American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists
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The chemistry and pharmacology, pharmacokinetics, pharmacodynamics, adverse effects, drug interactions, dosing and administration, and pharmacoeconomics of bivalirudin are reviewed; clinical trials of bivalirudin's application in percutaneous coronary intervention (PCI) are also discussed. Bivalirudin is a direct thrombin inhibitor approved for use in PCI. It reversibly binds to thrombin's catalytic site and substrate recognition site and blocks both circulating and fibrin-bound thrombin. ⋯ Major bleeding with bivalirudin has occurred in approximately 3% of patients in clinical trials, and it is not known to have any interactions with the cytochrome P-450 isoenzyme system. The acquisition cost of bivalirudin in one study was less than the combination of UFH and glycoprotein IIb/IIIa inhibitors. Bivalirudin combined with provisional glycoprotein IIb/IIIa inhibitors appears to be an acceptable alternative to the standard of care and is superior to UFH alone in PCI.
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Am J Health Syst Pharm · Sep 2003
Using medium-fill simulation to establish a benchmark microbiological contamination rate for low-risk-level compounding.
A benchmark contamination rate for prefilled syringe compounding was determined by using a medium-fill-simulation method. One thousand thirty-five 1-mL tuberculin syringes were aseptically filled with 0.9 mL of sterile soybean-casein digest medium and capped. These syringes were placed into clear nonsterile plastic bags and incubated at 35 degrees C for seven days, then inspected for cloudiness or colony formation indicative of bacterial growth. ⋯ Therefore, the contamination rate for aseptic compounding operation was less than 0.1%. Medium-fill-simulation testing of 1035 prefilled tuberculin syringes yielded no contamination. A contamination rate of less than 0.1% should be achievable and expected for this type of low-risk pharmacy preparation after pharmacies validate their own compounding operation.