Fosfomycin Tromethamine

Contraindications

CONTRAINDICATIONS Fosfomycin tromethamine granules for oral solution is contraindicated in patients with known hypersensitivity to the drug.

Pregnancy & Breastfeeding

Pregnancy: Teratogenic Effects When administered intramuscularly as the sodium salt at a dose of 1 gram to pregnant women, fosfomycin crosses the placental barrier. Fosfomycin tromethamine crosses the placental barrier of rats; it does not produce teratogenic effects in pregnant rats at dosages as high as 1000 mg/kg/day (approximately 9 and 1.4 times the human dose based on body weight and mg/m 2 , respectively). When administered to pregnant female rabbits at dosages as high as 1000 mg/kg/day (approximately 9 and 2.7 times the human dose based on body weight and mg/m 2 , respectively), fetotoxicities were observed. However, these toxicities were seen at maternally toxic doses and were considered to be due to the sensitivity of the rabbit to changes in the intestinal microflora resulting from the antibiotic administration. 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 clearly needed.