Esomeprazole Sandoz

Esomeprazole Sandoz

esomeprazole

Manufacturer:

Sandoz

Distributor:

Zuellig
/
Firma Vai Hong
Concise Prescribing Info
Contents
Esomeprazole
Indications/Uses
20 mg & 40 mg: Treatment of erosive reflux esophagitis in adults & adolescents ≥12 yr, & Zollinger Ellison syndrome in adults. 20 mg: Long-term management of patients w/ healed esophagitis to prevent relapse, symptomatic treatment of GERD in adults & adolescents ≥12 yr. 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: Adults: Prolonged treatment after IV induced prevention of rebleeding of peptic ulcers.
Dosage/Direction for Use
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. Zollinger-Ellison syndrome Initially 40 mg bd. Total daily dose: 80-160 mg in 2 divided doses. 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 daily for 4-8 wk. Prevention of gastric & duodenal ulcer 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.
Administration
Should be taken on an empty stomach: Swallow whole, do not chew/crush. For patients w/ swallowing difficulties, disperse tab in ½ glass of non-carbonated water. Do not use other liqd. Stir until tab dissolves into little pellets & drink immediately or w/in 30 min. Do not chew/crush pellets. Rinse glass w/ ½ glass of water & drink. Mixt may be given via a gastric tube.
Contraindications
Hypersensitivity to esomeprazole, or to substituted benzimidazoles. Concomitant use w/ nelfinavir.
Special Precautions
Exclude possibility of tumours (gastric malignancy) prior to treatment. Keep patients on long-term treatment under regular surveillance. May reduce absorption of vit B12. Monitor Mg levels prior to initiation & periodically in patients expected to be on prolonged treatment or when co-administered w/ medications that may cause hypomagnesaemia. Increased risk for osteoporosis-related fractures. Excessive unintentional wt loss, persistent vomiting, difficulty swallowing, vomiting blood or blood in faeces. Seriously reduced kidney function; severe liver problems. Glucose & sucrose intolerance. Increased risk for GI infections eg, Salmonella & Campylobacter & possibly Clostridium difficile. Consider stopping treatment if lesions occur, especially in sun-exposed areas of the skin, & if accompanied by arthralgia. Fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency. Stop treatment at least 5 days before Chromogranin A measurements. Pregnancy & lactation.
Adverse Reactions
Headache; abdominal pain, constipation, diarrhoea, flatulence, nausea/vomiting.
Drug Interactions
Decreased serum levels of nelfinavir & atazanavir. Increased serum levels of saquinavir (w/ concomitant ritonavir). Elevated & prolonged 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). Decreased clearance of diazepam. Increased in trough plasma levels of phenytoin in epileptic patients. Increased voriconazole clearance & Cmax. Increased Cmax & AUC for cilostazol. Increased AUC & prolonged t½ of cisapride. Decreased exposure of the active metabolite of clopidogrel. Doubling of exposure w/ CYP2C19 &/or CYP3A4 inhibitor (eg, clarithromycin). Decreased serum levels w/ CYP2C19 &/or CYP3A4 inducer (eg, rifampicin & St. John's wort). Few isolated cases of elevated INR w/ warfarin or other coumarine derivatives.
ATC Classification
A02BC05 - esomeprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).
Presentation/Packing
Form
Esomeprazole Sandoz FC tab 20 mg
Packing/Price
14's
Form
Esomperazole Sandoz FC tab 40 mg
Packing/Price
14's
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