Glipizide extended-release tablets are 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.

Glipizide 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 glipizide-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 glipizide extended-release tablets 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 glipizide.

In these cases, concomitant use of glipizide with other oral blood-glucose-lowering agents can be considered.

Other approaches that can be considered include substitution of glipizide therapy with that of another oral blood-glucose-lowering agent or insulin.

Glipizide 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 glipizide 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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Hyperglycemia -- Abnormally high BLOOD GLUCOSE level.

Diabetes Mellitus, Non-Insulin-Dependent -- subclass of diabetes mellitus that is not insulin responsive or dependent; characterized initially by insulin resistance and hyperinsulinemia and eventually by glucose intolerance, hyperglycemia, and overt diabetes; type II diabetes mellitus is no longer considered a disease exclusively found in adults; patients seldom develop ketosis but often exhibit obesity.

Symptoms -- An indication that a person has a condition or disease. Some examples of symptoms are headache, fever, fatigue, nausea, vomiting, and pain.

Complication -- Any disease or disorder that occurs during the course of (or because of) another disease.

Complication Aspects -- Used with diseases to indicate conditions that co-exist or follow, i.e., co-existing diseases, complications, or sequelae.

Diabetes --

Diabetes Mellitus -- A heterogeneous group of disorders characterized by HYPERGLYCEMIA and GLUCOSE INTOLERANCE.

Diabetes Mellitus, Insulin-Dependent -- subtype of diabetes mellitus that is characterized by insulin deficiency; it is manifested by the sudden onset of severe hyperglycemia, rapid progression to diabetic ketoacidosis, and death unless treated with insulin; the disease may occur at any age, but is most common in childhood or adolescence.

Disease Progression -- The worsening of a disease over time. This concept is most often used for chronic and incurable diseases where the stage of the disease is an important determinant of therapy and prognosis.

Diabetic Retinopathy -- Disease of the RETINA as a complication of DIABETES MELLITUS. It is characterized by the progressive microvascular complications, such as ANEURYSM, interretinal EDEMA, and intraocular PATHOLOGIC NEOVASCULARIZATION.

Kidney Diseases -- Pathological processes of the KIDNEY or its component tissues.

Neuropathy -- A disorder affecting the cranial nerves or the peripheral nervous system. It is manifested with pain, tingling, numbness, and muscle weakness. It may be the result of physical injury, toxic substances, viral diseases, diabetes, renal failure, cancer, and drugs. -- 2004

Glipizide extended-release tablets are contraindicated in patients with:Known hypersensitivity to the drug.Diabetic ketoacidosis, with or without coma.

This condition should be treated with insulin.

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Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Diabetic Ketoacidosis -- A life-threatening complication of diabetes mellitus, primarily of TYPE 1 DIABETES MELLITUS with severe INSULIN deficiency and extreme HYPERGLYCEMIA. It is characterized by excessive LIPOLYSIS, oxidation of FATTY ACIDS, production of KETONE BODIES, a sweet smell to the breath (KETOSIS;) DEHYDRATION; and depressed consciousness leading to COMA.

comatose -- A profound state of unconsciousness associated with depressed cerebral activity from which the individual cannot be aroused. Coma generally occurs when there is dysfunction or injury involving both cerebral hemispheres or the brain stem RETICULAR FORMATION.

SPECIAL WARNING ON INCREASED RISK OF CARDIOVASCULAR MORTALITY: The administration of oral hypoglycemic drugs has been reported to be associated with increased cardiovascular mortality as compared to treatment with diet alone or diet plus insulin.

This warning is based on the study conducted by the University Group Diabetes Program (UGDP), a long-term prospective clinical trial designed to evaluate the effectiveness of glucose-lowering drugs in preventing or delaying vascular complications in patients with type 2 diabetes.

The study involved 823 patients who were randomly assigned to one of four treatment groups (Diabetes, 19, SUPP.

2: 747-830, 1970).UGDP reported that patients treated for 5 to 8 years with diet plus a fixed dose of tolbutamide (1.5 grams per day) had a rate of cardiovascular mortality approximately 2 1/2 times that of patients treated with diet alone.

A significant increase in total mortality was not observed, but the use of tolbutamide was discontinued based on the increase in cardiovascular mortality, thus limiting the opportunity for the study to show an increase in overall mortality.

Despite controversy regarding the interpretation of these results, the findings of the UGDP study provide an adequate basis for this warning.

The patient should be informed of the potential risks and advantages of glipizide and of alternative modes of therapy.Although only one drug in the sulfonylurea class (tolbutamide) was included in this study, it is prudent from a safety standpoint to consider that this warning may also apply to other oral hypoglycemic drugs in this class, in view of their close similarities in mode of action and chemical structure.As with any other non-deformable material, caution should be used when administering glipizide extended-release tablets in patients with pre-existing severe gastrointestinal narrowing (pathologic or iatrogenic).

There have been rare reports of obstructive symptoms in patients with known strictures in association with the ingestion of another drug in this non-deformable sustained release formulation.

The following US Branded drugs contain Glipizide

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GLUCOTROL XL -- PFIZER INC

GLUCOTROL -- PFIZER INC

GLIPIZIDE AND METFORMIN HYDROCHLORIDE -- CARACO PHARMACEUTICAL LABORATORIES LTD

GLIPIZIDE AND METFORMIN HYDROCHLORIDE -- COREPHARMA LLC

GLIPIZIDE AND METFORMIN HYDROCHLORIDE -- MYLAN PHARMACEUTICALS INC

GLIPIZIDE AND METFORMIN HYDROCHLORIDE -- TEVA PHARMACEUTICALS USA

METAGLIP -- BRISTOL MYERS SQUIBB CO