Volume 52, No. 12/2014(December)
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Original
Switching between phenytoin generics in patients with epilepsy may lead to increased risk of breakthrough seizure: chart analysis and practice recommendations
Jung-Won Shin, Kon Chu, Keun-Hwa Jung, Soon-Tae Lee, Jangsup Moon, and Sang Kun Lee
Price
42.00 $
Page No. 1017
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 52 – No. 12/2014 (1017-1022)
Switching between phenytoin generics in patients with epilepsy may lead to increased risk of breakthrough seizure: chart analysis and practice recommendations
Jung-Won Shin, Kon Chu, Keun-Hwa Jung, Soon-Tae Lee, Jangsup Moon, and Sang Kun Lee
Department of Neurology, Laboratory for Neurotherapeutics, Comprehensive Epilepsy Center, Biomedical Research Institute, Seoul National University Hospital, Seoul; Program in Neuroscience, Seoul National University College of Medicine, Seoul, South Korea
Objective: The Food and Drug Administration (FDA) only requires bioequivalence testing of generic substitutions in order for them to be deemed equivalen to the original product. There may be a large difference of bioavailability among the generic drugs that especially have a narrow therapeutic index, and this may affect clinical outcomes. We aimed to determine whether switching from generic-to-generic equivalent anti-epileptic drugs (AEDs) in patients with epilepsy is associated with clinical outcomes. Methods: We performed a retrospective study using the electronic medical records of a tertiary hospital. Adults with a history of epilepsy who used a generic phenytoin and whose therapy was switched to another generic phenytoin between January 2012 and June 2013 were included (n = 80). We compared the drug concentration of phenytoin and seizure events before and after the switch. Results: After switching their generic phenytoin, 33 out of 80 patients (41%) suffered from increasing seizure events (pre-interchange period, 0.44 ± 0.97; post-interchange period, 1.24 ± 2.05; p < 0.0001). The number of medical visits for acute seizure significantly increased in the post-interchange period. The phenytoin serum concentration of all the patients was lesser in the post-interchange period than in the pre-interchange period. (pre-interchange period, 12.79 μg/mL; post-interchange period, 6.36 μg/mL; p < 0.0001). Among the patients with drug resistant epilepsy (DRE), 17 patients (84.2%) had increasing seizure events in the post-interchange period. Conclusions: We confirmed that there was a significant difference in bioavailability between generic phenytoin. Therefore, when using or switching generic anti-epileptic drugs, therapeutic drug monitoring must be done, and the patients’ condition must be considered.Correspondence to:
Sang Kun Lee, MD, PhD
Department of Neurology
Seoul National University Hospital
101, Daehangro, Jongro-Gu, Seoul, 110-744, South Korea
Email: [email protected]
Original
Effects of postoperative analgesia with the combination of tramadol and lornoxicam on serum inflammatory cytokines in patients with gastric cancer
He Liang Sun, Ying Chun Dong, Can Qin Wang, Yan Ning Qian, and Zhong Yun Wang
Price
42.00 $
Page No. 1023
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 52 – No. 12/2014 (1023-1029)
Effects of postoperative analgesia with the combination of tramadol and lornoxicam on serum inflammatory cytokines in patients with gastric cancer
He Liang Sun1, Ying Chun Dong2, Can Qin Wang3, Yan Ning Qian3, and Zhong Yun Wang3
1Department of Anesthesiology, Jinling Hospital, School of Medicine, Nanjing University, Nanjing, 2Department of Anesthesiology, Institute and Hospital of Stomatology, Nanjing Medical University, Nanjing, and 3Department of Anesthesiology, First Affiliated Hospital of Nanjing Medical University, Nanjing, China
