Proton pump inhibitor (PPI)
Updated · Methodology
First line
First-line for gastroesophageal reflux disease per 2022 and Spanish AEG 2024 alongside other PPIs. Standard dose 30 mg once daily for 4–8 weeks. In erosive esophagitis, extend to 8 weeks with possible step-down to maintenance 15 mg. The 2019 Cochrane meta-analysis showed comparable efficacy across PPIs; differences are in cost and individual tolerability.
Sources
ICD-10: K21 · ICD-11: DA22
First line
First-line for gastric and duodenal ulcer per 2017. Dose 30 mg once daily for 4–8 weeks within H. pylori eradication (with amoxicillin, clarithromycin, or metronidazole for 10–14 days) or as monotherapy in HP-negative ulcer.
Sources
ICD-10: K27 · ICD-11: DA61
The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.
Not recommended
Lansoprazole is used prophylactically in low-risk NSAID-gastropathy patients and for unevaluated heartburn. 2022 limits PPIs to patients with confirmed risk factors. In low-risk populations the benefit-risk balance is unfavorable, with long-term use linked to fractures ( DSC 2011), hypomagnesemia (FDA DSC 2011), B12 deficiency and CDI (FDA DSC 2012).
A benzimidazole. In the acidic secretory canaliculi of parietal cells, it converts to active sulfenamide that covalently binds the H+/K+-ATPase (proton pump). Suppresses basal and stimulated acid secretion by 80–95% over 24 hours. Compared with omeprazole, faster onset and higher bioavailability (80–90%). CYP2C19- and CYP3A4-metabolized. Half-life 1.5 hours, but the effect lasts over 24 hours via irreversible pump binding.
AEMPS summary of product characteristics (section 4.6): there are no clinical data on lansoprazole exposure during pregnancy. Animal studies do not suggest direct or indirect harmful effects on pregnancy, embryonic or fetal development, delivery or postnatal development. Therefore, lansoprazole is not recommended during pregnancy.
Compatible with breastfeeding.
Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.
Verbatim lines from the interaction sections, in the language of the label
«Inhibidores de la proteasa del VIH: No se recomienda la administración conjunta de lansoprazol con inhibidores de la proteasa del VIH, tales como atazanavir y nelfinavir, debido a que se produce una…»AEMPS, section 4.5 · Open on CIMA
«DRUG INTERACTIONS: Intervention: Rilpivirine-containing products: Concomitant use with lansoprazole delayed-release capsules is contraindicated [see Contraindications ( 4 )]. See prescribing…»FDA, section 7 · Open on DailyMed
«Ketoconazol e itraconazol: La absorción de ketoconazol e itraconazol por el tubo digestivo se incrementa por la presencia de ácidos gástricos. La administración de lansoprazol puede dar lugar a…»AEMPS, section 4.5 · Open on CIMA
«Ketoconazol e itraconazol: La absorción de ketoconazol e itraconazol por el tubo digestivo se incrementa por la presencia de ácidos gástricos. La administración de lansoprazol puede dar lugar a…»AEMPS, section 4.5 · Open on CIMA
«Digoxina: La administración concomitante de lansoprazol y digoxina puede aumentar la concentración plasmática de digoxina. Por lo tanto, se debe monitorizar la concentración plasmática de digoxina y…»AEMPS, section 4.5 · Open on CIMA
«DRUG INTERACTIONS: Intervention: Monitor digoxin concentrations. Dose adjustment of digoxin may be needed to maintain therapeutic drug concentrations. See prescribing information for digoxin.»FDA, section 7 · Open on DailyMed
«Fluvoxamina: Debe considerarse una reducción de la dosis al combinar lansoprazol con el inhibidor de CYP2C19 fluvoxamina. La concentración plasmática de lansoprazol se multiplica por cuatro.»AEMPS, section 4.5 · Open on CIMA
