Vituz

THE SAFETY OF HYDROCODONE BITARTRATE AND CHLORPHENIRAMINE MALEATE (VITUZ) 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 CAN CAUSE HARM TO YOUR BABY:

Hydrocodone/chlorpheniramine is not recommended during pregnancy or breastfeeding. It is important to weigh the risks versus benefits before administering this drug during pregnancy or breastfeeding.

What is hydrocodone bitartrate and chlorpheniramine maleate?

Hydrocodone/chlorpheniramine oral solution is a combination medication containing a pain reliever and an antihistamine.

What is hydrocodone bitartrate and chlorpheniramine maleate used to treat?

Hydrocodone/chlorpheniramine oral solution treats cough and cold symptoms in adults.

How does hydrocodone bitartrate and chlorpheniramine maleate work?

Hydrocodone is an opioid that works in the brain to relieve pain and suppress cough. Chlorpheniramine is an antihistamine that decreases inflammation in the lungs.

If I am taking hydrocodone bitartrate and chlorpheniramine maleate, can it harm my baby?

Little safety information has been collected around the use of this combination medication in pregnant women. However, studies have investigated the safety of hydrocodone and chlorpheniramine separately. Animal studies suggest that there may be an increased risk of birth defects with hydrocodone or chlorpheniramine use during pregnancy. Human studies have not identified a direct association between hydrocodone or chlorpheniramine exposure in utero and an increased risk of birth defects. Chlorpheniramine is considered a preferred antihistamine for use during pregnancy. Antihistamine use during the last two weeks of pregnancy has been associated with an eye condition known as retrolental fibroplasia, which can cause blindness in newborns. Opioids such as hydrocodone can cause respiratory depression in newborns as well as dependence and withdrawal symptoms in newborns including irritability, fever, and vomiting. Use of hydrocodone during labor and delivery can slow labor. Hydrocodone/chlorpheniramine should only be administered during pregnancy if the benefits to the mother outweigh the risks to the developing baby.

If I am taking hydrocodone bitartrate and chlorpheniramine maleate and become pregnant, what should I do?

Women who are trying to become pregnant or discover they are pregnant should avoid the use of hydrocodone/chlorpheniramine. This medication can increase the risk of negative side effects in newborns as well as slow labor and delivery and decreased milk production. It is important to talk to your doctor to discuss the safety of these medications. Chlorpheniramine can be used alone as an antihistamine during pregnancy.

If I am taking hydrocodone bitartrate and chlorpheniramine maleate, can I safely breastfeed my baby?

Hydrocodone and chlorpheniramine are excreted into human breast milk. Chlorpheniramine can decrease milk production in women. The risk of side effects in breastfeeding infants is higher with higher doses of hydrocodone and chlorpheniramine. Women are encouraged to either discontinue this medication while breastfeeding or avoid breastfeeding entirely while on this medication. Women who continue hydrocodone while breastfeeding should monitor their infants for drowsiness and difficulty feeding.

If I am taking hydrocodone bitartrate and chlorpheniramine maleate, will it be more difficult to get pregnant?

Hydrocodone and chlorpheniramine have not been associated with any negative effects on fertility.

If I am taking hydrocodone bitartrate and chlorpheniramine maleate, what should I know?

It is important to speak with your doctor to discuss the safety of hydrocodone/chlorpheniramine exposure during pregnancy or breastfeeding. Negative side effects have been associated with both medications.

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

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

You may find Pregistry's expert reports about the individual medications used to treat cough and cold symptoms here, and a report on having a cough during pregnancy here.   Additional information can also be found in the resources below. 

For more information about hydrocodone bitartrate and chlorpheniramine maleate 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:  Vituz 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.