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GlipizideER
Overview
What is GlipizideER?
Glipizide is an oral blood-glucose-lowering drug of the sulfonylurea class.
The Chemical Abstracts name of glipizide is 1-Cyclohexyl-3-[[-[2-(5-methylpyrazinecarboxamido)ethyl]phenyl]sulfonyl]urea. The molecular formula is CHNOS; 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 NaOH; it is freely soluble in dimethylformamide.
Glipizide extended-release tablets are formulated as a polymer matrix based once-a-day controlled release tablet for oral use and is designed to deliver 2.5 mg, 5 mg or 10 mg of glipizide. Each tablet contains the following inactive ingredients: acetyltributyl citrate, edible black ink, hydroxyethyl cellulose, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, methacrylic acid copolymer type A and polyethylene glycol.
The 2.5 mg and 5 mg tablets also contain FD&C Yellow #6.
What does GlipizideER look like?
What are the available doses of GlipizideER?
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What should I talk to my health care provider before I take GlipizideER?
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How should I use GlipizideER?
Glipizide extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
There is no fixed dosage regimen for the management of diabetes mellitus with glipizide extended-release tablets or any other hypoglycemic agent. Glycemic control should be monitored with hemoglobin A 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 glipizide extended-release tablets may be sufficient during periods of transient loss of control in patients usually controlled on diet.
In general, glipizide extended-release tablets should be given with breakfast.
Recommended Dosing:
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 glipizide extended-release tablet dosage, a single fasting glucose determination may not accurately reflect the response to therapy. In most cases, hemoglobin A level measured at three month intervals is the preferred means of monitoring response to therapy.
Hemoglobin A should be measured as glipizide extended-release tablet 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 glipizide extended-release tablet dose may be increased. Subsequent dosage adjustments should be made on the basis of hemoglobin A 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 glipizide extended-release tablet 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 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 glipizide extended-release tablets once-a-day at the nearest equivalent total daily dose. Patients receiving immediate release glipizide also may be titrated to the appropriate dose of glipizide extended-release tablets 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 section).
Combination Use:
When adding glipizide extended-release tablets to other blood-glucose-lowering agents, glipizide extended-release tablets 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:
For patients whose daily insulin requirement is 20 units or less, insulin may be discontinued and glipizide extended-release tablet 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 glipizide extended-release tablet 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:
What interacts with GlipizideER?
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What are the warnings of GlipizideER?
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What are the precautions of GlipizideER?
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What are the side effects of GlipizideER?
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What should I look out for while using GlipizideER?
Glipizide extended-release tablets are contraindicated in patients with:
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 (
, 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 2 1/2 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 glipizide extended-release tablets in patients with pre-existing 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.
What might happen if I take too much GlipizideER?
There is no well-documented experience with glipizide extended-release tablets overdosage in humans. There have been no known suicide attempts associated with purposeful overdosing with glipizide extended-release tablets. In nonclinical studies the acute oral toxicity of glipizide was extremely low in all species tested (LD 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.
How should I store and handle GlipizideER?
