Barole 20/Barole Injection Dosage/Direction for Use

Barole 20: Rabeprazole should be administered before meals.
Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD): The recommended adult oral dose is 20 mg Rabeprazole to be taken daily for four to eight weeks.
Maintenance of Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD Maintenance): The recommended adult oral dose is 20 mg Rabeprazole to be taken daily.
Healing of Duodenal Ulcers: The recommended adult oral dose is 20 mg Rabeprazole to be taken daily after the morning meal for a period up to four weeks. Most patients with duodenal ulcer heal within four weeks.
Treatment of Pathological hypersecretory conditions, including Zollinger-Ellison Syndrome: The dosage of Rabeprazole in patients with pathologic hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose is 60 mg once a day. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 100 mg QD and 60 mg BID have been administered.
No dosage adjustment is necessary in elderly patients, in patients with renal disease or in patients with mild to moderate hepatic impairment. Administration of Rabeprazole to patients with mild to moderate liver impairment resulted in increased exposure and decreased elimination. Due to the lack of clinical data on Rabeprazole in patients with severe hepatic impairment, caution should be exercised in those patients.
Rabeprazole (Barole) Capsules should be swallowed whole. The capsules should not be chewed, crushed or split.
Barole Injection: The intravenous administration is recommended only in cases where the oral administration is not indicated. As soon as an oral therapy is possible the intravenous therapy should be discontinued.
Recommended dose is intravenous administration of the content of one vial (20 mg Rabeprazole) once daily.
Parenteral routes of administration other than intravenous are not recommended.
Injection: The content of the vial needs to be reconstituted with 5 mL sterile water for injection, which should be given slowly over 5-15 min.
Infusion: For intravenous infusion the reconstituted solution should be further diluted and administered as short term infusion over 15-30 min.
Compatibility with various I.V. fluids: Rabeprazole sodium (Barole) Injection is compatible with Dextrose injection, Dextrose saline injection.
Dosage in Special Populations: No dosage adjustment is necessary in elderly patients, in patients with renal disease or in patients with mild to moderate hepatic impairment. Administration of Rabeprazole to patients with mild to moderate liver impairment results in increased exposure and decreased elimination. Due to the lack of clinical data on Rabeprazole in patients with severe hepatic impairment, caution should be exercised in these patients.
Reconstitution: To reconstitute add 5 mL of sterile water for injection to make a solution.
After preparation, the reconstituted solution must be used within 4 hours if stored at room temperature and within 24 hours if stored in refrigerator and the unused portion should be discarded.
As with all parenteral admixtures, the reconstituted or further diluted solution should be examined for change in colour, precipitation, haziness or leakage. The unused portion should be discarded.
pH of the reconstituted solution: Between 11.2-12.5.