Rabeprazole
Regulatory sources consulted
- openfda-label-cd95d6fc-099e-4ba3-98f1-b30a2301c268
- AEMPS CIMA FT_62461
- ANSM BDPM RCP 67462665
- PubMed PMID:38345252 ↗
- PubMed PMID:35787720 ↗
- PubMed PMID:36142643 ↗
- PubMed PMID:37635269 ↗
- PubMed PMID:35356038 ↗
- OpenFDA · A02BC04
- AEMPS CIMA · nº registro 62461 ↗
- ANSM BDPM · CIS 67462665 ↗
- RxNorm rxcui 114979 ↗
Approved indications
- Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD) in adults.
- Maintenance of Healing of Erosive or Ulcerative GERD in adults.
- Treatment of Symptomatic GERD in adults and adolescents 12 years of age and older.
- Healing of Duodenal Ulcers in adults.
- Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence (in combination with antibiotics).
- Treatment of Pathological Hypersecretory Conditions, Including Zollinger-Ellison Syndrome.
Contraindications
Absolute
- Known hypersensitivity to rabeprazole, substituted benzimidazoles, or to any component of the formulation.
- Concomitant use with rilpivirine-containing products.
- Pregnancy and lactation.
Clinical warnings
- PPI therapy may be associated with an increased risk of Clostridium difficile-associated diarrhea. — FDA
- Long-term use may be associated with an increased risk of osteoporosis-related bone fractures. — FDA
- Severe hypomagnesemia has been reported in patients treated with PPIs for at least 3 months. — FDA
- Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or deficiency of cyanocobalamin (vitamin B-12). — FDA
Drug interactions
- HighRilpivirineJ05AG05
Mechanism: Rabeprazole elevates gastric pH, which significantly reduces the absorption of rilpivirine and may lead to loss of virologic response.
Recommendation: Concomitant use is contraindicated.
FDA label
- HighMethotrexateL01BA01
Mechanism: Concomitant use, especially at high doses, may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to toxicity.
Recommendation: Avoid concomitant use with high-dose methotrexate. Consider temporary withdrawal of rabeprazole in some patients.
FDA labelANSM RCP
- ModerateWarfarinB01AA03
Mechanism: Increases in INR and prothrombin time have been reported. The exact mechanism is unclear, possibly competitive inhibition of metabolism.
Recommendation: Monitor INR and prothrombin time. Warfarin dose adjustment may be necessary.
FDA label
- HighAtazanavirJ05AE08
Mechanism: Atazanavir absorption is pH-dependent. Rabeprazole increases gastric pH, decreasing atazanavir exposure and efficacy.
Recommendation: Co-administration is not recommended. Refer to atazanavir prescribing information for specific guidance if unavoidable.
ANSM RCP
Adverse events
Common (≥1%)
headache · diarrhea · abdominal pain · pharyngitis · flatulence · constipation · nausea
Rare but serious
acute tubulointerstitial nephritis · hypomagnesemia · cutaneous and systemic lupus erythematosus · fundic gland polyps · Stevens-Johnson syndrome · toxic epidermal necrolysis · hepatotoxicity
Pregnancy and lactation
FDA category: Contraindicated
Contraindicated during pregnancy and lactation according to the European SPC. Human data is limited.
Recent literature (PubMed)
Este metaanálisis en red comparó los bloqueadores de ácido competitivos con potasio (P-CAB) con los IBP (incluido el rabeprazol) para la esofagitis grave (grado C/D). El vonoprazan (un P-CAB) se clasificó como el más eficaz para la curación inicial y de mantenimiento, aunque con un perfil de seguridad similar a corto y largo plazo que los IBP.
Revisión sobre las interacciones farmacológicas de los IBP. Destaca que el rabeprazol, junto con el pantoprazol y el dexlansoprazol, es un inhibidor débil del CYP2C19, lo que lo convierte en una opción preferible cuando se co-prescriben medicamentos metabolizados por esta vía, en comparación con inhibidores fuertes como el omeprazol.
Revisión narrativa que discute la asociación entre el uso a largo plazo de IBP y el riesgo de fracturas osteoporóticas. Aunque existe evidencia observacional sustancial, la relación no está completamente admitida debido a la falta de efectos consistentes en la densidad mineral ósea. El rabeprazol se incluye como parte de esta clase de fármacos.
Revisión sistemática Cochrane sobre el tratamiento farmacológico del reflujo gastroesofágico en niños. Concluye que hay evidencia limitada o poco clara sobre la eficacia de los IBP (principalmente omeprazol) en comparación con placebo en lactantes, debido a la heterogeneidad de los estudios.
Revisión sistemática sobre el manejo del bruxismo del sueño. El rabeprazol se menciona como una de las terapias farmacológicas que mostraron reducciones significativas en parámetros específicos del bruxismo, aunque se necesitan más estudios rigurosos para confirmar la eficacia y seguridad.