May 22 2022

Classification of the active ingredient amoxicillin / clavulanic acid


Risk level in pregnancy: This medicine is classified as Category B.

Have not been observed in experimental animals effects on the fetus associated with the administration of clavulanic acid in combination with amoxicillin at doses up to nine times the usual human doses of clavulanate.

Both amoxicillin as clavulanic acid cross the placental barrier and can be detected in amniotic fluid.

The literature on the use of this combination in pregnant women have not identified adverse effects associated with taking during the first trimester of pregnancy. Although some observations include more than 500 infants exposed to antibiotic association, there are no adequate and well-controlled studies on the use of these medications during pregnancy, so it should be used only if clearly needed, as the animal experimentation is not always predictive of what happens to people.

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Update 18.07.2009

Meaning of category B

Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.