Digestive System

 Git - Downoprazol Downoprazol 

Hard gelatin capsules 20 &40 mg/1100 mg 

Packets powder for oral suspension 20 &40 mg/1680 mg 

Omeprazole- sodium bicarbonate

1 INDICATIONS AND USAGE 
DOWNOPRAZOL for oral suspension and capsules are indicated in adults for the: 
1.1 Duodenal Ulcer 
DOWNOPRAZOL (omeprazole/sodium bicarbonate) is indicated for short-term treatment of active 
duodenal ulcer. Most patients heal within four weeks. Some patients may require an additional four 
weeks of therapy. 
1.2 Gastric Ulcer 
DOWNOPRAZOL is indicated for short-term treatment (4-8 weeks) of active benign gastric ulcer.  
1.3 Treatment of Gastroesophageal Reflux Disease (GERD) 
• Symptomatic GERD 
DOWNOPRAZOL is indicated for the treatment of heartburn and other symptoms associated with 
GERD for up to 4 weeks.  
• Erosive Esophagitis (EE) 
DOWNOPRAZOL is indicated for the short-term treatment (4-8 weeks) of erosive esophagitis which 
has been diagnosed by endoscopy. 
The efficacy of (omeprazole/sodium bicarbonate) used for longer than 8 weeks in patients with EE 

has not been established. If a patient does not respond to 8 weeks of treatment, it may be helpful 

to give up to an additional 4 weeks of treatment. If there is recurrence of erosive esophagitis or

 GERD symptoms (e.g., heartburn), additional 4-8 week courses of DOWNOPRAZOL may be considered.  

1.4 Maintenance of Healing of Erosive Esophagitis 
DOWNOPRAZOL is indicated to maintain healing of erosive esophagitis. Controlled studies do not 
extend beyond 12 months. 

DOWNOPRAZOL for oral suspension is indicated in adults used for the:  
• reduction of risk of upper GI bleeding in critically ill adult patients.