GLIMEPIRIDE (glimepiride)

There are 1 contraindications. Absolute contraindication.

Contraindication List
Lactation

There are 0 severe contraindications.

There are 10 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Alcohol use disorder
Autonomic dysreflexia
Debilitation
Disease of liver
Glucose-6-phosphate dehydrogenase (g6Pd) deficiency
Hemolytic anemia
Hypoglycemic disorder
Kidney disease with reduction in glomerular filtration rate (GFr)
Pituitary insufficiency
Primary adrenocortical insufficiency

There are 21 severe adverse reactions.

More Frequent	Less Frequent
Hypoglycemic disorder	None.

Rare/Very Rare
Abnormal hepatic function tests Agranulocytosis Anaphylaxis Angioedema Aplastic anemia Cutaneous vasculitis Dyspnea Erythema Hemolytic anemia Hepatitis Hyponatremia Hypotension Idiopathic thrombocytopenic purpura Leukopenia Pancytopenia Porphyria cutanea tarda SIADH syndrome Stevens-johnson syndrome Thrombocytopenic disorder Urticaria

There are 9 less severe adverse reactions.

More Frequent	Less Frequent
Dizziness Headache disorder Nausea Weight gain	Flu-like symptoms

Rare/Very Rare
Alopecia Dysgeusia Pruritus of skin Skin photosensitivity

Available data from a small number of published studies and decades of postmarketing experience with glimepiride in pregnancy have not identified any drug associated risk for major birth defects, miscarriage, or adverse maternal outcomes. However, sulfonylureas (including glimepiride) cross the placenta and have been associated with neonatal adverse reactions such as hypoglycemia. Prolonged hypoglycemia, lasting 4--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.

In animal studies, there was no increase in congenital anomalies, but an increase in fetal deaths occurred in rats and rabbits at glimepiride doses 50 times and 0.1 times the maximum recommended human dose (based on body surface area), respectively. This fetotoxicity was observed only at doses inducing maternal hypoglycemia and is believed to be directly related to the pharmacologic (hypoglycemic) action of glimepiride, as has been similarly noted with other sulfonylureas.

Poorly controlled diabetes in pregnancy is associated with risks to both the mother and fetus. Poorly controlled diabetes in pregnancy is associated with increased maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, and delivery complications. Poorly controlled diabetes also increases the fetal risk for major birth defects, still birth, and macrosomia-related morbidity.

Due to reports of prolonged hypoglycemia in neonates born to mothers receiving a sulfonylurea at the time of delivery, glimepiride should be discontinued at least 2 weeks before expected delivery. Observe newborns for symptoms of hypoglycemia and respiratory distress and manage accordingly.

There is no information regarding the presence of glimepiride in human milk or the effects on milk production. Glimepiride is distributed into milk in rats. During prenatal and postnatal studies in rats, significant concentrations of glimepiride were present in breast milk and the serum of the pups.

Offspring of rats exposed to high levels of glimepiride during pregnancy and lactation developed skeletal deformities consisting of shortening, thickening, and bending of the humerus during the postnatal period. These skeletal deformities were determined to be the result of nursing from mothers exposed to glimepiride. The developmental and health benefits of breastfeeding should be considered along with any potential adverse effects on the breast-fed child from glimepiride or from the underlying maternal condition.

Breast-fed infants of lactating women using glimepiride should be monitored for symptoms of hypoglycemia (e.g., jitters, cyanosis, apnea, hypothermia, excessive sleepiness, poor feeding, seizures).

In clinical trials of glimepiride, 1053 of 3491 patients (30%) were >65 years of age. No overall differences in safety or effectiveness were observed between these patients and younger patients, but greater sensitivity of some older individuals cannot be ruled out. There were no significant differences in the pharmacokinetics of glimepiride between patients with type 2 diabetes <=65 years and those >65 years of age.

Glimepiride is substantially excreted by the kidney. Geriatric patients are more likely to have renal impairment. Additionally, hypoglycemia may be difficult to recognize in geriatric patients. Use caution when initiating glimepiride and increasing the dosage of glimepiride in geriatric patients.