Catania Plus/Catania Max Use In Pregnancy & Lactation

Pregnancy: Risk Summary: Dapagliflozin and Metformin HCl (As Extended Release) Tablets is not advised during the second and third trimesters of pregnancy due to animal research indicating negative kidney consequences.
There is not enough information available about Dapagliflozin and Metformin HCl (As Extended Release) Tablets or dapagliflozin in pregnant women to assess the risk of serious birth abnormalities or miscarriage. There is no conclusive evidence linking metformin use during pregnancy to a significant risk of miscarriage or birth defects. Poorly managed diabetes during pregnancy carries dangers for both the mother and the fetus.
In animal experiments, rats given dapagliflozin at all tested doses during a period of renal development equivalent to the late second and third trimesters of human pregnancy experienced adverse renal pelvic and tubule dilatations that were not entirely reversible; the lowest dose exposed rats to 15 times the clinical dose of 10 mg.
In women with pre-gestational diabetes whose HbA1c is more than 7%, the estimated baseline risk of significant birth abnormalities is 6-10%; in women whose HbA1c is higher than 10%, it has been reported to be as high as 20-25%. The suggested population's estimated background risk of miscarriage is unknown. The estimated background risk for significant birth abnormalities and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively, in the general population of the United States.
Clinical Considerations: Disease-associated maternal and/or embryofetal risk: The risk of diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm birth, and delivery difficulties is increased for mothers with poorly managed diabetes during pregnancy. Uncontrolled diabetes raises the chance of serious birth abnormalities, stillbirth, and morbidity associated with macrosomia in the fetus.
Lactation: Risk Summary: Dapagliflozin and Metformin HCl (As Extended Release) Tablets presence in human milk, their effects on breastfed infants, and their impact on milk production are all unknown.
According to a small number of published studies, human milk contains metformin. Nevertheless, nothing is known about how metformin affects breastfed infants, and there is no evidence on how it affects milk production. The milk of nursing rats contains dapagliflozin. The clinical significance of these findings is unclear, nevertheless, because lactation physiology varies by species. The growing human kidney may be at danger since human kidney maturation takes place in utero and throughout the first two years of life, when lactational exposure may occur.
Advise women that using Dapagliflozin and Metformin HCl (As Extended Release) Tablets while nursing is not advised due to the possibility of severe adverse effects in breastfed infants.
Females and Males of Reproductive Potential: Talk to premenopausal women about the possibility of an unwanted pregnancy because metformin medication may cause some anovulatory women to ovulate.