title: Subcutaneous administration of cefepime.
abstract: 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, beta-t1/2, AUC0-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.
authors.affiliation: Department of Palliative Care and Rehabilitation Medicine, The University of Texas M. D. Anderson Cancer Center, Houston, Texas 77030, USA.
authors.forename: Paul
authors.initials: P
authors.lastname: Walker
authors.forename: Melinda N
authors.initials: MN
authors.lastname: Neuhauser
authors.forename: Vincent H
authors.initials: VH
authors.lastname: Tam
authors.forename: Jie S
authors.initials: JS
authors.lastname: Willey
authors.forename: J Lynn
authors.initials: JL
authors.lastname: Palmer
authors.forename: Eduardo
authors.initials: E
authors.lastname: Bruera
authors.forename: Randall A
authors.initials: RA
authors.lastname: Prince
mesh_terms: D000328:Adult; D000077723:Cefepime; D002511:Cephalosporins / Q000008:administration & dosage* / Q000493:pharmacokinetics*; D005260:Female; D006801:Humans; D007263:Infusions, Parenteral; D008297:Male; D008875:Middle Aged; D012016:Reference Values; D040521:Subcutaneous Tissue
chemical_list: D002511:Cephalosporins; D000077723:Cefepime