Objective: To compare the effects of postoperative patient-controlled intravenous analgesia (PCIA) with morphine, tramadol, or tramadol combined with lornoxicam on serum inflammatory cytokine production. Methods: 60 patients with an American Society of Anesthesiologists (ASA) physical status of I or II, undergoing radical correction of gastric cancer, were equally randomized to receive PCIA with morphine (M group), tramadol (T group), or tramadol combined with lornoxicam (L group). The visual analog scale (VAS) and Bruggemann comfort scale (BCS) scores were used to evaluate the postoperative analgesic efficacy. Serum levels of the interleukins (IL) IL-2, IL-6, and IL-10, and soluble IL-2 receptor (sIL-2R) were measured before anesthesia, 90 min after incision, and 24, 48, and 72 h after surgery. Results: No significant difference was found in the VAS, BCS, or baseline serum IL-2, IL-6, IL-10, or sIL-2R between the groups. At 90 min after incision, only the IL-6 levels increased (p < 0.05). At 24 h after surgery, the IL-2 levels decreased, with the M group having the lowest levels, while IL-6, IL-10, and sIL-2R levels increased, with the M group having the highest level and the L group having the lowest level (p < 0.05). At 48 h after surgery, the cytokine levels were starting to return to the baselines but still had statistical significance (p < 0.05). At 72 h after surgery, only the IL-6 levels had returned to their baseline. Conclusion: PCIA using tramadol combined with lornoxicam has less influence on inflammatory cytokines than morphine or tramadol alone in patients undergoing gastric cancer surgery.Correspondence to:
Zhong-yun Wang, MD
Department of Anesthesiology
First Affiliated Hospital of Nanjing Medical University
Nanjing 210029, China
Email: [email protected]
Original
Clinical evaluation of tigecycline in the treatment of nosocomial infection in a hospital in Taiwan
Man-Tzu Marcie Wu, Hsiang-Yin Chen, Tsong-Yih Ou, Li-Na Kuo, Kuei-Ju Cheng, and Wen-Sen Lee
Price
42.00 $
Page No. 1030
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 52 – No. 12/2014 (1030-1036)
Clinical evaluation of tigecycline in the treatment of nosocomial infection in a hospital in Taiwan
Man-Tzu Marcie Wu1,3, Hsiang-Yin Chen1,3, Tsong-Yih Ou2, Li-Na Kuo1,3, Kuei-Ju Cheng1,3, and Wen-Sen Lee2
1Department of Pharmacy, Wan Fang Hospital, 2Section of Infectious disease, Department of Internal Medicine, and 3Department of Clinical Pharmacy, School of Pharmacy, Taipei Medical University, Taipei, Taiwan
Objective: Clinical information on tigecycline use in serious nosocomial infections is limited, and the efficacy is uncertain. The aim of this retrospective study was to assess the utilization pattern and the effectiveness of tigecycline in a tertiary medical center in Taiwan. Methods: A retrospective study of the clinical and microbiological outcome of all patients treated with tigecycline for at least 72 hours over a 2-year period was conducted in a 730-bed teaching hospital. Results: Data from 133 patients with 149 cases of nosocomial infection were analyzed in this assessment. The mean APACHE II score at the initiation of tigecycline therapy was 22.5 ± 8.8, and the mean duration of treatment was 11.4 ± 5.6 days. Pneumonia was the most frequently diagnosed clinical indication for tigecycline use (113 cases, 76%). An overall positive clinical outcome was observed in 75 cases (50%). Multidrug-resistant Acinetobacter baumannii (MDRAB) is the most common organism for tigecycline therapy (n = 59), with a positive clinical outcome of 38% in tigecycline monotherapy, 66% in dualtherapy, and 17% in triple-therapy (p = 0.031). The most commonly used combining agents with tigecycline to treat MDRAB infections were intravenous colistin, inhaled colistin, and cepoferazone/sulbactam, with positive clinical outcome rates of 53%, 100%, and 80%, respectively. Admission to intensive care unit was identified as a predictive factor for negative clinical outcome. Conclusion: Our pneumonia-dominated study population demonstrated a lower clinical improvement rate of tigecycline compared to previous published data. Tigecycline monotherapy is not recommended for MDRAB infection, but colistin or cephoperazone/ sulbactam combined with tigecycline seemed to yield a good clinical outcome for MDRAB infection.Correspondence to:
Wen-Sen Lee, MD, Section of Infectious disease, Department of Internal Medicine, Wan Fang Hospital, Taipei Medical University, No. 111, Section 3, Hsing Long Road, Taipei 116, Taiwan
Email: [email protected]
Original
Pharmacokinetics and safety of sitafloxacin after single oral doses in healthy volunteers
Guolan Wu, Lihua Wu, Xingjiang Hu, Huili Zhou, Jian Liu, Meixiang Zhu, Yunliang Zheng, You Zhai, and Jianzhong Shentu
Price
42.00 $
Page No. 1037
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 52 – No. 12/2014 (1037-1044)
