ZESOPRAZ
Esomeprazole Sodium for Injection 40 mg
Esomeprazole 40mg Tablets
INDICATIONS
Esomeprazole is a proton pump inhibitor indicated for the treatment of:
Adult Patients
The recommended adult dose is 40 mg ZESOPRAZ given once daily by intravenous injection (no less than 3 minutes) or intravenous infusion (10 minutes to 30 minutes). Safety and efficacy of ZESOPRAZ for Injection as a treatment of GERD patients with erosive esophagitis for more than 10 days have not been demonstrated. Dosage adjustment is not required in patients with mild to moderate liver impairment (Child Pugh Classes A and B). For patients with severe liver impairment (Child Pugh Class C), a maximum dose of20 mg once daily of ZESOPRAZ should not be exceeded.
Pediatric Patients
The recommended doses for children ages 1 month to 17 years, inclusive, are provided below. Dose should be infused over 10 minutes to 30 minutes.
1 year to 17 years:
Body weight less than 55 kg: 10 mg Body weight 55 kg or greater: 20 mg 1 month to less than 1 year of age: 0.5 mg/kg
- Gastro-Oesophageal Reflux Disease (GERD)
- Treatment of erosive reflux oesophagitis
- Prolonged treatment after i.v induced prevention of rebleeding of peptic ulcers.
- Treatment of Zollinger-Ellison Syndrome
- Esomeprazole 40mg tablets are indicated in adolescents from the age of 12 years
Adult Patients
The recommended adult dose is 40 mg ZESOPRAZ given once daily by intravenous injection (no less than 3 minutes) or intravenous infusion (10 minutes to 30 minutes). Safety and efficacy of ZESOPRAZ for Injection as a treatment of GERD patients with erosive esophagitis for more than 10 days have not been demonstrated. Dosage adjustment is not required in patients with mild to moderate liver impairment (Child Pugh Classes A and B). For patients with severe liver impairment (Child Pugh Class C), a maximum dose of20 mg once daily of ZESOPRAZ should not be exceeded.
Pediatric Patients
The recommended doses for children ages 1 month to 17 years, inclusive, are provided below. Dose should be infused over 10 minutes to 30 minutes.
1 year to 17 years:
Body weight less than 55 kg: 10 mg Body weight 55 kg or greater: 20 mg 1 month to less than 1 year of age: 0.5 mg/kg