«DRUG INTERACTIONS: Intervention: A temporary withdrawal of lansoprazole delayed-release capsules may be considered in some patients receiving high-dose methotrexate.»FDA, section 7 · Open on DailyMed
«DRUG INTERACTIONS: Intervention: Mycophenolate mofetil (MMF): Coadministration of PPIs in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the…»FDA, section 7 · Open on DailyMed
«Tacrolimus: La administración concomitante de lansoprazol aumenta la concentración plasmática de tacrolimus (sustrato de CYP3A y glucoproteína P [Gp-P]). La exposición a lansoprazol aumentó la…»AEMPS, section 4.5 · Open on CIMA
«DRUG INTERACTIONS: Intervention: Monitor tacrolimus whole blood trough concentrations. Dose adjustment of tacrolimus may be needed to maintain therapeutic drug concentrations. See prescribing…»FDA, section 7 · Open on DailyMed
«DRUG INTERACTIONS: Intervention: Monitor INR and prothrombin time. Dose adjustment of warfarin may be needed to maintain target INR range. See prescribing information for warfarin.»FDA, section 7 · Open on DailyMed
«Antiinflamatorios no esteroideos: No se ha demostrado ninguna interacción clínicamente significativa entre lansoprazol y los antiinflamatorios no esteroideos, aunque no se han realizado estudios…»AEMPS, section 4.5 · Open on CIMA
«Sucralfato/AEMPS, section 4.5 · Open on CIMA
«DRUG INTERACTIONS: CYP2C19 OR CYP3A4 Inducers»FDA, section 7 · Open on DailyMed
«DRUG INTERACTIONS: CYP2C19 or CYP3A4 Inhibitors»FDA, section 7 · Open on DailyMed
«DRUG INTERACTIONS: Drugs Dependent on Gastric pH for Absorption (e.g., iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole/FDA, section 7 · Open on DailyMed
«DRUG INTERACTIONS: Drugs Dependent on Gastric pH for Absorption (e.g., iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole/FDA, section 7 · Open on DailyMed
«Metotrexato: La administración concomitante de lansoprazol con dosis altas de metotrexato puede elevar y prolongar los niveles séricos de metotrexato y/AEMPS, section 4.5 · Open on CIMA
«Medicamentos que inducen CYP2C19 y CYP3A4: Los inductores de enzimas que afectan a CYP2C19 y CYP3A4, como rifampicina y la hierba de San Juan o hipérico ( Hypericum perforatum ), pueden reducir…»AEMPS, section 4.5 · Open on CIMA
«Teofilina: Lansoprazol reduce la concentración plasmática de teofilina, lo que puede dar lugar a una reducción del efecto clínico previsto a una determinada dosis. Los pacientes tratados con…»AEMPS, section 4.5 · Open on CIMA
«DRUG INTERACTIONS: Theophylline»FDA, section 7 · Open on DailyMed
«DRUG INTERACTIONS: Intervention: Voriconazole: See prescribing information.»FDA, section 7 · Open on DailyMed
«Warfarina: Se han notificado casos de aumento del Índice Internacional Normalizado (INR) y del tiempo de protrombina en pacientes que toman IBPs conjuntamente con warfarina. Los aumentos en la INR y…»AEMPS, section 4.5 · Open on CIMA
«Cimetidina: La administración conjunta de escitalopram (el enantiómero activo de citalopram) con omeprazol 30 mg una vez al día (un inhibidor de la CYP2C19), produjo un incremento moderado…»AEMPS, section 4.5 · Open on CIMA
«CYP2C19 Inhibitors: Avoid concomitant use of clopidogrel with omeprazole or esomeprazole. In clinical studies, omeprazole was shown to reduce significantly the antiplatelet activity of clopidogrel…»FDA, section 7 · Open on DailyMed
«Pharmacokinetic Drug Interactions: Alprazolam, azithromycin, cyclosporine, diclofenac, diphenoxylate, epoprostenol, esomeprazole, ibuprofen, ketoconazole, lansoprazole, metformin, omeprazole Measure…»FDA, section 7 · Open on DailyMed
