PMID- 27287644
OWN - NLM
STAT- MEDLINE
DCOM- 20180123
LR  - 20190921
IS  - 1815-7920 (Electronic)
IS  - 1027-3719 (Print)
IS  - 1027-3719 (Linking)
VI  - 20
IP  - 7
DP  - 2016 Jul
TI  - Bioavailability of two licensed paediatric rifampicin suspensions: implications 
      for quality control programmes.
PG  - 915-9
LID - 10.5588/ijtld.15.0833 [doi]
AB  - SETTING: To assess the revised World Health Organization-recommended dose of 
      10-20 mg/kg rifampicin (RMP), we studied the steady state pharmacokinetics of RMP 
      in South African children who received standard treatment for drug-susceptible 
      tuberculosis (TB). OBJECTIVE: To determine the formulation effect on the 
      pharmacokinetics of RMP. DESIGN: RMP plasma concentrations were characterised in 
      146 children (median age 1.4 years, range 0.2-10.2). The morning dose on the day 
      of the pharmacokinetic evaluation was administered as one of two RMP single-drug 
      oral suspensions. RESULTS: While one formulation achieved 2 h concentrations in 
      the range of those observed in adults (median 6.54 mg/l, interquartile range 
      [IQR] 4.47-8.84), the other attained a median bioavailability of only 25% of 
      this, with a median 2 h concentration of 1.59 mg/l (IQR 0.89-2.38). CONCLUSION: 
      RMP is a key drug for the treatment of TB. It is critical that the quality of RMP 
      suspensions used to treat childhood TB is ensured.
FAU - McIlleron, H
AU  - McIlleron H
AD  - Division of Clinical Pharmacology, Department of Medicine, University of Cape 
      Town, Cape Town, South Africa.
FAU - Hundt, H
AU  - Hundt H
AD  - Division of Clinical Pharmacology, Department of Medicine, University of Cape 
      Town, Cape Town, South Africa.
FAU - Smythe, W
AU  - Smythe W
AD  - Division of Clinical Pharmacology, Department of Medicine, Clinical Research 
      Centre, Health Sciences Faculty, University of Cape Town, Cape Town, South 
      Africa.
FAU - Bekker, A
AU  - Bekker A
AD  - Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of 
      Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.
FAU - Winckler, J
AU  - Winckler J
AD  - Department of Paediatrics and Child Health, and Medical Research Council Unit on 
      Child and Adolescent Health, University of Cape Town, Cape Town, South Africa.
FAU - van der Laan, L
AU  - van der Laan L
AD  - Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of 
      Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.
FAU - Smith, P
AU  - Smith P
AD  - Division of Clinical Pharmacology, Department of Medicine, University of Cape 
      Town, Cape Town, South Africa.
FAU - Zar, H J
AU  - Zar HJ
AD  - Department of Paediatrics and Child Health, and Medical Research Council Unit on 
      Child and Adolescent Health, University of Cape Town, Cape Town, South Africa; 
      Red Cross War Memorial Children's Hospital, Cape Town, South Africa.
FAU - Hesseling, A C
AU  - Hesseling AC
AD  - Desmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of 
      Medicine and Health Sciences, Stellenbosch University, Cape Town, South Africa.
FAU - Maartens, G
AU  - Maartens G
AD  - Division of Clinical Pharmacology, Department of Medicine, University of Cape 
      Town, Cape Town, South Africa.
FAU - Wiesner, L
AU  - Wiesner L
AD  - Division of Clinical Pharmacology, Department of Medicine, University of Cape 
      Town, Cape Town, South Africa.
FAU - van Rie, A
AU  - van Rie A
AD  - Department of Epidemiology, University of North Carolina at Chapel Hill, Chapel 
      Hill, North Carolina, USA; International Health Unit, Epidemiology and Social 
      Medicine, Faculty of Medicine, University of Antwerp, Antwerp, Belgium.
LA  - eng
GR  - UM1 AI068632/AI/NIAID NIH HHS/United States
GR  - R01 HD069175/HD/NICHD NIH HHS/United States
GR  - UM1 AI106701/AI/NIAID NIH HHS/United States
GR  - U01 AI068632/AI/NIAID NIH HHS/United States
GR  - UM1 AI068634/AI/NIAID NIH HHS/United States
GR  - UM1 AI068636/AI/NIAID NIH HHS/United States
PT  - Clinical Trial
PT  - Comparative Study
PT  - Journal Article
PT  - Research Support, N.I.H., Extramural
PT  - Research Support, Non-U.S. Gov't
PL  - France
TA  - Int J Tuberc Lung Dis
JT  - The international journal of tuberculosis and lung disease : the official journal 
      of the International Union against Tuberculosis and Lung Disease
JID - 9706389
RN  - 0 (Antibiotics, Antitubercular)
RN  - 0 (Pharmaceutical Solutions)
RN  - VJT6J7R4TR (Rifampin)
SB  - IM
MH  - Administration, Oral
MH  - Antibiotics, Antitubercular/administration & 
      dosage/chemistry/*pharmacokinetics/standards
MH  - Biological Availability
MH  - Child
MH  - Child, Preschool
MH  - *Drug Approval
MH  - Drug Compounding
MH  - Drug Monitoring
MH  - Female
MH  - Humans
MH  - Infant
MH  - *Licensure/standards
MH  - Male
MH  - Pharmaceutical Solutions
MH  - Quality Assurance, Health Care
MH  - Quality Control
MH  - Rifampin/administration & dosage/chemistry/*pharmacokinetics/standards
MH  - South Africa
MH  - Tuberculosis/blood/diagnosis/*drug therapy
PMC - PMC4978631
MID - NIHMS805869
COIS- Conflicts of interest: none declared.
EDAT- 2016/06/12 06:00
MHDA- 2018/01/24 06:00
PMCR- 2016/08/10
CRDT- 2016/06/12 06:00
PHST- 2016/06/12 06:00 [entrez]
PHST- 2016/06/12 06:00 [pubmed]
PHST- 2018/01/24 06:00 [medline]
PHST- 2016/08/10 00:00 [pmc-release]
AID - 10.5588/ijtld.15.0833 [doi]
PST - ppublish
SO  - Int J Tuberc Lung Dis. 2016 Jul;20(7):915-9. doi: 10.5588/ijtld.15.0833.