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Glyburide / metformin Pregnancy and Breastfeeding Warnings

Glyburide / metformin is also known as: Glucovance

Glyburide / metformin Pregnancy Warnings

GlyBURIDE-metformin has been assigned to pregnancy category B by the FDA. Animal studies failed to reveal evidence of fetal harm. However, other sulfonylureas have been associated with an increased teratogenic risk in animal studies. There are no controlled data in human pregnancy. The use of oral sulfonylureas during pregnancy has been reported to result in neonatal hypoglycemia. Insulin remains the mainstay of therapy for gestational diabetes due to the close glucose control it affords. GlyBURIDE-metformin is only recommended for use during pregnancy when there are no alternatives and benefit outweighs risk. If glyBURIDE-metformin must be used, it should be discontinued at least two weeks before expected delivery to prevent neonatal side effects.

Maternal to fetal transfer of the second generation sulfonylureas (i.e. glyburide, glipizide) appears to be significantly lower than that of the first generation sulfonylureas. This data suggests that reduced or insignificant fetal exposure may occur with maternal administration of the second generation agents. Additional studies are needed to fully assess the safety of these agents for use during pregnancy.

See references

Glyburide / metformin Breastfeeding Warnings

Metformin is excreted into the milk of rats and achieves milk concentrations comparable to those found in plasma.

There are no data on the excretion of glyburide-metformin into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

See references

References for pregnancy information

  1. Elliott BD, Schenker S, Langer O, Johnson R, Prihoda T "Comparative placental transport of oral hypoglycemic agents in humans: a model of human placental drug transfer." Am J Obstet Gynecol 171 (1994): 653-60
  2. Koren G, Pastuszak A, Ito S "Drugs in pregnancy." N Engl J Med 338 (1998): 1128-37
  3. "Product Information. Diabeta (glyburide)." Hoechst Marion-Roussel Inc, Kansas City, MO.
  4. "Product Information. Micronase (glyburide)." Pharmacia and Upjohn, Kalamazoo, MI.
  5. "Product Information. Glucophage (metformin)." Bristol-Myers Squibb, Princeton, NJ.
  6. "Product Information. Glucovance (glyburide-metformin)" Bristol-Myers Squibb, Princeton, NJ.

References for breastfeeding information

  1. "Product Information. Glucophage (metformin)." Bristol-Myers Squibb, Princeton, NJ.
  2. "Product Information. Glucovance (glyburide-metformin)" Bristol-Myers Squibb, Princeton, NJ.
  3. "Product Information. Diabeta (glyburide)." Hoechst Marion-Roussel Inc, Kansas City, MO.
  4. "Product Information. Micronase (glyburide)." Pharmacia and Upjohn, Kalamazoo, MI.

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