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Itraconazole Pregnancy and Breastfeeding Warnings

Itraconazole is also known as: Onmel, Sporanox, Sporanox PulsePak

Itraconazole Pregnancy Warnings

Pregnant women exposed to itraconazole were matched with control subjects not exposed to any known teratogens in a prospect cohort study. A total of 198 women who used itraconazole during the first trimester were reported to the manufacturer and were compared to controls. The rate of major malformations in the study group (157 live births) was 3.2% and in the control group (187 live births) it was 4.8%. The rate of any pregnancy loss was higher in the exposed group and birth weight was found to be lower, although, this finding may not be clinically significant. Gestational age at birth, rate of preterm delivery, Apgar scores at 1 and 5 minutes, and neonatal complications were comparable for the two groups. Postmarketing adverse events reports of itraconazole use in women while pregnant include cases of congenital abnormalities (skeletal, genitourinary tract), cardiovascular and ophthalmic malformations, chromosomal and multiple malformations, although a causal relationship has not been established.

Itraconazole has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of dose-related maternal toxicity, embryotoxicity and teratogenicity. There are no controlled data in human pregnancies. Itraconazole should only be given during pregnancy when benefit outweighs risk. The manufacturer recommends against the use of itraconazole for the treatment of onychomycosis in pregnant patients or in women contemplating pregnancy. Itraconazole should not be administered to women of childbearing potential for the treatment of onychomycosis unless they are using effective contraceptive measures and they begin therapy on the second or third day following the onset of menses. Effective contraception should be continued during treatment with itraconazole and for two months after completion of treatment.

Itraconazole Breastfeeding Warnings

Itraconazole is excreted into human milk. The manufacturer recommends against the use of this drug during lactation. Expected benefits should be weighed against the potential risks to the infant from itraconazole exposure. The CDC recommends that HIV-infected mothers not breast-feed their infants due to the risk of transmission of HIV via breast milk.

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