Dormicum Use In Pregnancy & Lactation

Pregnancy: Film-coated tablet: Insufficient data are available on midazolam to assess its safety during pregnancy. Benzodiazepines should be avoided during pregnancy unless there is no safer alternative.
An increased risk of congenital malformation associated with the use of benzodiazepines during the first trimester of pregnancy has been suggested.
If the product is prescribed to a woman of childbearing potential, she should contact the physician regarding discontinuation of the product if she intends to become or suspects that she is pregnant.
The administration of midazolam in the last trimester of pregnancy or at high doses during labor has been reported to produce irregularities in the fetal heart rate, hypotonia, poor sucking and hypothermia and moderate respiratory depression in the neonate.
Moreover, infants born to mothers who took benzodiazepines chronically during the latter stages of pregnancy may have developed physical dependence and may be at some risk of developing withdrawal symptoms in the postnatal period.
Solution for injection: Insufficient data are available on midazolam to assess its safety during pregnancy. Benzodiazepines should be avoided during pregnancy unless there is no safer alternative. The administration of midazolam in the last trimester of pregnancy or at high doses during labor has been reported to produce irregularities in the fetal heart rate, hypotonia, poor sucking and hypothermia and moderate respiratory depression in the neonate. Moreover, infants born to mothers who received benzodiazepines chronically during the latter stage of pregnancy may have developed physical dependence and may be at some risk of developing withdrawal symptoms in the postnatal period.
An increased risk of congenital malformation associated with the use of benzodiazepines during the first trimester of pregnancy has been suggested.
Labor and Delivery: See Pregnancy as previously mentioned.
Nursing Mothers: Film-coated tablet: Since midazolam passes into breast milk, Midazolam (Dormicum) should not be administered to breast-feeding mothers.
Solution for injection: Midazolam passes in low quantities into breast milk. Nursing mothers should be advised to discontinue breast-feeding for 24 hours following administration of midazolam.