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Micronized Glyburide (Glyburide) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Micronized glyburide tablets are indicated as an adjunct to diet to lower the blood glucose in patients with non-insulin-dependent diabetes mellitus (Type II) whose hyperglycemia cannot be satisfactorily controlled by diet alone.

Glyburide may be used concomitantly with metformin when diet and glyburide or diet and metformin alone do not result in adequate glycemic control (see metformin insert).

In initiating treatment for non-insulin-dependent 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 the blood glucose and symptoms of hyperglycemia. The importance of regular physical activity should also be stressed, and 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 micronized glyburide must be viewed by both the physician and patient as a treatment in addition to diet and not as a substitution or as a convenient mechanism for avoiding dietary restraint. Furthermore, loss of blood glucose control on diet alone may be transient, thus requiring only short-term administration of micronized glyburide.

During maintenance programs, micronized glyburide should be discontinued if satisfactory lowering of blood glucose is no longer achieved. Judgment should be based on regular clinical and laboratory evaluations.

In considering the use of micronized glyburide in asymptomatic patients, it should be recognized that controlling blood glucose in non-insulin-dependent diabetes has not been definitely established to be effective in preventing the long-term cardiovascular or neural complications of diabetes.

DOSAGE AND ADMINISTRATION

Patients should be retitrated when transferred from glyburide or other oral hypoglycemic agents.

There is no fixed dosage regimen for the management of diabetes mellitus with micronized glyburide tablets or any other hypoglycemic agent. In addition to the usual monitoring of urinary glucose, the patient's blood glucose must also be monitored periodically to determine the minimum effective dose for the patient; to detect primary failure, ie, inadequate lowering of blood glucose at the maximum recommended dose of medication; and to detect secondary failure, ie, loss of adequate blood glucose lowering response after an initial period of effectiveness. Glycosylated hemoglobin levels may also be of value in monitoring the patient's response to therapy.

Short-term administration of micronized glyburide may be sufficient during periods of transient loss of control in patients usually controlled well on diet.

Usual Starting Dose

The suggested starting dose of micronized glyburide is 1.5 to 3 mg daily, administered with breakfast or the first main meal. Those patients who may be more sensitive to hypoglycemic drugs should be started at 0.75 mg daily. (See PRECAUTIONS Section for patients at increased risk.) Failure to follow an appropriate dosage regimen may precipitate hypoglycemia. Patients who do not adhere to their prescribed dietary and drug regimen are more prone to exhibit unsatisfactory response to therapy.

Transfer From Other Hypoglycemic Therapy; Patients Receiving Other Oral Antidiabetic Therapy

Patients should be retitrated when transferred from glyburide or other oral hypoglycemic agents. The initial daily dose should be 1.5 to 3 mg. When transferring patients from oral hypoglycemic agents other than chlorpropamide to micronized glyburide, no transition period and no initial or priming dose are necessary. When transferring patients from chlorpropamide, particular care should be exercised during the first two weeks because the prolonged retention of chlorpropamide in the body and subsequent overlapping drug effects may provoke hypoglycemia.

Patients Receiving Insulin

Some Type II diabetic patients being treated with insulin may respond satisfactorily to micronized glyburide. If the insulin dose is less than 20 units daily, substitution of micronized glyburide 1.5 to 3 mg as a single daily dose may be tried. If the insulin dose is between 20 and 40 units daily, the patient may be placed directly on micronized glyburide 3 mg daily as a single dose. If the insulin dose is more than 40 units daily, a transition period is required for conversion to micronized glyburide. In these patients, insulin dosage is decreased by 50% and micronized glyburide tablets 3 mg daily is started. Please refer to Titration to Maintenance Dose for further explanation.

Titration to Maintenance Dose

The usual maintenance dose is in the range of 0.75 to 12 mg daily, which may be given as a single dose or in divided doses (see Dosage Interval Section). Dosage increases should be made in increments of no more than 1.5 mg at weekly intervals based upon the patient's blood glucose response.

No exact dosage relationship exists between micronized glyburide and the other oral hypoglycemic agents, including glyburide. Although patients may be transferred from the maximum dose of other sulfonylureas, the maximum star ting dose of 3 mg of micronized glyburide tablets should be observed. A maintenance dose of 3 mg of micronized glyburide tablets provides approximately the same degree of blood glucose control as 250 to 375 mg chlorpropamide, 250 to 375 mg tolazamide, 5 mg of glyburide (nonmicronized tablets), 500 to 750 mg acetohexamide, or 1000 to 1500 mg tolbutamide.

When transferring patients receiving more than 40 units of insulin daily, they may be started on a daily dose of micronized glyburide tablets 3 mg concomitantly with a 50% reduction in insulin dose. Progressive withdrawal of insulin and increase of micronized glyburide in increments of 0.75 to 1.5 mg every 2 to 10 days is then carried out. During this conversion period when both insulin and micronized glyburide are being used, hypoglycemia may rarely occur. During insulin withdrawal, patients should test their urine for glucose and acetone at least three times daily and report results to their physician. The appearance of persistent acetonuria with glycosuria indicates that the patient is a Type I diabetic who requires insulin therapy.

Concomitant Glyburide and Metformin Therapy

Micronized glyburide tablets should be added gradually to the dosing regimen of patients who have not responded to the maximum dose of metformin monotherapy after four weeks (see Usual Starting Dose and Titration to Maintenance Dose). Refer to metformin package insert.

With concomitant glyburide and metformin therapy, the desired control of blood glucose may be obtained by adjusting the dose of each drug. However, attempts should be made to identify the optimal dose of each drug needed to achieve this goal. With concomitant glyburide and metformin therapy, the risk of hypoglycemia associated with sulfonylurea therapy continues and may be increased. Appropriate precautions should be taken (see PRECAUTIONS Section).

Maximum Dose

Daily doses of more than 12 mg are not recommended.

Dosage Interval

Once-a-day therapy is usually satisfactory. Some patients, particularly those receiving more than 6 mg daily, may have a more satisfactory response with twice-a-day dosage.

Specific Patient Populations

Micronized glyburide tablets are not recommended for use in pregnancy or for use in pediatric patients.

In elderly patients, debilitated or malnourished patients, and patients with impaired renal or hepatic function, the initial and maintenance dosing should be conservative to avoid hypoglycemic reactions. (See PRECAUTIONS Section.)

HOW SUPPLIED

Micronized glyburide tablets are supplied as follows:

1.5 mg (white, ovoid, imprinted G3781, contour, scored)

Plastic Bottles of 100NDC 59762-3781-1

3 mg (blue, ovoid, imprinted G3782, contour, scored)

Plastic Bottles of 100NDC 59762-3782-1
Plastic Bottles of 1000NDC 59762-3782-3

6 mg (yellow, ovoid, imprinted G3783, contour, scored)

Plastic Bottles of 100NDC 59762-3783-1
Plastic Bottles of 500NDC 59762-3783-2
Plastic Bottles of 1000 NDC 59762-3783-3

Rx Only

Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Dispensed in well closed containers with safety closures. Keep container tightly closed.

LAB-0111-2.0

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