Drugs for peptic ulcer and GORD. Proton pump inhibitors
Código ATC: A02BC05 (Esomeprazole)
Marcas comerciales
Nexium, Nexium 24HR
The S-enantiomer of omeprazole, specifically and irreversibly inhibits the H+/K+-ATPase (proton pump) of gastric parietal cells. Reduces basal and stimulated hydrochloric acid secretion by 80–95% with daily dosing. The advantage over omeprazole is more consistent pharmacokinetics: the S-enantiomer is less dependent on CYP2C19 metabolism and less affected by genetic variability. With daily dosing, a steady antisecretory effect is reached by days 3–5.
Primera línea
Esomeprazole is used for gastric and duodenal ulcers in adults. Standard dose 20–40 mg daily for 4–8 weeks. PPIs accelerate healing and reduce recurrence. In H. pylori-associated ulcer, esomeprazole is part of eradication therapy. In NSAID-related ulcers, the NSAID is discontinued and a PPI course is given with reassessment in 4–8 weeks.
Sources
Primera línea
First-line therapy for GERD in adults and adolescents. CG184 (2014, updated 2019) and 2022 recommend PPIs as the baseline GERD therapy, with dose chosen by esophagitis severity. Erosive esophagitis is treated for 8 weeks, non-erosive disease for 4 weeks with reassessment. Esomeprazole shows efficacy comparable to other PPIs at equivalent doses; at 40 mg it outperforms omeprazole 20 mg in healing of severe erosive esophagitis.
After the course, the patient attempts withdrawal or switches to on-demand dosing. Continuous use beyond 8 weeks is reviewed every 6–12 months.
Sources
Primera línea
Esomeprazole is one of the PPIs used in H. pylori eradication. Maastricht VI/Florence 2022 and 2017 recommend triple or bismuth quadruple therapy for 14 days. Esomeprazole 40 mg twice daily within the regimen provides acid suppression that supports antibiotic activity and concentration stability in the stomach.
Primera línea
In Barrett esophagus, PPIs are prescribed lifelong to suppress acid reflux and reduce metaplasia progression. 2022 supports continuous PPI therapy in confirmed Barrett esophagus. Adenocarcinoma prevention data are observational; randomized evidence of cancer risk reduction is lacking, but reflux control remains standard practice.
No recomendado
Long-term PPI therapy for functional dyspepsia without H. pylori-associated gastritis, esophagitis or other indications is not clinically justified. CG184 recommends reassessing the need to continue after 4 weeks; if there is no clear effect, the drug is discontinued. PPI use «just in case» for general epigastric heaviness is in the overuse category.
No recomendado
PPI prophylaxis is not indicated in patients without risk factors for NSAID-induced gastropathy. Risk factors: age ≥ 65, history of peptic ulcer, history of GI bleeding, concurrent glucocorticoids or anticoagulants, high-dose or combined NSAID use, chronic kidney disease. Routine PPI «cover» without these factors is an overuse category.
Long-term (over 2 years) suppression of gastric secretion reduces release of B12 from dietary proteins, leading to subclinical or clinical deficiency in some patients. Annual serum B12 monitoring is recommended for continuous therapy beyond 2 years; oral or parenteral replacement is prescribed at levels below 200 pg/mL.
PPIs reduce gastric acidity and impair release of dietary B12 from proteins. Long-term use (>2 years) raises B12 deficiency risk 1.5–2 fold. Check B12 levels in PPI courses longer than 12 months, especially in the elderly.
Fuente: FDA: FDA Drug Safety Communication: PPIs and vitamin B12 deficiency (2010)
Calcium carbonate absorption is acid-dependent, and long-term PPI use lowers its bioavailability. Meta-analyses link long-term (> 1 year) PPI use to a modest increase in hip and vertebral fracture risk, mainly in older adults. For PPI users at osteoporosis risk, organic calcium salts (citrate) that do not require an acidic environment are preferred.
Iron salts (sulfate, fumarate) require gastric acid to convert to Fe2+ and be absorbed. On PPI therapy their bioavailability falls by 20–50%. In iron-deficiency anemia in PPI users, parenteral forms or chelated iron are preferred.
PPIs reduce magnesium absorption in the small intestine. Long-term therapy leads to hypomagnesemia in some patients, with clinical manifestations: seizures, tetany, arrhythmias, tremor. issued a dedicated warning in 2011. Monitor magnesium every 12 months; every 3–6 months with concurrent diuretics.
Importante
Resumen breve de la ficha técnica oficial. No sustituye el texto completo ni la consulta médica. Ficha del 26/05/2025. Fuente: AEMPS.
