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