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A comparison of the pharmacokinetics of Aspen Ceftriaxone and Rocephin in community-acquired meningitis

Guy A Richards, Eugene Elliott, Erica J Shaddock, David Mushi, Mogiyana Mzileni, Roanne Ray, Stephen Rulisa, Freddy Seolwane, Sarah L Stacey, Anton Stoltz, Jacqueline P Venturas, Herman Schoeman

Abstract


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. 


Authors' affiliations

Guy A Richards, Division of Pulmonology and Critical Care, Department of Medicine, University of the Witwatersrand and Charlotte Maxeke Johannesburg Academic Hospital, Johannesburg, South Africa

Eugene Elliott, Department of Microbiology, University of the Free State, Bloemfontein, South Africa

Erica J Shaddock, Division of Pulmonology and Critical Care, Department of Medicine, University of the Witwatersrand and Charlotte Maxeke Johannesburg Academic Hospital, Johannesburg, South Africa

David Mushi, Department of Internal Medicine, School of Medicine, University of Limpopo, MEDUNSA Campus, Pretoria, South Africa

Mogiyana Mzileni, Department of Internal Medicine, School of Medicine, University of Limpopo, MEDUNSA Campus, Pretoria, South Africa

Roanne Ray, Division of Pulmonology and Critical Care, Department of Medicine, University of the Witwatersrand and Charlotte Maxeke Johannesburg Academic Hospital, Johannesburg, South Africa

Stephen Rulisa, Department of Research, University Teaching Hospital of Kigali, Rwanda

Freddy Seolwane, Department of Internal Medicine, School of Medicine, University of Limpopo, MEDUNSA Campus, Pretoria, South Africa

Sarah L Stacey, Division of Pulmonology and Critical Care, Department of Medicine, University of the Witwatersrand and Charlotte Maxeke Johannesburg Academic Hospital, Johannesburg, South Africa

Anton Stoltz, Division of Infectious Diseases, University of Pretoria and Department of Internal Medicine, Steve Biko Academic Hospital, Pretoria, South Africa

Jacqueline P Venturas, Division of Pulmonology and Critical Care, Department of Medicine, University of the Witwatersrand and Charlotte Maxeke Johannesburg Academic Hospital, Johannesburg, South Africa

Herman Schoeman, ClinStat, Pretoria, South Africa

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Keywords

infectious diseases; meningitis; antibiotics; generics; pharmacokinetics

Cite this article

South African Medical Journal 2013;103(12):906-909. DOI:10.7196/SAMJ.7086

Article History

Date submitted: 2013-05-28
Date published: 2013-09-03

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