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Pregnancy: Glubitor/Glubitor-OD (PR tab): There is no or limited amount of data (less than 300 pregnancy outcomes) from the use of gliclazide in pregnant women, even though there are few data with other sulfonylureas.
Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical Safety Data under Actions).
In animal studies, gliclazide is not teratogenic.
As a precautionary measure, it is preferable to avoid the use of gliclazide during pregnancy.
Control of diabetes should be obtained before the time of conception to reduce the risk of congenital abnormalities linked to uncontrolled diabetes.
Oral hypoglycemic agents are not suitable, insulin is the drug of first choice for treatment of diabetes during pregnancy. It is recommended that oral hypoglycemic therapy is changed to insulin before a pregnancy is attempted, or as soon as pregnancy is discovered.
Glubitor-OD (MR tab): Category C. Oral hypoglycemic agents (including gliclazide) are not recommended during pregnancy. Maintaining blood glucose levels as close to normal as possible is necessary during pregnancy since abnormal blood glucose levels are associated with a higher incidence of congenital abnormalities. Insulin is recommended during pregnancy.
Breastfeeding/Lactation: Glubitor/Glubitor-OD (PR tab): It is unknown whether gliclazide or its metabolites are excreted in human milk. Given the risk of neonatal hypoglycemia, the product is therefore contraindicated in breastfeeding mothers. A risk to the newborn infant/children cannot be excluded.
Glubitor-OD (MR tab): It is not known whether breastfeeding will lead to exposure of the human infant to gliclazide. However, gliclazide should not be used by breastfeeding mothers since other sulfonylureas have been found in human milk. Discontinue use in breastfeeding mothers because of potential hypoglycemia in breastfeeding infants. Consider insulin therapy for adequate glycemic control if gliclazide is discontinued.
Fertility: Glubitor/Glubitor-OD (PR tab): No effect on fertility or reproductive performance was noted in male and female rats (see Pharmacology: Toxicology: Preclinical Safety Data under Actions).
