Glimepiride/​Rosiglitazone

DEA Class; Rx

Common Brand Names; Avandaryl

Indicated for the treatment of type 2 diabetes mellitus uncontrolled by diet and exercise alone.
NOTE: Patients treated with glimepiride; rosiglitazone should be monitored for cardiovascular adverse events. The use of combination glimepiride; rosiglitazone with insulin has not been studied and is not recommended by the manufacturer.
NOTE: When adding rosiglitazone to glimepiride in patients with or without symptomatic heart disease and diabetes, monitor closely for signs of weight gain, peripheral edema, or congestive heart failure. In general, rosiglitazone should be initiated at the lowest dose and increased gradually after at least 3 months of therapy. The risk of these symptoms is increased when higher doses of rosiglitazone are used in combination with a sulfonylurea or insulin in patients at risk of congestive heart failure. Rosiglitazone should not be added to glimepiride therapy in patients with New York Heart Association Class III or IV heart failure. Discontinue the drug if any deterioration in cardiac status occurs during therapy.

History of a hypersensitivity reaction to rosiglitazone or glimepiride or any of the product’s ingredients

History of allergic reaction to sulfonamide derivatives

Diabetic ketoacidosis, with or without coma

Heart failure NYHA Class III-IV

• Edema (3%)
• Myocardial infarction (≤3%)
• Cerebrovascular accident (≤2%)
• Cardiac failure (≤3%)
• Headache (3-6%)
• Hypoglycemia (4-6%)
• Bone fracture (≤8%)
• Nasopharyngitis (4-5%)
• Weight gain
• Cardiac failure
• Increased serum ALT
• Thrombocytopenia and thrombocytopenic purpura

Edema; thiazolidinediones, which are peroxisome proliferator-activated receptor (PPAR) gamma agonists, can cause dose-related fluid retention, particularly when used in combination with insulin

Hypersensitivity reactions reported in patients treated with glimepiride, including serious reactions such as anaphylaxis, angioedema, and Stevens-Johnson syndrome; if hypersensitivity reaction suspected, promptly discontinue therapy, assess for other potential causes for the reaction, and institute alternative treatment for diabetes

Hemolytic anemia may occur with glucose 6-phosphate dehydrogenase (G6PD) deficiency when treated with sulfonylurea agents

Pregnancy Category: C

Lactation: not known if crosses into breast milk, avoid

4 mg/day PO glimepiride with 8 mg/day PO rosiglitazone.

4 mg/day PO glimepiride with 8 mg/day PO rosiglitazone.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Glimepiride/rosiglitazone

tablet

• 4mg/1mg
• 4mg/2mg
• 4mg/4mg
• 8mg/2mg
• 8mg/4mg