Overview

Levofloxacin was found to be non-teratogenic in rats at dosages up to 810 mg/kg/day, which is 9.4 times the maximum recommended oral human dose based on relative body surface area. Fetal body weight in rats was reduced and fetal mortality was increased when the animals were given an oral dose of 810 mg/kg/day. It was found that oral dosing rabbits at 50 mg/kg/day, which is 1.1 times the maximal authorized oral human dose based on relative body surface area, did not cause teratogenicity. Unfortunately, there are no good studies with pregnant women that have been properly controlled for variables. You should only take LEVAQUIN(R) while pregnant if the benefits outweigh the risks. Women Who Are Breastfeeding It can be assumed that levofloxacin will be excreted in human milk based on data on other fluoroquinolones and very little data on LEVAQUIN(R). Considering the significance of the drug to the mother, it is necessary to decide whether to terminate nursing or to quit LEVAQUIN(R) because of the risk for serious adverse effects in nursing infants.

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