Int J Clin Pharm Th
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Int J Clin Pharm Th · Feb 2014
Safety of blood reinfusion after local infiltration analgesia with ropivacaine in total knee arthroplasty.
The authors hypothesized that it is safe to combine local infiltration analgesia (LIA) in total knee arthroplasty (TKA) with a retransfusion drain since ropivacaine concentrations would not exceed the arterial toxicity threshold concentrations of 4.3 mg/L for total and 0.56 mg/L for unbound ropivacaine. ⋯ The combination of LIA and reinfusion presented herein are considered safe. However, differences in pain protocol lead to changes in the safety evaluation. Compared with previous studies, the technique of administration is of greater importance for the effect on unbound ropivacaine because of unknown mechanisms.
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Int J Clin Pharm Th · Feb 2014
Randomized Controlled TrialCorrelation of genotype, phenotype, and mRNA expression of CYP2D6 and CYP2C19 in peripheral blood leukocytes (PBLs).
The genetic polymorphism of drug metabolizing enzymes of the cytochrome P450 (CYP) families, especially CYP2D6 and CYP2C19, is the most important cause of variable responses of many drugs. Enzyme activity ranges from complete deficiency, so called poor metabolizers (PMs), to an ultrafast metabolism. While PMs and extensive metabolizers (EMs) can be well distinguished by genotyping, phenotyping is necessary to subdivide EMs from intermediate metabolizers (IMs). The aim of the study was to evaluate if messenger RNA (mRNA) concentration for CYP-enzymes in peripheral blood leukocytes (PBLs) will be predictive of systemic enzyme activity, allowing an easy and safe determination of metabolic activity. ⋯ The results do not support the concept of using mRNA expression profiles for CYP2D6 and CYP2C19 enzymes in PBLs for prediction of systemic enzyme activity.
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Int J Clin Pharm Th · Feb 2014
Randomized Controlled TrialBioequivalence assessment of two transdermal delivery systems of fentanyl in healthy Chinese volunteers.
The objective of this study was to investigate the bioequivalence of two formulations (generic preparation and Durogesic patch) of 4.2 mg fentanyl. They were assessed in relative bioavailability in 20 healthy Chinese male volunteers according to a single dose, 2-sequence, crossover randomized design. The two formulations were administered at two treatment days, separated by a washout period of 14 days. ⋯ ANOVA and two one-sided t-test procedures showed no significant difference in log-transformed Cmax, AUC0-T and AUC0-∞ while the 90% confidence interval (CI) of the ratio of the geometric means of their values were also used to assess bioequivalence between the two formulations. Based on these statistical inferences it was concluded that the two formulations exhibited comparable pharmacokinetic profiles and that test formulation is bioequivalent to reference formulation. The point estimate (90% CI) of two formulations was: AUC0-T, 96.7% (85 - 105%); AUC0-∞, 97.5% (89 - 110%); Cmax, 96.2% (91 - 104%); tmax, 97.1% (93 - 101%), respectively.
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Int J Clin Pharm Th · Dec 2013
Randomized Controlled TrialA pharmacokinetic assessment of an alternate titration strategy for fentanyl pectin nasal spray.
Fentanyl pectin nasal spray (FPNS) is approved for management of breakthrough pain in cancer. It is available in 100 and 400 μg strength products which allow for doses of 100 - 800 μg (1 or 2 sprays). Existing titration strategies require a transition from the 100 μg product to the 400 μg product when increasing the dose from 200 to 400 μg. This study assessed the pharmacokinetic (PK) profile of FPNS administered as 4 sprays of 100 μg as an alternate titration strategy. ⋯ Given that systemic fentanyl exposure from FPNS administered as 4 × 100 μg is similar to that from FPNS as 1 × 400 μg, the 4 × 100 μg regimen provides an alternate titration strategy for patients needing more than 200 μg. This alternate strategy will facilitate a patient's ability to achieve an optimized FPNS regimen and reduce opioid wastage.
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Int J Clin Pharm Th · Dec 2013
Randomized Controlled TrialNo clinically relevant interaction between sugammadex and aspirin on platelet aggregation and coagulation parameters.
This study evaluated interaction potential between sugammadex and aspirin on platelet aggregation. ⋯ There was no clinically relevant reduction in platelet aggregation with addition of sugammadex 4 mg/kg to aspirin. Pre-determined non-inferiority margins were not exceeded for bleeding time and APTT.