Leuprolide / norethindrone Pregnancy and Breastfeeding Warnings
Leuprolide / norethindrone is also known as: Lupaneta Pack
Medically reviewed by Drugs.com. Last updated on Feb 19, 2019.
Leuprolide / norethindrone Pregnancy Warnings
Leuprolide administered to animals at 1/300 to 1/3 of the human dose on day 6 of pregnancy produced a dose-related increase in major fetal abnormalities. Increased fetal mortality and decreased fetal weights with higher doses of leuprolide (highest dose being 0.024 mg/kg) were also seen in animals.
There are no controlled data in human pregnancy.
FDA pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.
FDA pregnancy category: X
Use of Leuprolide-norethindrone is contraindicated.
Comments: Since contraception is not ensured by taking leuprolide-norethindrone, patients should use a nonhormonal method of contraception during treatment.
Leuprolide / norethindrone Breastfeeding Warnings
Leuprolide-norethindrone is contraindicated in lactating women.
Excreted into human milk: Leuprolide: Unknown; Norethindrone: Yes
Excreted into animal milk: Unknown
The effects in the nursing infant are unknown. Detectable amounts of progestins have been identified in the milk of mothers.
References for pregnancy information
- "Product Information. Lupaneta Pack (leuprolide-norethindrone)." Abbott Pharmaceutical, Abbott Park, IL.
References for breastfeeding information
- "Product Information. Lupaneta Pack (leuprolide-norethindrone)." Abbott Pharmaceutical, Abbott Park, IL.
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Further information
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