<abstract xmlns="http://www.w3.org/1999/xhtml"> Background: Cefepime, a fourth generation cephalosporin, is a broad spectrum antibiotic effective against both Gram positive and Gram negative bacteria. It is available from several pharmaceutical firms in southeast Asia. We studied bioequivalence of two products. Objective: To assess the bioequivalence of two cefepime formulations: Cefamax 1 g intramuscular (Siam Pharmaceutical, Bangkok, Thailand) as the test formulation and Maxipime 1 g (Bristol-Myers Squibb, Bangkok, Thailand) as the reference formulation. Methods: The study was conducted as an open, randomized, two-period crossover trial with a 1 week washout period in 18 healthy volunteers. Each subject received a single dose of 1 g intramuscular injection of the test or reference formulation. Blood samples were collected via an intravascular catheter at several time points over a 12 h period. Plasma cefepime concentrations were quantified by HPLC with photodiode array detection at 280 nm. The statistical comparisons for pharmacokinetic parameters were made using a paired t test. Results: There was no significant difference in the logarithmically transformed values of Cmax, AUC0-12, and AUC0-∞ between Cefamax and Maxipime using an analysis of variance (ANOVA). The 90% confidence intervals (CIs) of Cmax, AUC0-12, and AUC0-∞ between the two formulations were 91.17-105.78, 90.29-97.63, and 88.89-96.57, respectively. All subjects had good tolerance and no serious adverse events were observed. Conclusion: Cefamax 1 g intramuscular formulation is bioequivalent to Maxipime 1 g intramuscular formulation based on 90% CIs for Cmax, AUC0-12, and AUC0-∞ within 80%-125%.</abstract>

Background: Cefepime, a fourth generation cephalosporin, is a broad spectrum antibiotic effective against both Gram positive and Gram negative bacteria. It is available from several pharmaceutical firms in southeast Asia. We studied bioequivalence of two products. Objective: To assess the bioequivalence of two cefepime formulations: Cefamax 1 g intramuscular (Siam Pharmaceutical, Bangkok, Thailand) as the test formulation and Maxipime 1 g (Bristol-Myers Squibb, Bangkok, Thailand) as the reference formulation. Methods: The study was conducted as an open, randomized, two-period crossover trial with a 1 week washout period in 18 healthy volunteers. Each subject received a single dose of 1 g intramuscular injection of the test or reference formulation. Blood samples were collected via an intravascular catheter at several time points over a 12 h period. Plasma cefepime concentrations were quantified by HPLC with photodiode array detection at 280 nm. The statistical comparisons for pharmacokinetic parameters were made using a paired t test. Results: There was no significant difference in the logarithmically transformed values of Cmax, AUC0-12, and AUC0-∞ between Cefamax and Maxipime using an analysis of variance (ANOVA). The 90% confidence intervals (CIs) of Cmax, AUC0-12, and AUC0-∞ between the two formulations were 91.17-105.78, 90.29-97.63, and 88.89-96.57, respectively. All subjects had good tolerance and no serious adverse events were observed. Conclusion: Cefamax 1 g intramuscular formulation is bioequivalent to Maxipime 1 g intramuscular formulation based on 90% CIs for Cmax, AUC0-12, and AUC0-∞ within 80%-125%.

Bioequivalence study of cefepime intramuscular injection

Department of Medicine, Faculty of Medicine, Prince of Songkla University, Hat Yai, Songkla 90110,

Asian Biomedicine

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 License.

{"article-title":"Bioequivalence study of cefepime intramuscular injection"}

Background: Cefepime, a fourth generation cephalosporin, is a broad spectrum antibiotic effective against both Gram positive and Gram negative bacteria. It is...

Bioequivalence study of cefepime intramuscular injection

Article Category: Brief communication (Original)

Publicado en línea: 04 feb 2017

Páginas: 237 - 240

DOI: https://doi.org/10.5372/1905-7415.0802.284

Palabras clave
Bioequivalence study, Cefamax, cefepime, fourth generation cephalosporin, pharmacokinetics

© 2017

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 License.

Bioequivalence study of cefepime intramuscular injection

Article Category: Brief communication (Original)

Publicado en línea: 04 feb 2017

Páginas: 237 - 240

DOI: https://doi.org/10.5372/1905-7415.0802.284

Palabras claveBioequivalence study, Cefamax, cefepime, fourth generation cephalosporin, pharmacokinetics

© 2017

This work is licensed under the Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 License.

Palabras clave
Bioequivalence study, Cefamax, cefepime, fourth generation cephalosporin, pharmacokinetics