Digestives. Multienzyme preparations
Código ATC: A09AA02 (Multienzymes (lipase, protease etc.))
Marcas comerciales
Creon, Pancreaze, Zenpep
Contains proteolytic, amylolytic and lipolytic enzymes of animal origin (porcine pancreas). Replaces the exocrine pancreatic function when it is deficient. The enteric coating of microspheres protects enzymes from inactivation by gastric acid; activation occurs in the small intestine at pH > 5.5. Efficacy depends on lipase content – the key enzyme for steatorrhea.
Primera línea
In chronic pancreatitis with confirmed exocrine insufficiency (fecal elastase < 200 µg/g or clinically evident steatorrhea), pancreatin is a mandatory component of therapy. Without replacement, patients develop weight loss, osteoporosis and fat-soluble vitamin deficiency. The standard starting dose is 25 000–40 000 lipase units per main meal.
Primera línea
Pancreatic enzyme replacement therapy (PERT) is the standard of care for exocrine pancreatic insufficiency. Evidence is based on RCTs and observational data in chronic pancreatitis, cystic fibrosis and post-pancreatectomy patients. Goals: control steatorrhea, restore nutritional status, normalize absorption of fat-soluble vitamins (A, D, E, K). Dose is titrated by lipase units per kilogram of body weight or per gram of dietary fat.
Primera línea
85% of cystic fibrosis patients develop exocrine insufficiency from childhood. PERT is lifelong, started immediately after diagnosis. Doses are based on lipase per kilogram of body weight: 500–1000 IU lipase/kg/meal in children, 500–2500 IU lipase/kg/meal in adults. Maximum 10 000 IU lipase/kg/day to prevent fibrosing colonopathy.
Primera línea
After partial or total pancreatic resection, PERT is initiated as soon as oral nutrition resumes and continued lifelong after total pancreatectomy. The dose depends on resection extent and is titrated clinically: weight, stool frequency and character, symptoms.
No recomendado
In patients without confirmed exocrine pancreatic insufficiency, pancreatin for general «digestive support», after overeating or for epigastric heaviness has no evidence base. Marketing under «for overeating» slogans falls into the overuse category. Before prescribing, workup is required: fecal elastase, stool examination, clinical assessment.
Importante
Resumen breve de la ficha técnica oficial. No sustituye el texto completo ni la consulta médica. Ficha del 20/05/2024. Fuente: AEMPS.
Tratamiento de sustitución de la enzima pancreática en insuficiencia pancreática exocrina debida a fibrosis quística u otras enfermedades (p. ej., pancreatitis crónica, pancreatectomía o cáncer pancreático). Las cápsulas gastrorresistentes de Kreon están indicadas en niños, adolescentes y adultos.
Hipersensibilidad al principio activo o a alguno de los excipientes incluidos en la sección 6.1.
Posología La posología se centra en las necesidades individuales y depende de la gravedad de la enfermedad y de la composición de la comida. El tratamiento se debe iniciar con la dosis más baja recomendada y aumentarse de forma gradual con una supervisión estrecha de la respuesta, de los síntomas y del estado nutricional del paciente. Se debe indicar a los pacientes que no deben aumentar la dosis ellos mismos. Los cambios en la dosis pueden necesitar un periodo de ajuste de varios días. Dosificación en caso de fibrosis quística Niños: Es posible que las concentraciones de 20.000 y 35.000 U. Ph.Eur. (unidades de Farmacopea Europea) de lipasa no sean adecuadas para el inicio del tratamiento en pacientes por debajo de un determinado peso corporal, según la edad. En el grupo de edad pediátrico, se recomienda iniciar la dosificación con 1000 U. Ph.Eur de lipasa por kilogramo de peso corporal por comida en niños menores de cuatro años y con 500 U. Ph.Eur de lipasa por kilogramo de peso corporal por comida en niños a partir de cuatro años. Por lo tanto, es posible que se tenga que establecer la dosis necesaria para esta población con formas de dosificación que contengan menos unidades de lipasa (p. ej., 10.000 o 5000 U. Ph.Eur de lipasa ). Adolescentes y adultos: La dosificación de la enzima basada en peso debe empezar con 500 U. Ph.Eur por kilogramo de peso corporal por comida. Todos los grupos de edad: La dosis se debe ajustar según la gravedad de la enfermedad, el control de la…
No FDA category assigned. In pregnant patients with exocrine insufficiency, therapy is continued – discontinuation causes nutritional deficiency and fetal risk. The Russian label advises caution and physician supervision during pregnancy.
Enzymes are not absorbed and do not transfer into milk in active form. Use during breastfeeding is acceptable.
Pancreatin is evaluated for the following indications with varying evidence strength: Exocrine pancreatic insufficiency (evidence tier A), Chronic pancreatitis (evidence tier A), Pancreatic insufficiency in cystic fibrosis (evidence tier A). See the full indication matrix with dosing and citations above on this page.
Common side effects of Pancreatin (≥ 1 in 100): Diarrhea, constipation, abdominal discomfort, Nausea, Rash, pruritus. See the Safety section for uncommon and serious reactions.
No FDA category assigned. In pregnant patients with exocrine insufficiency, therapy is continued – discontinuation causes nutritional deficiency and fetal risk. The Russian label advises caution and physician supervision during pregnancy.
Enzymes are not absorbed and do not transfer into milk in active form. Use during breastfeeding is acceptable.
Pancreatin is contraindicated in: Acute pancreatitis; Acute phase of chronic pancreatitis exacerbation; Hypersensitivity to porcine protein; Bowel obstruction. Full list in the Safety section.
a healthy pancreas handles any meal load. Prophylactic enzyme use «just in case» is not indicated and may mask diagnostically important symptoms.
heaviness more often reflects GERD, functional dyspepsia, H. pylori gastritis, biliary disease. Enzymes do not target these mechanisms.
pancreatin is prescribed only for confirmed pancreatic insufficiency, not «for growth and appetite».