Quazepam Pregnancy and Breastfeeding Warnings

Quazepam is also known as: Doral

Quazepam Pregnancy Warnings

No adverse effects on morphological development seen in animal studies. However, data for other benzodiazepines have indicated possible adverse developmental effects (long-term effects on neurobehavioral and immunological function) in animals. A syndrome of hypothermia, hypotonia, respiratory depression and difficulty feeding may occur in in infants of mothers administered benzodiazepines immediately prior to or during childbirth. Withdrawal symptoms may occur in neonates whose mothers were taking benzodiazepines late in pregnancy. There are no controlled data in human pregnancy 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.

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus. US FDA pregnancy category: C

Quazepam Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug. Excreted into human milk: Yes The effects in breastfed infant are unknown.

Quazepam and its metabolites are excreted into human milk and both the drug and its metabolites may accumulate in the breastfed infant, therefore an alternative drug should be considered, especially for newborn or preterm infants. Based on a study in 4 women receiving a single dose of quazepam 15 mg, estimated human milk concentrations of 2.3% maternal weight-adjusted dose are achieved. Due to the expected accumulation with repeat dosing, an exclusively breastfed infant may receive 0.19% of the mother's absolute dose or 4% of the maternal weight-adjusted dose.

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