Fixed-dose antidiabetic combination

PrandiMet stimulates release of insulin, improves insulin sensitivity, and decreases gluconeogenesis
PrandiMet stimulates release of insulin, improves insulin sensitivity, and decreases gluconeogenesis

Product: PrandiMet 1 mg/500 mg

Company: Novo Nordisk and Sciele

Pharmacologic class:Antidiabetic agent (meglitinide analog + biguanide)

Active ingredient: Repaglinide 1 mg, metformin 500 mg; tabs.

ALSO: PrandiMet 2 mg/500 mg

Active ingredient: Repaglinide 2 mg, metformin 500 mg; tabs.

Indication: Adjunct to diet and exercise in type 2 diabetes.

Pharmacology: PrandiMet is an oral antidiabetic agent that combines two drugs with different mechanisms of action to improve glycemic control in patients with type 2 diabetes. Repaglinide lowers blood glucose by stimulating the release of insulin from the pancreas. This action is dependent upon functioning beta cells in the pancreatic islets. Metformin is an antihyperglycemic agent that lowers basal and postprandial blood glucose levels. It decreases hepatic glucose production, decreases the intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.

Adults: Take within 30 minutes before food; give in two to three divided doses; individualize. Previously on metformin alone: initially one 1 mg/500 mg tab twice daily. Previously on repaglinide alone: initially add metformin component 500 mg twice daily. Previously on both components: switch to similar doses of PrandiMet then titrate. Max 4 mg/1,000 mg per meal, or 10 mg/2,500 mg per day. Withhold drug if meal is skipped.

Children: Not recommended.

Contraindications: Renal impairment. Metabolic acidosis. Diabetic ketoacidosis. Concomitant both gemfibrozil and itraconazole.

Precautions: Not for treating type 1 diabetes. Avoid in hepatic disease. Congestive heart failure, renal or hepatic dysfunction, sepsis, dehydration, excessive alcohol intake: increased risk of lactic acidosis. Confirm normal renal function before starting and monitor (especially in patients age 80 years and older). Monitor blood glucose, hepatic function, hematology (especially serum vitamin B12 levels). Discontinue if lactic acidosis, shock, acute MI, sepsis, or hypoxemia occurs. Suspend therapy if dehydration occurs and before surgery. Stress. Uncompensated strenuous exercise, malnourished or caloric deficiency, adrenal or pituitary insufficiency, or acute alcohol intoxication: increased risk of hypoglycemia. Elderly. Debilitated. Pregnancy (Cat. C), nursing mothers: not recommended.

Interactions: See Contraindications. Not for use with NPH insulin. Suspend therapy during and for 48 hours after the use of intravascular iodinated radiocontrast agents. Repaglinide potentiated by gemfibrozil and itraconazole. Metformin may be potentiated by cationic drugs eliminated by renal tubular secretion (e.g., amiloride, digoxin, morphine, procainamide, quinidine, trimethoprim, ranitidine, vancomycin), furosemide, nifedipine. Repaglinide may be potentiated by CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin). Repaglinide may be antagonized by CYP3A4 inducers (e.g., rifampin). Avoid excessive alcohol. Diuretics, steroids, phenothiazines, phenytoin, sympathomimetics, calcium channel blockers, isoniazid, niacin, others may cause hyperglycemia. Increased risk of hypoglycemia with alcohol, sulfonylureas, insulin. Beta-blockers may mask hypoglycemia.

Adverse reactions: Hypoglycemia, headache, GI upset; lactic acidosis (rare, half the cases are fatal).

How supplied: Tabs—20, 100

For more information, call 800.727.6500 or visit www.PrandiMet.com.

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