Pharmacokinetics and safety of sitafloxacin after single oral doses in healthy volunteers
Guolan Wu, Lihua Wu, Xingjiang Hu, Huili Zhou, Jian Liu, Meixiang Zhu, Yunliang Zheng, You Zhai, and Jianzhong Shentu
Research center of Clinical Pharmacy, State Key Laboratory for Diagnosis and Treatment of Infectious Disease, First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China
Objective: Sitafloxacin is a new fluoroquinolone with a broad spectrum of antibacterial activity, including grampositive and gram-negative bacteria. This study was to evaluate the pharmacokinetic characteristics of a single dose of sitafloxacin in healthy Chinese volunteers. Methods: This was a single-center, open-label, randomized-sequence study conducted in 12 subjects. Subjects were randomly assigned to receive single doses of 50, 100, and 200 mg of sitafloxacin in a 3-way crossover design with a 7-day washout period between administrations. Quantification was carried out using a validated high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) method. Pharmacokinetic parameters were calculated and analyzed statistically. Safety assessments were conducted throughout the study. Results: After administration of single doses of 50, 100, and 200 mg, geometric mean estimate for sitafloxacin Cmax were 0.72, 1.62, and 2.73 μg/mL and the mean of AUClast were 3.97, 8.71, and 18.03 μg×h/mL, respectively. Sitafloxacin was rapidly absorbed, reaching Cmax ranged from 0.85 to 1.21 hours. The terminal half-life ranged from 5.19 to 6.28 hours. The Cmax and AUC last were proportional to the doses. The mean clearance, the half-life, and the volume of distribution were constant, irrespective of the dose. Conclusion: In healthy Chinese subjects, single dosing of sitafloxacin resulted in linear plasma pharmacokinetics.Correspondence to:
Jianzhong ShenTu, MD, PhD
Research Center of Clinical Pharmacy
State Key Laboratory for Diagnosis and
Treatment of Infectious Disease
First Affiliated Hospital, College of Medicine
Zhejiang University, No.79 Qingchun Road
Hangzhou 310003, China
Email: [email protected]
Original
Utility of a population pharmacokinetic metaanalysis during the approval process of teduglutide for the treatment of short bowel syndrome
Stefan Roepcke, Ruediger Nave, Jane Cyran, Nele Plock, Gezim Lahu, and Axel Facius
Price
42.00 $
Page No. 1045
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 52 – No. 12/2014 (1045-1058)
Utility of a population pharmacokinetic metaanalysis during the approval process of teduglutide for the treatment of short bowel syndrome
Stefan Roepcke1, Ruediger Nave2, Jane Cyran3, Nele Plock1, Gezim Lahu1, and Axel Facius1
1Takeda Pharmaceuticals International GmbH, Zurich, Switzerland, 2Takeda GmbH, Konstanz, Germany, and 3NPS Pharmaceuticals, Bedminster, NJ, USA
Objective: Teduglutide is a recombinant analogue of human glucagonlike peptide-2 (GLP-2) that was recently approved by the US and European regulatory agencies FDA and EMA for the treatment of short bowel syndrome (SBS). The objectives of this work were, firstly, to develop a population pharmacokinetic (popPK) model based on the available PK data of the entire clinical development program and, secondly, to utilize the model for the justification of the proposed dosing regimen. The exploratory analysis was based on a previously established structural PK model and focused primarily on the investigation of covariate effects. Results: The plasma concentrationtime profiles of teduglutide after subcutaneous application were adequately described by a 1-compartment model with first order absorption and elimination. The area under the curve (AUC) was lower for male subjects, for subjects with higher creatinine clearance, for overweight subjects, and for SBS patients. However, except for subjects with severe renal impairment no clinically relevant effects on AUC were identified. Conclusion: Our model-based analysis supports the approved dose adjustment for SBS patients with and without renal impairments maintaining the exposure in a value range with acceptable variance for the target population.Correspondence to:
Dr. Stefan Roepcke
Takeda Pharmaceuticals International GmbH
Thurgauerstraße 130, Glattpark-Opfikon 8152 Zürich, Switzerland
Email: [email protected]
Original
Pharmacokinetic overview of ethinyl estradiol dose and bioavailability using two transdermal contraceptive systems and a standard combined oral contraceptive
