Drugs Details

Drugs Info of GlipiZIDE XL, Glucotrol, Glucotrol XL
Drugs Details
  • Drugs Type  : Multum
  • Date : 28th Jan 2015 12:33 am
  • Brand Name : GlipiZIDE XL, Glucotrol, Glucotrol XL
  • Generic Name : glipizide (Pronunciation: GLIP i zide)
Descriptions

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:

 

GLUCOTROL XL® (glipizide) Structural Formula Illustration

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).

System Components and Performance

GLUCOTROL XL (glipizide extended release) 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 (glipizide extended release) 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 (glipizide extended release) 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.

What are the possible side effects of glipizide (GlipiZIDE XL, Glucotrol, Glucotrol XL)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking glipizide and call your doctor at once if you have a serious side effect such as:

  • easy bruising or bleeding (nosebleeds, bleeding gums), feeling tired or short of breath, rapid heart rate;
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • pale skin, fever, confusion;...

Read All Potential Side Effects and See Pictures of Glucotrol XL »

What are the precautions when taking glipizide extended release (Glucotrol XL)?

Before taking glipizide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, thyroid disease, certain hormonal conditions (adrenal/pituitary insufficiency, syndrome of inappropriate secretion of antidiuretic hormone-SIADH), electrolyte imbalance (hyponatremia), stomach/intestine problems (such as gastrointestinal stenosis or stricture, impaired emptying).

You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar levels. Do...

Read All Potential Precautions of Glucotrol XL »


This monograph has been modified to include the generic and brand name in many instances.

Indications

GLUCOTROL XL (glipizide extended release) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Dosage Administration

There is no fixed dosage regimen for the management of diabetes mellitus with GLUCOTROL XL (glipizide extended release) 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 (glipizide extended release) Extended Release Tablet may be sufficient during periods of transient loss of control in patients usually controlled on diet. In general, GLUCOTROL XL (glipizide extended release) should be given with breakfast.

Recommended Dosing

The usual starting dose of GLUCOTROL XL (glipizide extended release) 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 (glipizide extended release) 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 (glipizide extended release) 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 (glipizide extended release) 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 (glipizide extended release) 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 (glipizide extended release) 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 (glipizide extended release) 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 (glipizide extended release) 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 (glipizide extended release) 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 (glipizide extended release) 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 (glipizide extended release) due to potential overlapping of drug effect.

How Supplied

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 (glipizide extended release) 2.5” on one side.

Bottles of 30: NDC 0049-1620-30

5 mg tablets are white and imprinted with “GLUCOTROL XL (glipizide extended release) 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 (glipizide extended release) 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,

Distributed by: Roerig., Division of Pfizer Inc., NY, NY 10017. September 2008. FDA rev date: 10/27/2008


This monograph has been modified to include the generic and brand name in many instances.

Side Effects

In U.S. controlled studies the frequency of serious adverse experiences reported was very low and causal relationship has not been established.

The 580 patients from 31 to 87 years of age who received GLUCOTROL XL (glipizide extended release) Extended Release Tablets in doses from 5 mg to 60 mg in both controlled and open trials were included in the evaluation of adverse experiences. All adverse experiences reported were tabulated independently of their possible causal relation to medication.

Hypoglycemia

See PRECAUTIONS and OVERDOSAGE sections.

Only 3.4% of patients receiving GLUCOTROL XL (glipizide extended release) Extended Release Tablets had hypoglycemia documented by a blood-glucose measurement < 60 mg/dL and/or symptoms believed to be associated with hypoglycemia. In a comparative efficacy study of GLUCOTROL XL and Glucotrol, hypoglycemia occurred rarely with an incidence of less than 1% with both drugs.

In double-blind, placebo-controlled studies the adverse experiences reported with an incidence of 3% or more in GLUCOTROL XL (glipizide extended release) - treated patients include:

 

Adverse Effect GLUCOTROL XL (%)
(N=278)
Placebo (%)
(N=69)
Asthenia 10.1 13.0
Headache 8.6 8.7
Dizziness 6.8 5.8
Nervousness 3.6 2.9
Tremor 3.6 0.0
Diarrhea 5.4 0.0
Flatulence 3.2 1.4

The following adverse experiences occurred with an incidence of less than 3% in GLUCOTROL XL (glipizide extended release) -treated patients:

Body as a whole - pain
Nervous system - insomnia, paresthesia, anxiety, depression and hypesthesia
Gastrointestinal - nausea, dyspepsia, constipation and vomiting
Metabolic - hypoglycemia
Musculoskeletal - arthralgia, leg cramps and myalgia
Cardiovascular - syncope
Skin - sweating and pruritus
Respiratory - rhinitis
Special senses - blurred vision
Urogenital - polyuria

Other adverse experiences occurred with an incidence of less than 1% in GLUCOTROL XL-treated patients:

Body as a whole - chills
Nervous system - hypertonia, confusion, vertigo, somnolence, gait abnormality and decreased libido
Gastrointestinal - anorexia and trace blood in stool
Metabolic - thirst and edema
Cardiovascular - arrhythmia, migraine, flushing and hypertension
Skin - rash and urticaria
Respiratory - pharyngitis and dyspnea
Special senses - pain in the eye, conjunctivitis and retinal hemorrhage
Urogenital - dysuria

Although these adverse experiences occurred in patients treated with GLUCOTROL XL, a causal relationship to the medication has not been established in all cases.

There have been rare reports of gastrointestinal irritation and gastrointestinal bleeding with use of another drug in this non-deformable sustained release formulation, although causal relationship to the drug is uncertain.

