Pharmacokinetics and dosing of arbekacin in preterm and term newborn infants

Suzuki, Keiji; Tanikawa, Kouji; Matsuzaki, Takashi

doi:10.1046/j.1442-200x.2003.01679.x

Cited by 5 publications

(4 citation statements)

References 18 publications

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“…(CL) ϭ 38.8% (V 1 ) ϭ 37.1% (V 2 ) ϭ 164.6% Intraindividual residual variability ( ϭ 1.07 g/ml) ously, only a small amount of data was published (13,39) and these reports used a one-compartment model. The one-compartment model trends towards overestimation of concentration at early time points and underestimation at later times (33).…”

Section: Discussionmentioning

confidence: 99%

Population Pharmacokinetics of Arbekacin in Patients Infected with Methicillin-Resistant Staphylococcus aureus

Satō

Morita

Kaku

et al. 2006

Antimicrob Agents Chemother

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Arbekacin, a derivative of dibekacin, is an aminoglycoside developed and widely used in Japan for the treatment of patients infected with methicillin-resistant Staphylococcus aureus (MRSA). The population pharmacokinetics of arbekacin was investigated in the Japanese, using 353 patients infected with MRSA and 50 healthy or renally impaired volunteers. The age of the study population ranged from 8 to 95 years, and weight ranged from 10.8 to 107 kg. In total, 1,581 serum arbekacin concentrations were measured (primarily from routine patient care) and used to perform the present pharmacokinetic analysis. Drug concentration-time data were well described by a two-compartment open model. Factors influencing arbekacin pharmacokinetics were investigated using a nonlinear mixed-effect model analysis. The best-developed model showed that drug clearance ( Arbekacin [1-N-(S)-4-amino-2-hydroxybutyl dibekacin] is an effective aminoglycoside antibiotic against methicillin-resistant Staphylococcus aureus (MRSA) and is stable in the presence of aminoglycoside-inactivating enzymes produced by MRSA (1,10,22). Arbekacin is a derivative of dideoxykanamycin B (dibekacin), developed in Japan, with specific activities against both gram-positive and gram-negative bacteria (16). The anti-MRSA potency of arbekacin was superior to that of vancomycin (1), and arbekacin showed a longer postantibiotic effect than vancomycin did (44).In this decade, arbekacin, vancomycin, and teicoplanin have been used for the treatment of MRSA infections in Japan. Similar to other aminoglycosides, arbekacin is excreted exclusively in urine in its unchanged form via glomerular filtration, and some portion is reabsorbed by tubular reabsorption. In subjects with normal renal function receiving a single intramuscular dose of 3 mg/kg of body weight (typical half-life of arbekacin is 1.5 to 2.7 h), the apparent volume of distribution (V) is 0.28 to 0.37 liter/kg, and the total body clearance (CL) is 97 to 146 ml/min per 1.73 m 2 (6). In patients with severe renal insufficiency (creatinine clearance [CL CR ], Ͻ10 ml/min), the half-life is 18.5 to 46.4 h, the apparent V is 0.26 to 0.56 liter/kg, and total body CL is 8 to 12 ml/min per 1.73 m 2 (6). Thus, linear relationships are observed between arbekacin pharmacokinetics and the glomerular filtration rate.Although the approved dose and dosage of arbekacin for adult patients (150 to 200 mg per day) is usually administered as a divided dose by intravenous or intramuscular injection, therapeutic drug monitoring (TDM) is often used to achieve drug concentrations within the therapeutic range for individual patients. Since patients treated with arbekacin usually suffer from severe infections, it is important to reach the target therapeutic concentration quickly. The effective peak concentration of arbekacin is presumed to be 7 to 12 g/ml, and the safe trough concentration is less than 2 g/ml. However, these recommended serum concentrations of arbekacin were based on other aminoglycosides, such as gentamicin, amikacin, and...

