title: Tigecycline pharmacokinetics in subjects with various degrees of renal function.
abstract: The pharmacokinetic parameters of tigecycline were assessed in subjects with severe renal impairment (creatinine clearance <30 mL/min, n = 6), subjects receiving hemodialysis (4 received tigecycline before and 4 received tigecycline after hemodialysis), and subjects with age-adjusted, normal renal function (n = 6) after administration of single 100-mg doses. Serial serum and urine samples were collected and assayed using validated liquid chromatography with tandem mass spectrometer (LC/MS/MS) methods. Concentration-time data were then analyzed using noncompartmental pharmacokinetic methods. Tigecycline renal clearance in subjects with normal renal function represented approximately 20% of total systemic clearance. Tigecycline clearance was reduced by approximately 20%, and area under the tigecycline concentration-time curve increased by approximately 30% in subjects with severe renal impairment. Tigecycline was not efficiently removed by dialysis; thus, it can be administered without regard to timing of hemodialysis. Based on these pharmacokinetic data, tigecycline requires no dosage adjustment in patients with renal impairment.
authors.affiliation: Pfizer, Inc, 500 Arcola Rd, Collegeville, PA 19426-3982, USA. Joan.Korth-Bradley@pfizer.com
authors.forename: Joan M
authors.initials: JM
authors.lastname: Korth-Bradley
authors.forename: Steven M
authors.initials: SM
authors.lastname: Troy
authors.forename: Kyle
authors.initials: K
authors.lastname: Matschke
authors.forename: Gopal
authors.initials: G
authors.lastname: Muralidharan
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Fruncillo
authors.forename: John L
authors.initials: JL
authors.lastname: Speth
authors.forename: Donald G
authors.initials: DG
authors.lastname: Raible
mesh_terms: D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000097:blood / Q000493:pharmacokinetics* / Q000652:urine; D005260:Female; D006801:Humans; D007668:Kidney / Q000378:metabolism; D008297:Male; D008875:Middle Aged; D008911:Minocycline / Q000031:analogs & derivatives* / Q000097:blood / Q000493:pharmacokinetics / Q000652:urine; D006435:Renal Dialysis; D051437:Renal Insufficiency / Q000378:metabolism* / Q000503:physiopathology; D000078304:Tigecycline
chemical_list: D000900:Anti-Bacterial Agents; D000078304:Tigecycline; D008911:Minocycline