In post-marketing experience of GLUCOTROL XL (glipizide extended release) , the additional adverse reaction of abdominal pain has been reported.

The following are adverse experiences reported with immediate release glipizide and other sulfonylureas, but have not been observed with GLUCOTROL XL (glipizide extended release) :

Hematologic

Leukopenia, agranulocytosis, thrombocytopenia, hemolytic anemia, aplastic anemia, and pancytopenia have been reported with sulfonylureas.

Metabolic

Hepatic porphyria and disulfiram-like reactions have been reported with sulfonylureas. In the mouse, glipizide pretreatment did not cause an accumulation of acetaldehyde after ethanol administration. Clinical experience to date has shown that glipizide has an extremely low incidence of disulfiram-like alcohol reactions.

Endocrine Reactions

Cases of hyponatremia and the syndrome of inappropriate antidiuretic hormone (SIADH) secretion have been reported with glipizide and other sulfonylureas.

Laboratory Tests

The pattern of laboratory test abnormalities observed with glipizide was similar to that for other sulfonylureas. Occasional mild to moderate elevations of SGOT, LDH, alkaline phosphatase, BUN and creatinine were noted. One case of jaundice was reported. The relationship of these abnormalities to glipizide is uncertain, and they have rarely been associated with clinical symptoms.

Read the Glucotrol XL (glipizide extended release) Side Effects Center for a complete guide to possible side effects

Interactions

The hypoglycemic action of sulfonylureas may be potentiated by certain drugs including nonsteroidal anti-inflammatory agents and other drugs that are highly protein bound, salicylates, sulfonamides, chloramphenicol, probenecid, coumarins, monoamine oxidase inhibitors, and beta-adrenergic blocking agents. When such drugs are administered to a patient receiving glipizide, the patient should be observed closely for hypoglycemia. When such drugs are withdrawn from a patient receiving glipizide, the patient should be observed closely for loss of control. In vitro binding studies with human serum proteins indicate that glipizide binds differently than tolbutamide and does not interact with salicylate or dicumarol. However, caution must be exercised in extrapolating these findings to the clinical situation and in the use of glipizide with these drugs.

Certain drugs tend to produce hyperglycemia and may lead to loss of control. These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid. When such drugs are administered to a patient receiving glipizide, the patient should be closely observed for loss of control. When such drugs are withdrawn from a patient receiving glipizide, the patient should be observed closely for hypoglycemia.

A potential interaction between oral miconazole and oral hypoglycemic agents leading to severe hypoglycemia has been reported. Whether this interaction also occurs with the intravenous, topical, or vaginal preparations of miconazole is not known. The effect of concomitant administration of Diflucan® (fluconazole) and Glucotrol has been demonstrated in a placebo-controlled crossover study in normal volunteers. All subjects received Glucotrol alone and following treatment with 100 mg of Diflucan® as a single daily oral dose for 7 days. The mean percentage increase in the Glucotrol AUC after fluconazole administration was 56.9% (range: 35 to 81%).

Read the Glucotrol XL Drug Interactions Center for a complete guide to possible interactions

Learn More »


This monograph has been modified to include the generic and brand name in many instances.

Warnings

Special Warning On Increased Risk Of Cardiovascular Mortality

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 (glipizide extended release) 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.

Precautions

General

Macrovascular Outcomes

There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with GLUCOTROL XL (glipizide extended release) or any other anti-diabetic drug.

Renal and Hepatic Disease

The pharmacokinetics and/or pharmacodynamics of glipizide may be affected in patients with impaired renal or hepatic function. If hypoglycemia should occur in such patients, it may be prolonged and appropriate management should be instituted.

GI Disease

Markedly reduced GI retention times of the GLUCOTROL XL (glipizide extended release) Extended Release Tablets may influence the pharmacokinetic profile and hence the clinical efficacy of the drug.

Hypoglycemia

All sulfonylurea drugs are capable of producing severe hypoglycemia. Proper patient selection, dosage, and instructions are important to avoid hypoglycemic episodes. Renal or hepatic insufficiency may affect the disposition of glipizide and the latter may also diminish gluconeogenic capacity, both of which increase the risk of serious hypoglycemic reactions. Elderly, debilitated or malnourished patients, and those with adrenal or pituitary insufficiency are particularly susceptible to the hypoglycemic action of glucose-lowering drugs. Hypoglycemia may be difficult to recognize in the elderly, and in people who are taking beta-adrenergic blocking drugs. Hypoglycemia is more likely to occur when caloric intake is deficient, after severe or prolonged exercise, when alcohol is ingested, or when more than one glucose-lowering drug is used. Therapy with a combination of glucose-lowering agents may increase the potential for hypoglycemia.

Loss of Control of Blood Glucose

When a patient stabilized on any diabetic regimen is exposed to stress such as fever, trauma, infection, or surgery, a loss of control may occur. At such times, it may be necessary to discontinue glipizide and administer insulin.

The effectiveness of any oral hypoglycemic drug, including glipizide, in lowering blood glucose to a desired level decreases in many patients over a period of time, which may be due to progression of the severity of the diabetes or to diminished responsiveness to the drug. This phenomenon is known as secondary failure, to distinguish it from primary failure in which the drug is ineffective in an individual patient when first given. Adequate adjustment of dose and adherence to diet should be assessed before classifying a patient as a secondary failure.

Laboratory Tests

Blood and urine glucose should be monitored periodically. Measurement of hemoglobin A1C may be useful.

