Glucotrol Xl
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Questions & Answers
Side Effects & Adverse Reactions
The 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 type 2 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 2½ 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 glipizide 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.
As with any other non-deformable material, caution should be used when administering GLUCOTROL XL Extended Release Tablets in patients with preexisting severe gastrointestinal narrowing (pathologic or iatrogenic). There have been rare reports of obstructive symptoms in patients with known strictures in association with the ingestion of another drug in this non-deformable sustained release formulation.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
GLUCOTROL XL is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
History
There is currently no drug history available for this drug.
Other Information
Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class.
The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-methylpyrazinecarboxamido)ethyl] phenyl]sulfonyl]urea. The molecular formula is C21H27N5O4S; the molecular weight is 445.55; the structural formula is shown below:
Glipizide is a whitish, odorless powder with a pKa of 5.9. It is insoluble in water and alcohols, but soluble in 0.1 N NaOH; it is freely soluble in dimethylformamide. GLUCOTROL XL® is a registered trademark for glipizide GITS. Glipizide GITS (Gastrointestinal Therapeutic System) is formulated as a once-a-day controlled release tablet for oral use and is designed to deliver 2.5, 5, or 10 mg of glipizide.
Inert ingredients in the 2.5 mg, 5 mg and 10 mg formulations are: polyethylene oxide, hypromellose, magnesium stearate, sodium chloride, red ferric oxide, cellulose acetate, polyethylene glycol, Opadry® blue (OY-LS-20921)(2.5 mg tablets), Opadry® white (YS-2-7063)(5 mg and 10 mg tablet) and black ink (S-1-8106).
GLUCOTROL XL Extended Release Tablet is similar in appearance to a conventional tablet. It consists, however, of an osmotically active drug core surrounded by a semipermeable membrane. The core itself is divided into two layers: an "active" layer containing the drug, and a "push" layer containing pharmacologically inert (but osmotically active) components. The membrane surrounding the tablet is permeable to water but not to drug or osmotic excipients. As water from the gastrointestinal tract enters the tablet, pressure increases in the osmotic layer and "pushes" against the drug layer, resulting in the release of drug through a small, laser-drilled orifice in the membrane on the drug side of the tablet.
The GLUCOTROL XL Extended Release Tablet is designed to provide a controlled rate of delivery of glipizide into the gastrointestinal lumen which is independent of pH or gastrointestinal motility. The function of the GLUCOTROL XL Extended Release Tablet depends upon the existence of an osmotic gradient between the contents of the bi-layer core and fluid in the GI tract. Drug delivery is essentially constant as long as the osmotic gradient remains constant, and then gradually falls to zero. The biologically inert components of the tablet remain intact during GI transit and are eliminated in the feces as an insoluble shell.
Sources
Glucotrol Xl Manufacturers
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Physicians Total Care, Inc.
![Glucotrol Xl (Glipizide) Tablet, Extended Release [Physicians Total Care, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Glucotrol Xl | Physicians Total Care, Inc.
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 A1C 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 DosingThe 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 A1C level measured at three month intervals is the preferred means of monitoring response to therapy.
Hemoglobin A1C 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 A1C 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 A1C 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 UseWhen 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 InsulinAs 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 AgentsAs 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.
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Roerig
Glucotrol Xl | Roerig
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 A1C 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 DosingThe 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 A1C level measured at three month intervals is the preferred means of monitoring response to therapy.
Hemoglobin A1C 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 A1C 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 A1C 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 UseWhen 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.
When colesevelam is coadministered with glipizide ER, maximum plasma concentration and total exposure to glipizide is reduced. Therefore, GLUCOTROL XL should be administered at least 4 hours prior to colesevelam.
Patients Receiving InsulinAs 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 AgentsAs 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) Tablet, Extended Release [Roerig]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=eed99b60-d043-4249-9b2a-f05e46fb588d&name=glucotrol-xl-03.jpg)
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