Amara/Amara-4 Use In Pregnancy & Lactation







Full Prescribing Info
Use In Pregnancy & Lactation
Pregnancy: Amara: Glimepiride must not be taken during pregnancy. Otherwise there is risk of harm to the child. The patient must change over to insulin during pregnancy.
Patients planning a pregnancy must inform their physician.
It is recommended that such patients change over to insulin.
Amara-4: Risk related to the diabetes: Abnormal blood glucose levels during pregnancy are associated with a higher incidence of congenital abnormalities and perinatal mortality. So the blood glucose level must be closely monitored during pregnancy in order to avoid the teratogenic risk. The use of insulin is required under such circumstances. Patients who consider pregnancy should inform their physician.
Risk related to glimepiride: There are no adequate data from the use of glimepiride in pregnant women. Animal studies have shown reproductive toxicity which likely was related to the pharmacologic action (hypoglycaemia) of glimepiride.
Consequently, glimepiride should not be used during the whole pregnancy. In case of treatment by glimepiride, if the patient plans to become pregnant or if a pregnancy is discovered, the treatment should be switched as soon as possible to insulin therapy.
Lactation: Amara: To prevent possible ingestion with the breast milk and possible harm to the child, Glimepiride must not be taken by breastfeeding women. If necessary the patient must change over to insulin, or must stop breastfeeding.
Amara-4: The excretion in human milk is unknown. Glimepiride is excreted in rat milk. As other sulfonylureas are excreted in human milk and because there is a risk of hypoglycaemia in nursing infants, breastfeeding is advised against during treatment with glimepiride.
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