MICRONASE 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 con- trolled by diet alone.

Glyburide may be used concomitantly with met- formin 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 con- trolling the blood glucose and symptoms of hyper- glycemia. The importance of regular physical activity should also be stressed, and cardiovascular risk fac- tors 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 MICRONASE 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 MICRONASE.

During maintenance programs, MICRONASE 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 MICRONASE in asymp- tomatic patients, it should be recognized that control- ling 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.

There is no fixed dosage regimen for the manage- ment of diabetes mellitus with MICRONASE 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 MICRONASE may be sufficient during periods of transient loss of control in patients usually controlled well on diet.

Usual Starting Dose

The usual starting dose of MICRONASE Tablets is 2.5 to 5 mg daily, administered with breakfast or the first main meal. Those patients who may be more sensitive to hypoglycemic drugs should be started at 1.25 mg daily. (See PRECAUTIONS section for patients at increased risk.) Failure to follow an appropriate dosage regimen may precipitate hypo- glycemia. Patients who do not adhere to their pre- scribed dietary and drug regimen are more prone to exhibit unsatisfactory response to therapy.

Transfer From Other Hypoglycemic Therapy Patients Receiving Other Oral Antidiabetic Therapy: Transfer of patients from other oral antidia- betic regimens to MICRONASE should be done conservatively and the initial daily dose should be 2.5 to 5 mg. When transferring patients from oral hypo- glycemic agents other than chlorpropamide to MICRONASE, 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 pro- voke hypoglycemia.

Patients Receiving Insulin: Some Type II diabetic patients being treated with insulin may respond satis- factorily to MICRONASE. If the insulin dose is less than 20 units daily, substitution of MICRONASE Tablets 2.5 to 5 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 MICRONASE Tablets 5 mg daily as a single dose. If the insulin dose is more than 40 units daily, a tran- sition period is required for conversion to MICRONASE. In these patients, insulin dosage is decreased by 50% and MICRONASE Tablets 5 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 1.25 to 20 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 2.5 mg at weekly intervals based upon the patient's blood glucose response.

No exact dosage relationship exists between MICRONASE and the other oral hypoglycemic agents. Although patients may be transferred from the maximum dose of other sulfonylureas, the maxi- mum starting dose of 5 mg of MICRONASE Tablets should be observed. A maintenance dose of 5 mg of MICRONASE Tablets provides approximately the same degree of blood glucose control as 250 to 375 mg chlorpropamide, 250 to 375 mg tolazamide, 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 MICRONASE Tablets 5 mg concomitantly with a 50% reduction in insulin dose. Progressive withdrawal of insulin and increase of MICRONASE in increments of 1.25 to 2.5 mg every 2 to 10 days is then carried out. During this conversion period when both insulin and MICRONASE are being used, hypo- glycemia may rarely occur. During insulin withdrawal, patients should test their urine for glucose and ace- tone at least three times daily and report results to their physician. The appearance of persistent ace- tonuria with glycosuria indicates that the patient is a Type I diabetic who requires insulin therapy.

Concomitant Glyburide and Metformin Therapy

MICRONASE 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 hypo- glycemia associated with sulfonylurea therapy contin- ues and may be increased. Appropriate precautions should be taken (see PRECAUTIONS section).

Maximum Dose

Daily doses of more than 20 mg are not recommended.

Dosage Interval

Once-a-day therapy is usually satisfactory. Some patients, particularly those receiving more than 10 mg daily, may have a more satisfactory response with twice-a-day dosage.

Specific Patient Populations

MICRONASE is not recommended for use in preg- nancy 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.)

MICRONASE Tablets are supplied as follows:

MICRONASE Tablets 1.25 mg (White, Round, Scored, imprinted MICRONASE 1.25)

Bottles of 100..............................NDC 0009-0131-01

MICRONASE Tablets 2.5 mg (Dark Pink, Round, Scored, imprinted MICRONASE 2.5)

Bottles of 100..............................NDC 0009-0141-01
Bottles of 1000............................NDC 0009-0141-03
Unit Dose Pkg of 100.................NDC 0009-0141-02

MICRONASE Tablets 5 mg (Blue, Round, Scored imprinted MICRONASE 5)

Bottles of 30..............................NDC 0009-0171-11
Bottles of 60..............................NDC 0009-0171-12
Bottles of 100............................NDC 0009-0171-05
Bottles of 500............................NDC 0009-0171-06
Bottles of 1000..........................NDC 0009-0171-07
Unit Dose Pkg of 100...............NDC 0009-0171-03

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.

Pharmacia & Upjohn Company. A subsidiary of Pharmacia Corporation, Kalamazoo, MI 49001, USA. Revised March 2002. FDA Rev date: 11/30/1999

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