Information for Patients

Patients should be informed that GLUCOTROL XL (glipizide extended release) Extended Release Tablets should be swallowed whole. Patients should not chew, divide or crush tablets. Patients should not be concerned if they occasionally notice in their stool something that looks like a tablet.

In the GLUCOTROL XL (glipizide extended release) Extended Release Tablet, the medication is contained within a nonabsorbable shell that has been specially designed to slowly release the drug so the body can absorb it. When this process is completed, the empty tablet is eliminated from the body.

Patients should be informed of the potential risks and advantages of GLUCOTROL XL and of alternative modes of therapy. They should also be informed about the importance of adhering to dietary instructions, of a regular exercise program, and of regular testing of urine and/or blood glucose.

The risks of hypoglycemia, its symptoms and treatment, and conditions that predispose to its development should be explained to patients and responsible family members. Primary and secondary failure also should be explained.

Physician Counseling Information for 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 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. Use of GLUCOTROL XL (glipizide extended release) or other antidiabetic medications 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 GLUCOTROL XL (glipizide extended release) or other antidiabetic medications. Maintenance or discontinuation of GLUCOTROL XL (glipizide extended release) or other antidiabetic medications should be based on clinical judgment using regular clinical and laboratory evaluations.

Carcinogenesis, Mutagenesis, Impairment of Fertility

A twenty month study in rats and an eighteen month study in mice at doses up to 75 times the maximum human dose revealed no evidence of drug-related carcinogenicity. Bacterial and in vivo mutagenicity tests were uniformly negative. Studies in rats of both sexes at doses up to 75 times the human dose showed no effects on fertility.

Pregnancy

Pregnancy Category C

Glipizide was found to be mildly fetotoxic in rat reproductive studies at all dose levels (5–50 mg/kg). This fetotoxicity has been similarly noted with other sulfonylureas, such as tolbutamide and tolazamide. The effect is perinatal and believed to be directly related to the pharmacologic (hypoglycemic) action of glipizide. In studies in rats and rabbits no teratogenic effects were found. There are no adequate and well controlled studies in pregnant women. Glipizide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Because recent information suggests that abnormal blood-glucose levels during pregnancy are associated with a higher incidence of congenital abnormalities, many experts recommend that insulin be used during pregnancy to maintain blood-glucose levels as close to normal as possible.

Nonteratogenic Effects

Prolonged severe hypoglycemia (4 to 10 days) has been reported in neonates born to mothers who were receiving a sulfonylurea drug at the time of delivery. This has been reported more frequently with the use of agents with prolonged half-lives. If glipizide is used during pregnancy, it should be discontinued at least one month before the expected delivery date.

Nursing Mothers

Although it is not known whether glipizide is excreted in human milk, some sulfonylurea drugs are known to be excreted in human milk. Because the potential for hypoglycemia in nursing infants may exist, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. If the drug is discontinued and if diet alone is inadequate for controlling blood glucose, insulin therapy should be considered.

Pediatric Use

Safety and effectiveness in children have not been established.

Geriatric Use

Of the total number of patients in clinical studies of GLUCOTROL XL (glipizide extended release) , 33 percent were 65 and over. Approximately 1–2 days longer were required to reach steady-state in the elderly. (See CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION.) There were no overall differences in effectiveness or safety between younger and older patients, but greater sensitivity of some individuals cannot be ruled out. As such, it should be noted that elderly, debilitated or malnourished patients, and those with adrenal or pituitary insufficiency, are particularly susceptible to the hypoglycemic action of glucose-lowering drugs. Hypoglycemia may be difficult to recognize in the elderly. In addition, in elderly, debilitated or malnourished patients, and patients with impaired renal or hepatic function, the initial and maintenance dosing should be conservative to avoid hypoglycemic reactions.


This monograph has been modified to include the generic and brand name in many instances.

OverDose

There is no well-documented experience with GLUCOTROL XL (glipizide extended release) overdosage in humans. There have been no known suicide attempts associated with purposeful overdosing with GLUCOTROL XL. In nonclinical studies the acute oral toxicity of glipizide was extremely low in all species tested (LD50 greater than 4 g/kg). Overdosage of sulfonylureas including glipizide can produce hypoglycemia. Mild hypoglycemic symptoms without loss of consciousness or neurologic findings should be treated aggressively with oral glucose and adjustments in drug dosage and/or meal patterns. Close monitoring should continue until the physician is assured that the patient is out of danger. Severe hypoglycemic reactions with coma, seizure, or other neurological impairment occur infrequently, but constitute medical emergencies requiring immediate hospitalization. If hypoglycemic coma is diagnosed or suspected, the patient should be given rapid intravenous injection of concentrated (50%) glucose solution. This should be followed by a continuous infusion of a more dilute (10%) glucose solution at a rate that will maintain the blood glucose at a level above 100 mg/dL. Patients should be closely monitored for a minimum of 24 to 48 hours since hypoglycemia may recur after apparent clinical recovery. Clearance of glipizide from plasma may be prolonged in persons with liver disease. Because of the extensive protein binding of glipizide, dialysis is unlikely to be of benefit.

ContrainDications

Glipizide is contraindicated in patients with:

  1. Known hypersensitivity to glipizide or any excipients in the GITS tablets.
  2. Type 1 diabetes mellitus, diabetic ketoacidosis, with or without coma. This condition should be treated with insulin.


