Pregnancy: Uncontrolled diabetes during pregnancy (gestational or permanent) is associated with increased risk of congenital abnormalities and perinatal mortality.
A limited amount of data from the use of metformin in pregnant women does not indicate an increased risk of congenital abnormalities. Animal studies do not indicate harmful effects with respect to pregnancy, embryonic or fetal development, parturition, or postnatal development. When the patient plans to become pregnant and during pregnancy, it is recommended that impaired glycemic control or diabetes are not treated with metformin. For diabetes it is recommended that insulin should be used to maintain blood glucose levels as close to normal as possible to reduce the risk of malformations of the fetus.
Breastfeeding: Metformin is found excreted in human breast milk. No adverse effects were seen in breastfed newborns/infants. However, due to limited data available, breastfeeding is not recommended during metformin treatment. A decision on whether to terminate breast-feeding should be made, considering the benefit of breast-feeding and the potential risk of adverse effect on the child.
Fertility: 500 mg: Metformin had no effect on male or female rat fertility when administered at dosages as high as 600 mg/kg/day, which is around three times the maximum recommended human daily dose based on body surface area comparisons.
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