Indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

PRANDIN should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.

All glinides, including PRANDIN, can cause hypoglycemia.

There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with PRANDIN.

Patients with moderate to severe impairment of liver function had higher and more prolonged serum concentrations. Therefore, PRANDIN should be used cautiously in patients with impaired liver function.

The incidence of total serious cardiovascular adverse events, including ischemia, was higher for PRANDIN than for sulfonylurea drugs in controlled comparator clinical trials.

Concomitant use with gemfibrozil is contraindicated.

Do not exceed a total daily dose of 6 mg of PRANDIN in patients receiving cyclosporine.

Avoid concomitant use of PRANDIN with clopidogrel. If concomitant use cannot be avoided, initiate PRANDIN at 0.5 mg before each meal and do not exceed a total daily dose of 4 mg.

PRANDIN is not indicated for use in combination with NPH-insulin.

PRANDIN dose reductions and increased frequency of glucose monitoring may be required when co-administered with CYP2C8 and CYP3A4 Inhibitors. Drugs that are known to inhibit CYP3A4 include antifungal agents (ketoconazole, itraconazole) and antibacterial agents (clarithromycin, erythromycin). Drugs that are known to inhibit CYP2C8 include trimethoprim, gemfibrozil, montelukast, deferasirox, and clopidogrel.

PRANDIN dose increases and increased frequency of glucose monitoring may be required when co-administered with CYP2C8 and CYP3A4 Inducers. Drugs that induce the CYP3A4 and/or 2C8 enzyme systems include rifampin, barbiturates, and carbamazepine.

PRANDIN dose reductions and increased frequency of glucose monitoring may be required when co-administered with drugs that may increase the risk of hypoglycemia such as antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, nonsteroidal anti-inflammatory agents (NSAIDs), pentoxifylline, pramlintide, propoxyphene, salicylates, somatostatin analogs (e.g., octreotide), and sulfonamide antibiotics.

PRANDIN dose increases and increased frequency of glucose monitoring may be required when co-administered with drugs that may decrease the blood glucose lowering effect of PRANDIN such as atypical antipsychotics (e.g., olanzapine and clozapine), calcium channel antagonists, corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines, progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin, sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), and thyroid hormones.

Increased frequency of glucose monitoring may be required when PRANDIN is co-administered with drugs that may blunt signs and symptoms of hypoglycemia such as beta-blockers, clonidine, guanethidine, and reserpine.

Limited available data from case reports and case series with PRANDIN use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.

There are no data on the presence of repaglinide in human milk, the effects on the breastfeeding infant, or the effects on milk production. The drug is present in animal milk. When a drug is present in animal milk, it is likely that the drug will be present in human milk. Because of the potential for hypoglycemia in breastfed infants, PRANDIN is not recommended for use when breastfeeding.

GoToSource

• Use in patients under the age of 18. GoToSource

• Type 1 diabetes or diabetic ketoacidosis. GoToSource

• Cystic fibrosis-related diabetes. GoToSource

Hypoglycemia. GoToSource 

Maculopapular rash. GoToSource 

Liver damage. GoToSource 

Upper respiratory infections. GoToSource 

Left ventricular dysfunction. GoToSource

Increased morbidity and acute ischemic events. GoToSource

Weight gain. GoToSource

No major injury lawsuits reported.