Anti-infective (Quinolone)
PREGNANCY RECOMMENDATION: Human Data Suggest Low Risk
BREASTFEEDING RECOMMENDATION: No Human Data—Probably Compatible
PREGNANCY SUMMARY
No reports describing the use of gemifloxacin during human pregnancy have been located. The animal toxicity (fetal growth restriction) observed at exposures close to those obtained in humans should be considered before this agent is used in pregnant women. Moreover, some reviewers have concluded that all fluoroquinolones should be considered contraindicated in pregnancy (e.g., see Ciprofloxacin and Norfloxacin) because safer alternatives are usually available.
FETAL RISK SUMMARY
Gemifloxacin is a synthetic, broad-spectrum, fluoroquinolone antibacterial agent. It is in the same anti-infective class as ciprofloxacin, enoxacin, gatifloxacin, levofloxacin, lomefloxacin, moxifloxacin, norfloxacin, ofloxacin, sparfloxacin, and trovafloxacin. Gemifloxacin is available in an oral formulation. Gemifloxacin and its metabolites are primarily eliminated in the feces (about 61%), with the remainder excreted in the urine (about 36%). Plasma protein binding ranges from 55% to 73% and the elimination half-life is about 7 hours (range 4–12 hours) (1).
Reproduction studies have been conducted with gemifloxacin in mice, rats, and rabbits. Fetal growth restriction was observed in all three species given doses resulting in exposures, based on AUC, that were two-, four-, and three-fold greater, respectively, than those obtained in women given oral doses of 325 mg (HD). The growth restriction appeared to be reversible in rats, but this was not studied in mice and rabbits. In rats, a dose eight times the HD not only caused fetal brain and ocular malformations but also caused maternal toxicity. The no-observed-effect-level (NOEL) in pregnant animals was about 0.8–3 times the HD (1).
It is not known if gemifloxacin crosses the human placenta. The molecular weight of the mesylate salt (about 485), plasma protein binding (55%–73%), and elimination half-life (about 7 hours) suggest that passage to the fetus should be expected.
BREASTFEEDING SUMMARY
No reports describing the use of gemifloxacin in lactating humans have been located. The molecular weight (about 485), plasma protein binding (55%–73%), and elimination half-life (about 7 hours) suggest that the drug will be excreted into breast milk. The effect of this exposure on a nursing infant is unknown. However, other fluoroquinolones are classified by the American Academy of Pediatrics as compatible with breastfeeding (see Ciprofloxacin).
Reference
1.Product information. Factive. GeneSoft Pharmaceuticals, 2004.