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THE SAFETY OF AMOXICILLIN/CLAVULANIC ACID (AUGMENTIN XR) DURING PREGNANCY OR BREASTFEEDING

The information provided below is for readers based in the United States of America. Readers outside of the United States of America should seek the information from local sources.

THIS h5 IS UNLIKELY TO CAUSE HARM TO YOUR BABY:

Limited information is available on the safety of amoxicillin/clavulanic acid during pregnancy, but the medication is considered safe during pregnancy and breastfeeding.

What is amoxicillin/clavulanic acid?

Amoxicillin/clavulanic acid is a penicillin antibiotic that is used to treat bacterial infections.

What is amoxicillin/clavulanic acid used to treat?

Amoxicillin/clavulanic acid is an antibiotic used to treat community-acquired pneumonia, lower respiratory tract infections, sinusitis, and urinary tract infections.

How does amoxicillin/clavulanic acid work?

Amoxicillin interferes with bacterial cell wall formation and growth, killing bacteria in the body. Clavulanic acid helps amoxicillin to work better.

If I am taking amoxicillin/clavulanic acid, can it harm my baby?

Amoxicillin/clavulanic acid is expected to cross the human placenta and reach the developing baby. Amoxicillin/clavulanic acid is not associated with an increase in the risk of birth defects, but similar antibiotics in the same class such as ampicillin are linked to cases of cleft lip and cleft palate. Some reports link amoxicillin/clavulanic acid use for preterm rupture of membranes to necrotizing enterocolitis or infection/inflammation of the intestinal wall in infants.

If I am taking amoxicillin/clavulanic acid and become pregnant, what should I do?

It is important that you speak with your doctor if you become pregnant while taking amoxicillin/clavulanic acid. If there are clear indications for use, amoxicillin/clavulanic acid can be used during pregnancy.

If I am taking amoxicillin/clavulanic acid, can I safely breastfeed my baby?

Amoxicillin/clavulanic acid is expected to be excreted in breast milk. The estimated dose of the medication reaching the infant is 0.02% to 0.07% of the mother’s dose. Potential concerns with amoxicillin/clavulanic acid exposure in breastfeeding infants include diarrhea and allergic reactions. The American Academy of Pediatrics and the World Health Organization consider amoxicillin to be compatible with breastfeeding.

If I am taking amoxicillin/clavulanic acid, will it be more difficult to get pregnant?

No negative effects on animal or human fertility have been reported.

If I am taking amoxicillin/clavulanic acid, what should I know?

It is important to speak with your doctor to determine if you should continue amoxicillin/clavulanic acid therapy during pregnancy. Amoxicillin/clavulanic acid should only be used during pregnancy if it is needed. Your baby should be monitored for side effects if you are breastfeeding.

If I am taking any medication, what should I know?

This report provides a summary of available information about the use of penicillin antibiotics during pregnancy and breastfeeding. Content is from the product label unless otherwise indicated.

You may find Pregistry's expert reports about infections here,  and reports about the individual medications used to treat infections here.   Additional information can also be found in the resources below. 

For more information about amoxicillin/clavulanic acid during and after pregnancy, contact http://www.womenshealth.gov/ (800-994-9662 [TDD: 888-220-5446]) or check the following link:

U.S. Food and Drug Administration: Augmentin XR Prescribing Information

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General information

It is very common for women to worry about having a miscarriage or giving birth to a child with a birth defect while they are pregnant. Many decisions that women make about their health during pregnancy are made with these concerns in mind.

For many women these concerns are very real. As many as 1 in 5 pregnancies end in a miscarriage, and 1 in 33 babies are born with a birth defect. These rates are considered the background population risk, which means they do not take into consideration anything about the health of the mom, the medications she is taking, or the family history of the mom or the baby’s dad. A number of different things can increase these risks, including taking certain medications during pregnancy.

It is known that most medications, including over-the-counter medications, taken during pregnancy do get passed on to the baby. Fortunately, most medicines are not harmful to the baby and can be safely taken during pregnancy. But there are some that are known to be harmful to a baby’s normal development and growth, especially when they are taken during certain times of the pregnancy. Because of this, it is important to talk with your doctor or midwife about any medications you are taking, ideally before you even try to get pregnant.

If a doctor other than the one caring for your pregnancy recommends that you start a new medicine while you are pregnant, it is important that you let them know you are pregnant.

If you do need to take a new medication while pregnant, it is important to discuss the possible risks the medicine may pose on your pregnancy with your doctor or midwife. They can help you understand the benefits and the risks of taking the medicine.

Ultimately, the decision to start, stop, or change medications during pregnancy is up to you to make, along with input from your doctor or midwife. If you do take medications during pregnancy, be sure to keep track of all the medications you are taking.