Avandaryl

Generic name:

Rosiglitazone maleate and glimepiride

Drug class:

Thiazolidinedione and sulfonylurea combination antidiabetic

Dosage form:

Tablet: 4 mg/1 mg, 4 mg/2 mg, 4 mg/4 mg

Root of administration:

Oral

Dose:

Starting dose one tablet (rosiglitazone 4 mg/glimepiride 1 mg) once daily with breakfast; may increase to rosiglitazone 4 mg/glimepiride 2 mg or 4 mg/glimepiride 4 mg based on glycemic response; maximum daily dose: 4 mg rosiglitazone/4 mg glimepiride.

Mechanism of action:

Rosiglitazone activates peroxisome proliferator-activated receptor gamma (PPARγ) enhancing insulin sensitivity in adipose tissue, muscle and liver; glimepiride stimulates insulin release from pancreatic β-cells by inhibiting ATP-sensitive potassium channels.

Drug usage cases:

• Type 2 diabetes mellitus (improvement of glycemic control)
• Off-label: Varies by indication; consult label.

Drug contra indications:

• Hypersensitivity to rosiglitazone, glimepiride, or other sulfonylureas
• Type 1 diabetes mellitus
• Diabetic ketoacidosis
• NYHA class III/IV heart failure
• Severe hepatic impairment
• Concomitant use of insulin

Side effects:

• Hypoglycemia
• Weight gain
• Fluid retention and edema
• Heart failure exacerbation
• Anemia
• Headache
• Upper respiratory tract infection
• Gastrointestinal disturbances (nausea, diarrhea)
• Hepatotoxicity (elevated liver enzymes)

Warnings:

• Monitor for signs and symptoms of heart failure
• Avoid in patients with NYHA class III/IV heart failure
• Periodic hepatic function tests before and during therapy
• Risk of hypoglycemia when used with other antidiabetics
• Use with caution in renal impairment
• Potential increased risk of bone fractures
• Monitor for macular edema in long-term use

Use during pregnancy or breastfeeding:

Use only if potential benefit justifies potential risk to fetus. Rosiglitazone and glimepiride cross the placenta; risk of neonatal hypoglycemia. Limited human data; no adequate studies. Use alternative glycemic control measures. Discontinue or use with caution during breastfeeding; components may be excreted in breast milk and cause hypoglycemia in nursing infants.