Birte Hofmann, Isabel Reinecke, Barbara Schuett, Martin Merz, and Christian Zurth
Page No. 1059
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 52 – No. 12/2014 (1059-1070)
Pharmacokinetic overview of ethinyl estradiol dose and bioavailability using two transdermal contraceptive systems and a standard combined oral contraceptive
Birte Hofmann, Isabel Reinecke, Barbara Schuett, Martin Merz, and Christian Zurth
Bayer Pharma AG, Berlin, Germany
Objective: To determine the relative bioavailability of ethinyl estradiol (EE) and gestodene (GSD) after application of a novel transdermal contraceptive patch vs. a Materials: Participants were healthy, nonobese women aged 18 – 45 years (study 1) or 18 – 35 years (study 2). Compositions of study treatments were as follows: 0.55 mg EE/2.1 mg GSD (EE/GSD patch); 0.02 mg EE/0.075 mg GSD (standard COC); 0.6 mg EE/6 mg NGMN (EE/NGMN patch). Methods: In study 1, which consisted of 3 treatment periods (each followed by 7 patch- or pill-free days), treatments were administered in one of two randomized orders: either P–M–E (EE/GSD patch (P) every 7 days for 28 days → COC (M) once-daily for 21 days → two 7-day patch-wearing periods followed by one 10-day patch-wearing phase (E)), or the same treatments administered in sequence M–P–E. For study 2, participants received either the EE/GSD patch or EE/NGMN patch for seven treatment cycles (one patch per week for 3 weeks followed by a 7-day patch-free interval). Results: In study 1, average daily exposure to EE was similar for treatments P and M; the mean daily area under the concentration-time curve (AUC) ratio of treatment P vs. treatment M for EE was 1.06 (90% confidence interval (CI): 0.964 – 1.16), indicating average daily delivery similar to oral administration of 0.019 – 0.023 mg EE. For unbound GSD, average daily exposure was lower for treatment P vs. treatment M. The mean AUC ratio of treatment P vs. treatment M for unbound GSD was 0.820 (90% CI: 0.760 – 0.885), indicating average daily delivery from the patch of 0.057 – 0.066 mg GSD. Prolonged patch wearing did not result in a distinct decline in GSD and EE serum concentrations. In study 2, AUC at steady state (AUC0–168,ss), average steady-state serum concentration, and maximum steady-state serum concentration for EE was 2.0 – 2.7-fold higher for the EE/NGMN patch vs. the EE/GSD patch. The EE/GSD patch was well tolerated in both studies. Conclusions: Based on the 90% CI of the AUC ratio of oral treatment vs. patch application for unbound GSD and EE, the daily doses of GSD and EE released from the EE/GSD patch over the 7-day application period provided the same systemic exposure as those recorded after daily oral administration of a COC containing 0.02 mg EE and 0.06 mg GSD. The EE/GSD patch showed reduced EE exposure compared with the EE/NGMN patch. Together with its good tolerability, these properties support the EE/GSD patch as an effective and well-tolerated alternative to available transdermal and oral contraceptives.Correspondence to:
Birte Hofmann, DVM
Global Drug Discovery, Clinical Sciences
Bayer Pharma AG
Sellerstr. 31, P300, 04, A405, 13353 Berlin, Germany
Email: [email protected]
Original
A statistical analysis to assess the most critical bioequivalence parameters for generic liposomal products
Li-feng Hsu and Jin-ding Huang
Price
42.00 $
Page No. 1071
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 52 – No. 12/2014 (1071-1082)
A statistical analysis to assess the most critical bioequivalence parameters for generic liposomal products
Li-feng Hsu and Jin-ding Huang
Department of Clinical Pharmacy and Pharmaceutical Sciences, National Cheng Kung University, Medical College, Tainan, Taiwan
