Monograph Details
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Endocrine System
> Diabetes
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AVANDIA |
| 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. |
| Generic Name |
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Rosiglitazone (as maleate) 2mg, 4mg, 8mg; tabs. |
| Indications |
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Adjunct to diet and exercise in type 2 diabetes, as monotherapy, or in combination with metformin and/or a sulfonylurea. |
| Children |
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<18yrs: not recommended. |
| Adults |
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≥18yrs: Give once daily or in two divided doses (AM & PM). Initially 4mg/day. Monotherapy or with metformin and/or sulfonylurea: may increase after 8–12 weeks; max 8mg/day. |
| Contraindications |
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Concomitant metformin in renal impairment. NYHA Class III or IV heart failure. |
| Precautions |
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Not for treating type 1 diabetes or diabetic ketoacidosis. Symptomatic HF or acute coronary syndromes: not recommended; discontinue if occurs. 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. 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. 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 or nitrates: not recommended. Potentiated by CYP2C8 inhibitors (eg, gemfibrozil). Antagonized by CYP2C8 inducers (eg, rifampin). |
| Adverse Reactions |
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Upper respiratory tract infection, injury, headache, edema, weight gain, anemia, changes in serum lipids, macular edema (possible); also women: risk of fracture. See literature re: risk of myocardial ischemic events. |
| How Supplied |
Tabs 2mg—60
4mg, 8mg—30, 90 |
| Additional Resources |
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• Related Prescribing Note |
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