Medications
Repaglinide - Prandin - Prandimet
PRANDIMET is a combination of repaglinide, a glinide, and metformin, a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are already treated with a glinide and metformin or who have inadequate glycemic control on a glinide alone or metformin alone.
Limitation of Use:
• Not for treatment of type 1 diabetes mellitus or diabetic ketoacidosis
• Hypoglycemia and headache were the most common adverse reactions (≥10%) reported among patients treated with repaglinide in combination with metformin.
• Gastrointestinal reactions (e.g., diarrhea, nausea and vomiting) are the most common adverse reactions with metformin
• Carbonic anhydrase inhibitors may increase risk of lactic acidosis. Consider more frequent monitoring.
• Drugs that reduce metformin clearance (such as ranolazine, vandetanib, dolutegravir, and cimetidine) may increase the accumulation of metformin. Consider the benefits and risks of concomitant use.
• Alcohol can potentiate the effect of metformin on lactate metabolism. Warn patients against excessive alcohol intake.
• Clopidogrel: Avoid concomitant use; if used concomitantly limit total daily dose of repaglinide to 4 mg.
• Cyclosporine: Limit daily dose of repaglinide to 6 mg and increase frequency of glucose monitoring when co-administered.
• CYP2C8 and CYP3A4 Inhibitors and Drugs That May Increase the Risk of Hypoglycemia: Co-administration may require dose reductions and increased frequency of glucose monitoring.
• CYP2C8 and CYP3A4 Inducers and Drugs That May Decrease the Blood Glucose Lowering Effect of PRANDIMET: Co-administration may require dose increases and increased frequency of glucose monitoring.
• Drugs That May Blunt Signs and Symptoms of Hypoglycemia: Increased frequency of glucose monitoring may be required when co-administered.
• Lactic acidosis: See boxed warning.
• Hypoglycemia: PRANDIMET may cause hypoglycemia. Skip the scheduled dose if a meal is skipped to reduce the risk of hypoglycemia. Reduce the dose if hypoglycemia occurs.
• Vitamin B12 deficiency: Metformin can lower vitamin B12 levels. Monitor hematological parameters annually.
• Serious Cardiovascular Adverse Reactions with Concomitant NPH-insulin: PRANDIMET is not indicated for use with NPH-insulin.
• Macrovascular outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with PRANDIMET.
