Augmentin Use in Pregnancy
Augmentin (amoxicillin-clavulanate) can be safely used throughout pregnancy when clinically indicated, as it is classified as FDA Pregnancy Category B with no evidence of fetal harm in animal studies or increased congenital abnormalities in human studies. 1, 2, 3
Safety Profile and Evidence Base
The FDA label explicitly states that reproduction studies in pregnant rats and mice at doses up to 1200 mg/kg/day (4 times the maximum human dose for amoxicillin, 9 times for clavulanate) revealed no evidence of harm to the fetus. 1, 2
A large population-based case-control study of 6,935 cases and 10,238 controls found no increased risk of congenital abnormalities with augmentin use during pregnancy (crude OR 1.4,95% CI 0.9-2.0), including during the critical second-third month period. 3
Beta-lactam antibiotics, including amoxicillin-clavulanate, have a long history of safe use in pregnancy and remain first-line agents. 4, 5
Clinical Context and Limitations
While augmentin is safe for general use in pregnancy, it is NOT recommended as a first-line agent for Group B Streptococcus (GBS) prophylaxis during labor. 6
For intrapartum GBS prophylaxis, penicillin G (5 million units IV initially, then 2.5-3.0 million units every 4 hours) or ampicillin (2 g IV initially, then 1 g every 4 hours) are the CDC-recommended agents. 7, 6
For urinary tract infections in pregnancy, nitrofurantoin is preferred as first-line therapy, with ampicillin 500 mg orally every 6 hours for 3-7 days as an alternative when first-line agents cannot be used. 8, 9
Dosing Recommendations
Standard adult dosing of augmentin can be used in pregnancy: 875 mg/125 mg every 12 hours or 500 mg/125 mg every 8 hours, depending on infection severity. 1, 2
Dose adjustment is required only in severe renal impairment (GFR <30 mL/min). 1, 2
Treatment duration should be based on the specific infection being treated (typically 7-10 days for most infections). 8
Important Caveats
The FDA label notes that oral ampicillin-class antibiotics are poorly absorbed during labor, and effects on labor duration or need for obstetrical intervention are unknown. 1, 2
Amoxicillin is excreted in breast milk, and use by nursing mothers may lead to infant sensitization; caution is advised during breastfeeding. 1, 2
While augmentin is safe, the principle remains that antibiotics should be used during pregnancy "only if clearly needed" with appropriate clinical indication. 1, 2, 5