Esomeprazol Normon cápsulas está indicado en adultos para: Enfermedad por reflujo gastroesofágico (ERGE) - tratamiento de la esofagitis erosiva por reflujo - control a largo plazo de pacientes con esofagitis curada para prevenir las recidivas - tratamiento sintomático de la enfermedad por reflujo gastroesofágico (ERGE). En combinación con un régimen terapéutico antibacteriano apropiado para la erradicación de Helicobacter pylori - cicatrización de la úlcera duodenal asociada a Helicobacter pylori y - prevención de las recidivas de las úlceras pépticas en pacientes con úlceras asociadas a Helicobacter pylori . Pacientes que necesitan tratamiento continuado con AINE - cicatrización de las úlceras gástricas asociadas al tratamiento con AINE. - prevención de las úlceras gástricas y duodenales asociadas al tratamiento con AINE en pacientes de riesgo. Tratamiento de continuación de la prevención del resangrado por úlcera péptica inducida por vía intravenosa Tratamiento del síndrome de Zollinger Ellison. Esomeprazol Normon cápsulas está indicado en adolescentes desde 12 años para: Enfermedad por reflujo gastroesofágico (ERGE) - Tratamiento de la esofagitis erosiva por reflujo - Control…
Hipersensibilidad al principio activo, a benzimidazoles sustituidos o a alguno de los excipientes incluidos en la sección 6.1. Esomeprazol no debe utilizarse de forma concomitante con nelfinavir (ver sección 4.5).
Adultos Enfermedad por reflujo gastroesofágico (ERGE) Tratamiento de la esofagitis erosiva por reflujo 40 mg una vez al día durante 4 semanas. Se recomienda un tratamiento adicional de 4 semanas para pacientes en los que la esofagitis no ha curado o que presentan síntomas persistentes. Control a largo plazo de pacientes con esofagitis curada para prevenir las recidivas 20 mg una vez al día. Tratamiento sintomático de la enfermedad por reflujo gastroesofágico (ERGE) 20 mg una vez al día en pacientes sin esofagitis. Si no se ha obtenido el control de los síntomas tras 4 semanas, se deberá reconsiderar el tratamiento. Una vez que los síntomas se han resuelto, se puede obtener el control posterior de los mismos empleando 20 mg una vez al día. Puede emplearse un régimen a demanda tomando 20 mg una vez al día, cuando sea necesario. En pacientes tratados con AINE con riesgo de desarrollar úlceras gástricas y duodenales, no se recomienda el control posterior de los síntomas empleando un régimen a demanda. En combinación con un régimen terapéutico antibacteriano apropiado para la erradicación de Helicobacter pylori cicatrización de la úlcera duodenal asociada a Helicobacter pylori prevención de las recidivas de las úlceras pépticas en pacientes con úlceras asociadas a Helicobacter pylori. 20 mg de Esomeprazol Normon con 1 g de amoxicilina y 500 mg de claritromicina, dos veces al día durante 7 días. Pacientes que necesitan tratamiento continuado con AINE cicatrización de las úlceras…
FDA category B. Large cohort studies show no increased risk of congenital malformations. During pregnancy, used on indication, preferably after the first trimester, at the minimum effective dose. Alternatives: antacids and H2 blockers for episodic symptoms.
Passes into breast milk in minimal amounts. LactMed classifies it as compatible with breastfeeding. Monitor the infant for gastrointestinal symptoms.
Esomeprazole is evaluated for the following indications with varying evidence strength: GERD pharmacological treatment (evidence tier A), Peptic ulcer disease (evidence tier A), Helicobacter pylori infection (evidence tier A). See the full indication matrix with dosing and citations above on this page.
Common side effects of Esomeprazole (≥ 1 in 100): Headache, Diarrhea, constipation, flatulence, Nausea, abdominal discomfort, Dry mouth. See the Safety section for uncommon and serious reactions.
FDA category B. FDA category B. Large cohort studies show no increased risk of congenital malformations. During pregnancy, used on indication, preferably after the first trimester, at the minimum effective dose. Alternatives: antacids and H2 blockers for episodic symptoms.
Passes into breast milk in minimal amounts. LactMed classifies it as compatible with breastfeeding. Monitor the infant for gastrointestinal symptoms.
Esomeprazole is contraindicated in: Hypersensitivity to esomeprazole or substituted benzimidazoles; Co-administration with rilpivirine; Age under 1 year for most formulations. Full list in the Safety section.
long-term therapy is linked to B12 and magnesium deficiency, increased fracture and C. difficile infection risk. Prescriptions must be justified, and duration reviewed.
40 mg esomeprazole is roughly equivalent to 40 mg omeprazole but more pharmacokinetically stable. The advantage is predictability, not «power».
PPIs suppress acid but do not eliminate the cause. After withdrawal, symptoms often return.