From the Guidelines
Augmentin is generally considered safe during pregnancy, but its safety profile is not explicitly mentioned in the provided evidence, however, amoxicillin, a component of Augmentin, is considered possibly safe during pregnancy 1. The provided evidence does not directly address the safety of Augmentin during pregnancy, but it does mention amoxicillin, which is a component of Augmentin, as possibly safe during pregnancy 1. Some key points to consider when prescribing Augmentin during pregnancy include:
- The FDA classification of Augmentin as a Category B medication, meaning animal studies have not shown risk to the fetus, and there are no adequate well-controlled studies in pregnant women showing adverse effects.
- The typical adult dosage is 500 mg (amoxicillin component) every 12 hours or 250 mg every 8 hours for mild to moderate infections, with treatment usually lasting 7-10 days depending on the infection type.
- Potential side effects, such as diarrhea, nausea, and vaginal yeast infections.
- The importance of completing the full course of antibiotics as prescribed, even if symptoms improve before finishing.
- Informing your doctor about your pregnancy before taking any medication, as they can weigh individual risks and benefits for your specific situation. It's essential to consult with a healthcare provider to determine the best course of treatment for bacterial infections during pregnancy, as they can assess individual risks and benefits and provide personalized guidance 1.
From the FDA Drug Label
- 1 Pregnancy Teratogenic Effects: Reproduction studies have been performed in mice and rats at doses up to 2000 mg/kg (3 and 6 times the 3 g human dose, based on body surface area). There was no evidence of harm to the fetus due to amoxicillin. There are, however, no adequate and well-controlled studies in pregnant women Because animal reproduction studies are not always predictive of human response, amoxicillin should be used during pregnancy only if clearly needed.
Augmentin safety in pregnancy is not fully established due to the lack of adequate and well-controlled studies in pregnant women. However, reproduction studies in animals have shown no evidence of harm to the fetus. The drug should be used during pregnancy only if clearly needed 2.
From the Research
Safety of Augmentin in Pregnancy
- The safety of Augmentin (amoxicillin/clavulanate) in pregnancy has been studied in several research papers 3, 4, 5, 6.
- A study published in 2001 found that Augmentin treatment during pregnancy did not increase the risk of congenital abnormalities in newborn infants 5.
- Another study published in 2011 compared the efficacy of single-dose and multiple-dose antibiotics, including amoxicillin clavulanate, for lower urinary tract infection in pregnancy and found that treatment with amoxicillin clavulanate was effective and did not differ significantly in terms of demographics, clinical success rate, microbiological cure rate, or adverse effects 6.
- A literature review published in 2022 found that international guidelines agree on several key points about antibiotic use in pregnancy, including the use of amoxicillin/clavulanate for urinary tract infections 7.
- However, it is essential to note that the number of cases and controls in some studies was limited, and further multicenter-multinational studies are needed for the final risk assessment 5.
Key Findings
- Augmentin treatment during pregnancy is unlikely to increase the risk of congenital abnormalities in newborn infants 5.
- Amoxicillin clavulanate is effective for the treatment of urinary tract infections in pregnancy 6.
- International guidelines agree on the use of amoxicillin/clavulanate for urinary tract infections in pregnancy 7.
- Further studies are needed to confirm the safety of Augmentin in pregnancy 5.