Esomeprazole Sandoz

Esomeprazole

20 mg & 40 mg: Treatment of erosive reflux esophagitis in adults & adolescents ≥12 yr, & Zollinger-Ellison syndrome in adults. 20 mg: Adults & adolescents ≥12 yr: Long-term management of patients w/ healed esophagitis to prevent relapse. Symptomatic treatment of GERD. Adults: In combination w/ appropriate antibacterial therapeutic regimens for the eradication of H. pylori & healing of H. pylori associated duodenal ulcer & prevention of relapse of peptic ulcers in patients w/ H. pylori associated ulcers. Healing of gastric ulcers associated w/ NSAID therapy. Prevention of gastric & duodenal ulcers associated w/ NSAID therapy in patients at risk. 40 mg: Prolonged treatment after IV induced prevention of rebleeding of peptic ulcers in adults.

20 mg & 40 mg Adult & adolescent ≥12 yr Treatment of erosive reflux esophagitis 40 mg once daily for 4 wk. Continue for additional 4 wk if esophagitis has not healed or symptoms persist. Adult Treatment of Zollinger-Ellison syndrome Initially 40 mg bd. Total daily dose: 80-160 mg in 2 divided doses. Patient w/ severe hepatic impairment Max dose: 20 mg. 20 mg Adult & adolescent ≥12 yr 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. Adult Healing of H. pylori associated duodenal ulcer & prevention of relapse of H. pylori associated peptic ulcers 20 mg bd in combination w/ amoxicillin 1 g bd & clarithromycin 500 mg bd for 7 days. Healing of gastric ulcers associated w/ NSAID therapy 20 mg once daily for 4-8 wk. Prevention of gastric & duodenal ulcers associated w/ NSAID therapy in patients at risk 20 mg once daily. 40 mg Adult Prolonged treatment after IV induced prevention of rebleeding of peptic ulcers 40 mg once daily for 4 wk.

Should be taken on an empty stomach: Swallow tab whole, do not chew/crush. Patient w/ swallowing difficulties: Disperse tab in ½ glass of non-carbonated water. Do not use other liqd. Stir until tab disintegrates & drink liqd w/ pellets immediately or w/in 30 min. Do not chew/crush pellets. Rinse glass w/ ½ glass of water & drink. Mixt may be administered through a gastric tube.

Hypersensitivity to esomeprazole or substituted benzimidazoles. Concomitant use w/ nelfinavir.

Exclude gastric malignancy as treatment may alleviate symptoms. Keep patients on long-term treatment under regular surveillance. Slightly increased risk of GI infections eg, Salmonella & Campylobacter & possibly Clostridium difficile. May reduce absorption of vit B₁₂. Monitor Mg levels prior to treatment initiation & periodically in patients expected to be on prolonged treatment or when co-administered w/ medications eg, digoxin or drugs that may cause hypomagnesaemia (eg, diuretics). Increased risk for osteoporosis-related fractures of the hip, wrist or spine w/ long-term therapy & multiple daily doses. Risk of subacute cutaneous lupus erythematosus; consider stopping treatment if lesions occur, especially in sun-exposed areas of the skin, & if accompanied by arthralgia. Concomitant use w/ CYP2C19 substrates & MTX. Not recommended w/ atazanavir. Consider interactions w/ other pharmaceuticals during on-demand therapy. Possible interactions for all components in triple therapy for H. pylori eradication. Stop treatment for at least 5 days before chromogranin A (CgA) measurements. Patients w/ rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine. Minor influence on ability to drive or use machines. Patients w/ severe renal impairment. Pregnancy. Do not use during breast-feeding.

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

Decreased absorption of ketoconazole, itraconazole & erlotinib. Increased absorption of digoxin. Decreased serum levels of atazanavir & nelfinavir. Increased serum levels of saquinavir (w/ concomitant ritonavir); tacrolimus. Elevated & prolonged serum levels of MTX &/or its metabolite hydroxymethotrexate. Increased plasma conc of CYP2C19 substrates eg, diazepam, citalopram, imipramine, clomipramine, phenytoin. Decreased clearance of diazepam. Increased trough plasma levels of phenytoin in epileptic patients. Increased C_max & AUC of voriconazole; cilostazol. Increased AUC & prolonged t_½ of cisapride. Decreased exposure of clopidogrel's active metabolite. Doubling of exposure w/ CYP2C19 &/or CYP3A4 inhibitors. Decreased serum levels w/ CYP2C19 &/or CYP3A4 inducers. Few isolated post-marketing cases of elevated INR during concomitant treatment w/ warfarin or other coumarin derivatives.

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).

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