Objectives: The purpose of the study was to identify the most sensitive analyte (i.e., encapsulated, free, and total forms) for assessing the bioequivalence (BE) of liposome drug products using Monte Carlo simulation. Methods: We proposed a liposome classification system that divided liposome drug products into four classes according to the extent of reticuloendothelial system uptake and in vivo release rate: class I: low reticuloendothelial system uptakerapid release rate; class II: low reticuloendothelial system uptake-slow release rate; class III: high reticuloendothelial system uptakerapid release rate; Class IV: high reticuloendothelial system uptake-slow release rate. In conjunction with the proposed classification scheme, a variety of drug classes were simulated to determine which analyte provides the most sensitive measure of BE. All drug classes were investigated in single and multiple dose studies. The sensitivity of analytes for measuring BE was evaluated using the power curve. Results and conclusions: Our simulations indicated the encapsulated form provides the most accurate assessment BE for liposome drug products with low reticuloendothelial system uptake (i.e., class I and II). For liposome drug products with high reticuloendothelial system uptake (i.e., class III and IV), the free form provides the best indication BE. Measurement of total drug form to assess BE was preferred only for liposome drug products with low reticuloendothelial system uptake and slow release rates (i.e., class II liposomal drug product). In general, a single dose form is sufficient for demonstrating the BE of liposome drug products.Correspondence to:
Jin-ding Huang, PhD
Department of Clinical Pharmacy and Pharmaceutical Sciences
National Cheng Kung University, Medical College
1 University Road, Tainan 70101, Taiwan
Email: [email protected]
Original
Pharmacokinetic evaluation of a newly developed piperazine dithioctate formulation in healthy volunteers
Renhua Zheng, Hyung Ho Song, Young Ee Kwon, and Bo-Hyung Kim
Price
42.00 $
Page No. 1083
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 52 – No. 12/2014 (1083-1092)
Pharmacokinetic evaluation of a newly developed piperazine dithioctate formulation in healthy volunteers
Renhua Zheng1, Hyung Ho Song3, Young Ee Kwon3, and Bo-Hyung Kim1,2
1Department of Clinical Pharmacology and Therapeutics, 2East-West Medical Research Institute, Kyung Hee University College of Medicine and Hospital, and 3Korea Pharmaceutical Test & Research Institute (KPTR), Seoul, Republic of Korea
Background: The formulation investigated as reference contains thioctic acid which is known to be poorly soluble in water and have some instability during storage at high temperature. To overcome these limitations, a new piperazine dithioctate (PDT) tablet formulation was developed by a domestic pharmaceutical company in Korea. Objective: The aim of this clinical study was to evaluate the pharmacokinetic characteristics of PDT in healthy volunteers. Methods: This study consisted of two clinical trials. In the part 1 study, a randomized, singledose, parallel study was performed with 24 healthy volunteers. All of the subjects were administered one of the three study formulations, Thioctacid® HR (High Release) as the reference, PDT-1 or PDT-2 (each containing thioctic acid 600 mg), respectively. To determine the harmacokinetic characteristics, blood samples were serially collected at pre-dose and at pre-defined timepoints after dosing. In the part 2 study, a randomized, single-dose, two-way crossover study was conducted with 48 subjects. All of the subjects were administered both the reference and PDT-2 formulations, with a 7-day washout period between the two medications. Blood samples were collected at the same timepoints as in the part 1 study. Tolerability was evaluated throughout the study. Results: 23 volunteers completed the part 1 study. The maximum plasma concentration (Cmax) of thioctic acid after administration of the reference tablet was 4.08 ± 2.35 μg/mL (means ± SD), and the Cmax of PDT-1 and PDT-2 was 3.53 ± 2.87 μg/mL and 4.15 ± 1.62 μg/mL, respectively. The AUClast value was 2.96 ± 1.13 μg×h/mL for the reference, 2.84 ± 1.12 μg×h/mL for PDT-1, and 3.30 ± 1.32 μg×h/mL for PDT-2. 42 volunteers completed the part 2 study. The Cmax of reference and PDT-2 was 5.59 ± 3.07 μg/mL and 5.14 ± 3.18 μg/mL, respectively. The AUClast value was 4.01 ± 1.65 μg×h/mL for the reference and 3.96 ± 1.47 μg×h/mL for PDT-2. The geometric mean ratios (PDT-2/reference) and the 90% CI for Cmax and AUClast were 0.93 (0.78 – 1.11) and 1.01 (0.94 – 1.09), respectively. Conclusion: Both studies suggested that the pharmacokinetic profile of the newly developed piperazine dithioctate formulation was comparable to the pharmacokinetic profile of the reference tablet. Both study tablets were well tolerated in all of the subjects.Correspondence to:
Bo-Hyung Kim, MD, PhD
Department of Clinical Pharmacology and Therapeutics
