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Ceftin

Clinical Pharmacology
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Clinical Pharmacology

  CAE-516 and CAE-517* CAEA4001 and CAEA4002
5 Day
(n = 127)
10 Day
(n = 139)
5 Day
(n = 173)
10 Day
(n = 192)
Clinical success (cure + improvement) 80% 87% 84% 82%
Clinical cure 61% 70% 73% 72%
Clinical improvement 19% 17% 11% 10%
*95% Confidence interval around the success difference [-0.164, +0.029].
95% Confidence interval around the success difference [-0.061, +0.103].

The response rates for patients who were both clinically and bacteriologically evaluable were consistent with those reported for the clinically evaluable patients.

Safety: In these clinical trials, 399 patients were treated with CEFTIN for 5 days and 402 patients with CEFTIN for 10 days. No difference in the occurrence of adverse events was observed between the 2 regimens.

REFERENCES

1.National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically. 3rd ed. Approved Standard NCCLS Document M7-A3, Vol. 13, No. 25. Villanova, Pa: NCCLS; 1993.

2.National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Disk Susceptibility Tests. 4th ed. Approved Standard NCCLS Document M2-A4, Vol. 10, No. 7. Villanova, Pa: NCCLS; 1990.

Brand Name: Ceftin
Generic Name: Cefuroxime Axetil
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