From the Guidelines
Augmentin, a combination of amoxicillin and clavulanic acid, is generally considered safe for use in pregnant women for the treatment of dental infections, including dental caries.
Key Considerations
- The use of Augmentin in pregnant women should be reserved for cases where the benefits outweigh the risks, as with any medication during pregnancy 1.
- Alternative treatments such as penicillin V or clindamycin may be considered, depending on the specific circumstances of the patient and the infection being treated.
- Dosing: Augmentin can be used at a dose of 500/125mg or 875/125mg orally every 12 hours for 7-10 days, as typically recommended for dental infections in non-pregnant patients 1.
- It's crucial that all medications, including antibiotics like Augmentin, be used in pregnancy only when necessary and under the guidance of a healthcare provider, to minimize potential risks to the fetus while effectively treating the infection.
Safety Profile
- Amoxicillin-clavulanic acid is classified as a Category B drug, meaning that animal reproduction studies have not demonstrated a fetal risk but there are no controlled studies in pregnant women, or animal reproduction studies have shown an adverse effect that was not confirmed in controlled studies in women 1.
- There is a low risk of necrotizing enterocolitis in the fetus associated with the use of amoxicillin-clavulanic acid, particularly in women at risk of pre-term delivery 1.
- The American College of Obstetricians and Gynecologists and other medical guidelines recommend cautious use of antibiotics during pregnancy, emphasizing the importance of weighing the benefits against the potential risks to the fetus 1.
From the FDA Drug Label
8 USE IN SPECIFIC POPULATIONS
- 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.
The use of Augmentin (amoxicillin-clavulanate) in pregnant women for the treatment of dental caries is not directly addressed in the drug label. However, based on the available information, Augmentin should be used during pregnancy only if clearly needed. The drug label does not provide specific guidance on the treatment of dental caries in pregnant women, and there are no adequate and well-controlled studies in pregnant women to support its use for this indication 2. Therefore, a conservative clinical decision would be to exercise caution and consider alternative treatments for dental caries in pregnant women, if possible. The safety of Augmentin for this specific use in pregnant women cannot be determined.
From the Research
Safety of Augmentin in Pregnant Women
- According to 3, antibiotics such as beta-lactams, which include amoxicillin-clavulanate (Augmentin), are generally considered safe and effective in pregnancy.
- However, the study also notes that only 10% of medications have sufficient data related to safe and effective use in pregnancy, highlighting the need for caution and careful consideration when prescribing any medication during pregnancy.
- A study on pharmacists' knowledge of antibiotic safety 4 found that 51.1% of respondents correctly identified antibiotics that can be used during pregnancy, including those in the beta-lactam class, but the study did not specifically address Augmentin.
Use of Augmentin in Dental Caries
- There is no direct evidence in the provided studies on the use of Augmentin for the treatment of dental caries in pregnant women.
- However, Augmentin is a broad-spectrum antibacterial agent that has been used to treat a variety of infections, including those caused by beta-lactamase-producing bacteria 5, 6.
- A study on the use of amoxicillin and clavulanic acid in the treatment of skin and soft tissue infections in children 7 found that the combination was effective and well-tolerated, but this study did not address dental caries or pregnant women.
Pharmacokinetics and Safety
- The pharmacokinetics of antibiotics can be altered in pregnancy due to changes in glomerular filtration rate, total body volume, and cardiac output 3.
- Augmentin has a well-known safety and tolerance profile, and high-dose formulations have been developed for use in adult and pediatric respiratory tract infections 5.