Dosing and uses of Avandaryl (glimepiride-rosiglitazone)
Adult dosage forms and strengths
rosiglitazone/glimepiride
tablet
- 4mg/1mg
- 4mg/2mg
- 4mg/4mg
- 8mg/2mg
- 8mg/4mg
Type 2 Diabetes
Starting Dose: 1 tab (4mg/1mg) qDay with first meal of day
Titrate: glimepiride component increased not to exceed 2 mg q1-2 week
Not to exceed 8 mg rosiglitazone/4 mg glimepiride
Dosage modifications
Renal impairment, starting dose: 1 tab (4mg/1mg) qDay with first meal of day; titrate carefully
Hepatic impairment
- Starting dose: 1 tab (4mg/1mg) qDay with first meal of day; titrate carefully
- ALT <2.5 xULN: Use caution
- ALT >2.5 xULN: Do not administer
- ALT >3 xULN or jaundice after initiating therapy: Discontinue
Pediatric dosage forms and strengths
Safety and efficacy not established
Geriatric dosage forms and strengths
Starting Dose: 1 tab (4mg/1mg) qDay with first meal of day
Titrate dose carefully
Avandaryl (glimepiride-rosiglitazone) adverse (side) effects
1-10%
Edema (3%)
Myocardial infarction (≤3%)
Cerebrovascular accident (≤2%)
Cardiac failure (≤3%)
Headache (3-6%)
Hypoglycemia (4-6%)
Bone fracture (≤8%)
Nasopharyngitis (4-5%)
<1%
Weight gain
Cardiac failure
Increased serum ALt
Postmarketing Reports
Thrombocytopenia and thrombocytopenic purpura
Warnings
Black box warnings
Congestive heart failure risk
- Thiazolidinediones, including rosiglitazone, cause or exacerbate congestive heart failure in some patients
- After initiation, and after dose increases, observe patients carefully for signs and symptoms of heart failure (including excessive, rapid weight gain, dyspnea, and/or edema)
- If these signs and symptoms develop, the heart failure should be managed according to current standards of care
- Furthermore, discontinuation or dose reduction must be considered
- Not recommended in patients with symptomatic heart failure
- Initiation with established NYHA Class III or IV heart failure is contraindicated
- There have been no clinical trials directly comparing cardiovascular risk of rosiglitazone and pioglitazone, another thiazolidinedione
Contraindications
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
Cautions
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
See also individual monographs
- Rosiglitazone
- Glimepiride
Pregnancy and lactation
Pregnancy category: C
Lactation: not known if crosses into breast milk, avoid
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
