Is cefixime safe to use during pregnancy and what is the appropriate dosage and precautions?

Cefixime Safety During Pregnancy

Cefixime is safe to use during pregnancy and can be administered at the standard adult dose of 400 mg once daily for appropriate indications, particularly for urinary tract infections and gonorrhea. 1

Safety Profile

Cefixime belongs to the third-generation cephalosporins, which have an established safety record in pregnancy. The evidence supporting its use includes:

• Cephalosporins as a class are considered compatible with pregnancy, with most studies finding no increased risk of fetal damage or congenital malformations at usual therapeutic doses 2

• Cefixime demonstrates extremely low penetration into fetal tissues and breast milk (<1% of the dose), based on preclinical pharmacokinetic studies 3

• The FDA label indicates cefixime should be used during pregnancy only if clearly needed, though this conservative language is standard for most medications 1

• Human data from cephalosporins (including ceftazidime and cefuroxime) show no increase in congenital defects in second and third trimester exposures, though first trimester data are more limited 2

Dosing and Administration

Standard adult dosing of 400 mg once daily should be used, as pharmacokinetic parameters remain stable during pregnancy 1, 3:

• The high oral bioavailability and once-daily dosing improve adherence
• Sufficient urinary concentrations are achieved with the 400 mg daily dose
• No dose adjustment is needed unless creatinine clearance is <60 mL/min 1

Approved Indications in Pregnancy

Cefixime is particularly useful for:

• Uncomplicated urinary tract infections and acute pyelonephritis, especially in outpatient settings 3
• Uncomplicated gonorrhea (cervical/urethral) - a single 400 mg oral dose achieved a 95.2% cure rate in pregnant women with excellent tolerability 4
• Alternative therapy when first-line agents are contraindicated or resistance is present 3

Clinical Evidence Supporting Use

The safety data, while not extensive for cefixime specifically, is supported by:

• A study of 102 pregnant women treated with single-dose cefixime for gonorrhea showed 95.2% efficacy with minimal side effects (only 3 patients reported nausea/vomiting or diarrhea) 4

• Cefuroxime (another cephalosporin) showed no developmental abnormalities in 80 infants followed for 18 months after maternal treatment during pregnancy 5

• First trimester cefuroxime exposure in 106 women showed malformation rates (3.2%) comparable to controls (2%) 6

Important Caveats

Pregnant women should not be treated with doxycycline, quinolones (including ciprofloxacin), or tetracyclines 2:

• Doxycycline is associated with tooth discoloration and transient bone growth suppression in second and third trimesters 2
• Fluoroquinolones may cause fetal cartilage damage in animal studies, though human risk appears low 2

For gonococcal infections, cefixime serves as an alternative when ceftriaxone is unavailable, though ceftriaxone 250 mg IM remains the preferred first-line treatment 2

Breastfeeding Considerations

Consideration should be given to temporarily discontinuing nursing during cefixime treatment, though the extremely low breast milk penetration (<1%) suggests minimal infant exposure 1, 3

Preferred Alternatives in Pregnancy

When treating common infections in pregnancy, the following antibiotics have stronger safety data:

• Amoxicillin and cephalexin are preferred first-line agents with extensive pregnancy safety data 2
• Azithromycin is safe for use with moderate-quality evidence supporting its use 2
• Ceftriaxone remains the gold standard for gonococcal infections 2