This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Mechanism of Action

Glipizide appears to lower blood glucose acutely by stimulating the release of insulin from the pancreas, an effect dependent upon functioning beta cells in the pancreatic islets. Extrapancreatic effects also may play a part in the mechanism of action of oral sulfonylurea hypoglycemic drugs. Two extrapancreatic effects shown to be important in the action of glipizide are an increase in insulin sensitivity and a decrease in hepatic glucose production. However, the mechanism by which glipizide lowers blood glucose during long-term administration has not been clearly established. Stimulation of insulin secretion by glipizide in response to a meal is of major importance. The insulinotropic response to a meal is enhanced with GLUCOTROL XL (glipizide extended release) administration in diabetic patients. The postprandial insulin and C-peptide responses continue to be enhanced after at least 6 months of treatment. In 2 randomized, double-blind, dose-response studies comprising a total of 347 patients, there was no significant increase in fasting insulin in all GLUCOTROL XL (glipizide extended release) -treated patients combined compared to placebo, although minor elevations were observed at some doses. There was no increase in fasting insulin over the long term.

Some patients fail to respond initially, or gradually lose their responsiveness to sulfonylurea drugs, including glipizide. Alternatively, glipizide may be effective in some patients who have not responded or have ceased to respond to other sulfonylureas.

Effects on Blood Glucose

The effectiveness of GLUCOTROL XL (glipizide extended release) Extended Release Tablets in type 2 diabetes at doses from 5–60 mg once daily has been evaluated in 4 therapeutic clinical trials each with long-term open extensions involving a total of 598 patients. Once daily administration of 5, 10 and 20 mg produced statistically significant reductions from placebo in hemoglobin A1C, fasting plasma glucose and postprandial glucose in patients with mild to severe type 2 diabetes. In a pooled analysis of the patients treated with 5 mg and 20 mg, the relationship between dose and GLUCOTROL XL (glipizide extended release) 's effect of reducing hemoglobin A1C was not established. However, in the case of fasting plasma glucose patients treated with 20 mg had a statistically significant reduction of fasting plasma glucose compared to the 5 mg-treated group.

The reductions in hemoglobin A1C and fasting plasma glucose were similar in younger and older patients. Efficacy of GLUCOTROL XL (glipizide extended release) was not affected by gender, race or weight (as assessed by body mass index). In long term extension trials, efficacy of GLUCOTROL XL (glipizide extended release) was maintained in 81% of patients for up to 12 months.

In an open, two-way crossover study 132 patients were randomly assigned to either GLUCOTROL XL (glipizide extended release) or Glucotrol® for 8 weeks and then crossed over to the other drug for an additional 8 weeks. GLUCOTROL XL (glipizide extended release) administration resulted in significantly lower fasting plasma glucose levels and equivalent hemoglobin A1C levels, as compared to Glucotrol.

In 12 week, well-controlled studies there was a maximal average net reduction in hemoglobin A1c of 1.7% in absolute units between placebo-treated and GLUCOTROL XL (glipizide extended release) -treated patients.

Other Effects

It has been shown that GLUCOTROL XL (glipizide extended release) therapy is effective in controlling blood glucose without deleterious changes in the plasma lipoprotein profiles of patients treated for type 2 diabetes.

In a placebo-controlled, crossover study in normal volunteers, glipizide had no antidiuretic activity, and, in fact, led to a slight increase in free water clearance.

Pharmacokinetics and Metabolism

Glipizide is rapidly and completely absorbed following oral administration in an immediate release dosage form. The absolute bioavailability of glipizide was 100% after single oral doses in patients with type 2 diabetes. Beginning 2 to 3 hours after administration of GLUCOTROL XL (glipizide extended release) Extended Release Tablets, plasma drug concentrations gradually rise reaching maximum concentrations within 6 to 12 hours after dosing. With subsequent once daily dosing of GLUCOTROL XL Extended Release Tablets, effective plasma glipizide concentrations are maintained throughout the 24 hour dosing interval with less peak to trough fluctuation than that observed with twice daily dosing of immediate release glipizide. The mean relative bioavailability of glipizide in 21 males with type 2 diabetes after administration of 20 mg GLUCOTROL XL (glipizide extended release) Extended Release Tablets, compared to immediate release Glucotrol (10 mg given twice daily), was 90% at steady-state. Steady-state plasma concentrations were achieved by at least the fifth day of dosing with GLUCOTROL XL (glipizide extended release) Extended Release Tablets in 21 males with type 2 diabetes and patients younger than 65 years. Approximately 1 to 2 days longer were required to reach steady-state in 24 elderly ( ≥ 65 years) males and females with type 2 diabetes. No accumulation of drug was observed in patients with type 2 diabetes during chronic dosing with GLUCOTROL XL (glipizide extended release) Extended Release Tablets. Administration of GLUCOTROL XL (glipizide extended release) with food has no effect on the 2 to 3 hour lag time in drug absorption. In a single dose, food effect study in 21 healthy male subjects, the administration of GLUCOTROL XL (glipizide extended release) immediately before a high fat breakfast resulted in a 40% increase in the glipizide mean Cmax value, which was significant, but the effect on the AUC was not significant. There was no change in glucose response between the fed and fasting state. Markedly reduced GI retention times of the GLUCOTROL XL (glipizide extended release) tablets over prolonged periods (e.g., short bowel syndrome) may influence the pharmacokinetic profile of the drug and potentially result in lower plasma concentrations. In a multiple dose study in 26 males with type 2 diabetes, the pharmacokinetics of glipizide were linear over the dose range of 5 to 60 mg of GLUCOTROL XL (glipizide extended release) in that the plasma drug concentrations increased proportionately with dose. In a single dose study in 24 healthy subjects, four 5 mg, two 10 mg, and one 20 mg GLUCOTROL XL (glipizide extended release) Extended Release Tablets were bioequivalent. In a separate single dose study in 36 healthy subjects, four 2.5-mg GLUCOTROL XL Extended Release Tablets were bioequivalent to one 10-mg GLUCOTROL XL Extended Release Tablet.

