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Gemifloxacin Pregnancy and Breastfeeding Warnings

Gemifloxacin is also known as: Factive

Gemifloxacin Pregnancy Warnings

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus; safety has not been established during pregnancy. US FDA pregnancy category: C

Animal studies have revealed evidence of fetotoxicity with higher doses; the overall no-effect exposure level in pregnant animals was about 0.8- to 3-fold clinical exposure. Delayed fetal growth was observed in mice (450 mg/kg/day orally), rats (600 mg/kg/day orally), and rabbits (40 mg/kg/day IV) at AUC levels about 2-, 4-, and 3-fold AUC levels in women (taking 320 mg orally) but appeared reversible in rats; at maternotoxic doses in pregnant rats (8-fold clinical exposure [based on AUC]), fetal brain and ocular malformations were observed. There are no controlled data in human pregnancy. Cartilage damage and arthropathy have been reported in immature animals of various species giving rise to concern over possible toxic effects on human fetal bone formation. Because safer alternatives are generally available, some experts consider fluoroquinolones contraindicated during pregnancy, especially during the first trimester. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Gemifloxacin Breastfeeding Warnings

Cartilage erosion and arthropathy have been observed in immature animals giving rise to concern over toxic effects in the developing joints of nursing infants; however, some studies suggest risk is low. Absorption of the small amounts of fluoroquinolones in milk may be blocked by the calcium in milk; data insufficient to prove or disprove. A nursing mother was administered a single 320 mg oral tablet. A single breast milk sample was collected 3 hours after dosing; milk drug level was about 0.9 mg/L.

LactMed: Use is considered acceptable with monitoring of the infant for possible effects on the gastrointestinal flora (e.g., diarrhea or candidiasis [thrush, diaper rash]); however, an alternate agent with safety information available is preferred. -According to some authorities: This drug should not be used unless the benefit to the mother outweighs the risk to the infant. Excreted into human milk: Yes (small amounts) Comments: -The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Factive (gemifloxacin)." GeneSoft Inc, San Francisco, CA.
  2. Bhavnani SM, Andes DR "Gemifloxacin for the treatment of respiratory tract infections: in vitro susceptibility, pharmacokinetics and pharmacodynamics, clinical efficacy, and safety." Pharmacotherapy 25 (2005): 717-40

References for breastfeeding information

  1. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL:" ([cited 2013 -]):
  2. "Product Information. Factive (gemifloxacin)." GeneSoft Inc, San Francisco, CA.
  3. Bhavnani SM, Andes DR "Gemifloxacin for the treatment of respiratory tract infections: in vitro susceptibility, pharmacokinetics and pharmacodynamics, clinical efficacy, and safety." Pharmacotherapy 25 (2005): 717-40

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