Cetraxal Otic (Ciprofloxacin) and Pregnancy
Cetraxal otic (ciprofloxacin otic solution) should be avoided during pregnancy, as fluoroquinolones are contraindicated in pregnant women according to expert panel guidelines, despite the minimal systemic absorption from otic administration. 1
Guideline Recommendations
Expert panels explicitly recommend against fluoroquinolone use during pregnancy. Both the 2016 and 2020 European rhinosinusitis guidelines state that fluoroquinolones should not be used during pregnancy, categorizing them alongside tetracyclines, aminoglycosides, and trimethoprim-sulfamethoxazole as antibiotics that "put the fetus at risk." 1
FDA Classification and Systemic Exposure Considerations
The FDA labels ciprofloxacin otic solution as Pregnancy Category C, noting that animal reproduction studies showed no harm at oral doses up to 100 mg/kg and IV doses up to 30 mg/kg in rats and mice, but rabbit studies at 30-100 mg/kg orally produced maternal gastrointestinal disturbances, weight loss, and increased abortion rates (though no teratogenicity). 2
Systemic absorption from otic administration is negligible - the maximum anticipated plasma concentration after 0.25 mL of 0.2% ciprofloxacin otic solution (0.5 mg total dose) is less than 5 ng/mL. 2
For context, oral ciprofloxacin achieves therapeutic plasma concentrations of approximately 1,600 ng/mL (1.6 μg/mL), which is over 300-fold higher than otic administration. 3
The Disconnect Between Guidelines and Otic Use
There is an important clinical nuance here: The guideline recommendations against fluoroquinolones during pregnancy 1 are based on systemic (oral/IV) administration concerns, particularly regarding potential cartilage toxicity observed in juvenile animals receiving systemic quinolones. 2
Recent evidence suggests that fears about fluoroquinolone exposure during pregnancy may be overstated - a 2022 review found that data from exposed pregnancies "have not so far confirm these fears" and suggested fluoroquinolones can be considered "when clearly indicated, whatever the term of pregnancy." 4
Placental transfer studies show ciprofloxacin crosses at a slow, constant rate with fetal concentrations reaching only 22% of maternal levels after 3 hours at therapeutic (systemic) concentrations. 3
Clinical Decision Framework
Despite minimal systemic absorption from otic use, the safest approach is to avoid Cetraxal during pregnancy and use alternative antibiotics:
Preferred alternatives for otitis externa: Penicillins and cephalosporins are the safest antibiotic classes during pregnancy and should be first-line choices. 1
If Cetraxal has already been used inadvertently: The extremely low systemic absorption (< 5 ng/mL plasma concentration) makes clinically significant fetal exposure highly unlikely, and this should not be considered grounds for pregnancy termination. 2
Risk-benefit in severe cases: If a pregnant woman has severe otitis externa unresponsive to safer alternatives and culture shows organisms only sensitive to fluoroquinolones, the negligible systemic absorption from otic administration may justify use after consultation with obstetrics. 2
Common Pitfalls
Do not confuse otic with systemic fluoroquinolone risks - the pharmacokinetic profile is dramatically different, with otic administration producing plasma levels 300+ times lower than oral therapy. 2, 3
Avoid reflexive anxiety about accidental exposure - if a patient used Cetraxal before knowing she was pregnant, reassure her that the minimal systemic absorption makes fetal harm extremely unlikely. 2, 4
The FDA label notes that "no adequate and well controlled studies have been performed in pregnant women" and recommends caution, but this applies to all routes of administration without distinguishing the vastly different exposure from otic use. 2