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Benzgalantamine Pregnancy and Breastfeeding Warnings

Brand names: Zunveyl

Benzgalantamine Pregnancy Warnings

Safety has not been established during pregnancy.

US FDA pregnancy category: Not assigned

Risk summary: There are no adequate data available on use of this drug (or galantamine) in pregnant women to inform a drug-related risk. Based on findings from animal studies, this drug may cause fetal harm.

Animal studies have revealed evidence of pre- and postnatal developmental toxicity. Administration of this drug to pregnant animals during the period of organogenesis resulted in fetal skeletal variations, fetal visceral malformations, and decreased offspring weights at doses ranging from equal to the maximum recommended human dose (MRHD) to about 20 times the MRHD. Dose-related fetal harm was generally associated with 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.

See references

Benzgalantamine Breastfeeding Warnings

Safety has not been established.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments:
-This drug is a prodrug of galantamine.
-There are no data on the presence of this drug (or galantamine) in human milk or the effects on milk production.
-Developmental and health benefits of breastfeeding should be considered as well as the mother's clinical need for this drug.
-The effects in the nursing infant are unknown; potential adverse effects in the breastfed child due to this drug or the mother's underlying condition should be considered.

See references

See also

References for pregnancy information

  1. (2024) "Product Information. Zunveyl (benzgalantamine)." Alpha Cognition, Inc., SUPPL-1

References for breastfeeding information

  1. (2024) "Product Information. Zunveyl (benzgalantamine)." Alpha Cognition, Inc., SUPPL-1

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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