GLUCOTROL XL is 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. GLUCOTROL XL 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 A_1C of 1.7% in absolute units between placebo-treated and GLUCOTROL XL-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 GLUCOTROL XL 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 GLUCOTROL XL. In these cases, concomitant use of GLUCOTROL XL with other oral blood-glucose-lowering agents can be considered. Other approaches that can be considered include substitution of GLUCOTROL XL therapy with that of another oral blood-glucose-lowering agent or insulin. GLUCOTROL XL 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 GLUCOTROL XL 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.

There is no fixed dosage regimen for the management of diabetes mellitus with GLUCOTROL XL Extended Release Tablet or any other hypoglycemic agent. Glycemic control should be monitored with hemoglobin A_1C and/or blood-glucose levels to determine the minimum effective dose for the patient; to detect primary failure, i.e., inadequate lowering of blood glucose at the maximum recommended dose of medication; and to detect secondary failure, i.e., loss of an adequate blood-glucose-lowering response after an initial period of effectiveness. Home blood-glucose monitoring may also provide useful information to the patient and physician. Short-term administration of GLUCOTROL XL Extended Release Tablet may be sufficient during periods of transient loss of control in patients usually controlled on diet.

In general, GLUCOTROL XL should be given with breakfast.

Recommended Dosing: The usual starting dose of GLUCOTROL XL as initial therapy is 5 mg per day, given with breakfast. Those patients who may be more sensitive to hypoglycemic drugs may be started at a lower dose.

Dosage adjustment should be based on laboratory measures of glycemic control. While fasting blood-glucose levels generally reach steady-state following initiation or change in GLUCOTROL XL dosage, a single fasting glucose determination may not accurately reflect the response to therapy. In most cases, hemoglobin A_1C level measured at three month intervals is the preferred means of monitoring response to therapy.

Hemoglobin A_1C should be measured as GLUCOTROL XL therapy is initiated and repeated approximately three months later. If the result of this test suggests that glycemic control over the preceding three months was inadequate, the GLUCOTROL XL dose may be increased. Subsequent dosage adjustments should be made on the basis of hemoglobin A_1C levels measured at three month intervals. If no improvement is seen after three months of therapy with a higher dose, the previous dose should be resumed. Decisions which utilize fasting blood glucose to adjust GLUCOTROL XL therapy should be based on at least two or more similar, consecutive values obtained seven days or more after the previous dose adjustment.

Most patients will be controlled with 5 mg to 10 mg taken once daily. However, some patients may require up to the maximum recommended daily dose of 20 mg. While the glycemic control of selected patients may improve with doses which exceed 10 mg, clinical studies conducted to date have not demonstrated an additional group average reduction of hemoglobin A_1C beyond what was achieved with the 10 mg dose.

Based on the results of a randomized crossover study, patients receiving immediate release glipizide may be switched safely to GLUCOTROL XL Extended Release Tablets once-a-day at the nearest equivalent total daily dose. Patients receiving immediate release Glucotrol also may be titrated to the appropriate dose of GLUCOTROL XL starting with 5 mg once daily. The decision to switch to the nearest equivalent dose or to titrate should be based on clinical judgment.

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).

Combination Use

When adding other blood-glucose-lowering agents to GLUCOTROL XL for combination therapy, the agent should be initiated at the lowest recommended dose, and patients should be observed carefully for hypoglycemia. Refer to the product information supplied with the oral agent for additional information.

When adding GLUCOTROL XL to other blood-glucose-lowering agents, GLUCOTROL XL can be initiated at 5 mg. Those patients who may be more sensitive to hypoglycemic drugs may be started at a lower dose. Titration should be based on clinical judgment.

Patients Receiving Insulin: As with other sulfonylurea-class hypoglycemics, many patients with stable type 2 diabetes receiving insulin may be transferred safely to treatment with GLUCOTROL XL Extended Release Tablets. When transferring patients from insulin to GLUCOTROL XL, the following general guidelines should be considered:

For patients whose daily insulin requirement is 20 units or less, insulin may be discontinued and GLUCOTROL XL therapy may begin at usual dosages. Several days should elapse between titration steps.

For patients whose daily insulin requirement is greater than 20 units, the insulin dose should be reduced by 50% and GLUCOTROL XL therapy may begin at usual dosages. Subsequent reductions in insulin dosage should depend on individual patient response. Several days should elapse between titration steps.

During the insulin withdrawal period, the patient should test urine samples for sugar and ketone bodies at least three times daily. Patients should be instructed to contact the prescriber immediately if these tests are abnormal. In some cases, especially when the patient has been receiving greater than 40 units of insulin daily, it may be advisable to consider hospitalization during the transition period.

Patients Receiving Other Oral Hypoglycemic Agents: As with other sulfonylurea-class hypoglycemics, no transition period is necessary when transferring patients to GLUCOTROL XL Extended Release Tablets. Patients should be observed carefully (1-2 weeks) for hypoglycemia when being transferred from longer half-life sulfonylureas (e.g., chlorpropamide) to GLUCOTROL XL due to potential overlapping of drug effect.

GLUCOTROL XL (glipizide) Extended Release Tablets are supplied as 2.5 mg, 5 mg, and 10 mg round, biconvex tablets and imprinted with black ink as follows:

2.5 mg tablets are blue and imprinted with “GLUCOTROL XL 2.5” on one side.

Bottles of 30: NDC 0049-1620-30

5 mg tablets are white and imprinted with “GLUCOTROL XL 5” on one side.

Bottles of 100: NDC 0049-1550-66
Bottles of 500: NDC 0049-1550-73

10 mg tablets are white and imprinted with “GLUCOTROL XL 10” on one side.

Bottles of 100: NDC 0049-1560-66
Bottles of 500: NDC 0049-1560-73

Recommended Storage: The tablets should be protected from moisture and humidity and stored at controlled room temperature, 59° to 86° F (15° to 30° C).

Revised September 2006. Distributed by: Roerig, Division of Pfizer Inc., NY, NY 10017. FDA rev date: 9/17/2003

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