Pregnancy & Lactation : הריון/הנקה

4.6    Fertility, pregnancy and lactation

Pregnancy
There are no adequate data from the use of naloxone in pregnant women. Studies in animals have shown reproductive toxicity only at maternally toxic doses (see section 5.3). The potential risk for humans is unknown. Nyxoid should not be used during pregnancy unless the clinical condition of the woman requires treatment with naloxone.

In pregnant women who have been treated with Nyxoid, the fetus should be monitored for signs of distress.

In opioid dependent pregnant women, naloxone administration can cause withdrawal symptoms in newborn infants (see section 4.4).

Breast-feeding

It is unknown whether naloxone is excreted in human breast milk and it has not been established whether infants who are breast-fed are affected by naloxone. However, as naloxone is practically not orally bioavailable its potential to affect a breast-fed infant is negligible. Caution should be exercised when naloxone is administered to a breast-feeding mother but there is no need to discontinue breast-feeding. Breast-fed babies from mothers who have been treated with Nyxoid should be monitored to check for sedation or irritability.

Fertility

No clinical data on effects of naloxone on fertility are available, however data from rat studies (see section 5.3) indicate no effects.