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Levels of fasting venous plasma lactate above the upper limit of normal but less than 5 mmol/ L in patients taking AVANDAMET do not necessarily indicate impending lactic acidosis and may be explainable by other mechanisms, such as poorly controlled diabetes or obesity, vigorous physical activity or technical problems in sample handling (see also PRECAUTIONS). Lactic acidosis should be suspected in any diabetic patient with metabolic acidosis lacking evidence of ketoacidosis (ketonuria and ketonemia). Lactic acidosis is a medical emergency that must be treated in a hospital setting. In a patient with lactic acidosis who is taking AVANDAMET, the drug should be discontinued immediately and general supportive measures promptly instituted. Because metformin hydrochloride is dialyzable (with a clearance of up to 170 mL/ min under good hemodynamic conditions), prompt hemodialysis is recommended to correct the acidosis and remove the accumulated metformin. Such management often results in prompt reversal of symptoms and recovery (see also CONTRAINDICATIONS and PRECAUTIONS). Rosiglitazone maleate Cardiac Failure and Other Cardiac Effects: Text Continues Below
Rosiglitazone, like other thiazolidinediones, alone or in combination with other antidiabetic agents, can cause fluid retention, which may exacerbate or lead to heart failure. Patients should be observed for signs and symptoms of heart failure. AVANDAMET should be discontinued if any deterioration in cardiac status occurs. Patients with New York Heart Association (NYHA) Class 3 and 4 cardiac status were not studied during the clinical trials with rosiglitazone maleate. In patients requiring pharmacologic treatment for congestive heart failure, AVANDAMET should not be used (see CONTRAINDICATIONS). In combination with insulin, thiazolidinediones may increase the risk of other cardiovascular adverse events. In three 26-week trials in patients with type 2 diabetes, 216 received 4 mg of rosiglitazone plus insulin, 322 received 8 mg of rosiglitazone plus insulin, and 338 received insulin alone. Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
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