Itraconazole is an antifungal medication that doctors prescribe for serious fungal infections. It’s used for conditions like aspergillosis, blastomycosis, histoplasmosis, and onychomycosis, as well as yeast infections in the mouth and esophagus.
If you are taking itraconazole and find out you’re pregnant, or if you’re considering itraconazole while breastfeeding, it’s important to understand the potential effects of the drug. Like many medications, it carries potential risks for the developing fetus and the nursing infant. That’s why doctors usually only prescribe it during pregnancy in life-threatening situations.
The US Food and Drug Administration has assigned itraconazole to pregnancy category C, which means that animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
This article takes a look at the pregnancy and breastfeeding warnings associated with itraconazole, along with other important considerations if you’re taking this medication during pregnancy.
What is itraconazole used for?
Itraconazole is an antifungal medication that’s used to treat serious fungal infections, including:
- Oropharyngeal candidiasis (thrush)
- Esophageal candidiasis
- Aspergillosis
- Blastomycosis
- Histoplasmosis
- Onychomycosis (nail fungus)
It can be taken as a capsule or as a liquid solution.
However, it’s important to be aware of the risks associated with itraconazole, especially during pregnancy.
When is itraconazole not recommended?
Itraconazole should not be used during pregnancy to treat nail fungus, unless there are no other options and the infection is life-threatening.
The FDA has issued warnings about the potential risks of using itraconazole during pregnancy, including the possibility of birth defects.
Itraconazole and Pregnancy: Assessing the Risks
If you’re pregnant or hoping to become pregnant, you’re probably thinking a lot about what’s safe and what’s not. When it comes to medications, it’s always best to err on the side of caution, and that’s definitely true with itraconazole.
Pregnancy Warnings and Contraindications
Itraconazole comes with a very serious warning: it’s generally not safe to use during pregnancy. The official guidance says it’s “contraindicated,” meaning it should absolutely not be used, unless there’s a life-threatening situation where the benefits outweigh the risk to the fetus. That’s not something to take lightly.
And if you’re thinking about using it to treat onychomycosis (a fungal nail infection) and you’re of childbearing age, there’s another strong recommendation: don’t use itraconazole unless you’re using effective birth control and you start the medication on the second or third day of your period. This is to minimize the risk of unknowingly taking the medication during the very early stages of pregnancy.
Animal Studies and Potential Toxicity
So, where does this concern come from? A lot of it has to do with what researchers have seen in animal studies. These studies have shown that itraconazole can potentially cause problems for the mother, the developing embryo, and the fetus. We’re talking about doses of 40 to 160 mg/kg/day in rats and 80 mg/kg/day in mice causing adverse effects.
Now, it’s important to remember that these are animal studies, and the doses used are much higher than what a human would typically take. In fact, the maximum recommended human dose (MRHD) is usually 5 to 20 times lower than the doses that caused problems in the animal studies. But the fact that these effects were seen at all raises a red flag.
Human Studies and Post-Marketing Reports
When it comes to human studies, the information is limited. It’s difficult to study medication effects during pregnancy, for obvious ethical reasons. The studies that do exist often have small sample sizes and don’t always agree on the findings, particularly when it comes to miscarriage rates.
Some cohort studies (studies that follow a group of people over time) have compared pregnant women who were exposed to itraconazole with those who weren’t. These studies, with sample sizes ranging from around 200 to almost 700 participants, have hinted at a potentially higher rate of pregnancy loss and lower birth weight in the exposed group. However, the results aren’t always clear-cut.
There are also post-marketing reports to consider. These are reports of adverse events that people have experienced after taking the medication. These reports suggest a potential link between itraconazole exposure during pregnancy and congenital abnormalities (birth defects). One analysis of these reports found that the rate of major malformations in babies exposed to itraconazole during the first trimester was 3.2%, compared to 4.8% in a control group. While this might seem reassuring, it’s important to remember that these are just reports, and it’s difficult to establish a direct cause-and-effect relationship.
Itraconazole and Breastfeeding: What Nursing Mothers Need to Know
If you’re a nursing mother, you’re probably wondering about the safety of taking itraconazole. Here’s what the current research says:
Excretion in Breast Milk
Itraconazole does pass into breast milk, but in small amounts. A small study looked at two healthy women who were taking itraconazole. The researchers measured the amount of itraconazole in their breast milk at different times:
- 4 hours after taking the medication: 70.2 mcg/L
- 24 hours after taking the medication: 27.7 mcg/L
- 48 hours after taking the medication: 16.2 mcg/L
- 72 hours after taking the medication: 20.1 mcg/L
These numbers tell us that the amount of itraconazole in breast milk varies over time after a mother takes the medication.
Potential Effects on the Nursing Infant
The big question is: What does this mean for the baby? Unfortunately, the effects of itraconazole on a nursing infant are not well known. We need more research to understand the potential risks and benefits.
What we do know is that the amount of itraconazole a baby gets through breast milk is much lower than the dose a baby would receive if they were being treated with the medication directly. Estimates show that an infant’s exposure to itraconazole through breast milk is only about 1.48% of the mother’s weight-adjusted dose. Also, the amount of itraconazole in the baby’s blood is estimated to be only 0.77% of the mother’s blood level.
