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Itraconazole Pregnancy and Breastfeeding Warnings

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

Itraconazole Pregnancy Warnings

Animal studies have revealed evidence of dose-related maternal toxicity, embryotoxicity, and teratogenicity. There are no controlled data in human pregnancy. Pregnant women exposed to this drug were matched with control subjects not exposed to any known teratogens in a prospect cohort study. A total of 198 women who used this drug during the first trimester (mostly for short-term vulvovaginal candidiasis) 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; 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 2 groups. During postmarketing experience, cases of congenital abnormalities have been reported including skeletal, genitourinary tract, cardiovascular, and ophthalmic malformations as well as chromosomal and multiple malformations; causal relationship has not been established. US: This drug is not recommended for the treatment of onychomycosis in pregnant patients or in women contemplating pregnancy. This drug should not be used to treat onychomycosis in women of childbearing potential unless they are using effective contraceptive measures and they begin therapy on the second or third day after the onset of menses. AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. US FDA pregnancy category C: 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.

AU, UK: Use is contraindicated during pregnancy, except in life-threatening cases when the benefit outweighs the risk to the fetus. US: Use for the treatment of onychomycosis is contraindicated during pregnancy; this drug should be used during pregnancy only if the benefit outweighs the risk to the fetus. AU TGA pregnancy category: B3 US FDA pregnancy category: C Comments: Effective contraception is recommended during therapy and for up to 2 months after the last dose; local protocol should be consulted regarding contraception timing.

Itraconazole Breastfeeding Warnings

Alternate therapy may be preferred. A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Expected benefits of therapy should outweigh the potential risk of nursing; breastfeeding is not recommended if there is doubt. Excreted into human milk: Yes (small amount) Comments: The effects in the nursing infant are unknown.

Exposure to this drug in the nursing infant has been calculated at about 450 times lower than in the mother. It has been estimated through data in the literature that fully breastfed infants (aged 3 to 12 months) would receive 1.48% of the mother's weight-adjusted dose and reach a plasma level of 0.77% of the mother's plasma level.

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