«Influencia de otros medicamentos en la farmacocinética de escitalopram: Por lo tanto, hay que tener precaución cuando se utiliza junto con inhibidores de la enzima CYP2C19 (ej. omeprazol…»AEMPS, section 4.5 · Open on CIMA
«Effects of Other Drugs on Tacrolimus: Mild or Moderate CYP3A Inhibitors: Clotrimazole, antibiotics (e.g., erythromycin, fluconazole), calcium channel blockers (e.g., verapamil, diltiazem, nifedipine…»FDA, section 7 · Open on DailyMed
«Se han observado reducciones menos pronunciadas de la exposición al metabolito con pantoprazol o lansoprazol.»AEMPS, section 4.5 · Open on CIMA
«Inhibidores enzimáticos: El inhibidor de la bomba de protones, omeprazol, inhibidor de CYP3A4 y CYP2C19, administrado a dosis de 20 mg al día incrementa el AUC de diazepam en un 40% y la semivida en…»AEMPS, section 4.5 · Open on CIMA
«Medicamentos para los trans tornos relacionados con la acidez: Antiácidos (aluminio, calcio, magnesio o bicarbonato de sodio), Antagonistas del receptor-H2 (p.ej., cimetidina, ranitidina)…»AEMPS, section 4.5 · Open on CIMA
«La absorción del hierro puede incrementarse por la administración simultánea de 200 mg de ácido ascórbico y reducirse con la administración simultánea de antiácidos, colestiramina o inhibidores de la…»AEMPS, section 4.5 · Open on CIMA
«Antiácidos e inhibidores de la bomba de protones (IBPs): Se observó un descenso en la exposición del MPA cuando antiácidos, como hidróxidos de magnesio y aluminio, e IBPs, incluyendo lansoprazol y…»AEMPS, section 4.5 · Open on CIMA
«Effect of Other Drugs on Mycophenolate Mofetil: Examples Lansoprazole, pantoprazole»FDA, section 7 · Open on DailyMed
«La co-administración de atazanavir 300 mg/AEMPS, section 4.5 · Open on CIMA
«Medicamentos metabolizados por el citocromo P450: En las personas que son metabolizadores lentos de CYP2C19, los niveles plasmáticos de sertralina se aumentan aproximadamente en un 50% en comparación…»AEMPS, section 4.5 · Open on CIMA
«Recomendaciones relativas a la a dministración simultánea: Inhibidores del CYP3A4 moderados o débiles: agentes antifúngicos (p. ej., fluconazol, isavuconazol, clotrimazol, miconazol), antibióticos…»AEMPS, section 4.5 · Open on CIMA
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Lansoprazole is evaluated for the following indications with varying evidence strength: Peptic ulcer disease (evidence tier A), Gastroesophageal reflux disease (evidence tier A), PPI for NSAID gastric prophylaxis in low-risk patients (evidence tier F). See the full indication matrix with dosing and citations above on this page.
Common side effects of Lansoprazole (≥ 1 in 100): Headache, Diarrhea or constipation, Nausea, Abdominal pain, Flatulence, Skin rash. See the Safety section for uncommon and serious reactions.
AEMPS summary of product characteristics (section 4.6): there are no clinical data on lansoprazole exposure during pregnancy. Animal studies do not suggest direct or indirect harmful effects on pregnancy, embryonic or fetal development, delivery or postnatal development. Therefore, lansoprazole is not recommended during pregnancy.
Compatible with breastfeeding.
Lansoprazole is contraindicated in: Lansoprazole or other PPI hypersensitivity; Concomitant rilpivirine (antiretroviral); Severe hepatic impairment – dose adjustment needed. Full list in the Safety section.
Direct links to regulator labels. Open in a new tab.
Magnesium hydroxide, Mastic gum, Omeprazole, Pantoprazole, Sodium alginate, Deglycyrrhizinated licorice (DGL), Rabeprazole, Slippery elm (inner bark)