Tolazamide Pregnancy and Breastfeeding Warnings

Brand names: Tolinase

Tolazamide Pregnancy Warnings

Use should be avoided

US FDA pregnancy category: C

Comments:
-Women of childbearing potential should discuss adequate contraception with their healthcare provider.
-Most experts recommend insulin use during pregnancy to maintain blood glucose levels as close to normal as possible.
-Prolonged hypoglycemia has been reported in neonates born to mothers receiving a sulfonylurea at the time of delivery; if this drug is used during pregnancy, it should be discontinued at least 2 weeks before the expected delivery date.

In pregnant rats dosed at 10 times the human dose, decreased litter size was observed; at doses of 14 mg/kg/day no reproductive aberrations or drug related fetal anomalies were reported. At doses of 100 mg/kg/day, a reduction in number of pups born and an increase in perinatal mortality occurred. There are no adequate and well controlled studies in pregnant women.

Abnormal blood glucose levels during pregnancy have been associated with a higher incidence of congenital abnormalities. If diet alone is not adequate to maintain guideline recommended blood glucose levels, most experts suggest insulin as the drug of choice to achieve these ranges during pregnancy.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Tolazamide Breastfeeding Warnings

Breastfeeding is not recommended during use of this drug

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments: There is a theoretical risk of hypoglycemia in the nursing infant; if diet alone is adequate for controlling blood glucose in the mother, insulin therapy should be considered.

See references

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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