Glipizide is eliminated primarily by hepatic biotransformation: less than 10% of a dose is excreted as unchanged drug in urine and feces; approximately 90% of a dose is excreted as biotransformation products in urine (80%) and feces (10%). The major metabolites of glipizide are products of aromatic hydroxylation and have no hypoglycemic activity. A minor metabolite which accounts for less than 2% of a dose, an acetylamino-ethyl benzene derivative, is reported to have 1/10 to 1/3 as much hypoglycemic activity as the parent compound. The mean total body clearance of glipizide was approximately 3 liters per hour after single intravenous doses in patients with type 2 diabetes. The mean apparent volume of distribution was approximately 10 liters. Glipizide is 98–99% bound to serum proteins, primarily to albumin. The mean terminal elimination half-life of glipizide ranged from 2 to 5 hours after single or multiple doses in patients with type 2 diabetes. There were no significant differences in the pharmacokinetics of glipizide after single dose administration to older diabetic subjects compared to younger healthy subjects. There is only limited information regarding the effects of renal impairment on the disposition of glipizide, and no information regarding the effects of hepatic disease. However, since glipizide is highly protein bound and hepatic biotransformation is the predominant route of elimination, the pharmacokinetics and/or pharmacodynamics of glipizide may be altered in patients with renal or hepatic impairment.

In mice no glipizide or metabolites were detectable autoradiographically in the brain or spinal cord of males or females, nor in the fetuses of pregnant females. In another study, however, very small amounts of radioactivity were detected in the fetuses of rats given labelled drug.


This monograph has been modified to include the generic and brand name in many instances.

Patient Information

GLUCOTROL XL
(glipizide) extended release tablets

Read this information carefully before you start taking this medicine. Read the information you get with your medicine each time you refill your prescription. There may be new information. This information does not take the place of your healthcare provider's advice. Ask your healthcare provider or pharmacist if you do not understand some of this information or if you want to know more about this medicine.

What is GLUCOTROL XL (glipizide extended release) ?

GLUCOTROL XL (glipizide extended release) (glue-kuh-troll-ex-el) is a medicine you take by mouth. It is used to treat type 2 diabetes (also called non-insulin­ dependant diabetes mellitus). Your healthcare provider has prescribed GLUCOTROL XL (glipizide extended release) because your current treatment, including diet and exercise, has not been able to bring your blood sugar level under good control.

Your body makes insulin to keep the amount of sugar (glucose) in your blood at the right level. With type 2 diabetes:

  • your body may not be making enough insulin
  • your body may not be using the insulin that you have already made
  • the level of sugar in your blood is too high

If your blood sugar level is not under control, it can lead to serious medical problems, such as kidney damage, nerve damage, blindness, problems with circulation (blood movement in your body), loss of feet, legs or other limbs, high blood pressure, heart attack, or stroke.

GLUCOTROL XL (glipizide extended release) works mainly by:

  • helping the body release more of its own insulin
  • helping the body respond better to its own insulin
  • lowering the amount of sugar (glucose) made by the body

Even after you start taking GLUCOTROL XL (glipizide extended release) , you must continue to follow your program of diet and exercise.

Who Should Not Use GLUCOTROL XL (glipizide extended release) ?

Do not use GLUCOTROL XL (glipizide extended release) if you:

  • have a condition called diabetic ketoacidosis
  • have ever had an allergic reaction to glipizide or any of the other ingredients in GLUCOTROL XL (glipizide extended release) . Ask your healthcare provider or pharmacist for a list of these ingredients.

Only your healthcare provider can decide if GLUCOTROL XL (glipizide extended release) is right for you. Before you start GLUCOTROL XL (glipizide extended release) , tell the healthcare provider if you:

  • are taking or using any prescription medicines or non-prescription medicines, including natural or herbal remedies. Other medications can increase your chance of getting low blood sugar or high blood sugar. Be sure to tell your healthcare provider if you take the medicines miconazole or fluconazole, used to fight fungus infections.
  • have ever had a condition called diabetic ketoacidosis
  • have kidney or liver problems
  • have had blockage or narrowing of your intestines due to illness or past surgery
  • have chronic (continuing) diarrhea
  • are pregnant or might be pregnant. Your healthcare provider may switch you to insulin injections some time during your pregnancy. You should not take GLUCOTROL XL (glipizide extended release) during the last month of pregnancy.
  • are breast-feeding. GLUCOTROL XL (glipizide extended release) may pass to the baby through your milk and cause harm.

How Should I Take GLUCOTROL XL (glipizide extended release) ?

GLUCOTROL XL (glipizide extended release) tablets come in three different strengths (2.5 mg, 5 mg and 10 mg). Your healthcare provider will prescribe the dose that is right for you.

  • Take GLUCOTROL XL (glipizide extended release) once a day with breakfast. The tablet is designed to release the medicine slowly over 24 hours. This is why you have to take it only once a day.
  • Swallow the tablet whole. Never chew, crush or cut the tablet in half. This would damage the tablet and release too much medicine into your body at one time.
  • After all of the medicine has been released, the empty tablet shell will pass out of the body normally in a bowel movement. Do not be concerned if you see the empty tablet shell in your stool (bowel movement).

It is important to take GLUCOTROL XL (glipizide extended release) every day to help keep your blood sugar level under good control. Your healthcare provider may adjust your dose depending on your blood glucose test results. If your blood sugar level is not under control, call your healthcare provider. Do not change your dose without your healthcare provider's approval. In case of overdose, call the poison control center or your healthcare provider right away, or have someone drive you to the nearest emergency room.

