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Pregnancy: Risk related to diabetes: When uncontrolled, diabetes (gestational or permanent) gives rise to an increase in congenital abnormalities and perinatal mortality. Diabetes must be controlled as far as possible during the period of conception in order to reduce the risk of congenital abnormalities.
Recent information strongly suggests that abnormal blood glucose levels during pregnancy are associated with a higher incidence of congenital abnormalities. Most experts recommend that insulin be used during pregnancy to maintain blood glucose as close to normal as possible. Because animal reproduction studies are not always predictive of human response, GLUCOVANCE should not be used during pregnancy unless clearly needed. (See as follows.)
There are no adequate and well-controlled studies in pregnant women with GLUCOVANCE (Metformin HCl and Glibenclamide Tablets) or its individual components. No animal studies have been conducted with the combined products in GLUCOVANCE. The following data are based on findings in studies performed with the individual products.
Risk related to glibenclamide: Reproduction studies were performed in rats and rabbits at doses up to 500 times the maximum recommended human daily dose of 20 mg of the glibenclamide component of GLUCOVANCE based on body surface area comparisons and revealed no evidence of impaired fertility or harm to the fetus due to glibenclamide.
Risk related to metformin: Metformin alone was not teratogenic in rats or rabbits at doses up to 600 mg/kg/day. This represents an exposure of about two and six times the maximum recommended human daily dose of 2000 mg of the metformin component of GLUCOVANCE based on body surface area comparisons for rats and rabbits, respectively. Determination of fetal concentrations demonstrated a partial placental barrier to metformin.
Non-teratogenic effects: Prolonged severe hypoglycemia (4 to 10 days) has been reported in neonates born to mothers who were receiving a sulfonylurea drug at the time of delivery. This has been reported more frequently with the use of agents with prolonged half-lives. It is not recommended that GLUCOVANCE be used during pregnancy. However, if it is used, GLUCOVANCE should be discontinued at least two weeks before the expected delivery date. (See Pregnancy: Teratogenic Effects: Pregnancy Category B as follows.)
Management: Adequate blood glucose control allows pregnancy to proceed normally in this category of patients. Glucovance must not be used for the treatment of diabetes during pregnancy.
It is imperative that insulin be used to achieve adequate blood glucose control. It is recommended that the patient be transferred from oral antidiabetic therapy to insulin as soon as she plans to become pregnant or if pregnancy is exposed to this medicinal product. Neonatal blood glucose monitoring is recommended.
Nursing Mothers: Studies in lactating rats show that metformin is excreted into milk. In humans, in the absence of data concerning passage of GLUCOVANCE into breast milk, and in view of the risk of neonatal hypoglycaemia, this medicinal product is contraindicated in the event of breast-feeding.
