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Nitrolingual and Pregnancy

Based on the results of animal studies, the Food and Drug Administration considers Nitrolingual a pregnancy Category C medication. This means that it could be considered for a pregnant woman provided the benefits to the mother outweigh the risk to the unborn child. In fact, the active ingredient in Nitrolingual has been used to treat hypertension during pregnancy as well as premature labor.

Can Pregnant Women Use Nitrolingual?

Nitrolingual® Pumpspray (nitroglycerin spray) is a prescription mouth spray approved for the treatment of chest pain (angina). Based on the information currently available, it is unclear if the drug is safe for use during pregnancy.
 

What Is Pregnancy Category C?

The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category C is given to medicines that have not been studied in pregnant humans but do appear to cause harm to the fetus in animal studies.
 
In addition, medicines that have not been studied in any pregnant women or animals are given a pregnancy Category C rating automatically.
 
When given to pregnant rats, nitroglycerin (the active ingredient in Nitrolingual) did not cause any problems for the mothers or babies, except slight developmental delays at high doses. However, it cannot be assumed that the same is true for humans.
 
Animals do not always respond to medicines the same way that humans do. Therefore, a pregnancy Category C medicine (including Nitrolingual) should be given to a pregnant woman only if the healthcare provider believes that the benefits to the woman outweigh any possible risks to the unborn child.
 
Nitroglycerin has been used in various forms to control high blood pressure during pregnancy. It also has been used to help stop preterm labor by relaxing the uterus. Due to the rapid and short action of the spray form of nitroglycerin, Nitrolingual is probably inappropriate for such uses.
 
Pregnancy and Pain

Nitrolingual Spray Information

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