Pregnancy Category C Risk cannot be ruled out.
Approval History Calendar Drug history at FDA More FDA updates.
Availability Rx Prescription only.
CSA Schedule 4 Some potential for abuse.
-Effects on the neonate (e.g., hypothermia, hypotonia, moderate respiratory depression) can be expected if this drug is administered during the late phase of pregnancy or during labor. AU TGA pregnancy category: B3 US FDA pregnancy category: C Comments: -Advise a female patient of childbearing potential to stop using this drug if she intends to become or suspects that she is pregnant. US: Use during pregnancy only if the potential benefit outweighs the potential risk to the fetus. See references. AU, UK: Safety in pregnancy has not been established; avoid use in pregnancy, especially during the first trimester.
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US: Use with caution in nursing mothers. AU, UK: Use in nursing mothers is not recommended. See references. Excreted into human milk: Yes Comments: Due to the low levels of this drug in breastmilk and its short half-life, amounts ingested by nursing infants are small and would not be expected to cause any adverse effects in these infants.
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In animals, administration of this drug during the latter part of pregnancy and throughout lactation produced decreased offspring growth and survival at all but the lowest dose tested. Breastmilk collected 3 hours after a single oral 20 mg dose of this drug was administered to 5 nursing mothers (who were 3 to 4 days postpartum) showed the breastmilk contained between 0.004% to 0.019% of the maternal dosage; the drug was undetectable (less than 0.5 mcg/L) in the breastmilk 13 and 16 hours after the dose.
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Infants born to mothers who took benzodiazepines or benzodiazepine-like agents chronically during the latter stages of pregnancy may be at risk for developing physical dependence and withdrawal symptoms in the postnatal period. Cases of severe neonatal respiratory depression have been reported when this drug was used at the end of pregnancy, especially when used with other central nervous system (CNS) depressants. Animal studies have revealed no evidence of teratogenicity or fertility impairment, but adverse effects including incomplete fetal skeletal ossification and increased embryo-fetal death have occurred. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. Additionally, neonatal flaccidity also has been reported in infants born to mothers who received sedative/hypnotic drugs during pregnancy. AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed.
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