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.