Stadnex 20/40

Esomeprazole

Treatment of erosive reflux esophagitis; long-term management of healed esophagitis to prevent relapse; symptomatic treatment of GERD in adults & adolescents ≥12 yr. In combination w/ antibiotics for the treatment of H. pylori-associated duodenal ulcer in adults & adolescents ≥12 yr; prevention of peptic ulcer relapse in adults w/ H. pylori-associated ulcers. Healing of NSAID-associated gastric ulcers in adults requiring continued NSAID therapy. Prevention of NSAID-associated gastric & duodenal ulcers in adults at risk & requiring continued NSAID therapy. Prolonged treatment after IV-induced prevention of peptic ulcer re-bleeding in adults. Treatment of Zollinger-Ellison Syndrome in adults.

Adult Treatment of erosive reflux esophagitis 40 mg once daily for 4 wk. Additional 4 wk if esophagitis has not healed or if symptoms are persistent. Long-term management of patients w/ healed esophagitis to prevent relapse 20 mg once daily. Symptomatic treatment of GERD 20 mg once daily in patients w/o esophagitis. Further investigate patient if symptom control has not been achieved after 4 wk. Subsequent symptom control w/ 20 mg once daily once symptoms have resolved. On-demand regimen w/ 20 mg once daily when needed. Eradication of H. pylori & healing of H. pylori-associated duodenal ulcer & prevention of peptic ulcer relapse in patients w/ H. pylori-associated ulcers Esomeprazole 20 mg + amoxicillin 1 g + clarithromycin 500 mg bd for 7 days. Healing of NSAID-associated gastric ulcers in patients requiring continued NSAID therapy 20 mg once daily for 4-8 wk. Prevention of NSAID-associated gastric & duodenal ulcers in patients at risk & requiring continued NSAID therapy 20 mg once daily. Prolonged treatment after IV-induced prevention of peptic ulcer re-bleeding 40 mg once daily for 4 wk. Treatment of Zollinger-Ellison Syndrome Initially 40 mg bd. Adolescent ≥12 yr Treatment of erosive reflux esophagitis 40 mg once daily for 4 wk. Additional 4 wk if esophagitis has not healed or if symptoms are persistent. Long-term management of patients w/ healed esophagitis to prevent relapse 20 mg once daily. Symptomatic treatment of GERD 20 mg once daily in patients w/o esophagitis. Further investigate patient if symptom control has not been achieved after 4 wk. Subsequent symptom control w/ 20 mg once daily once symptoms have resolved. Treatment of H. pylori-associated duodenal ulcer >40 kg: Esomeprazole 20 mg + amoxicillin 1 g + clarithromycin 500 mg bd for 1 wk. 30-40 kg: Esomeprazole 20 mg + amoxicillin 750 mg + clarithromycin 7.5 mg/kg bd for 1 wk. Patient w/ severe liver impairment Max dose: 20 mg.

May be taken with or without food: Swallow whole w/ water, do not chew/crush.

Hypersensitivity to esomeprazole &/or substituted benzimidazoles. Should not be used concomitantly w/ nelfinavir.

Malignancy should be excluded in the presence of any alarm symptom (eg, significant unintentional wt loss, recurrent vomiting, dysphagia, haematemesis or melaena) & when gastric ulcer is suspected or present. Patients on long-term treatment (particularly those treated for >1 yr) should be kept under regular surveillance. Subsequent symptom control w/ on-demand regimen is not recommended in NSAID-treated patients at risk of developing gastric & duodenal ulcers. Consider possible interactions for all components in the triple therapy when prescribing for eradication of H. pylori. May reduce vit B₁₂ absorption due to hypo- or achlorhydria. Risk of symptomatic & asymptomatic hypomagnesaemia. May lead to slightly increased risk of GI infections, eg, Salmonella, Campylobacter, & possibly Clostridium difficile. Consider temporary w/drawal if receiving treatments w/ high-dose methotrexate. Increased risk of hip, wrist & spine fracture, especially in high doses & over long durations (>1 yr) & in presence of risk factors. Stop treatment for at least 5 days before Chromogranin A measurements to avoid interference w/ neuroendocrine tumour investigations. Risk of subacute cutaneous lupus erythematosus (SCLE). Potential for interactions w/ CYP2C19 substrates. Concomitant use w/ clopidogrel should be discouraged. Patients w/ rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. Minor influence on the ability to drive or use machines. Patients w/ severe renal insufficiency. Pregnancy. Should not be used during breast-feeding. Should not be used in childn <12 yr.

Headache; abdominal pain, constipation, diarrhoea, flatulence, nausea/vomiting, fundic gland polyps (benign).

Concomitant administration w/ atazanavir is not recommended. May elevate & prolong serum levels of methotrexate &/or its metabolite, hydroxymethotrexate. Increased serum levels of tacrolimus. Decreased absorption of ketoconazole, itraconazole & erlotinib. Increased absorption of digoxin. Increased plasma conc of CYP2C19 substrates (eg, diazepam, citalopram, imipramine, clomipramine, phenytoin, voriconazole, cilostazol). Increased AUC & prolonged t_½ of cisapride. Reports of elevated INR w/ warfarin. Decreased exposure to the active metabolite of clopidogrel. Increased exposure w/ CYP2C19 &/or CYP3A4 inhibitors. Decreased serum levels w/ CYP2C19 &/or CYP3A4 inducers (eg, rifampicin & St. John's wort).

Antacids, Antireflux Agents & Antiulcerants

A02BC05 - esomeprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).

P₁S₁S₃