East-West Medical Research Institute
Kyung Hee University College of Medicine and Hospital
23 Kyungheedae-ro, Dongdaemun-gu, Seoul 130-872, Korea
Email: [email protected]
Original
Development of a HPLC method to determine 5-fluorouracil in plasma: application in pharmacokinetics and steady-state concentration monitoring
Chao Pi1,2, Yumeng Wei, Hongru Yang, Yang Zhou, Junjiang Fu, Siyun Yang, Yun Ye, and Ling Zhao
Price
42.00 $
Page No. 1093
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 52 – No. 12/2014 (1093-1101)
Development of a HPLC method to determine 5-fluorouracil in plasma: application in pharmacokinetics and steady-state concentration monitoring
Chao Pi1,2*, Yumeng Wei3*, Hongru Yang4, Yang Zhou3, Junjiang Fu5, Siyun Yang6, Yun Ye1,3, and Ling Zhao3
1Department of Pharmacy, the First Affiliated Hospital of Luzhou Medical College, 2Department of Anus-intestines (Colorectal Surgery), the People’s Hospital of Luzhou City, 3Department of Pharmaceutical Sciences, School of Pharmacy, Luzhou Medical College, 4Department of Oncology, the First Affiliated Hospital of Luzhou Medical College, 5Research Center for Preclinical Medicine, Luzhou Medical College, and 6Department of Pharmacy of Nanchong Central Hospital, Nanchong, Sichuan Province, China
A simple, rapid and sensitive high-power liquid chromatographic (HPLC) method for analysis of 5-fluorouracil (5-FU) in patient plasma was developed and validated to study clinical pharmacokinetics (PK). Plasma sample preparation was processed with ammonium acetate buffer (pH 3.5; 0.01M) followed by liquid-liquid extraction with isopropanol/ethyl acetate (15 : 85, v/v). Extraction recovery ranged from 87.55 to 95.26%. Separation was performed using a C18 column at 25 °C with UV detection at 265 nm. The isocratic mobile phase composed of acetonitrile-ammonium acetate buffer (pH 3.5; 0.01M) (2.5 : 97.5 v/v) at a flow rate of 0.8 mL/min. Retention time was less than 7 minutes. Standard curve was linear between 0.01 – 10 μg/mL and 10 – 100 μg/ mL for plasma sample. The limit of quantification was 10 ng/mL. The intra- and interday precision was below 10% (RSD). The accuracy ranged from 85.24 to 104.14%. The analysis method is rapid because it needs neither time-consuming extraction procedures nor complex chromatographic condition. The method was successfully applied to access pharmacokinetics and plasma concentration at steady state (SSC) of 5-FU. The results showed the PK and SSC of 5-FU characterized by a large interpatient variability. To increase therapeutic response and reduce toxicity, we should optimize 5-FU dose by investigating PK behavior to obtain ideal SSC.
*These authors contributed equally to this work.Correspondence to:
Yun Ye and Ling Zhao
School of Pharmacy, Luzhou Medical University
No.3-319, Zhongshan Road, Jiangyang District,
Luzhou city, Sichuan Province, 646000, China
Email: [email protected]
Case Report
Lansoprazole-induced acute lung and liver injury: a case report
Christopher Atkins, Tina Maheswaran, Simon Rushbrook, and Ajay Kamath
Price
42.00 $
Page No. 1102
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 52 – No. 12/2014 (1102-1104)
Lansoprazole-induced acute lung and liver injury: a case report
Christopher Atkins, Tina Maheswaran, Simon Rushbrook, and Ajay Kamath
Norfolk and Norwich University Hospital, Norwich, UK
A 61-year old woman was admitted with increasing dyspnea and deranged liver function tests. A chest X-ray revealed small volume lungs with reticulo-nodular shadowing. High resolution computed tomography of the chest revealed interlobular septal thickening. The patient subsequently underwent an open lung biopsy and ultrasound-guided liver biopsy, which were consistent with a hypersensitivity pneumonitis and drug-induced liver injury respectively. The patient had previously been commenced on lansoprazole 10 days before the onset of symptoms; this had been stopped at diagnosis. High dose prednisolone was commenced, and the patient went on to make a full recovery. Hypersensitivity pneumonitis is a form of interstitial lung disease that is rarely associated with lansoprazole; this is the first report of it causing an idiosyncratic reaction affecting the lung and liver simultaneously. This case demonstrates the importance of obtaining a full drug history, as early identification of the offending agent will improve outcomes.Correspondence to:
