Zemidapa Use In Pregnancy & Lactation

Pregnancy: No studies have been conducted with the combined active substances of Gemigliptin/Dapagliflozin. Studies in animals with gemigliptin have shown that gemigliptin was transferred to placenta and up to 48.1% and 1.6% were detected in amniotic fluids when administered to pregnant rats and rabbits, respectively, at 2 hours post dose. Studies with dapagliflozin in rats have shown toxicity to the developing kidney in the time period corresponding to the second and third trimesters of human pregnancy (see Pharmacology: Toxicology: Preclinical safety data under Actions). Therefore, Gemigliptin/Dapagliflozin should not be used during pregnancy. If pregnancy is detected, treatment with Gemigliptin/Dapagliflozin should be discontinued.
Breast-feeding: No studies have been conducted with the combined active substances of Gemigliptin/Dapagliflozin. Available pharmacodynamic/toxicological data in animals have shown excretion of dapagliflozin/metabolites in milk, as well as pharmacologically-mediated effects in breast-feeding offspring (see Pharmacology: Toxicology: Preclinical safety data under Actions). A risk to the newborns/infants cannot be excluded. Gemigliptin/Dapagliflozin should not be used while breast-feeding.
Fertility: No studies have been conducted with the combined active substances of Gemigliptin/Dapagliflozin. In male and female rats, dapagliflozin showed no effects on fertility at any dose tested. Animal studies with gemigliptin do not indicate harmful effects to fertility in male and female rat.