S.MARK
ESOMEPRAZOLE · by ACE
Composition
Cap 20 mg/40 mg: Esomeprazole (as magnesium trihydrate) 20 mg/40 mg. Tab 20 mg/40 mg: Esomeprazole (as magnesium trihydrate) 20 mg/40 mg. Susp 10 mg: Per Sachet: Esomeprazole (as magnesium tr
Indications & Dosage
NSAID-associated gastric ulcer: Adult: 20 mg once daily for 4-8 weeks BY IV INJ, OR BY INF: Adult: 20 mg daily continue until oral administration possible, injection to be given over at least 3 minutes. Prophylaxis of NSAID-associated gastric or duodenal ulcer: BY IV INJ, OR BY INF: Adult: 20 mg daily continue until oral administration possible, injection to be given over at least 3 minutes. Gastro-oesophageal reflux disease (in the presence of erosive reflux oesophagitis): Child 1-11 years (body-weight 10 kg and above): 10 mg once dailyfor 8 weeks. Child above 12yrs and adults: Initially 40 mg once daily for 4 weeks,continued for further 4 weeks if symptoms persist; maintenance 20 mg daily. BY IV INJ, OR BY INF: Adult: 40 mg daily continue until oral administration possible, injection over at least 3 minutes. Symptomatic treatment of Gastro-Oesophageal Reflux Disease GORD (in the absence of oesophagitis): Child 1-11 years (body-weight 10 kg and above): 10 mg once daily for up to 8 weeks Children above 12yrs and adults: 20 mg once daily for up to 4 weeks, continue for further 4 wks if required. BY IV INJ, OR BY INF: Adult: 20 mg once daily continue until oral administration is possible, injection to be given over at least 3 minutes. Zollinger-Ellison syndrome: Adult: 40 mg twice daily, adjusted according to response; usual dose 80-160 mg daily. Severe peptic ulcer bleeding (following endoscopic treatment): BY INF: Adult: 80 mg, to be given over 30 minutes, then (by continuous intravenous INF) 8 mg/hour for 72 hours, then (by mouth) 40 mg once daily for 4 wks. Helicobacter pylori eradication in combination with clarithromycin and amoxicillin or metronidazole: Adult: 20 mg twice daily Children: Not recommended.
Administration
Continuous or intermittent IV infusion in NaCI 0.9%. Reconstitute 40-80 mg with up to 100 ml infusion fluid; For Intermittent infusion, give requisite dose over 10-30 min. For IV injection: Adults: Reconstitute powder with 5 ml NS. For IV infusion: Children: Initially reconstitute powder with 5 ml of NS, then further dilute to a final volume of 50 ml. Adults: Initially reconstitute powder with 5 ml of NS, LR, D5W, then further dilute to a final volume of 50 ml. Reconstituted solution in NS or LR should be used in 12 hours.
Stability
Store vials at 25C; excursions permitted to 15C-30C. Protect from light. Reconstituted solution for infusion prepared in D5W should be used in 6 hours.
Precautions
Exclude malignancy prior to treatment, prolong use, renal impairment, severe hepatic impairment; in adults in severe hepatic impairment max. 20mg daily, in children 1-11years max 10 mg daily in severe impairment.
Interactions
Diazepam, citalopram, ketoconazole, itraconazole, imipramine, clomipramine, phenytoin, other drugs metabolized by CYP2C19, warfarin
Pregnancy
Use only if clearly needed
Lactation
Contraindicated
Side Effects
Headache, GI upset, skin reaction, dry mouth, rarely angioedema, anaphylaxis.