March 2006aManufactured by:sanofi-aventis U.S.LLCBridgewater, NJ 08807 USAManufactured for:Prasco LaboratoriesCincinnati, OH 45249 USA
Glimepiride is indicated as an adjunct to diet and exercise to lower the blood glucose in patients with noninsulin-dependent (Type 2) diabetes mellitus (NIDDM) whose hyperglycemia cannot be controlled by diet and exercise alone.
Glimepiride may be used concomitantly with metformin when diet, exercise, and Glimepiride or metformin alone do not result in adequate glycemic control.Glimepiride is also indicated for use in combination with insulin to lower blood glucose in patients whose hyperglycemia cannot be controlled by diet and exercise in conjunction with an oral hypoglycemic agent.
Combined use of glimepiride and insulin may increase the potential for hypoglycemia.In initiating treatment for noninsulin-dependent diabetes, diet and exercise should be emphasized as the primary form of treatment.
Caloric restriction, weight loss, and exercise are essential in the obese diabetic patient.
Proper dietary management and exercise alone may be effective in controlling the blood glucose and symptoms of hyperglycemia.
In addition to regular physical activity, cardiovascular risk factors should be identified and corrective measures taken where possible.If this treatment program fails to reduce symptoms and/or blood glucose, the use of an oral sulfonylurea or insulin should be considered.
Use of Glimepiride must be viewed by both the physician and patient as a treatment in addition to diet and exercise and not as a substitute for diet and exercise or as a convenient mechanism for avoiding dietary restraint.
Furthermore, loss of blood glucose control on diet and exercise alone may be transient, thus requiring only short-term administration of Glimepiride.During maintenance programs, Glimepiride monotherapy should be discontinued if satisfactory lowering of blood glucose is no longer achieved.
Judgments should be based on regular clinical and laboratory evaluations.
Secondary failures to Glimepiride monotherapy can be treated with Glimepiride-insulin combination therapy.In considering the use of Glimepiride in asymptomatic patients, it should be recognized that blood glucose control in Type 2 diabetes has not definitely been established to be effective in preventing the long-term cardiovascular and neural complications of diabetes.However, the Diabetes Control and Complications Trial (DCCT) demonstrated that control of HbA1cand glucose was associated with a decrease in retinopathy, neuropathy, and nephropathy for insulin-dependent diabetic (IDDM) patients.
Glimepiride is contraindicated in patients withKnown hypersensitivity to the drug.Diabetic ketoacidosis, with or without coma.This condition should be treated with insulin.