Pregnancy & Lactation : הריון/הנקה

4.6   Fertility, pregnancy and lactation

Pregnancy
There are no systematic data from the use of brotizolam in pregnant or breast-feeding women.
Preclinical studies have shown reproductive toxicity (see section 5.3). Brotizolam should not be used during pregnancy or lactation.

Infants born to mothers who were taking benzodiazepines over a longer period of time during pregnancy may develop physical dependence. These children displayed withdrawal symptoms in the postnatal period.

If, for compelling medical reasons, brotizolam is administered during the late phase of pregnancy or during labour at high doses, effects on the neonate such as respiratory insufficiency, hypothermia, hypotonia and feeding difficulties ("floppy infant syndrome") can be expected.

If brotizolam is prescribed to a woman of child-bearing potential, she should be warned to contact her doctor immediately if she intends to become, or suspects that she is pregnant.

The risk of malformations following administration of therapeutic doses of benzodiazepines to women in the early phase of pregnancy appears to be low, although evidence from some epidemiological studies indicates an increased risk of cleft palate. There have been case reports of malformations and mental retardation in prenatally exposed children following benzodiazepine overdose or intoxication.
Lactation
Brotizolam and its metabolites are excreted into human breast milk. There is therefore a risk of accumulation in the breast-feeding child. Accordingly, breast-feeding should be discontinued or interrupted on repeated administration of brotizolam to the mother.

Fertility
There are no clinical data on the effects of brotizolam on fertility. Preclinical studies do not indicate harmful effects with respect to fertility (see section 5.3).