Corlopam Pregnancy Warnings
Animal studies have revealed evidence of maternal toxicity. There are no controlled data in human pregnancy.
US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.
The manufacturer makes no recommendation regarding use during pregnancy.
US FDA pregnancy category: Not assigned.
Risk Summary: Insufficient data exist to determine drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
See references
Corlopam Breastfeeding Warnings
A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
Excreted into human milk: Unknown
Excreted into animal milk: Yes
Comments:
-According to some authorities, this drug is unlikely to adversely affect a nursing infant due to its poor oral bioavailability and short half-life.
-This drug can be administered intravenously to pediatric patients less than 1 month (at least 2 kg or full term).
See references
