Generic Name and Formulations:
Repaglinide, metformin HCl; 1mg/500mg, 2mg/500mg; tabs.

Company:
Novo Nordisk
ndications for PRANDIMET:
Adjunct to diet and exercise in type 2 diabetes patients already treated with a meglitinide and metformin or who have inadequate glycemic control on a meglitinide alone or metformin alone.

Adult:
Take within 30mins before food; give in 2–3 divided doses; individualize. Previously on metformin alone: initially one 1mg/500mg tab twice daily. Previously on repaglinide alone: initially add metformin component 500mg twice daily. Previously on both components: switch to similar doses of PrandiMet then titrate. Max 4mg/1000mg per meal, or 10mg/2500mg per day. Withhold drug if meal is skipped.

Children:
Not recommended.

Pharmacological Class:
Meglitinide analogue + biguanide.

Contraindications:
Renal impairment. Metabolic acidosis. Diabetic ketoacidosis. Concomitant gemfibrozil.

Warnings/Precautions:
Not for treating type 1 diabetes. Avoid in hepatic disease. CHF, renal or hepatic dysfunction, sepsis, dehydration, excessive alcohol intake: increased risk of lactic acidosis. Confirm normal renal function before starting and monitor (esp. in patients ≥80years). Monitor blood glucose, hepatic function, hematology (esp. serum Vit. 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 concomitant gemfibrozil and itraconazole. Metformin may be potentiated by cationic drugs eliminated by renal tubular secretion (eg, amiloride, digoxin, morphine, procainamide, quinine, triamterene, quinidine, trimethoprim, ranitidine, vancomycin), furosemide, nifedipine. Repaglinide may be potentiated by CYP2C8/3A4 inhibitors (eg, trimethoprim, ketoconazole, clarithromycin, deferasirox), OATP1B1 inhibitors (eg, cyclosporine); may need to reduce PrandiMet dose. Repaglinide may be antagonized by CYP2C8/3A4 inducers (eg, rifampin). Avoid excessive alcohol. Increased risk of hypoglycemia with alcohol, sulfonylureas, insulin. β-blockers may mask hypoglycemia.

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

How Supplied:
Tabs—20, 100