Glucovance Use In Pregnancy & Lactation

Use in pregnancy: Teratogenic Effects: Pregnancy Category B: 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.
There are no adequate and well-controlled studies in pregnant women with Glucovance 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.
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.
Metformin hydrochloride: Metformin alone was not teratogenic in rats or rabbits at doses up to 600 mg/kg/day. This represents an exposure of about 2 and 6 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.
Nonteratogenic Effects: Prolonged severe hypoglycemia (4-10 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 2 weeks before the expected delivery date.
Use in lactation: Although it is not known whether glibenclamide is excreted in human milk, some sulfonylurea drugs are known to be excreted in human milk. Studies in lactating rats show that metformin is excreted into milk and reaches levels comparable to those in plasma. Similar studies have not been conducted in nursing mothers. Because the potential for hypoglycemia in nursing infants may exist, a decision should be made whether to discontinue nursing or to discontinue Glucovance, taking into account the importance of the drug to the mother. If Glucovance is discontinued and if diet alone is inadequate for controlling blood glucose, insulin therapy should be considered.