AUGUST 2001
IV Pantoprazole (Protonix®)
Use Restricted to Approved Protocol
The Pharmacy and Therapeutics Committee has approved the addition of pantoprazole IV to the KUMC formulary with restrictions. A protocol has been developed to establish criteria for ordering, dosing, and use of pantoprazole IV (see form below). Use is restricted to the following types of patients: (1) Those with actively bleeding ulcers, ulcers with non-bleeding visible vessels, or clots that have underlying vessels (all must have been confirmed via endoscopy) and an inability to absorb oral medications. (2) Those with an active upper GI bleed and thrombocytopenia (platelets < 50,000/mm3) potentially related to treatment with an H2-antagonist and an inability to absorb oral medications. If the patient does not meet the specified criteria, either a Critical Care consult or a GI consult must be obtained prior to ordering pantoprazole IV. The recommended dose (per protocol) is an 80 mg bolus followed by a continuous infusion of 8 mg/hour for 72 hours1,2 (estimated cost for 72 hours is $330). Oral lansoprazole should be administered for the remainder of the treatment period (estimated cost per day is $0.25).
Pantoprazole IV is available as a freeze-dried powder. When reconstituted according to manufacturer guidelines, the final concentration is 0.4 mg/mL. The rate of administration must not exceed 3 mg/min (7 mL/min). The injection should be administered through a dedicated line, using the in-line filter provided. A filter must be used to remove any precipitates that may form when the reconstituted drug product is mixed with the IV solutions. If administration through a Y-site is desired, the filter must be positioned below the Y-site that is closest to the patient. The admixed solution may be stored at room temperature for up to 12 hours prior to intravenous infusion. It does not need to be protected from light.
No dosage adjustment is needed for patients with mild, moderate, or severe renal insufficiency, mild or moderate hepatic impairment, or in the elderly. Pantoprazole is not removed by hemodialysis. Pantoprazole kinetics have not been well studied in patients with severe hepatic impairment. Caution should be used when administering pantoprazole to these patients as dosage adjustment may be warranted.
Pantoprazole metabolism is independent of the route of administration (IV or oral), and is extensively metabolized by the cytochrome P450 system, mainly CYP2C19. Approximately 71% of the dose is renally eliminated with the rest being excreted in the feces. No significant drug interactions have been reported between pantoprazole and drugs metabolized by cytochrome P450 2C19, 3A4, 2D6, 2C9, and 1A2 (theophylline, diazepam, phenytoin, warfarin, metoprolol, nifedipine, carbamazepine, and oral contraceptives). Pantoprazole may interfere with absorption of drugs with require gastric acidity for absorption (ketoconazole, ampicillin, iron).
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