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Basic Drug Info
Drug Name:Glimepiride
Manufacturer:COREPHARMA LLC.
Other Info:

Patients Receiving Other Oral Hypoglycemic AgentsAs with other sulfonylurea hypoglycemic agents, no transition period is necessary when transferring patients to glimepiride.

Patients should be observed carefully (1-2 weeks) for hypoglycemia when being transferred from longer half-life sulfonylureas (e.g., chlorpropamide) to glimepiride due to potential overlapping of drug effect.



Clinical Trials:


Indications and Usage

INDICATIONS AND USAGEGlimepiride tablets are 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 tablets are 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 tablets 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 tablets.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 tablets 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 HbAlc and glucose was associated with a decrease in retinopathy, neuropathy, and nephropathy for insulin-dependent diabetic (IDDM) patients.
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.

hypoglycemia -- A syndrome of abnormally low BLOOD GLUCOSE level. Clinical hypoglycemia has diverse etiologies. Severe hypoglycemia eventually lead to glucose deprivation of the CENTRAL NERVOUS SYSTEM resulting in HUNGER; SWEATING; PARESTHESIA; impaired mental function; SEIZURES; COMA; and even DEATH.

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.

Retinal Diseases -- pathologic condition of the innermost of the three tunics of the eyeball or retina.

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

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

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.

Contraindications

CONTRAINDICATIONSGlimepiride tablets are contraindicated in patients with:Known hypersensitivity to the drug.Diabetic ketoacidosis, with or without coma.

This condition should be treated with insulin.
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.

Warnings

SPECIAL WARNING ON INCREASED RISK OF CARDIOVASCULAR MORTALITYThe 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 non-insulin-dependent 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 glimepiride 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.
Branded Drugs
The following US Branded drugs contain Glimepiride


AMARYL -- SANOFI AVENTIS US LLC

DUETACT -- TAKEDA GLOBAL RESEARCH DEVELOPMENT CENTER INC

AVANDARYL -- SB PHARMCO PUERTO RICO INC


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