Augmentin

[Amoxicillin/Clavulanate]

NDC 0029-6092-29..... 50 mL bottle NDC 0029-6092-39...... 75 mL bottle
NDC 0029-6092-51.... 100 mL bottle
AUGMENTIN 125 MG (125 mg amoxicillin/ 31.25 mg clavulanic acid) CHEWABLE TABLETS:

NDC 0029-6073-47........... carton of 30 (5x6) tablets
AUGMENTIN 200 MG (200 mg amoxicillin/ 28.5 mg clavulanic acid) CHEWABLE TABLETS: NDC 0029-6071-12.............. carton of 20 tablets

AUGMENTIN 250 MG (250 mg amoxicillin/ 62.5 mg clavulanic acid) CHEWABLE TABLETS: NDC 0029-6074-47..................... carton of 30 (5x6) tablets

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AUGMENTIN 400 MG (400 mg amoxicillin/ 57.0 mg clavulanic acid) CHEWABLE TABLETS: NDC 0029-6072-12................... carton of 20 tablets
Store tablets and dry powder at or below 25° C (77° F). Dispense in original container.

CLINICAL STUDIES

Data from two pivotal studies in 1,191 patients treated for either lower respiratory tract infections or complicated urinary tract infections compared a regimen of 875 mg Augmentin tablets q12h to 500 mg Augmentin tablets dosed q8h (584 and 607 patients, respectively). Comparable efficacy was demonstrated between the q12h and q8h dosing regimens. There was no significant difference in the percentage of adverse events in each group. The most frequently reported adverse event was diarrhea; incidence rates were similar for the 875 mg q12h and 500 mg q8h dosing regimens (14.9% and 14.3%, respectively). However, there was a statistically significant difference (p< 0.05) in rates of severe diarrhea or withdrawals with diarrhea between the regimens: 1.0% for 875 mg q12h dosing versus 2.5% for the 500 mg q8h dosing.

In one 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 Augmentin tablets q12h or 500 mg Augmentin tablets 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

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