Monograph Details
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Endocrine System
> Diabetes
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AVANDAMET 2mg/1000mg |
| 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 + biguanide. |
| Generic Name |
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Rosiglitazone (as maleate) 2mg, metformin HCl 1000mg; tabs. |
| Also |
• AVANDAMET 2mg/500mg
• AVANDAMET 4mg/1000mg
• AVANDAMET 4mg/500mg
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| Indications |
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Adjunct to diet and exercise for type 2 diabetes when dual therapy is appropriate. |
| Children |
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Not recommended. |
| Adults |
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Give in divided doses with meals. Drug-naive: initially 2mg/500mg once or twice daily; may increase by 2mg/500mg per day after 4 weeks; max 8mg/2000mg per day. Previously on metformin alone: add rosiglitazone 4mg/day to current metformin dose; may increase after 8–12 weeks. Previously on rosiglitazone alone: add metformin 1000mg/day to current rosiglitazone dose; may increase after 1–2 weeks. Previously on rosiglitazone + metformin: switch on a mg/mg basis; may increase by rosiglitazone 4mg and/or metformin 500mg per day; max 8mg/2000mg per day. |
| Contraindications |
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NYHA Class III or IV heart failure. Renal disease or dysfunction. Metabolic acidosis, diabetic ketoacidosis. Concomitant intravascular iodinated contrast agents (suspend during and for 48 hrs after). |
| Precautions |
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Not for treating type 1 diabetes. Confirm normal renal function before starting and monitor (esp. in patients ≥80yrs). Do not start therapy in active liver disease or if ALT >2.5xULN. Monitor transaminases at baseline, then periodically. Follow up and monitor closely if ALT is mildly elevated (≤2.5xULN); 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 HF); discontinue if cardiac status deteriorates, or if lactic acidosis, shock, acute MI, sepsis, or hypoxemia occurs. Suspend if dehydration occurs and before surgery. Monitor blood (esp. Vit. B12 in susceptible patients). Stress. Elderly, debilitated, uncompensated strenuous exercise, malnourished or deficient caloric intake, adrenal or pituitary insufficiency, or alcohol intoxication increases hypoglycemia risk. Resumption of premenopausal ovulation in anovulatory patients may occur (may result in unintended pregnancy). Reevaluate if menstrual dysfunction occurs. Labor & delivery. Pregnancy (Cat.C), nursing mothers: not recommended; consider using insulin instead. |
| Interactions |
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Rosiglitazone potentiated by CYP2C8 inhibitors (eg, gemfibrozil). Rosiglitazone antagonized by CYP2C8 inducers (eg, rifampin). Metformin potentiated by cationic drugs eliminated by renal tubular secretion (eg, amiloride, cimetidine, digoxin, procainamide, quinidine, trimethoprim, ranitidine), furosemide, nifedipine. Hyperglycemia with diuretics, steroids, phenytoin, phenothiazines, nicotinic acid, sympathomimetics, calcium channel blockers, isoniazid. Excess alcohol potentiates metformin's effect on lactate. |
| Adverse Reactions |
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Lactic acidosis (rare, ½ the cases are fatal), GI upset (eg, diarrhea), upper respiratory tract infection, anemia, headache, edema, weight gain, changes in serum lipids, hypoglycemia; also women: risk of fracture. |
| How Supplied |
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Tabs—60 |
| Additional Resources |
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• Related Prescribing Note |
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