TY - JOUR
T1 - Subcutaneous administration of cefepime
AU - Walker, Paul
AU - Neuhauser, Melinda N.
AU - Tam, Vincent H.
AU - Willey, Jie S.
AU - Palmer, J. Lynn
AU - Bruera, Eduardo
AU - Prince, Randall A.
N1 - Funding Information:
The authors would like to acknowledge the assistance of Kenneth Roston, Jingduan Chi, Robert A. Newman, Stanley R. Hamilton, Edward Yeh, Hui Ming Chang, Susan Spivey, Paul Roach, and Guddi Kaur; and for secretarial support Edith Gipson and Vivian Brannen. This study was funded by the Department of Symptom Control and Palliative Care, M. D. Anderson Cancer Center. Serum drug level testing was provided free of charge from the College of Pharmacy, University of Houston. The cefepime used in this study was provided free of charge by Bristol-Myers Squibb. Bristol-Myers Squibb had no other role in the development, performance, analysis, or reporting of this research.
PY - 2005/8
Y1 - 2005/8
N2 - Management of symptomatic infections can aid in palliation. We investigated the pharmacokinetics and tolerability of cefepime given as a subcutaneous infusion. This novel route of administration is proposed as an alternative to intravenous and intramuscular administration for patients treated outside an institutional setting, such as home hospice. Ten healthy adult volunteers received a single dose of 1g cefepime infused subcutaneously over 30 minutes. Serial serum samples (0.5, 1, 1.5, 2, 4, 6, 9, and 12 hours) were obtained after the end of infusion, and cefepime concentrations were determined by high performance liquid chromatography (HPLC). All serum concentration profiles were modeled by a population pharmacokinetic analysis using the Non-Parametric Adaptive Grid (NPAG) program. Acceptability of administration was evaluated using subjective sensation grading, observation of the subcutaneous site, and a final global evaluation. The mean (median) Cmax, β-t1/2, AUC 0-oo and total clearance were found to be 36.1 (30.9) mg/L, 2.34 (2.56) hours, 134.8 (125.3) h•mg/L, and 7.42 (7.98) L/h, respectively. All infusions were completed without difficulty or discomfort. No drug side effects occurred. The global acceptability was "strongly agreeable" with all the subjects. Subcutaneous infusion of cefepime appeared to result in a pharmacokinetic profile similar to that of an intramuscular injection. Our evaluations showed excellent tolerability and acceptability. These favorable results warrant further clinical evaluation.
AB - Management of symptomatic infections can aid in palliation. We investigated the pharmacokinetics and tolerability of cefepime given as a subcutaneous infusion. This novel route of administration is proposed as an alternative to intravenous and intramuscular administration for patients treated outside an institutional setting, such as home hospice. Ten healthy adult volunteers received a single dose of 1g cefepime infused subcutaneously over 30 minutes. Serial serum samples (0.5, 1, 1.5, 2, 4, 6, 9, and 12 hours) were obtained after the end of infusion, and cefepime concentrations were determined by high performance liquid chromatography (HPLC). All serum concentration profiles were modeled by a population pharmacokinetic analysis using the Non-Parametric Adaptive Grid (NPAG) program. Acceptability of administration was evaluated using subjective sensation grading, observation of the subcutaneous site, and a final global evaluation. The mean (median) Cmax, β-t1/2, AUC 0-oo and total clearance were found to be 36.1 (30.9) mg/L, 2.34 (2.56) hours, 134.8 (125.3) h•mg/L, and 7.42 (7.98) L/h, respectively. All infusions were completed without difficulty or discomfort. No drug side effects occurred. The global acceptability was "strongly agreeable" with all the subjects. Subcutaneous infusion of cefepime appeared to result in a pharmacokinetic profile similar to that of an intramuscular injection. Our evaluations showed excellent tolerability and acceptability. These favorable results warrant further clinical evaluation.
KW - Antibiotic
KW - Cefepime
KW - Pharmacokinetics
KW - Subcutaneous infusion
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U2 - 10.1016/j.jpainsymman.2005.03.007
DO - 10.1016/j.jpainsymman.2005.03.007
M3 - Article
C2 - 16125032
AN - SCOPUS:23944516820
SN - 0885-3924
VL - 30
SP - 170
EP - 174
JO - Journal of pain and symptom management
JF - Journal of pain and symptom management
IS - 2
ER -