You must continue your diet and exercise program while taking GLUCOTROL XL (glipizide extended release) . You must also have your blood and urine tested regularly to be sure GLUCOTROL XL is working.

GLUCOTROL XL (glipizide extended release) may not work for everyone. If it does work, you may find that GLUCOTROL XL (glipizide extended release) is not working as well for you after you have used it for a while. Tell your healthcare provider if GLUCOTROL XL (glipizide extended release) is not working well.

What Should I Avoid While Taking GLUCOTROL XL (glipizide extended release) ?

Some medicines can affect how well GLUCOTROL XL (glipizide extended release) works or may affect your blood sugar level. Check with your healthcare provider or pharmacist before you start or stop taking prescription or over-the-counter medicines, including natural/herbal remedies, while on GLUCOTROL XL (glipizide extended release) .

What are the Possible Side Effects of GLUCOTROL XL (glipizide extended release) ?

Low blood sugar. GLUCOTROL XL (glipizide extended release) may lower your blood sugar to low levels that are dangerous (hypoglycemia). This can happen if you do not follow your diet, exercise too much, drink alcohol, are under stress, or get sick. This could also happen if your dose of GLUCOTROL XL (glipizide extended release) is higher than you need. Your healthcare provider may need to adjust it. Do not adjust the dose on your own.

Be sure you know how to recognize your body's signs that your blood sugar is too low. These signs include:

  • a cold clammy feeling
  • unusual sweating
  • dizziness
  • weakness
  • trembling
  • shakiness
  • hunger
  • fast heartbeat
  • headache
  • blurred vision
  • slurred speech
  • tingling in the lips or hands

If you notice any of these signs, eat or drink something with sugar in it right away, such as a regular (not diet) soft drink, orange juice, honey, sugar candy. You can also keep glucose tablets on hand that are available at your pharmacy. If you do not feel better shortly or your blood sugar level does not go up, call your healthcare provider. If you cannot reach your healthcare provider in an emergency, call 911 or have someone drive you to the nearest emergency room.

Other side effects. GLUCOTROL XL (glipizide extended release) may cause other side effects in some people. However, the incidence of serious side effects with GLUCOTROL XL (glipizide extended release) is very low. Other than the signs of low blood sugar listed above, possible side effects include:

  • feeling jittery
  • diarrhea
  • gas

GLUCOTROL XL (glipizide extended release) may cause other less common side effects besides those listed here. For a list of all side effects that have been reported, ask your healthcare provider or pharmacist.

While it has never been reported with GLUCOTROL XL (glipizide extended release) , another similar type of diabetes medicine has been linked to a higher risk of heart attacks. If you have risk factors for heart disease and take GLUCOTROL XL (glipizide extended release) , be sure to see your healthcare provider for regular checkups.

How To Store GLUCOTROL XL (glipizide extended release)

Keep GLUCOTROL XL (glipizide extended release) and all medicines out of reach of children. Store GLUCOTROL XL in a dry place, in its original container, and at room temperature (between 59°–86° F or 15°–30° C).

General Advice About Prescription Medicines

Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. If you have any concerns about GLUCOTROL XL (glipizide extended release) , ask your healthcare provider. Your healthcare provider or pharmacist can give you information about GLUCOTROL XL (glipizide extended release) that was written for healthcare professionals. Do not use GLUCOTROL XL (glipizide extended release) for a condition for which it was not prescribed. Do not share GLUCOTROL XL (glipizide extended release) with other people. For more information about GLUCOTROL XL, you can visit the Pfizer internet site at www.pfizer.com.


This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

GLIPIZIDE EXTENDED-RELEASE TABLET - ORAL

 

(GLIP-i-zide)

 

COMMON BRAND NAME(S): Glucotrol XL

 

USES: Glipizide is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. It may also be used with other diabetes medications. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke. Glipizide belongs to the class of drugs known as sulfonylureas. It lowers blood sugar by causing the release of your body's natural insulin.

 

HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking glipizide and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with breakfast as directed by your doctor, usually once daily. The dosage is based on your medical condition and response to treatment.

To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully.

If you are already taking another anti-diabetic drug (such as chlorpropamide), follow your doctor's directions carefully for stopping the old drug and starting glipizide.

Do not crush or chew extended-release tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.

Colesevelam can decrease the absorption of glipizide. If you are taking colesevelam, take glipizide at least 4 hours before taking colesevelam.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

Tell your doctor if your condition does not improve or if it worsens (your blood sugar levels are too high or too low).

Consumer Overview Side Effect

SIDE EFFECTS: Nausea, vomiting, loss of appetite, diarrhea, constipation, upset stomach, gas, headache, and weight gain may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

An empty tablet shell may appear in your stool. This effect is harmless because your body has already absorbed the medication.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: signs of infection (such as persistent sore throat, fever), easy bleeding/bruising, stomach pain, yellowing eyes/skin, dark urine, unusual tiredness/weakness, unusual/sudden weight gain, mental/mood changes, swelling hands/feet, seizures.

This medication can cause low blood sugar (hypoglycemia). This may occur if you do not consume enough calories from food or if you do unusually heavy exercise. Symptoms of low blood sugar include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or drink fruit juice or non-diet soda. Tell your doctor immediately about the reaction and the use of this product. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Check with your doctor or pharmacist to find out what you should do if you miss a meal.

Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, and fruity breath odor. If these symptoms occur, tell your doctor immediately. Your dosage may need to be increased.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Glucotrol XL (glipizide extended release) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: Before taking glipizide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, kidney disease, thyroid disease, certain hormonal conditions (adrenal/pituitary insufficiency, syndrome of inappropriate secretion of antidiuretic hormone-SIADH), electrolyte imbalance (hyponatremia), stomach/intestine problems (such as gastrointestinal stenosis or stricture, impaired emptying).

You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar levels. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely.

Limit alcohol while taking this medication because it can increase your risk of developing low blood sugar. Alcohol can rarely interact with glipizide and cause a serious reaction (disulfiram-like reaction) with symptoms such as facial flushing, nausea, vomiting, dizziness, or stomach pain. Consult your doctor or pharmacist about the safe use of alcohol.

It may be harder to control your blood sugar when your body is stressed (such as due to fever, infection, injury, or surgery). Consult your doctor because this may require a change in your treatment plan, medications, or blood sugar testing.

This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially low blood sugar.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

Pregnancy may cause or worsen diabetes. Discuss a plan with your doctor for managing your blood sugar while pregnant. Your doctor may change your diabetes treatment during your pregnancy (such as diet and medications including insulin).

It is unknown if this medication passes into breast milk. However, similar drugs pass into breast milk. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: See also How to Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Many drugs can affect your blood sugar levels, making it more difficult to control your blood sugar. Before you start, stop, or change any medication, talk with your doctor or pharmacist about how the medication may affect your blood sugar. Check your blood sugar levels regularly as directed by your doctor. Tell your doctor about the results and of any symptoms of high or low blood sugar. (See also Side Effects section.) Your doctor may need to adjust your anti-diabetic medication, exercise program, or diet.

Beta-blocker medications (including metoprolol, propranolol, glaucoma eye drops such as timolol) may prevent the fast/pounding heartbeat you would usually feel when your blood sugar level falls too low (hypoglycemia). Other symptoms of low blood sugar such as dizziness, hunger, or sweating are unaffected by these drugs.

Check the labels on all your medicines (such as cough-and-cold products) because they may contain ingredients that could affect your blood sugar. Ask your pharmacist about using those products safely.

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: shakiness, fast heartbeat, sweating, loss of consciousness.

 

NOTES: Do not share this medication with others.

Attend a diabetes education program to learn more about diabetes and the important aspects of its treatment, including medications, diet, exercise, and getting regular eye/foot/medical exams.

Learn the symptoms of high and low blood sugar and how to treat low blood sugar. Check your blood sugar levels regularly as directed.

Keep all regular medical and laboratory appointments. Laboratory and/or medical tests (such as liver and kidney function tests, fasting blood glucose, hemoglobin A1c, complete blood counts) should be performed periodically to monitor your progress or check for side effects.

 

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

 

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

 

Information last revised November 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: GlipiZIDE XL, Glucotrol, Glucotrol XL

Generic Name: glipizide (Pronunciation: GLIP i zide)

  • What is glipizide (Glucotrol XL)?
  • What are the possible side effects of glipizide (Glucotrol XL)?
  • What is the most important information I should know about glipizide (Glucotrol XL)?
  • What should I discuss with my doctor before taking glipizide (Glucotrol XL)?
  • How should I take glipizide (Glucotrol XL)?
  • What happens if I miss a dose (Glucotrol XL)?
  • What happens if I overdose (Glucotrol XL)?
  • What should I avoid while taking glipizide (Glucotrol XL)?
  • What other drugs will affect glipizide (Glucotrol XL)?
  • Where can I get more information?

What is glipizide (Glucotrol XL)?

Glipizide is an oral diabetes medicine that helps control blood sugar levels. This medication helps your pancreas produce insulin.

Glipizide is used together with diet and exercise to treat type 2 diabetes.

Glipizide may also be used for other purposes not listed in this medication guide.

Glipizide 10 mg-APO

round, white, imprinted with APO, GLP 10

What are the possible side effects of glipizide (Glucotrol XL)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking glipizide and call your doctor at once if you have a serious side effect such as:

  • easy bruising or bleeding (nosebleeds, bleeding gums), feeling tired or short of breath, rapid heart rate;
  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • pale skin, fever, confusion; or
  • throbbing headache, severe nausea and vomiting, fast or pounding heartbeats, sweating or thirst, feeling like you might pass out.

Less serious side effects may include:

  • mild nausea;
  • diarrhea, constipation;
  • dizziness, drowsiness; or
  • skin rash, redness, or itching.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Glucotrol XL (glipizide extended release) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about glipizide (Glucotrol XL)?

Do not use this medication if you are allergic to glipizide, or if you are in a state of diabetic ketoacidosis. Call your doctor for treatment with insulin.

Before taking glipizide, tell your doctor if you have kidney or liver disease, chronic diarrhea or a blockage in your intestines, glucose-6-phosphate dehydrogenase deficiency (G6PD), a disorder of your pituitary or adrenal glands, a history of heart disease, or if you are malnourished.

Take care not to let your blood sugar get too low. Low blood sugar (hypoglycemia) can occur if you skip a meal, exercise too long, drink alcohol, or are under stress. Symptoms include headache, hunger, weakness, sweating, tremors, irritability, or trouble concentrating. Carry hard candy or glucose tablets with you in case you have low blood sugar. Other sugar sources include orange juice and milk. Be sure your family and close friends know how to help you in an emergency.

Also watch for signs of blood sugar that is too high (hyperglycemia). These symptoms include increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, and weight loss. Your blood sugar will need to be checked often, and you may need to adjust your glipizide dose.

