Pregnancy & Lactation : הריון/הנקה

4.6   Fertility, Pregnancy and lactation
Fertility
Preclinical studies gave no evidence that bifonazole can impair male or female fertility (see section 5.3).

Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids.
Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.

Pregnancy
Pregnancy category C

Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

There are no clinical data from the use of bifonazole in pregnant women. Studies in animals have shown reproductive toxicity at high oral doses (see section 5.3) however these effects should not be anticipated at the low systemic exposures observed following topical bifonazole administration (see section 5.2).
Bifonazole should only be used during pregnancy after an evaluation by a doctor of the benefit to the patient and the risk to the fetus.

Lactation
It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk.
Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.

It is unknown whether bifonazole is excreted in human breast milk after topical application.
Bifonazole is excreted in milk after intravenous administration in animals (see section 5.3).
A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue bifonazole therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
During the lactation period bifonazole should not be applied to the chest area.