Z-Pak

THE SAFETY OF AZITHROMCIN OPTHALMIC SOLUTION (AZASITE) 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 MEDICATION MAY CAUSE HARM TO YOUR BABY:

Limited information is available on the safety of azithromycin ophthalmic solution during pregnancy. Use this medication with caution if pregnant or breastfeeding.

What is azithromycin ophthalmic solution?

Azithromycin ophthalmic solution is a macrolide antibiotic that is used to treat bacterial infections in the eye.

What is azithromycin ophthalmic solution used to treat?

Azithromycin ophthalmic solution is an antibiotic used to treat bacterial conjunctivitis or pink eye.

How does azithromycin ophthalmic solution work?

Azithromycin interferes with bacterial protein development and growth, killing the bacteria in the body.

If I am taking azithromycin ophthalmic solution, can it harm my baby?

Evidence on the safety of azithromycin ophthalmic solution in pregnant women is limited. Oral or injected azithromycin is expected to cross the human placenta and reach the developing baby. However, azithromycin ophthalmic solution is not expected to cross the placenta, so absorption by the baby should be minimal. No birth defects that could be associated with oral or injectable azithromycin use during pregnancy, particularly in the first trimester, have been reported. Several studies have evaluated the risk of infant hypertrophic pyloric stenosis, a blockage of the connection between the stomach and small intestine, finding no association with azithromycin exposure. 

If I am taking azithromycin ophthalmic solution and become pregnant, what should I do?

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

If I am taking azithromycin ophthalmic solution, can I safely breastfeed my baby?

Oral or injected azithromycin is expected to be excreted in breast milk. The amount of azithromycin ophthalmic solution reaching the breast milk should be minimal. Caution is advised in women using azithromycin during breastfeeding. Breastfeeding infants should be monitored for side effects such as diarrhea.

If I am taking azithromycin ophthalmic solution, will it be more difficult to get pregnant?

No negative effects on fertility from azithromycin exposure have been reported.

If I am taking azithromycin ophthalmic solution, what should I know?

It is important to speak with your doctor to determine if you should start or continue azithromycin ophthalmic solution during pregnancy. Azithromycin ophthalmic solution should only be used during pregnancy or breastfeeding if it is needed. Infants should be monitored for side effects during breastfeeding.

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

This report provides a summary of available information about the use of azithromycin ophthalmic solution 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 azithromycin ophthalmic solution during and after pregnancy, contact http://www.womenshealth.gov/ (800-994-9662 [TDD: 888-220-5446]) or check the following link:

Akorn: AzaSite 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.