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.