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Pantoprazole (PANTOVEX) should be inspected visually for particulate matter and discoloration prior to and during administration whenever solution and container permits.
Pantoprazole routes of administration other than intravenous are not recommended. Pantoprazole for injection may be administered intravenously through a dedicated line or through a Y-site. The intravenous line should be flushed before and after administration of pantoprazole for injection.
Midazolam HCl has been shown incompatible with Y-site administration of Pantoprazole for injection. Pantoprazole for injection may be compatible with products containing zinc. When Pantoprazole for injection is administered through a Y-site, immediately stop use if precipitation or discoloration occurs.
Gastroesophageal Reflux Disease (GERD) associated with a history of Erosive esophagitis: Recommended dosage: The recommended adult dose is 40 mg given once daily by intravenous infusion for 7 to 10 days.
Administration and Preparation Instructions: Data on the safe and effective dosing for conditions other than those described in the Indications such as life-threatening upper gastrointestinal bleeds, are not available. PANTOPRAZOLE 40 mg once daily does not raise gastric pH to levels sufficient to contribute to the treatment of such life-threatening conditions.
Fifteen Minute Infusion: Pantoprazole should be reconstituted with 10 mL of 0.9% Sodium Chloride Injection, USP, and further diluted with 100 mL of 5% Dextrose Injection, USP, 0.9% Sodium Chloride Injection, USP, or Lactated Ringer's Injection, USP, to a final concentration of approximately 0.4 mg/mL. The reconstituted solution may be stored for up to 12 hours at room temperature prior to further dilution. Both the reconstituted solution and the admixed solution do not need to be protected from light.
Pantoprazole for injection admixtures should be administered intravenously over a period of approximately 15 minutes at a rate of approximately 7 mL/min.
Pathological Hypersecretion Including Zollinger-Ellison Syndrome: Recommended dosage: The dosage of Pantoprazole for injection in patients with pathological hypersecretory conditions including Zollinger-Ellison Syndrome varies with individual patients. The recommended adult dose is 80 mg intravenously every 12 hours. The frequency of dosing can be adjusted to individual patient needs based on acid output measurements. In those patients who need higher dosage, 80 mg intravenously every 8 hours is expected to maintain acid outflow below 10 mEq/h.
Administration and Preparation Instructions: Fifteen Minute Infusion: Each vial of PANTOPRAZOLE should be reconstituted with 10 mL of 0.9% Sodium Chloride Injection, USP. The contents of the two vials should be combined and further diluted (admixed) with 80 mL of 5% Dextrose Injection, USP, 0.9% Sodium Chloride Injection, USP, or Lactated Ringer's Injection, USP, to a total volume of 100 mL with a final concentration of approximately 0.8 mg/mL. The reconstituted solution may be stored for up to 12 hours at room temperature prior to further dilution. Both the reconstituted solution and the admixed solution do not need to be protected from light.
Pantoprazole for injection admixtures should be administered intravenously over a period of approximately 15 minutes at a rate of approximately 7 mL/min.
Administration in Renal Impairment: Most studies have not found the pharmacokinetics of pantoprazole to be altered in patients with renal impairment and licensed drug information in the UK and US generally does not recommend dosage adjustment in this group; however some UK sources, including the British National Formulary, suggest that a maximum dose of 40 mg daily should be observed.
Administration in hepatic impairment: Dosage of pantoprazole may need to be reduced in severe hepatic impairment, or doses given only on alternate days. A maximum dose of 20 mg daily, or 40 mg on alternate days, has been suggested.
