Glycopyrronium topical Pregnancy and Breastfeeding Warnings

Brand names: Qbrexza

Medically reviewed by Drugs.com. Last updated on Nov 6, 2023.

Glycopyrronium topical Pregnancy Warnings

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned

Comments:
-There is no data on use in pregnant women to know this drugs risks, including the risk of fetal harm or reproductive effects.
-The available animal data does not support relevant comparisons of those systemic exposures to human exposure after topical use.

Animal studies of oral doses of up to 400 mg/kg/day administered during organogenesis did not affect maternal survival, maternal weight gain decreased during the dosing period, mean fetal weight was significantly reduced in the 200 and 400 mg/kg/day groups, at 400 mg/kg/day two litters had all the fetuses resorbed, and minor treatment related skeletal effects including reduced ossification of bones (possibly secondary to maternal toxicity) were seen in the 200 and 400 mg/kg/day groups but no gross external or visceral defects were seen. Intravenous administration during organogenesis of 0.1, 0.5, and 1 mg/kg/day did not affect maternal survival, maternal weight gain and food consumption decreased during the dosing period, and no effects on fetal parameters (including survival, weight, and incidence of external, visceral, or skeletal defects) were seen. Animals given oral glycopyrrolate at doses up to 400 mg/kg/day from gestation day 7 to day 20 of lactation had reduced pup weight in all treatment groups during the nursing period, however weights recovered to comparable to controls after weaning; no treatment related effects on survival or adverse effects were seen in the pups, including on behavior, learning, memory, or reproductive function of the offspring. 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

Glycopyrronium topical Breastfeeding Warnings

The manufacturer makes no recommendation regarding use during lactation.

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

Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this medication as well as any potential adverse effects from this drug or the underlying maternal condition.

Animals given oral glycopyrrolate at doses up to 400 mg/kg/day from gestation day 7 to day 20 of lactation had reduced pup weight in all treatment groups during the nursing period, however weights recovered to comparable to controls after weaning; no treatment related effects on survival or adverse effects were seen in the pups, including on behavior, learning, memory, or reproductive function of the offspring.

See references

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