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured and Distributed by: Carlsbad, CA 92008 Repackaged By :Aidarex Pharmaceuticals LLC,Corona, CA 92880Revised: 06/12CTI-12 Rev. C Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured and Distributed by: Carlsbad, CA 92008 Repackaged By :Aidarex Pharmaceuticals LLC,Corona, CA 92880Revised: 06/12CTI-12 Rev. C Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured and Distributed by: Carlsbad, CA 92008 Repackaged By :Aidarex Pharmaceuticals LLC,Corona, CA 92880Revised: 06/12CTI-12 Rev. C Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured and Distributed by: Carlsbad, CA 92008 Repackaged By :Aidarex Pharmaceuticals LLC,Corona, CA 92880Revised: 06/12CTI-12 Rev. C Glipizide Extended-Release Tablets are supplied as 5 mg, and 10 mg round, film-coated tablets and are printed with black ink as follows: 5 mg tablets are orange and printed with and , and are supplied in bottles of 30.10 mg tablets are white to off-white and printed with and , and are supplied in bottles of 30.Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture and humidity.Mfd. for:Mfd. by:Repackaged By :Aidarex Pharmaceuticals LLC,Corona, CA 92880Revised: January 2013Glipizide Extended-Release Tablets are supplied as 5 mg, and 10 mg round, film-coated tablets and are printed with black ink as follows: 5 mg tablets are orange and printed with and , and are supplied in bottles of 30.10 mg tablets are white to off-white and printed with and , and are supplied in bottles of 30.Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture and humidity.Mfd. for:Mfd. by:Repackaged By :Aidarex Pharmaceuticals LLC,Corona, CA 92880Revised: January 2013Glipizide Extended-Release Tablets are supplied as 5 mg, and 10 mg round, film-coated tablets and are printed with black ink as follows: 5 mg tablets are orange and printed with and , and are supplied in bottles of 30.10 mg tablets are white to off-white and printed with and , and are supplied in bottles of 30.Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture and humidity.Mfd. for:Mfd. by:Repackaged By :Aidarex Pharmaceuticals LLC,Corona, CA 92880Revised: January 2013Glipizide Extended-Release Tablets are supplied as 5 mg, and 10 mg round, film-coated tablets and are printed with black ink as follows: 5 mg tablets are orange and printed with and , and are supplied in bottles of 30.10 mg tablets are white to off-white and printed with and , and are supplied in bottles of 30.Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture and humidity.Mfd. for:Mfd. by:Repackaged By :Aidarex Pharmaceuticals LLC,Corona, CA 92880Revised: January 2013Glipizide Extended-Release Tablets are supplied as 5 mg, and 10 mg round, film-coated tablets and are printed with black ink as follows: 5 mg tablets are orange and printed with and , and are supplied in bottles of 30.10 mg tablets are white to off-white and printed with and , and are supplied in bottles of 30.Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture and humidity.Mfd. for:Mfd. by:Repackaged By :Aidarex Pharmaceuticals LLC,Corona, CA 92880Revised: January 2013Glipizide Extended-Release Tablets are supplied as 5 mg, and 10 mg round, film-coated tablets and are printed with black ink as follows: 5 mg tablets are orange and printed with and , and are supplied in bottles of 30.10 mg tablets are white to off-white and printed with and , and are supplied in bottles of 30.Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture and humidity.Mfd. for:Mfd. by:Repackaged By :Aidarex Pharmaceuticals LLC,Corona, CA 92880Revised: January 2013
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
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 glipizide 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 glipizide-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.
Non-Clinical Toxicology
Glipizide extended-release tablets are contraindicated in patients with: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 (
, 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 2 1/2 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 glipizide extended-release tablets in patients with pre-existing 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.
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. 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 fluconazole and glipizide has been demonstrated in a placebo-controlled crossover study in normal volunteers. All subjects received glipizide alone and following treatment with 100 mg of fluconazole as a single daily oral dose for 7 days. The mean percentage increase in the glipizide AUC after fluconazole administration was 56.9% (range: 35 to 81%).
Macrovascular Outcomes:
Renal and Hepatic Disease:
GI Disease:
Hypoglycemia:
Loss of Control of Blood Glucose:
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.
Hemolytic Anemia:
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 glipizide 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:
Only 3.4% of patients receiving glipizide 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 glipizide extended-release tablets and glipizide tablets, 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 glipizide extended-release tablet-treated patients include:
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 glipizide extended-release tablet-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 glipizide extended-release tablets, 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.
Postmarketing Experience
The following adverse events have been reported in postmarketing surveillance:
Gastrointestinal:
Hepatobiliary:
The following are adverse experiences reported with immediate release glipizide and other sulfonylureas, but have not been observed with glipizide extended-release tablets:
Hematologic:
),
Metabolic:
Endocrine Reactions:
Laboratory Tests:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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