PRECOSE®, as monotherapy, is indicated as an adjunct to diet to lower blood glucose in patients with type 2 diabetes mellitus whose hyperglycemia cannot be managed on diet alone.

PRECOSE® may also be used in combination with a sulfonylurea when diet plus either PRECOSE® or a sulfonylurea do not result in adequate glycemic control.

Also, PRECOSE® may be used in combination with insulin or metformin.

The effect of PRECOSE® to enhance glycemic control is additive to that of sulfonylureas, insulin, or metformin when used in combination, presumably because its mechanism of action is different.In initiating treatment for type 2 diabetes mellitus, 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 when appropriate should also be stressed.

If this treatment program fails to result in adequate glycemic control, the use of PRECOSE® should be considered.

The use of PRECOSE® 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.

---

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.

Hyperglycemia -- Abnormally high BLOOD GLUCOSE level.

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

PRECOSE® is contraindicated in patients with known hypersensitivity to the drug and in patients with diabetic ketoacidosis or cirrhosis.

PRECOSE® is also contraindicated in patients with inflammatory bowel disease, colonic ulceration, partial intestinal obstruction or in patients predisposed to intestinal obstruction.

In addition, PRECOSE® is contraindicated in patients who have chronic intestinal diseases associated with marked disorders of digestion or absorption and in patients who have conditions that may deteriorate as a result of increased gas formation in the intestine.

---

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.

Cirrhosis --

Liver Cirrhosis -- Liver disease in which the normal microcirculation, the gross vascular anatomy, and the hepatic architecture have been variably destroyed and altered with fibrous septa surrounding regenerated or regenerating parenchymal nodules.

Inflammatory Bowel Diseases -- Chronic, non-specific inflammation of the GASTROINTESTINAL TRACT. Etiology may be genetic or environmental. This term includes CROHN DISEASE and ULCERATIVE COLITIS.

Ulcer -- A lesion on the surface of the skin or a mucous surface, produced by the sloughing of inflammatory necrotic tissue.

Unspecified disorder of intestine -- Pathological processes in any segment of the INTESTINE from DUODENUM to RECTUM.

Chronic disease -- Diseases which have one or more of the following characteristics: they are permanent, leave residual disability, are caused by nonreversible pathological alteration, require special training of the patient for rehabilitation, or may be expected to require a long period of supervision, observation, or care. (Dictionary of Health Services Management, 2d ed)

Disease -- A definite pathologic process with a characteristic set of signs and symptoms. It may affect the whole body or any of its parts, and its etiology, pathology, and prognosis may be known or unknown.