title: Pharmacokinetics of single-dose primaquine in patients with chronic kidney dysfunction.
abstract: OBJECTIVE
  The pharmacokinetics of primaquine has not been studied in special populations. Being a basic compound, preferential binding to alpha-1 acid glycoprotein and substrate for P-glycoprotein, may predispose the drug for an altered pharmacokinetics in states of renal dysfunction. This study attempts to evaluate the pharmacokinetics of a single oral dose (15 mg) of primaquine in severely impaired renal function and end stage renal dysfunction patients compared to healthy participants.
  
  
  METHODS
  Twelve patients each with chronic kidney disease classified as either Stage IV or V (not on dialysis) were recruited. Data from 12 healthy participants was used as concurrent controls. Serial blood collections were performed following a single dose 15 mg Primaquine orally. Primaquine concentrations were measured in the plasma using a validated HPLC method.
  
  
  RESULTS
  The Cmax [median (range) in ng/ml] was 29.3 (14.6-104.3), 40.3 (14.8 - 78.6), and 49.8 (15 - 169.6) and the tmax [median (range) in hours] was 3.0 (1.0- 6.0), 2.0 (1.5 - 8) and 2.0 (1.0 - 4.0) for healthy and stage IV, V (not on dialysis) CKD participants, respectively. No statistically significant difference was observed in any of the pharmacokinetic parameters between healthy, stage IV and V CKD participants.
  
  
  CONCLUSIONS
  Pharmacokinetics of single oral dose primaquine (15 mg) does not appear to be altered in patients with severely impaired renal function and end stage renal dysfunction. A change in dose or frequency of the drug administration perhaps may not be required in this population.
authors.affiliation: Department of Pharmacology, Seth GS Medical College and KEM Hospital, Parel, Mumbai, India.
authors.forename: Shaunak P
authors.initials: SP
authors.lastname: Kulkarni
authors.forename: Sanjana R
authors.initials: SR
authors.lastname: Shah
authors.forename: Prashant P
authors.initials: PP
authors.lastname: Kadam
authors.forename: Kannan
authors.initials: K
authors.lastname: Sridharan
authors.forename: Nivrutti K
authors.initials: NK
authors.lastname: Hase
authors.forename: Partha P
authors.initials: PP
authors.lastname: Shetty
authors.forename: Urmila M
authors.initials: UM
authors.lastname: Thatte
authors.forename: Nithya J
authors.initials: NJ
authors.lastname: Gogtay
mesh_terms: D000328:Adult; D000962:Antimalarials / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011319:Primaquine / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*; D051436:Renal Insufficiency, Chronic / Q000378:metabolism*; D055815:Young Adult
chemical_list: D000962:Antimalarials; D011319:Primaquine
keywords: Antimalarials; chronic kidney disease; renal failure; special populations