Effectiveness and Safety of Generic Formulation of Piperacillin/Tazobactam (Astaz-PR) for Treatment of Infected Patients at Siriraj Hospital
Lantharita Charoenpong MD*, Sasima Tongsai PhD*, Visanu Thamlikitkul MD*
Affiliation : * Division of Infectious Diseases and Tropical Medicine, Department of Medicine, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok, Thailand
Objective : To determine effectiveness and safety of generic piperacillin/tazobactam (Astaz-PR) that has been available as a
substitute for original piperacillin/tazobactam (TazocinR) in Siriraj Hospital since October 2011.
Material and Method: Medical records of hospitalized adult patients who received piperacillin/tazobactam for at least 48
hours from January 2011 to June 2012 were reviewed. The data on demographics, clinical features of infections, antibiotic
treatments, clinical courses and outcomes of the patients who received original piperacillin/tazobactam and generic piperacillin/
tazobactam were analyzed and compared.
Results : The medical records of 300 patients who received original piperacillin/tazobactam and 300 patients who received
generic piperacillin/tazobactam were included. The characteristics of the patients and clinical and microbiological features of
infections of the patients in both groups were not significantly different. Overall favorable clinical outcome and overall
mortality were comparable between generic and original groups (74.0% vs. 74.7%, p = 0.93; 18.3% vs. 18.0%, p = 1.00,
respectively). No significant difference of adverse effect was found between two groups. The non-inferiority test indicated that
the clinical outcome and overall mortality of the patients who received generic piperacillin/tazobactam were not inferior to
those who received original piperacillin/tazobactam (p = 0.004 and p = 0.001, respectively).
Conclusion : Generic piperacillin/tazobactam (Astaz-PR) was not inferior to original piperacillin/ tazobactam (TazocinR) for
therapy of infections in the hospitalized patients at Siriraj Hospital.
Keywords : Piperacillin/tazobactam, Original, Generic, Non-inferiority, Effectiveness, Safety
