Composition

Each tablet contains:
Repaglinide ............................... 0.5 mg, 1 mg, or 2 mg

Therapeutic Indications

Oral antidiabetic agent in patients with type 2 diabetes mellitus, as an adjunct to diet and exercise where hyperglycemia cannot be controlled satisfactorily by diet and exercise alone.
In combination therapy with metformin to lower blood glucose in patients whose hyperglycemia cannot be controlled by exercise, diet and either agent alone.

Dosage and Administration

REPAGLINIDE Tablets are taken immediately to 30 minutes before each meal.
Starting dose is 0.5 mg, for patients not previously treated or whose glycosylated hemoglobin is below 8%; or
1-2 mg for patients previously treated with glucose-lowering drugs and whose glycosylated hemoglobin is 8% or more.
The dose may be adjusted, at intervals of 1-2 weeks, up to a maximum of 4 mg before meals.
Recommended dosage range is 0.5 mg to 4 mg taken with meals.
REPAGLINIDE may be dosed preprandially 2, 3, or 4 times a day, depending on patient’s meal pattern.
The maximum recommended daily dose is 16 mg.

Contraindications

Hypersensitivity to the product.
Patients with type 1 diabetes mellitus.
Diabetic ketoacidosis, with or without coma.

Warnings and Precautions

All oral blood glucose-lowering medications may cause hypoglycemia.
REPAGLINIDE should be taken with caution in:
Patients with hepatic insufficiency in whom reduced metabolism could increase blood REPAGLINIDE levels and cause hypoglycemia.
Elderly, debilitated or malnourished patients, because they are more susceptible to hypoglycemia.
Patients with renal function impairment or renal failure requiring hemodialysis.
Patients with adrenal or pituitary insufficiency.
Patients should be instructed to skip a dose if they skip a meal and to add a dose if they add an extra meal.
Because of the potential for hypoglycemia, the ability to drive or operate machinery may be impaired.

Drug Interactions

REPAGLINIDE metabolism may be inhibited by cytochrome P-450 enzyme system 3A4 inhibitors such as: Ketoconazole, miconazole, erythromycin, and clarithromycin. Monitor blood glucose and adjust Repaglinide® dose as needed.
Drugs that indue the cytochrome P-450 enzyme system 3A4 such as troglitazone, rifampin, barbiturates, and carbamazepine, may increase REPAGLINIDE metabolism. Monitor blood glucose and adjust REPAGLINIDE dose as needed.
The action of REPAGLINIDE may be potentiated by certain drugs including beta-blockers, chloramphenicol, coumarins, MAO inhibitors, NSAIDs, salicylates, probenecid, and sulfonamides. Observe for hypoglycemia and loss of glycemic control.
Certain drugs tend to produce hyperglycemia and may lead to loss of glycemic control, such as calcium channel blockers, corticosteroids, estrogens, isoniazid, nicotinic acid, oral contraceptives, phenothiazines, phenytoin, sympathomimetics, thiazides and other diuretics, and thyroid products.
Monitor glucose level.
The use of REPAGLINIDE with gemfibrozil causes reduction in REPAGLINIDE clearance, and severe hypoglycemia; the combination is contraindicated.

Pregnancy and Lactation

REPAGLINIDE is contraindicated in pregnancy and lactation.