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Section: Discussionmentioning

confidence: 99%

Population Pharmacokinetics of Arbekacin in Patients Infected with Methicillin-Resistant Staphylococcus aureus

Satō

Morita

Kaku

et al. 2006

Antimicrob Agents Chemother

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“…Additionally, the pathophysiology of some diseases and pharmacologic receptor functions change during infancy and childhood and differ from those of adults 16 . All of abovementioned differences may affect PK, pharmacodynamics, and optimum doses of various drugs in the developing child 17‐19 . Therefore, there is a relevant need for more research on developmental pharmacology such as the impact of ontogeny on a drug's PK disposition, and it is essential to include a drug's PK and response to the clinical pharmacology assessment and to describe the exposure‐response relationship to help dose selection and clinical trial design in the pediatric population.…”

Section: Discussionmentioning

confidence: 99%

Population Pharmacokinetics and Exposure‐Response Analysis of nab‐Paclitaxel in Pediatric Patients With Recurrent or Refractory Solid Tumors

Li¹,

Kassir²,

Chen³

et al. 2020

Clinical Pharm in Drug Dev

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Pediatric malignancies are most commonly of primary central nervous system or hematopoietic origin. The main reason for cancer death in pediatrics is refractory and relapsed disease, and improved therapeutic options are needed in the pediatric population. Nanoparticle albumin‐bound (nab)‐paclitaxel (Abraxane) is a human albumin‐stabilized formulation of paclitaxel and was designed to improve the chemotherapeutic effects of paclitaxel and to reduce toxicities. Although nab‐paclitaxel pharmacokinetics (PK) has been extensively studied in adults, no information is available on its PK in children. ABI‐007‐PST‐001 was the first nab‐paclitaxel clinical trial conducted in pediatrics, and the current analysis is the first study of nab‐paclitaxel PK in pediatrics. Our analyses suggested that ontogeny and maturation play a role in nab‐paclitaxel PK disposition, as demonstrated by the finding that both blood clearance and volume of distribution increased from younger to older pediatric age groups and from pediatrics to adults. A 3‐compartment population PK (PPK) model with saturable elimination was developed to describe the paclitaxel whole blood concentrations in pediatrics. The PPK model was customized by estimating the allometric function on PK parameters to take into account the ontogeny/maturation of patients. PPK estimates are consistent with the fast and deep distribution of paclitaxel that was previously observed in adults. Finally, the exposure‐safety analysis showed an increased probability of drug‐related adverse events (>grade 2) in cycle 1 and the first cycle of neutropenia (>grade 2) associated with higher doses. However, there is no statistically significant association between exposures (measured by area under the concentration‐time curve) and the probabilities of either safety event.

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“…Adult patients with MRSA infection often have various underlying diseases, and TDM is recommended during ABK administration 1 . In the case of newborns and infants, it is also important to construct a dosage regimen suitable for each case based on TDM; however, there are few reports discussing the timing of blood collection for TDM and TDM‐based dosage regimens for newborns and infants 2 .…”

Section: Discussionmentioning

confidence: 99%

Dosage regimen of arbekacin for methicillin‐resistant Staphylococcus aureus infection in newborns and infants

Yoshida

Minowa

Ebisu

et al. 2004

Pediatrics International

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Pharmacokinetics and dosing of arbekacin in preterm and term newborn infants

Abstract: With the new dosing regimen, more infants achieved serum ABK levels within the optimal range than the conventional one.

Cited by 5 publications

References 18 publications

Population Pharmacokinetics of Arbekacin in Patients Infected with Methicillin-Resistant Staphylococcus aureus

Population Pharmacokinetics of Arbekacin in Patients Infected with Methicillin-Resistant Staphylococcus aureus

Population Pharmacokinetics and Exposure‐Response Analysis of nab‐Paclitaxel in Pediatric Patients With Recurrent or Refractory Solid Tumors

Dosage regimen of arbekacin for methicillin‐resistant Staphylococcus aureus infection in newborns and infants

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