GLUCOTROL XL SUMMARY
GLUCOTROL XL®
(glipizide)
Extended Release Tablets
For Oral Use
Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class.
GLUCOTROL XL is indicated as an adjunct to diet for the control of hyperglycemia and its associated symptomatology in patients with type 2 diabetes formerly known as non-insulin-dependent diabetes mellitus (NIDDM) or maturity-onset diabetes, after an adequate trial of dietary therapy has proved unsatisfactory. GLUCOTROL XL is indicated when diet alone has been unsuccessful in correcting hyperglycemia, but even after the introduction of the drug in the patient's regimen, dietary measures should continue to be considered as important. In 12 week, well-controlled studies there was a maximal average net reduction in hemoglobin A1C of 1.7% in absolute units between placebo-treated and GLUCOTROL XL-treated patients.
In initiating treatment for type 2 diabetes, diet should be emphasized as the primary form of treatment. Caloric restriction and weight loss are essential in the obese diabetic patient. Proper dietary management alone may be effective in controlling blood glucose and symptoms of hyperglycemia. The importance of regular physical activity should also be stressed, 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 should be considered. If additional reduction of symptoms and/or blood glucose is required, the addition of insulin to the treatment regimen should be considered. Use of GLUCOTROL XL must be viewed by both the physician and patient as a treatment in addition to diet, and not as a substitute for diet or as a convenient mechanism for avoiding dietary restraint. Furthermore, loss of blood-glucose control on diet alone also may be transient, thus requiring only short-term administration of glipizide.
Some patients fail to respond initially or gradually lose their responsiveness to sulfonylurea drugs, including GLUCOTROL XL. In these cases, concomitant use of GLUCOTROL XL with other oral blood-glucose-lowering agents can be considered. Other approaches that can be considered include substitution of GLUCOTROL XL therapy with that of another oral blood-glucose-lowering agent or insulin. GLUCOTROL XL should be discontinued if it no longer contributes to glucose lowering. Judgment of response to therapy should be based on regular clinical and laboratory evaluations.
In considering the use of GLUCOTROL XL in asymptomatic patients, it should be recognized that controlling blood glucose in type 2 diabetes has not been definitely established to be effective in preventing the long-term cardiovascular or neural complications of diabetes. However, in insulin-dependent diabetes mellitus controlling blood glucose has been effective in slowing the progression of diabetic retinopathy, nephropathy, and neuropathy.
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