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Augmentin
Clinical Pharmacology
Augmentin
In 1 of these pivotal studies, 629 patients with either pyelonephritis or a complicated urinary tract infection (i.e., patients with abnormalities of the urinary tract that predispose to relapse of bacteriuria following eradication) were randomized to receive either 875-mg tablets of AUGMENTIN q12h or 500-mg tablets of AUGMENTIN q8h in the following distribution:
| 875 mg q12h | 500 mg q8h | |
| Pyelonephritis | 173 patients | 188 patients |
| Complicated UTI | 135 patients | 133 patients |
| Total patients | 308 | 321 |
The number of bacteriologically evaluable patients was comparable between the 2 dosing regimens. AUGMENTIN produced comparable bacteriological success rates in patients assessed 2 to 4 days immediately following end of therapy. The bacteriologic efficacy rates were comparable at 1 of the follow-up visits (5 to 9 days post-therapy) and at a late post-therapy visit (in the majority of cases, this was 2 to 4 weeks post-therapy), as seen in the table below:
| 875 mg q12h | 500 mg q8h | |
| 2 to 4 days | 81%, n = 58 | 80%, n = 54 |
| 5 to 9 days | 58.5%, n = 41 | 51.9%, n = 52 |
| 2 to 4 weeks | 52.5%, n = 101 | 54.8%, n = 104 |
As noted before, though there was no significant difference in the percentage of adverse events in each group, there was a statistically significant difference in rates of severe diarrhea or withdrawals with diarrhea between the regimens.
REFERENCES
1. National Committee for Clinical Laboratory Standards. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically - Third Edition. Approved Standard NCCLS Document M7-A3, Vol. 13, No. 25. NCCLS, Villanova, PA, December 1993.
2. National Committee for Clinical Laboratory Standards. Performance Standards for Antimicrobial Disk Susceptibility Tests - Fifth Edition. Approved Standard NCCLS Document M2-A5, Vol. 13, No. 24. NCCLS, Villanova, PA, December 1993.
Generic Name: Amoxicillin Clavulanate
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