Gemifloxacin

The Basics

What is Gemifloxacin?

Used in the treatment of acute bacterial exacerbation of chronic bronchitis and mild-to-moderate pneumonia.

Brand names for Gemifloxacin

Factive

How Gemifloxacin is classified

Fluoroquinolones, Quinolones

Gemifloxacin During Pregnancy

Gemifloxacin pregnancy category

Category CNote that the FDA has deprecated the use of pregnancy categories, so for some medications, this information isn’t available. We still think it’s useful to list historical info, however, given what a common proxy this has been in the past.

What we know about taking Gemifloxacin while pregnant

Gemifloxacin treatment during organogenesis caused fetal growth retardation in mice (oral dosing at 450 mg/kg/day), rats (oral dosing at 600 mg/kg/day) and rabbits (IV dosing at 40 mg/kg/day) at AUC levels which were 2-, 4- and 3-fold those in women given oral doses of 320 mg. In rats, this growth retardation appeared to be reversible in a pre- and postnatal development study (mice and rabbits were not studied for the reversibility of this effect). Treatment of pregnant rats at 8-fold clinical exposure (based upon AUC comparisons) caused fetal brain and ocular malformations in the presence of maternal toxicity. The overall no-effect exposure level in pregnant animals was approximately 0.8 to 3-fold clinical exposure. The safety of FACTIVE in pregnant women has not been established. FACTIVE should not be used in pregnant women unless the potential benefit to the mother outweighs the risk to the fetus. There are no adequate and well-controlled studies in pregnant women.

Taking Gemifloxacin While Breastfeeding

What are recommendations for lactation if you're taking Gemifloxacin?

No information is available on the clinical use of gemifloxacin during breastfeeding; however, amounts in breastmilk appear to be low. Fluoroquinolones have traditionally not been used in infants because of concern about adverse effects on the infants’ developing joints. However, recent studies indicate little risk.[1][2] The calcium in milk might prevent absorption of the small amounts of fluoroquinolones in milk,[3] but insufficient data exist to prove or disprove this assertion. Use of gemifloxacin is acceptable in nursing mothers. However, it is preferable to use an alternate drug for which safety information is available.

Maternal / infant drug levels

No information is available on the clinical use of gemifloxacin during breastfeeding; however, amounts in breastmilk appear to be low. Fluoroquinolones have traditionally not been used in infants because of concern about adverse effects on the infants’ developing joints. However, recent studies indicate little risk.[1][2] The calcium in milk might prevent absorption of the small amounts of fluoroquinolones in milk,[3] but insufficient data exist to prove or disprove this assertion. Use of gemifloxacin is acceptable in nursing mothers. However, it is preferable to use an alternate drug for which safety information is available.

Possible effects of Gemifloxacin on milk supply

Relevant published information was not found as of the revision date.

Possible alternatives to Gemifloxacin

Ciprofloxacin, Levofloxacin.