"The U.S. Food and Drug Administration today approved three new related products for use with diet and exercise to improve blood sugar control in adults with type 2 diabetes: Nesina (alogliptin) tablets, Kazano (alogliptin and metformin hydrochlor"...
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Details with Side Effects
Rosiglitazone: Limited data are available with regard to overdosage in humans. In clinical trials 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: Hypoglycemia has not been seen with ingestion of up to 85 grams of metformin, although lactic acidosis has occurred in such circumstances [see WARNINGS AND PRECAUTIONS]. 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.
- Initiation in patients with established New York Heart Association (NYHA) Class III or IV heart failure [see BOXED WARNING].
- Use in patients with 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].
- Use in patients with acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.
- Use 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. AVANDAMET should be temporarily discontinued in these patients. [See WARNINGS AND PRECAUTIONS]
- Use in patients with a history of a hypersensitivity reaction to rosiglitazone or any of the product's ingredients.
Last reviewed on RxList: 5/28/2014
This monograph has been modified to include the generic and brand name in many instances.
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