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Besifloxacin ophthalmic Pregnancy and Breastfeeding Warnings

Besifloxacin ophthalmic is also known as: Besivance

Besifloxacin ophthalmic Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus. US FDA pregnancy category: C

Animal studies have failed to reveal evidence of teratogenicity. Oral doses up to 1000 mg/kg/day (Cmax in rat dams about 20 mcg/mL, more than 45,000 times plasma levels in humans) were associated with maternal toxicity (reduced weight gain and food intake) and maternal mortality but not with visceral or skeletal malformations in rat pups; increased postimplantation loss and decreased fetal weight, fetal ossification, pup weight (compared to controls), and rate of neonate survival observed. The No Observed Adverse Effect Level for fetal and maternal toxicity was 100 mg/kg/day (Cmax 5 mcg/mL, more than 11,000 times plasma levels in humans). There are no controlled data in human pregnancy. 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

Besifloxacin ophthalmic Breastfeeding Warnings

Although this drug has not been measured in human milk, excretion in human milk can be presumed.

Caution is recommended. Excretion into human milk: Unknown Excreted into animal milk: Data not available Comments: -Maternal use of an ophthalmic drop containing this drug poses negligible risk for a nursing infant. -Placing pressure over the tear duct by the corner of the eye for at least 1 minute then removing excess solution with an absorbent tissue substantially reduces the amount of drug that reaches the breast milk after using eye drops.

See references

References for pregnancy information

  1. "Product Information. Besivance (besifloxacin ophthalmic)." Bausch and Lomb, Rochester, NY.

References for breastfeeding information

  1. "Product Information. Besivance (besifloxacin ophthalmic)." Bausch and Lomb, Rochester, NY.
  2. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL:" ([cited 2013 -]):

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