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Gemifloxacin Pregnancy and Breastfeeding Warnings

Gemifloxacin is also known as: Factive

Medically reviewed by Drugs.com. Last updated on Jan 7, 2019.

Gemifloxacin Pregnancy Warnings

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned.

Risk summary: Based on animal data, this drug may cause fetal harm; insufficient data available on use of this drug in pregnant women to inform a drug-related risk.

Comments:
-If this drug is used during pregnancy, the patient should be apprised of the potential harm to the fetus.

Animal studies have revealed evidence of embryofetal toxicity at exposures up to 2 (mice) and 3 (rabbits) times the maximum recommended human dose; delayed fetal growth, including reduced fetal body weights in mice and rabbits and delayed skeletal ossification in mice at 2 and 3 times, respectively, the clinical exposures (based on AUC); at maternotoxic doses in pregnant rats (about 8-times the clinical exposure [based on AUC]), reduced fetal birth weights and 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 Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

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.

Excreted into human milk: Yes (small amounts)

Comments:
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-The effects in the nursing infant are unknown; potential side effects in the breastfed child due to this drug or the mother's underlying condition should be considered

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: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([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

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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