Lansoprazole
Regulatory sources consulted
- openfda-label-ce9167b4-3b92-9cbd-f4f5-a8788ed0d47a
- https://cima.aemps.es/cima/dochtml/ft/66146/FT_66146.html
- https://base-donnees-publique.medicaments.gouv.fr/affichageDoc.php?specid=69966450&typedoc=R
- PubMed PMID:39466269 ↗
- PubMed PMID:36228734 ↗
- PubMed PMID:35679950 ↗
- PubMed PMID:36142643 ↗
- PubMed PMID:35787720 ↗
- Flockhart Table
- Professional Clinical Knowledge
- OpenFDA · A02BC03
- AEMPS CIMA · nº registro 66146 ↗
- ANSM BDPM · CIS 69966450 ↗
- RxNorm rxcui 17128 ↗
Approved indications
- Short-term treatment (for four weeks) for healing and symptom relief of active duodenal ulcer.
- Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence (in combination therapy).
- Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older.
- Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older.
- Healing of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults.
- Pathological hypersecretory conditions, including Zollinger-Ellison Syndrome (ZES) in adults.
Contraindications
Absolute
- Known hypersensitivity to lansoprazole or any component of the formulation.
- Concomitant use with rilpivirine-containing products.
Clinical warnings
- Major warning · Risk of Clostridium difficile-Associated Diarrhea. PPI use may increase risk. — FDA
- Bone Fracture: Long-term and high-dose use may increase the risk of hip, wrist, and spine fractures. — FDA
- Major warning · Hypomagnesemia: Has been rarely reported with prolonged treatment (usually >1 year). — FDA
- Major warning · Acute Tubulointerstitial Nephritis (ATIN): Has been observed in patients taking PPIs. — FDA
Drug interactions
- HighRilpivirineJ05AG05
Mechanism: Lansoprazole increases gastric pH, which can significantly decrease the absorption and plasma concentrations of rilpivirine, reducing its antiviral effect.
Recommendation: Concomitant use is contraindicated.
FDA label
- HighMethotrexateL01BA01
Mechanism: Concomitant use of PPIs with methotrexate (primarily at high dose) may elevate and prolong serum concentrations of methotrexate and/or its metabolite, possibly leading to toxicities.
Recommendation: Consider temporary withdrawal of lansoprazole during high-dose methotrexate administration.
FDA labelANSM RCP
- ModerateClopidogrelB01AC04
Mechanism: Lansoprazole is a strong inhibitor of CYP2C19, an enzyme required to activate the prodrug clopidogrel. Inhibition can reduce the antiplatelet efficacy of clopidogrel.
Recommendation: Avoid the combination if possible. Consider using a PPI with lower CYP2C19 inhibition potential (e.g., pantoprazole) or an alternative antiplatelet agent.
PMID:35787720
- HighTacrolimusL04AD02
Mechanism: Concomitant administration of lansoprazole increases plasma concentrations of tacrolimus (a CYP3A4 and P-gp substrate), which can increase the risk of nephrotoxicity.
Recommendation: Closely monitor tacrolimus plasma concentrations when initiating, modifying, or discontinuing lansoprazole. A tacrolimus dose adjustment may be necessary.
ANSM RCP
Adverse events
Common (≥1%)
diarrhea · abdominal pain · nausea · constipation · headache
Rare but serious
acute tubulointerstitial nephritis · Clostridium difficile-associated diarrhea · hypomagnesemia · bone fracture · cutaneous and systemic lupus erythematosus · pancytopenia · agranulocytosis · anaphylactic shock
Pregnancy and lactation
Based on animal data, may cause adverse effects on fetal bone growth and development. Available observational data do not indicate an association of adverse pregnancy outcomes with lansoprazole treatment.
Recent literature (PubMed)
En un ensayo aleatorizado de 1024 pacientes, vonoprazan 20 mg fue superior a lansoprazol 30 mg para la cicatrización de la esofagitis erosiva a las 8 semanas (92.9% vs 84.6%). En la fase de mantenimiento, vonoprazan (10 mg y 20 mg) también fue superior a lansoprazol 15 mg para mantener la cicatrización a las 24 semanas.
Ensayo fase 3 que compara regímenes basados en vonoprazan frente a la triple terapia estándar con lansoprazol para la erradicación de H. pylori. La triple terapia con vonoprazan fue superior a la triple terapia con lansoprazol en la población general (80.8% vs 68.5%) y marcadamente superior en infecciones resistentes a claritromicina (65.8% vs 31.9%).
Revisión sobre la enfermedad ulcerosa péptica que destaca que los inhibidores de la bomba de protones como el lansoprazol son el tratamiento principal, curando el 80-100% de las úlceras en 4 semanas. Subraya la importancia de erradicar H. pylori y suspender AINEs para prevenir la recurrencia.
Revisión de las interacciones farmacológicas de los IBP. Clasifica al lansoprazol, junto con omeprazol y esomeprazol, como un inhibidor potente de CYP2C19, lo que subraya la necesidad de vigilancia clínica, especialmente con profármacos como el clopidogrel. Sugiere que pantoprazol o rabeprazol pueden ser alternativas preferibles en ciertos escenarios de polimedicación.
Revisión narrativa que discute la evidencia que asocia el uso a largo plazo de IBP, incluido el lansoprazol, con un mayor riesgo de fracturas osteoporóticas. Aunque los estudios son observacionales y los mecanismos no están completamente elucidados, se recomienda una cuidadosa consideración del riesgo/beneficio en tratamientos prolongados.