Glycopyrrolate / neostigmine Pregnancy and Breastfeeding Warnings

Brand names: Prevduo

Medically reviewed by Drugs.com. Last updated on Jan 5, 2024.

Glycopyrrolate / neostigmine Pregnancy Warnings

According to some authorities, this drug should not be used during pregnancy unless the expected benefits outweigh any potential risk.

AU TGA pregnancy category: B2
US FDA pregnancy category: Not assigned

Risk summary: No data is available on the use of this drug combination in pregnant women to inform a drug-related risk.

Comments:
Glycopyrrolate (glycopyrronium) use during pregnancy has not been associated with miscarriage or fetal harm. Data from most studies are based on cesarean section deliveries, and none indicate adverse maternal outcomes. Neostigmine, like other anticholinesterase drugs, may cause uterine irritability and induce premature labor when administered near term.

Animal studies have failed to reveal evidence of teratogenicity. Neostigmine administered to animals at human equivalent doses up to 13 mcg/kg/day during organogenesis noted no adverse effects. Glycopyrrolate (glycopyrronium) administered orally and intramuscularly at ten times the maximum recommended human dose (MRHD) during organogenesis also revealed no teratogenic effects. There are no controlled data on human pregnancy.

AU TGA pregnancy category B2: Drugs that 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. Studies in animals are inadequate or may be lacking, but available data show no evidence of an increased occurrence of fetal damage.

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 healthcare 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

Glycopyrrolate / neostigmine Breastfeeding Warnings

Benefit should outweigh risk. Caution is recommended.

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

Comments: Glycopyrrolate (glycopyrronium) may suppress lactation like other anticholinergics. Some authorities indicate that a negligible amount of neostigmine may be excreted into breast milk. The expected benefits of breastfeeding and the potential adverse effects of this drug should be considered prior to use.

See references

Further information

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