Glimepiride/​Pioglitazone

DEA Class; Rx

Common Brand Names; Duetact

Indicated for management of type 2 diabetes mellitus as adjunct to diet and exercise

Indicated for type 2 diabetes mellitus in patients treated with combination of pioglitazone and a sulfonylurea, or patients not adequately controlled on a sulfonylurea alone, or who have initially responded to pioglitazone and require additional glycemic control Management of diabetes mellitus as adjunct to diet and exercise

Hypersensitivity

Diabetic ketoacidosis with of without coma

Active liver disease, increased serum transaminase levels

Not recommended in heart failure NYHA III-IV patients

• Peripheral edema (6-12%)
• Upper respiratory tract infection (12-15%)
• Weight gain (9-13%)
• Hypoglycemia (13-16%)
• Anemia (<2%)
• Limb pain (4-5%)
• Urinary tract infection (6-7%)
• Headache (4-7%)
• Diarrhea (4-6%)
• Nausea (4-5%)
• Thrombocytopenia and thrombocytopenic purpura

Increased risk of cardiovascular mortality

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

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

Fluid retention may occur and can exacerbate or lead to congestive heart failure; combination use with insulin and use in congestive heart failure NYHA Class I and II may increase risk; monitor patients for signs and symptoms

Hypoglycemia may be severe. when insulin or an insulin secretagogue is used with pioglitazone, a lower insulin dose or insulin secretagogue dose may be needed to reduce risk of hypoglycemia

Postmarketing reports for glimepiride include anaphylaxis, angioedema, and Stevens-Johnson syndrome; promptly discontinue glimepiride, assess for other causes, institute appropriate monitoring and treatment, and initiate alternative treatment for diabetes

Postmarketing reports of hepatic failure, sometimes fatal; causality cannot be excluded; if liver injury detected, promptly interrupt therapy and assess patient for probable cause, then treat cause if possible, to resolution or stabilization; do not restart therapy if liver injury confirmed and no alternate etiology can be found

Dose-related edema may occur

Increased incidence of bone fracture reported

Macular edema reported; recommend regular eye exams in all patients with diabetes according to current standards of care with prompt evaluation for acute visual changes

No clinical studies establishing conclusive evidence of macrovascular risk reduction with glimepiride/pioglitazone or any other antidiabetic drug exist

Increase in weight gain possibly related to pioglitazone effects on fluid retention and fat accumulation

Limited data in pregnant women are not sufficient to determine a drug-associated risk for major birth defects or miscarriage; there are clinical considerations related to fetal and neonatal adverse reactions and drug discontinuation if glimepiride is used during pregnancy

There is no information regarding presence of pioglitazone or glimepiride in human milk, effects on breastfed infant, or on milk production; pioglitazone and glimepiride are present in rat milk; however, due to species-specific differences in lactation physiology, animal data may not reliably predict drug levels in human milk

Pioglitazone/glimepiride

tablet

• 30mg/2mg
• 30mg/4mg