While these numbers seem low, it’s still important to be cautious.
Recommendations for Breastfeeding
Because of the uncertainties, it might be better to consider an alternative treatment for your fungal infection while you’re breastfeeding. Talk to your doctor about other options that might be safer for your baby.
Ultimately, the decision of whether to breastfeed while taking itraconazole should be made in consultation with your doctor. The benefits of treating your infection need to be weighed against the potential risks to your baby. If there’s any doubt about whether the benefits outweigh the risks, breastfeeding is generally not recommended.
Drug Interactions and Other Medical Considerations
Itraconazole is a powerful medication, and like many prescription drugs, it can interact with other substances in your body. Similar considerations about contraindications are important for other antifungals like Miconazole. It’s important to be aware of these interactions to ensure your safety and the effectiveness of your treatment.
Drug Interactions
Itraconazole is known to have significant interactions with many medications. Some medicines should not be taken at all with itraconazole, while others may require careful dose adjustments. It’s essential to provide your healthcare provider with a complete list of all medications you are currently taking, including prescription drugs, over-the-counter medications, and herbal supplements.
Even seemingly harmless supplements or vitamins can potentially interfere with itraconazole’s effectiveness or increase the risk of side effects. Always consult with your doctor or pharmacist before starting any new medication, vitamin, or supplement while taking itraconazole.
Other Interactions
In addition to drug interactions, certain foods and beverages can also affect how itraconazole is absorbed and metabolized by your body. For example, grapefruit juice is known to interact with many medications, including itraconazole, and should be avoided during treatment. Your doctor can provide specific guidance on any dietary restrictions or recommendations while you are taking itraconazole.
Pre-existing Medical Conditions
If you have any pre-existing medical conditions, it’s crucial to inform your healthcare provider before starting itraconazole. Certain conditions, such as chronic obstructive pulmonary disease (COPD), edema, heart disease, and kidney or liver disease, can affect how your body processes the medication. In some cases, your doctor may need to adjust the dosage of itraconazole or consider alternative treatment options to ensure your safety.
Be sure to have an open and honest conversation with your doctor about your medical history and any concerns you may have. This will help them make the best decisions about your treatment plan and minimize any potential risks.
Dosage, Administration, and Monitoring
It’s very important to use this medicine, itraconazole, exactly as your doctor has directed. That means taking the correct dosage, timing your doses with food, and following the full length of treatment. Understanding how long itraconazole takes to work and maximizing its effectiveness is also crucial. If you don’t follow these steps, the medicine may not work as well and you may experience unwanted side effects.
The dosage and administration of itraconazole vary widely depending on the condition being treated and the formulation of the medication (capsules, oral solution, or IV). Here are a couple of examples.
- Esophageal candidiasis: Adults usually take 100 milligrams (mg) or 10 milliliters (mL) once a day for at least 3 weeks.
- Onychomycosis of the toenails: Adults usually take 200 milligrams (mg) once a day for 12 weeks in a row.
The correct dosage for you will depend on your specific situation. Always follow your doctor’s instructions.
If you have questions about how to take itraconazole, talk with your doctor or pharmacist.
Because Itraconazole can cause serious side effects, it is very important to keep your doctor informed about any changes in your health. Regular check-ups with your doctor are essential, and blood or urine tests might be necessary to monitor your liver function and kidney function.
Frequently Asked Questions
Is itraconazole tablet safe in pregnancy?
Generally, itraconazole isn’t considered safe during pregnancy. Studies have shown a potential risk of birth defects when taken by pregnant women, particularly during the first trimester. It’s crucial to discuss alternative treatment options with your doctor if you’re pregnant or planning to become pregnant. Weighing the benefits against potential risks is essential.
What is the use of itraconazole in gynecology?
In gynecology, itraconazole is sometimes used to treat fungal infections, particularly vaginal yeast infections that are resistant to other treatments, but Fluconazole is another option to consider, albeit with its own pregnancy-related birth defect risks. However, its use is carefully considered due to potential side effects and, as mentioned above, risks associated with pregnancy. Doctors will typically explore other antifungal options first, especially if pregnancy is a possibility.
Can itraconazole cause infertility?
While the primary concern with itraconazole is its potential impact on a developing fetus, there’s limited evidence to suggest it directly causes infertility in women or men. However, any medication can potentially have indirect effects on reproductive health, and it’s always best to discuss any concerns about fertility with your healthcare provider, especially if you’re undergoing fertility treatments or experiencing difficulties conceiving.
To Conclude
Taking itraconazole while pregnant or breastfeeding carries risks. Animal studies have shown that it may be toxic to the mother, the embryo, and the fetus. Post-marketing reports have also linked the drug to potential birth defects.
Because of the possibility of harm, it’s important to talk with your doctor about whether itraconazole is right for you. There’s limited data available on the effects of itraconazole during pregnancy, so you and your doctor will need to carefully weigh the risks and benefits of taking the medication based on your specific situation. This article is for informational purposes, so make sure you talk to your healthcare provider to make sure the information applies to your personal circumstances.
Women who are able to become pregnant should use highly effective birth control while taking itraconazole and for two months after their last dose. Check with your doctor or pharmacist to determine which type of birth control is most effective for you.