Generic Name and Formulations:
Rosiglitazone (as maleate) 2mg, 4mg, 8mg; tabs.
Indications for AVANDIA:
Adjunct to diet and exercise in type 2 diabetes, as monotherapy, or in combination with metformin and/or a sulfonylurea. Limitations of use: not for treating type 1 diabetes or diabetic ketoacidosis. Not for use with insulin.
≥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.
<18yrs: not recommended.
Concomitant metformin in renal impairment. NYHA Class III or IV heart failure.
Symptomatic HF or acute coronary syndromes: not recommended. CHF: NYHA Class I or II: increased risk of cardiovascular events (monitor); discontinue or reduce dose if develops. Edema. Monitor for signs/symptoms of heart failure. 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. Monitor fasting blood glucose and HbA1c levels periodically. Not for use in patients with history of troglitazone-associated jaundice. Perform regular eye exams. 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.
Concomitant insulin or nitrates: not recommended. Potentiated by other CYP2C8 inhibitors (eg, gemfibrozil). Antagonized by CYP2C8 inducers (eg, rifampin). Increased risk of hypoglycemia with concomitant other hypoglycemics; may need to reduce dose.
Upper respiratory tract infection, injury, headache, edema, weight gain, anemia, changes in serum lipids, macular edema (possible); also women: risk of fracture. See full labeling re: risk of myocardial ischemic events.
Tabs 2mg—60; 4mg, 8mg—30
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