A comparison of the pharmacokinetics of Aspen Ceftriaxone and Rocephin in
community-acquired meningitis.
Author(s): Richards GA(1), Elliott E, Shaddock EJ, Mushi D, Mzileni M, Ray R, Rulisa S,
Seolwane F, Stacey SL, Stoltz A, Venturas JP, Schoeman H.
Affiliation(s): Author information:
(1)Division of Pulmonology and Critical Care, Department of Medicine, University of
the Witwatersrand and Charlotte Maxeke Johannesburg Academic Hospital,
Johannesburg, South Africa. guy.richards@wits.ac.za.
Publication date & source: 2013, S Afr Med J. , 103(12):906-9
BACKGROUND: Community-acquired bacterial meningitis (CABM) is a life-threatening
condition that is common among immunocompromised individuals. Intravenous
ceftriaxone, of which Rocephin (ROC) is the originator brand, is recommended as
first-line therapy in South Africa. Despite concerns regarding therapeutic
equivalence with generic agents, this is the first study that has been conducted
comparing clinical pharmacokinetics (PK) of a generic ceftriaxone formulation
with the originator.
OBJECTIVE: To compare the PK and safety of Aspen Ceftriaxone (AC) and ROC in the
treatment of adult CABM.Methods. A total of 63 eligible patients were randomised
1:1 to receive 2 g of either medication twice daily for a duration based on the
identity of the causative organism and their physician's clinical judgment. The
primary endpoint of this study was the comparison of clinical PK, specifically
the concentrations of each drug in the cerebrospinal fluid with corresponding
paired plasma samples. While this study was underpowered to assess efficacy,
safety could be evaluated on the basis of reported adverse events.
RESULTS: The two patient groups were epidemiologically similar. There were no
statistically significant differences in PK between either agent, nor any
difference with regard to safety.
CONCLUSION: AC can be considered as equivalent to ROC with regard to PK and
safety in patients with CABM.
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