Glipizide is only part of a complete program of treatment that may also include diet, exercise, weight control, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

Side Effects Centers
  • Glucotrol
  • Glucotrol XL

Patient Detailed How Take

What should I discuss with my doctor before taking glipizide (Glucotrol XL)?

Do not use this medication if you are allergic to glipizide, or if you are in a state of diabetic ketoacidosis. Call your doctor for treatment with insulin.

To make sure you can safely take glipizide, tell your doctor if you have any of these other conditions:

  • liver disease;
  • kidney disease;
  • chronic diarrhea or a blockage in your intestines;
  • an enzyme deficiency called glucose-6-phosphate dehydrogenase deficiency (G6PD);
  • a disorder of your pituitary or adrenal glands;
  • a history of heart disease; or
  • if you are malnourished.

Certain oral diabetes medications may increase your risk of serious heart problems. However, not treating your diabetes can damage your heart and other organs. Talk to your doctor about the risks and benefits of treating your diabetes with glipizide.

FDA pregnancy category C. It is not known whether glipizide will harm an unborn baby. Similar diabetes medications have caused severe hypoglycemia in newborn babies whose mothers had used the medication near the time of delivery. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether glipizide passes into breast milk or if it could be harmful to a nursing baby. Do not take glipizide without telling your doctor if you are breast-feeding a baby.

How should I take glipizide (Glucotrol XL)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results.

Take glipizide 30 minutes before a meal. If you take glipizide once daily, take it 30 minutes before breakfast.

Glipizide extended-release (Glucotrol XL) should be taken with breakfast.

Do not crush, chew, or break an extended-release tablet. Swallow it whole. Breaking the pill may cause too much of the drug to be released at one time.

Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office. Visit your doctor regularly.

Know the signs of low blood sugar (hypoglycemia) and how to recognize them: headache, hunger, weakness, sweating, tremors, irritability, or trouble concentrating.

Always keep a source of sugar available in case you have symptoms of low blood sugar. Sugar sources include orange juice, glucose gel, candy, or milk. If you have severe hypoglycemia and cannot eat or drink, use an injection of glucagon. Your doctor can give you a prescription for a glucagon emergency injection kit and tell you how to give the injection.

Also watch for signs of blood sugar that is too high (hyperglycemia). These symptoms include increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, and weight loss.

Check your blood sugar carefully during a time of stress or illness, if you travel, exercise more than usual, drink alcohol, or skip meals. These things can affect your glucose levels and your dose needs may also change.

Your doctor may want you to stop taking glipizide for a short time if you become ill, have a fever or infection, or if you have surgery or a medical emergency.

Ask your doctor how to adjust your glipizide dose if needed. Do not change your medication dose or schedule without your doctor's advice.

Some forms of glipizide are made with a shell that is not absorbed or melted in the body. Part of the tablet shell may appear in your stool. This is a normal side effect and will not make the medication less effective.

Glipizide is only part of a complete program of treatment that may also include diet, exercise, weight control, and testing your blood sugar. Follow your diet, medication, and exercise routines very closely. Changing any of these factors can affect your blood sugar levels.

Store at room temperature away from moisture, heat, and light.

Side Effects Centers
  • Glucotrol
  • Glucotrol XL

Patient Detailed Avoid Taking

What happens if I miss a dose (Glucotrol XL)?

Take the missed dose 30 minutes before your next meal, then return to your regular schedule. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Use glipizide regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

What happens if I overdose (Glucotrol XL)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A glipizide overdose can cause life-threatening hypoglycemia.

Symptoms of severe hypoglycemia include extreme weakness, blurred vision, sweating, trouble speaking, tremors, stomach pain, confusion, and seizure (convulsions).

What should I avoid while taking glipizide (Glucotrol XL)?

Avoid drinking alcohol. It lowers blood sugar and may interfere with your diabetes treatment.

What other drugs will affect glipizide (Glucotrol XL)?

You may be more likely to have hyperglycemia (high blood sugar) if you are taking glipizide with other drugs that raise blood sugar, such as:

  • isoniazid;
  • diuretics (water pills);
  • steroids (prednisone and others);
  • phenothiazines (Compazine and others);
  • thyroid medicine (Synthroid and others);
  • birth control pills and other hormones;
  • seizure medicines (Dilantin and others);
  • niacin (Advicor, Niaspan, Niacor, Simcor, Slo-Niacin, and others);
  • diet pills, medicines to treat asthma, colds or allergies; and
  • heart or blood pressure medication such as diltiazem (Cartia, Cardizem), nifedipine (Nifedical, Procardia), verapamil (Calan, Covera, Isoptin, Verelan), and others.

You may be more likely to have hypoglycemia (low blood sugar) if you are taking glipizide with other drugs that lower blood sugar, such as:

  • nonsteroidal anti-inflammatory drugs (NSAIDs);
  • aspirin or other salicylates (including Pepto-Bismol);
  • sulfa drugs (Bactrim and others);
  • a monoamine oxidase inhibitor (MAOI);
  • beta-blockers (Tenormin and others);
  • exenatide (Byetta);
  • fluconazole (Diflucan);
  • probenecid (Benemid);
  • a blood thinner (warfarin, Coumadin, Jantoven, and others); and
  • other oral diabetes medications, especially acarbose (Precose), metformin (Glucophage), miglitol (Glyset), pioglitazone (Actos), or rosiglitazone (Avandia).

These lists are not complete and there are many other medicines that can increase or decrease the effects of glipizide on lowering your blood sugar. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about glipizide.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 8.02. Revision date: 11/23/2011.

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