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Drug/ Laboratory Test Interactions: Oral administration of Augmentin will result in high urine concentrations of amoxicillin. High urine concentrations of ampicillin may result in false-positive reactions when testing for the presence of glucose in urine using Clinitest ® , Benedict's Solution or Fehling's Solution. Since this effect may also occur with amoxicillin and therefore Augmentin, it is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as Clinistix ® or Tes-Tape ® ) be used. Following administration of ampicillin to pregnant women a transient decrease in plasma concentration of total conjugated estriol, estriol-glucuronide, conjugated estrone and estradiol has been noted. This effect may also occur with amoxicillin and therefore Augmentin. Text Continues Below
Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term studies in animals have not been performed to evaluate carcinogenic potential. Mutagenesis The mutagenic potential of Augmentin was investigated in vitro with an Ames test, a human lymphocyte cytogenetic assay, a yeast test and a mouse lymphoma forward mutation assay, and in vivo with mouse micronucleus tests and a dominant lethal test. All were negative apart from the in vitro mouse lymphoma assay where weak activity was found at very high, cytotoxic concentrations. Impairment of Fertility: Augmentin at oral doses of up to 1200 mg/ kg/ day (5.7 times the maximum human dose, 1480 mg/ m 2 /day, based on body surface area) was found to have no effect on fertility and reproductive performance in rats, dosed with a 2: 1 ratio formulation of amoxicillin: clavulanate. Teratogenic effects. Pregnancy (Category B) Reproduction studies performed in pregnant rats and mice given Augmentin at oral dosages up to 1200 mg/ kg/ day, equivalent to 7200 and 4080 mg/ m 2 /day, respectively (4.9 and 2.8 times the maximum human oral dose based on body surface area), revealed no evidence of harm to the fetus due to Augmentin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if needed. Page: << Prev | 1 | 2 | 3 | 4 | Next >>
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