From the Guidelines
Augmentin is generally considered safe during pregnancy when prescribed by a healthcare provider. The safety of Augmentin, a combination of amoxicillin and clavulanate, is supported by the fact that amoxicillin has been extensively used during pregnancy without demonstrated risk, as seen in the study published in the European Respiratory Journal 1. Although the study does not directly address Augmentin, it mentions that amoxicillin is possibly safe during pregnancy.
Key Points to Consider
- The typical adult dosage of Augmentin ranges from 500-875 mg amoxicillin/125 mg clavulanate twice daily, depending on the severity of infection.
- Treatment duration usually ranges from 7-14 days based on the type of infection.
- Like all antibiotics, Augmentin may cause side effects such as diarrhea, nausea, or vaginal yeast infections.
- The safety profile of Augmentin during pregnancy is based on its components, with amoxicillin being safe and clavulanic acid enhancing effectiveness without adding significant risk.
- A more recent study published in the Journal of Infection 2 emphasizes the importance of careful risk-benefit discussion with the patient when prescribing medications during pregnancy, highlighting that medications like Augmentin can be used when the risks of inadequate treatment outweigh the risks of harm related to the treatment.
From the FDA Drug Label
8.1 Pregnancy Teratogenic Effects Pregnancy Category B Reproduction studies performed in pregnant rats and mice given amoxicillin and clavulanate potassium (2:1 ratio formulation of amoxicillin:clavulanate) at oral doses up to 1200 mg/kg/day revealed no evidence of harm to the fetus due to amoxicillin and clavulanate potassium The amoxicillin doses in rats and mice (based on body surface area) were approximately 4 and 2 times the maximum recommended adult human oral dose (875 mg/125 mg every 12 hours). For clavulanate, these dose multiples were approximately 9 and 4 times the maximum recommended adult human oral dose (125 mg every 8 hours). There are, however, no adequate and well-controlled studies in pregnant women Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Augmentin Safety During Pregnancy:
- The FDA drug label indicates that reproduction studies in animals have shown no evidence of harm to the fetus due to amoxicillin and clavulanate potassium.
- However, there are no adequate and well-controlled studies in pregnant women.
- The label advises that this drug should be used during pregnancy only if clearly needed 3.
- Therefore, Augmentin should be used with caution during pregnancy, and only when the benefits outweigh the potential risks.
From the Research
Safety of Augmentin During Pregnancy
There are no research papers provided that directly address the safety of Augmentin during pregnancy.
Available Information
- The provided studies discuss the efficacy and spectrum of activity of various antibiotics, including amoxicillin-clavulanate (Augmentin), against different bacterial strains 4, 5, 6, 7, 8.
- These studies do not provide information on the safety of Augmentin during pregnancy.
- It is essential to consult a healthcare professional for guidance on the safe use of medications during pregnancy.
Antibiotic Efficacy
- Amoxicillin-clavulanate has been shown to be effective against a range of bacterial strains, including Streptococcus pneumoniae and Haemophilus influenzae 6, 7, 8.
- The combination of amoxicillin and ceftriaxone has been found to be synergic against infection due to penicillin- and cephalosporin-resistant pneumococci 5.