Philcort-16 Use In Pregnancy & Lactation

Pregnancy: Corticosteroids have been shown to be teratogenic in many species when given in doses equivalent to the human dose. Some animal studies have shown that corticosteroids (such as methylprednisolone) have been shown to increase the incidence of fetal malformations of various kinds (cleft palate, skeletal malformations), embryo-fetal lethality (e.g., increase in resorptions), intra-uterine growth retardation and abortion. However, corticosteroids do not appear to cause congenital anomalies when given to pregnant women.
Since adequate human reproductive studies have not been done with methylprednisolone, this medicinal product should be used during pregnancy only after a careful assessment of the benefit-risk ratio to the mother and fetus.
Corticosteroids readily cross the placenta. An increased incidence of low-birth weights in infants born of mothers receiving corticosteroids has been reported. In humans, the risk of low birth weight appears to be dose related and may be minimised by administering lower corticosteroid doses.
Infants born to mothers who have received substantial doses of corticosteroids during pregnancy must be carefully observed and evaluated for signs of adrenal insufficiency, although neonatal adrenal insufficiency is rarely reported in infants exposed in utero to corticosteroids.
Cataracts have been observed in infants born to mothers treated with long-term corticosteroids during pregnancy.
Lactation: Corticosteroids are excreted in breastmilk.
Corticosteroids distributed into breast milk may suppress growth and interfere with endogenous glucocorticoid production in nursing infants. This medicinal product should be used during breast feeding only after a careful assessment of the benefit-risk ratio to the mother and infant.