Class: Sulfonylureas
VA Class: HS502
Chemical Name: 1-cyclohexyl-3-[[p-[2-(5-methylpyrazine-carboxamido)ethyl]phenyl]sulfonyl]urea
Molecular Formula: C21H27N5O4S
CAS Number: 29094-61-9
Brands: Glucotrol, Glucotrol XL, Metaglip
Introduction
Antidiabetic agent; sulfonylurea.1 2 3
Uses for Glipizide
Diabetes Mellitus
Used alone or in fixed combination with metformin as an adjunct to diet for the management of type 2 diabetes mellitus (noninsulin-dependent) in patients whose hyperglycemia cannot be controlled by diet alone.1 2 3 19 27 50 51 52 53 54 55 56 57 58 59 60 95
Used in combination with one or more other oral antidiabetic agents or insulin as an adjunct to diet and exercise in patients who do not achieve adequate glycemic control with diet, exercise, and oral antidiabetic agent monotherapy.95 120 127 128 129 130 139 154 155 157 158 161 159 160 161 162 164
Alternative therapy in some type 2 diabetic patients being treated with insulin.1 2 52 54 Useful in combination with insulin therapy to improve glycemic control and/or decrease insulin dosage in some type 2 diabetic patients.2 67
Not effective as sole therapy for patients with type 1 diabetes mellitus; insulin is necessary.
Not effective as sole therapy in patients with diabetes mellitus complicated by acidosis, ketosis, or coma.1 2
Glipizide Dosage and Administration
General
-
Adjust dosage according to tolerance and urine and/or fasting blood glucose determinations.1 Monitor glycosylated hemoglobin (hemoglobin A1c, HbA1c) to determine minimum effective dosage or detect primary or secondary failure.1 95 153
Administration
Oral Administration
Administer extended-release or conventional tablets once daily, generally with breakfast.1 95 1 Administer conventional tablets approximately 30 minutes before a meal.1 11 32
Administer glipizide in fixed combination with metformin once daily with a meal.153
Some patients may have a more satisfactory response when conventional oral tablets are administered in 2 or 3 divided doses daily.1 2 11 44 50 51 52 53 54 57 58 59 60 When dosage exceeds 15 mg daily as conventional tablets, administer in divided doses before meals of sufficient caloric content.1 2 59
Extended-release tablets should be swallowed whole and should not be divided, chewed, or crushed.95
Dosage
Adults
Diabetes Mellitus
Initial Dosage in Previously Untreated Patients
OralConventional or extended-release tablets: Initially, 5 mg daily.1 95 Titrate dosage of conventional tablets in increments of 2.5–5 mg daily at intervals of at least several days1 (usually 3–7 days).2 51 54 59 60 Maximum once daily dosage, 15 mg.1
For extended-release tablets, dosage adjustment should be based on at least 2 similar consecutive fasting glucose concentrations obtained at least 7 days after the previous dose adjustment.95
Initial Dosage in Patients Transferred from Conventional to Extended-release Tablets
OralWhen transferring, administer the nearest equivalent total daily dosage once daily.95 Alternatively, 5 mg once daily as extended-release tablets and titrate dosage.95
Initial Dosage in Patients Transferred from Other Oral Antidiabetic Agents
OralIndividualize initial dosage of glipizide; usually 5–10 mg daily.90 92 The other oral antidiabetic agent may be discontinued abruptly.1 95
Patients being transferred from a sulfonylurea agent with a longer half life (e.g., chlorpropamide) should be closely monitored for the occurrence of hypoglycemia during the initial 1–2 weeks.1 95 A drug-free interval of 2–3 days may be advisable before glipizide therapy is initiated as conventional tablets in patients being transferred from chlorpropamide, particularly if blood glucose concentration was adequately controlled with chlorpropamide.90 92
Initial Dosage in Patients Transferred from Insulin
OralInitially, 5 mg once daily, if insulin requirements were ≤20 units daily.1 Abruptly discontinue insulin.1
5 mg once daily if insulin requirements were >20 units daily, and reduce insulin dosage by 50%.1 Withdraw insulin gradually and adjust glipizide dosage in increments of 2.5–5 mg daily at intervals of at least several days.1
Maintenance Dosage
OralMaintenance dosage varies considerably, ranging from 2.5–40 mg daily.1 2 7 27 39 40 41 42 43 44 50 51 52 53 54 56 57 58 59 60 Most patients require 5–25 mg daily as conventional tablets27 39 40 41 42 43 44 50 51 52 53 54 56 57 58 59 60 or 5–10 mg daily as extended-release tablets, but higher dosages may be necessary.7 25 95
Combination Therapy with Other Oral Antidiabetic Agents
