Pharmacologic class: Sulfonylurea
Therapeutic class: Hypoglycemic
Pregnancy risk category C
Available data from a small number of published studies and postmarketing experience with Glimepir >Clinical Considerations). Poorly controlled diabetes in pregnancy is also associated with risks to the mother and fetus (see Clinical Considerations ). In animal studies (see Data) , there were no effects on embryo-fetal development following administration of Glimesan to pregnant rats and rabbits at oral doses approximately 4,000 times and 60 times the maximum human dose based on body surface area, respectively. However, fetotoxicity was observed in rats and rabbits at doses 50 times and 0.1 times the maximum human dose, respectively.
The estimated background risk of major birth defects is 6% to 10% in women with pregestational diabetes with a HbA1c >7% and has been reported to be as high as 20% to 25% in women with a HbA1c >10%. The estimated background risk of miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Disease-associated maternal and/or embryo-fetal risk
Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, still birth, and macrosomia-related morbidity.
Fetal/neonatal adverse reactions
Neonates of women with gestational diabetes who are treated with sulfonylureas during pregnancy may be at increased risk for neonatal intensive care admission and may develop respiratory distress, hypoglycemia, birth injury, and be large for gestational age. Prolonged severe hypoglycemia, lasting 4 to 10 days, has been reported in neonates born to mothers receiving a sulfonylurea at the time of delivery and has been reported with the use of agents with a prolonged half-life. Observe newborns for symptoms of hypoglycemia and respiratory distress and manage accordingly.
Dose adjustments during pregnancy and the postpartum period
Due to reports of prolonged severe hypoglycemia in neonates born to mothers receiving a sulfonylurea at the time of delivery, Glimepir >Fetal/Neonatal Adverse Reactions ).
In animal studies, there was no increase in congenital anomalies, but an increase in fetal deaths occurred in rats and rabbits at Glimesan doses 50 times (rats) and 0.1 times (rabbits) the maximum recommended human dose (based on body surface area). This fetotoxicity was observed only at doses inducing maternal hypoglycemia and is believed to be directly related to the pharmacologic (hypoglycemic) action of Glimesan, as has been similarly noted with other sulfonylureas.
What is the most important information I should know about Glimesan (Amaryl)?
You should not use Glimesan if you have diabetic ketoacidosis, or if you are allergic to sulfa drugs.
Glimesan may cause increased sensitivity to the sun (photosensitivity). While taking this medication, you should use sunscreen, wear protective clothing, and limit how often you’re in the sun.
What should I discuss with my healthcare provider before taking Glimesan (Amaryl)?
You should not use Glimesan if you are allergic to it, or if you have:
- an allergy to sulfa drugs; or
- diabetic ketoacidosis (call your doctor for treatment).
Tell your doctor if you have ever had:
- heart disease;
- liver or kidney disease; or
- an enzyme deficiency called glucose-6-phosphate dehydrogenase deficiency (G6PD).
Glimesan may increase your risk of serious heart problems, but not treating your diabetes can also damage your heart and other organs. Talk to your doctor about the risks and benefits of this medicine.
Follow your doctor's instructions about using this medicine if you are pregnant. Blood sugar control is very important during pregnancy, and your dose needs may be different during each trimester.
Medications similar to Glimesan have caused severe hypoglycemia in newborn babies whose mothers used the medicine near the time of delivery. If you take Glimesan during pregnancy, stop taking this medicine at least 2 weeks before your due date.
If you breastfeed while taking Glimesan, call your doctor if your baby shows signs of hypoglycemia (extreme drowsiness, feeding problems, mottled skin, blue lips, feeling cold or jittery, or having a seizure).
Glimesan is not approved for use by anyone younger than 18 years old.
Indications and Usage for Glimepir >
Glimepir >Clinical Studies ( 14.1) ].
Limitations of Use
Glimesan tablets should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.
What are the side effects of Glimesan?
Common side effects of Glimesan include:
A rash and allergic reactions also may occur. Flu-like symptoms have also been reported with Glimesan therapy.
Possible serious side effects of Glimesan include:
- Low blood platelets
- Low sodium
- Sensitivity to sunlight
- Liver dysfunction
- Serious allergic reactions
Low blood sugar (hypoglycemia) can occur during Glimesan therapy. Symptoms of low blood sugar include:
Glimesan is a derivative of a sulfonamide drug. People allergic to other sulfonamide-related drugs may develop an allergic reaction to Glimesan. Anyone who has an allergic reaction to sulfa drugs should not take Glimesan.