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Pregnancy: Teratogenic Effects: Pregnancy Category X (see Contraindications). When administered on day 6 of pregnancy at test dosages of 0.00024, 0.0024. and 0.024 mg/kg (1/300 to 1/3 of the human dose) to rabbits, Leuprorelin Acetate produced a dose-related increase in major fetal abnormalities. Similar studies in rats failed to demonstrate an increase in fetal malformations. There was increased fetal mortality and decreased fetal weights with the two higher doses of Leuprorelin Acetate in rabbits and with the highest dose (0.024 mg/kg) in rats.
Nursing Mothers: It is not known whether Leuprorelin Acetate is excreted in human milk. Many drugs are excreted in human milk, and because the effects of Leuprorelin Acetate on lactation and/or the breast-fed child have not been determined, Leuprorelin Acetate should not be used by nursing mothers.
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