Monograph Details
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Endocrine System
> Diabetes
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AVANDARYL 4mg/4mg |
| Manufacturer |
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GlaxoSmithKline Pharmaceuticals |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Thiazolidinedione + sulfonylurea. |
| Generic Name |
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Rosiglitazone (as maleate) 4mg, glimepiride 4mg; tabs. |
| Also |
• AVANDARYL 4mg/1mg
• AVANDARYL 4mg/2mg
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| Indications |
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Adjunct to diet and exercise for type 2 diabetes when dual therapy is appropriate. |
| Children |
<18yrs: not recommended.
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| Adults |
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≥18yrs: Take once daily with first meal of the day. Drug-naive: 4mg/1mg. Previously on rosiglitazone alone: initially 4mg/1mg or 4mg/2mg; if inadequate response after 1–2 weeks, may increase glimepiride component in ≤2mg increments at 1–2 week intervals. Previously on sulfonylurea monotherapy: initially 4mg/1mg or 4mg/2mg; if inadequate response, may increase rosiglitazone component after 8–12 weeks. Previously on rosiglitazone and glimepiride: switch on a mg/mg basis. Max 8mg rosiglitazone/4mg glimepiride per day. Elderly, debilitated, malnourished, renal, hepatic or adrenal insufficiency: initially 4mg/1mg once daily; titrate carefully to avoid hypoglycemia. |
| Contraindications |
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Diabetic ketoacidosis. NYHA Class III or IV heart failure. |
| Precautions |
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Not for treating type 1 diabetes. Hepatic disease. Do not start therapy in active liver disease or if ALT >2.5xULN. Monitor transaminases at baseline, then periodically. If ALT is mildly elevated (≤2.5xULN), follow-up and monitor closely; discontinue if ALT >3xULN or jaundice occurs. Not for use in patients with history of troglitazone-associated jaundice. CHF: NYHA Class I or II: increased risk of cardiovascular events (monitor). Edema. May increase plasma volume (monitor for heart failure); discontinue if cardiac status deteriorates. Monitor for weight gain/fluid retention. Risk of cardiovascular mortality. Stress, uncompensated strenuous exercise, deficient caloric intake, or alcohol intoxication: increased risk of hypoglycemia. Resumption of premenopausal ovulation in anovulatory patients may occur (may result in unintended pregnancy). Reevaluate if menstrual dysfunction occurs. Labor & delivery. Pregnancy (Cat.C) (consider using insulin instead), nursing mothers: not recommended. |
| Interactions |
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Concomitant insulin: not recommended. Potentiated by CYP2C8 inhibitors (eg, gemfibrozil). Antagonized by CYP2C8 inducers (eg, rifampin). May be potentiated by alcohol, NSAIDs, highly protein bound drugs, miconazole, salicylates, sulfonamides, chloramphenicol, warfarin, probenecid, MAOIs, β-blockers. May be antagonized by diuretics, corticosteroids, phenothiazines, phenytoin, niacin, sympathomimetics, isoniazid. Monitor for 1–2 weeks if transferring from long-acting sulfonylureas. |
| Adverse Reactions |
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Upper respiratory tract infection, injury, headache, anemia, weight gain, hypoglycemia, macular edema; also women: risk of fracture. |
| How Supplied |
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Tabs—30 |
| Additional Resources |
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• Related Prescribing Note |
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