YSP Clonidine Use In Pregnancy & Lactation

Pregnancy: Clonidine hydrochloride has not shown teratogenic potential when tested in rats, but in some circumstances, the incidence of embryonic and perinatal deaths was increased with doses comparable to those used clinically for antihypertensive therapy.
There are limited data from the use of clonidine in pregnant women, but the experience with clonidine hydrochloride since marketing does not include any positive evidence of adverse effect on the foetus. Since this experience cannot exclude such an effect, clonidine hydrochloride should be used during pregnancy only when the benefit clearly justifies the possible risk to the foetus.
Clonidine passes the placental barrier and may lower the heart rate of the foetus. There is no adequate experience regarding the long-term effects of prenatal exposure.
Clonidine hydrochloride may also induce transitory elevation of blood glucose and impairment of glucose tolerance. Children born to mothers treated with clonidine hydrochloride during pregnancy should be specifically examined for changes in glucose metabolism.
During pregnancy, the oral forms of clonidine are preferred. Intravenous injection of clonidine should be avoided.
Non-clinical studies in rats do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Postpartum, a transient rise in blood pressure in the newborn cannot be excluded.
Fertility: Clinical studies on the effect of clonidine on human fertility have not been conducted.
Clonidine had no effect on fertility in male or female rats when administered orally at doses up to 0.15 mg/kg/day (35% higher than the maximum recommended total daily dose of clonidine in humans, based on body surface area).
Lactation: Clonidine is excreted in human milk. As the effect on the newborn is not known, infants born to mothers being treated with Clonidine should not be breastfed.