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Overdosage & Contraindications
CONTRAINDICATIONS
AVANDAMET tablets are contraindicated in patients with: 1. Renal disease or renal dysfunction (e. g., as suggested by serum creatinine levels 1.5 mg/ dL [males], 1.4 mg/ dL [females], or abnormal creatinine clearance), which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and
septicemia (see WARNINGS and PRECAUTIONS). Text Continues Below
2. Congestive heart failure requiring pharmacologic treatment. 3. Known hypersensitivity to rosiglitazone maleate or metformin hydrochloride. 4. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin. AVANDAMET should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of renal function (see also PRECAUTIONS). OVERDOSAGE Rosiglitazone maleate Limited data are available with regard to overdosage in humans. In clinical studies in volunteers, rosiglitazone has been administered at single oral doses of up to 20 mg and was well tolerated. In the event of an overdose, appropriate supportive treatment should be initiated as dictated by the patient's clinical status. Metformin hydrochloride Hypoglycemia has not been seen with ingestion of up to 85 grams of metformin hydrochloride, although lactic acidosis has occurred in such circumstances (see WARNINGS). Metformin is dialyzable with a clearance of up to 170 mL/ min under good hemodynamic conditions. Therefore, hemodialysis may be useful for removal of accumulated metformin from patients in whom metformin overdosage is suspected.
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