Dr. Christopher Atkins
Norfolk and Norwich University Hospital
Colney Lane, Norwich, Norfolk, NR4 7UY, UK
Email: [email protected]
Case Report
Peramivir pharmacokinetics in a patient receiving continuous veno-venous hemodiafiltration during the 2009 H1N1 influenza A pandemic
Michael L. Bentley, Alan S. Hollister, Amanda C. Hansen, Jean A. Smith, and James S. Cain
Price
42.00 $
Page No. 1105
Abstract
International Journal of Clinical Pharmacology and Therapeutics, Vol. 52 – No. 12/2014 (1105-1111)
Peramivir pharmacokinetics in a patient receiving continuous veno-venous hemodiafiltration during the 2009 H1N1 influenza A pandemic
Michael L. Bentley1,2, Alan S. Hollister3a, Amanda C. Hansen4b, Jean A. Smith2,5, and James S. Cain2,6
1Department of Pharmacy, Carilion Clinic, 2Virginia Tech Carilion School of Medicine (VTCSOM), Roanoke, VA, 3Clinical Pharmacology Consulting LLC, Durham, NC, 4Department of Pharmacy, The Cleveland Clinic, Cleveland, OH, 5Department of Internal Medicine, Division of Infectious Disease, Carilion Clinic, and 6Valley Nephrology Associates, Roanoke, VA, USA
Objective: Peramivir is a neuraminidase inhibitor having activity against various influenza A and B subtypes. The main route of elimination is the kidney and a dose reduction is justified for multipleday therapy when the creatinine clearance is < 50 mL/min. Before the 2009 influenza pandemic, dosing guidelines did not exist for patients receiving continuous renal replacement therapy (CRRT). This case report provides data on the dialysis membrane saturation coefficient (SA) and pharmacokinetic parameters of peramivir in a 29-year-old female receiving continuous veno-venous hemodiafiltration (CVVHDF), a mode of CRRT. Methods: Plasma and effluent samples were collected to calculate the saturation coefficient, plasma half-life, maximum and minimum plasma concentrations, and area under the plasma drug concentrationtime curve (AUC) for peramivir. CVVHDF was performed using a Prisma pump and an AN69 filter. During peramivir sampling, the dialysate flow rate was 16.7 mL/min. The mean total ultrafiltrate produced was 14.2 mL/min. To calculate a saturation coefficient (SA), simultaneous sampling of blood and effluent was performed. Pre- and post-filter as well as effluent samples were obtained 4.5 and 8.5 hours following the 3rd dose of 480 mg. Plasma concentrations were also obtained at several time points and the AUC estimated from 0 to 24 hours (AUC0– 24). Results: The maximum plasma concentration (C30min) was 19,477 ng/mL, the minimum plasma concentration (Cmin) 2,750 ng/mL, and AUC0–24 196,166 ng×h/mL. The estimated plasma half-life was 8.2 hours with a log-linear decrease over the 24-hour period suggesting significant extracorporeal clearance. The calculated SA was 0.98, similar to an estimated SA of 1. Conclusion: Peramivir is readily cleared by CVVHDF having a calculated SA close to 1. The maximum and minimum plasma concentrations, AUC0–24, and plasma half-life was similar to those previously reported. These data will be useful in determining appropriate peramivir dosing regimens for severely ill influenza patients with acute renal impairment managed by CVVHDF.Correspondence to:
Michael L. Bentley, PharmD, FCCP, FCCM, FNAP
Department of Pharmacy
1960 Belleview Ave l 14th Floor, Roanoke, VA 24014, USA
Email: mlbentley@carilion clinic.org
Letter to the Editor
Reporting problems related to medications in Spain. The yonotifico (I report) project, an option for citizens
Francisco J. Jimeno, Esther Salgueiro- Vazquez, Lucía Ordoñez, Carmelo Aguirre, Alfonso Carvajal, and Gloria Manso
Page No. 1112
Abstract
Intern. Journal of Clinical Pharmacology and Therapeutics, Vol. 52 – No. 12/2014 – Letter to the editor
Reporting problems related to medications in Spain. The yonotifico (I report) project, an option for citizens
Francisco J. Jimeno1, Esther Salgueiro- Vazquez1, Lucía Ordoñez1, Carmelo Aguirre2, Alfonso Carvajal3, and Gloria Manso1
1Área de Farmacología, Departamento de Medicina, Universidad de Oviedo, Oviedo, 2Unidad de Farmacovigilancia del País Vasco. Hospital de Galdakao, and 3Centro de Estudios sobre la Seguridad de los Medicamentos, Universidad de Valladolid, Spain
Correspondence to:
Dr. Gloria Manso
Pharmacology, Department of Medicine
Faculty of Medicine
Julian Clavería 6, 33006 Oviedo, Spain
Email: [email protected]
