalamin (Vitamin B-12) Deficiency : Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin ( 5.8 ). Hypomagnesemia and Mineral Metabolism : Reported rarely with prolonged treatment with PPIs ( 5.9 ). Interaction with Methotrexate : Concomitant use with PPIs may elevate and/or prolong serum concentrations of methotrexate and/or its metabolite, possibly leading to toxicity.

Adverse reactions

Sourced from openFDA

Most common adverse reactions in adults (>2%) are pain, pharyngitis, flatulence, infection, and constipation ( 6.1 ). Most common adverse reactions in adolescents (≥2%) are headache, diarrhea, nausea, vomiting, and abdominal pain ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Torrent Pharma Inc. at 1-800-912-9561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch The following serious adverse reactions are described below and elsewhere in labeling: Acute Tubulointerstitial Nephritis [see Warnings and Precautions ( 5.3 )] Clostridium difficile- Associated Diarrhea [see Warnings and Precautions ( 5.4 )] Bone Fracture [see Warnings and Precautions ( 5.5 )] Cutaneous and Systemic Lupus Erythematosus [ see Warnings and Precautions ( 5.7 ) ] Cyanocobalamin (Vitamin B-12) Deficiency [see Warnings and Precautions ( 5.8 )] Hypomagnesemia and Mineral Metabolism [see Warnings and Precautions ( 5.9 )] Fundic Gland Polyps [see Warnings and Precautions ( 5.11 )] 6.1 Clinical Studies Experience Because clinical trials are conducted under varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adults The data described below reflect exposure to rabeprazole sodium delayed-release tablets in 1,064 adult patients exposed for up to 8 weeks. The studies were primarily placebo- and active-controlled trials in adult patients with Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD), Duodenal Ulcers and Gastric Ulcers.

Use in specific populations

Sourced from openFDA

Pediatric Use : Dosage strength not appropriate for patients less than 12 years ( 2 , 8.4 ). 8.1 Pregnancy Risk Summary There are no available human data on rabeprazole sodium delayed-release tablets use in pregnant women to inform the drug associated risk. The background risk of major birth defects and miscarriage for the indicated populations are unknown. However, the background risk in the U.S. general population of major birth defects is 2 to 4% and of miscarriage is 15 to 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 the human area under the plasma concentration-time curve (AUC) at the recommended dose for GERD, in rats and rabbits, respectively [see Data] . Changes in bone morphology were observed in offspring of rats treated with oral doses of a 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 the offspring at any age [ see Data] .

Pharmacokinetics

Sourced from openFDA
Metabolism
After oral administration of 20 mg rabeprazole sodium delayed-release tablets, peak plasma concentrations (C max ) of rabeprazole occur over a range of 2 to 5 hours (T max ). The rabeprazole C max and AUC are linear over an oral dose range of 10 mg to 40 mg.

Overdosage

Sourced from openFDA

Seven reports of accidental overdosage with rabeprazole have been received. The maximum reported overdose was 80 mg. There were no clinical signs or symptoms associated with any reported overdose. Patients with Zollinger-Ellison syndrome have been treated with up to 120 mg rabeprazole once daily. No specific antidote for rabeprazole is known. Rabeprazole is extensively protein bound and is not readily dialyzable. In the event of overdosage, treatment should be symptomatic and supportive. If over-exposure occurs, call your Poison Control Center at 1-800-222-1222 for current information on the management of poisoning or overdosage.

Approval history

Sourced from openFDA
  • Aug 19, 1999NDANDA020973Waylis Therap
  • Nov 8, 2013ANDAANDA202376Torrent
  • Nov 8, 2013ANDAANDA090678Lannett Co Inc
  • Jul 31, 2015ANDAANDA204179Amneal Pharms
  • Nov 18, 2015ANDAANDA204237Rubicon Research
  • Feb 17, 2017ANDAANDA205761Aurobindo Pharma Usa
  • Apr 24, 2018ANDAANDA208644Alkem Labs Ltd

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
37,801 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Chronic Kidney Disease4,97413%
  2. 2Renal Failure3,5359.4%
  3. 3Acute Kidney Injury2,8417.5%
  4. 4Drug Ineffective2,6397.0%
  5. 5Nausea2,5006.6%
  6. 6Pain2,0285.4%
  7. 7Off Label Use2,0065.3%
  8. 8Headache1,9655.2%
  9. 9Diarrhoea1,9155.1%
  10. 10Fatigue1,8925.0%
  11. 11Dyspnoea1,8845.0%
  12. 12Arthralgia1,7414.6%
  13. 13Dizziness1,5154.0%
  14. 14Death1,4903.9%
  15. 15Malaise1,4423.8%

Literature

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Recent PubMed references pinned to Rabeprazole as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 282 ClinicalTrials.gov registrations naming Rabeprazole as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Pharmacogenomics

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CPIC-curated drug–gene pairs for Rabeprazole. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

Frequently asked questions

How does Rabeprazole work?
Rabeprazole belongs to a class of antisecretory compounds (substituted benzimidazole proton-pump inhibitors) that do not exhibit anticholinergic or histamine H 2 -receptor antagonist properties, but suppress gastric acid secretion by inhibiting the gastric H + , K + ATPase at the secretory surface of the gastric parietal cell. Because this enzyme is regarded as the acid (proton) pump within the parietal cell, rabeprazole has been characterized as a gastric proton-pump inhibitor.
What is Rabeprazole used for?
According to FDA labeling, Rabeprazole carries indications including: Rabeprazole sodium delayed-release tablets is a proton pump inhibitor (PPI) indicated in adults for: Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD) ( 1.1 ). Maintenance of Healing of Erosive or Ulcerative GERD ( 1.2 ).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Rabeprazole?
Rabeprazole is classified as Proton pump inhibitors, Proton Pump Inhibitor, Proton Pump Inhibitors, Inhibition Gastric Acid Secretion.
What are the brand names for Rabeprazole?
Rabeprazole is marketed under brand names including Aciphex.
What are the contraindications for Rabeprazole?
Rabeprazole labeling lists contraindications including: Patients with a history of hypersensitivity to rabeprazole ( 4 ). PPIs, including rabeprazole sodium delayed-release tablets, are contraindicated in patients receiving rilpivirine-containing products ( 4 , 7 ).. Always consult the full prescribing information and a clinician.
Note. Data for rabeprazole is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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