Rx Update: June 2002
Mary Ross, R.Ph., M.B.A., Barbara Mutnick, R.Ph., M.H.P., Joan
Murhammer, R.Ph.
Peer Review Status: Internally Reviewed
Pantoprazole injection (Protonix® I.V.) is a proton pump inhibitor (PPI) that is FDA-labeled only for the short-term treatment of gastroesophageal reflux disease in patients unable to take an oral formulation. Clinical trials have shown efficacy of pantoprazole injection only in patients who were either eating a regular diet or who were given a pentagastrin infusion in addition to pantoprazole injection; this is important because proton pump inhibitors are most effective when food, gastrin, or vagal stimuli activate the parietal cells. No published data are available addressing the use of IV pantoprazole for acute gastrointestinal bleeding or stress ulcer prophylaxis; however, histamine-2 receptor antagonist injections (e.g., cimetidine) as well as oral bicarbonate-based PPI (e.g., lansoprazole) suspensions have been shown to be effective. Lansoprazole oral bicarbonate-based suspension is available at UIHC. Because it is not known if pantoprazole injection is effective in critically-ill patients or patients taking nothing by mouth, the Pharmacy and Therapeutics Subcommittee has decided to restrict the use of pantoprazole injection to the following criteria:
The most common adverse reactions seen with pantoprazole injection include injection site reactions (e.g., inflammation, thrombophlebitis, and abscess), abdominal pain, headache, diarrhea, nausea, vomiting, dyspepsia, dizziness, rash, and pruritus.
For gastroesophageal reflux disease, the recommended adult dose of pantoprazole injection is 40 mg administered by intravenous infusion once daily, converting to oral or nasogastric therapy as soon as feasible. Appropriate dosing for other uses has not been determined. No dosage adjustment is necessary in patients with renal impairment, hepatic impairment, or for elderly patients. Pantoprazole injection should be reconstituted with 10 mL of NS and further diluted with 100 mL of D5W, NS, or LR. Pantoprazole injection should be infused over 15 minutes at a rate no greater than 3 mg per minute. Pantoprazole injection should be administered through a dedicated line; the provided in-line filter must be used to remove the precipitates that may form. The intravenous line should be flushed before and after administration of pantoprazole injection with D5W, NS, or LR. Pantoprazole injection should not be administered simultaneously through the same line with other intravenous solutions or medications; pantoprazole is known to be incompatible with total parenteral nutrition (TPN) solutions. If administered through a y-site, the in-line filter must be positioned below the y-site that is closest to the patient.
Also, because of the lack of published efficacy data regarding the use of pantoprazole injection in patients who are NPO, for stress ulcer prophylaxis or for acute gastrointestinal bleeding, pH monitoring should be attempted in all patients who receive the drug.