OralWhen added to therapy with other antidiabetic agents, the glipizide extended-release tablets may be initiated at a dosage of 5 mg daily.95 Base titration on clinical judgment.95
Fixed combination: 2.5 mg of glipizide and 250 mg of metformin hydrochloride once daily with a meal in treatment-naive patients.153
For more severe hyperglycemia (i.e., fasting plasma glucose concentrations of 280–320 mg/dL), 2.5 mg of glipizide and 500 mg of metformin hydrochloride twice daily.153
Dosage may be increased in increments of one tablet153 (using the tablet strength at which therapy was initiated, either 2.5 mg glipizide/250 mg metformin hydrochloride or 2.5 mg glipizide/500 mg metformin hydrochloride)163 daily every 2 weeks until the minimum effective dosage required to achieve adequate glycemic control is reached.153
Maximum daily dosage, 10 mg of glipizide and 2 g of metformin hydrochloride.153
In previously treated patients with inadequate glycemic control with monotherapy, 2.5 or 5 mg of glipizide and 500 mg of metformin hydrochloride twice daily with the morning and evening meals.153
The initial dosage of the fixed combination should not exceed the daily dosage of glipizide or metformin hydrochloride previously received.153
Titrate upward in increments not exceeding 5 mg of glipizide and 500 mg of metformin hydrochloride until adequate glycemic control is reached.153
Maximum daily dosage, 20 mg of glipizide and 2 g of metformin hydrochloride in previously treated patients.153
For patients previouly receiving both glipizide (or another sulfonylurea antidiabetic agent) and metformin, the initial dosage of the fixed-combination preparation should not exceed the daily dosages of glipizide (or equivalent dosage of another sulfonylurea) and metformin hydrochloride currently being taken.153 158 Such patients should be monitored for signs and symptoms of hypoglycemia following the switch.153 In the transfer, the decision to switch to the nearest equivalent dosage or to titrate dosage is based on clinical judgment.153
Prescribing Limits
Adults
Diabetes Mellitus
Oral
Maximum once-daily dose as conventional tablets is 15 mg.1
Maximum total daily dosage is 40 mg as divided doses of conventional tablets or 20 mg as extended-release tablets.1 95
Maximum daily dosage of the fixed combination, 10 mg of glipizide and 2 g of metformin hydrochloride.153
Special Populations
Hepatic Impairment
Conventional tablets: Initially, 2.5 mg daily;1 conservative maintenance dosage.1
Extended-release tablets: Use conservative initial and maintenance dosage.1
Adjust dosage carefully.1 27 71
Generally, do not use in patients with severe hepatic impairment.2 65 72
Renal Impairment
Use conservative initial and maintenance dosage.1 95
Use generally not recommended in patients with severe renal impairment.2 65 72
Cautious dosing recommended.
Geriatric Patients
Conventional tablets: Initially, 2.5 mg daily.1
Initially, 5 mg (extended-release tablets) may be used.1 95
Use conservative initial and maintenance dosage of glipizide-containing formulations.1 95 153
Adjust dosage carefully.1 Any dosage adjustment of glipizide in fixed combination with metformin hydrochloride requires careful assessment of renal function.153
Dosage of glipizide and metformin hydrochloride in fixed combination should not be titrated to the maximum dosage.
Debilitated or Malnourished Patients
Conservative initial and maintenance dosage of conventional and extended-release tablets.1 95
Dosage of glipizide and metformin hydrochloride in fixed combination should not be titrated to the maximum dosage.153
Cautions for Glipizide
Contraindications
-
Known hypersensitivity to glipizide or any ingredient in the formulation.1
-
Diabetes mellitus complicated by acidosis, ketosis, or coma; use of insulin is necessary.1 2
-
Monotherapy for type 1 diabetes mellitus.
Warnings/Precautions
Warnings
Cardiovascular Effects
Possible increased cardiovascular mortality reported with other sulfonylurea antidiabetic agents (i.e., tolbutamide or phenformin).1 75 However, the American Diabetes Association considers the benefits of intensive glycemic control with insulin or sulfonylureas to outweigh the risks overall.97 107 113
General Precautions
Hypoglycemia
Reported infrequently; usually mild;2 27 50 58 59 60 Possible severe hypoglycemia, especially geriatric patients, malnourished patients, and those with adrenal, pituitary, hepatic, or renal insufficiency.1 27 70 71 Strenuous exercise, alcohol ingestion, insufficient caloric intake, or use in combination with other antidiabetic agents may increase risk.1
Appropriate patient selection and careful attention to dosage are important to avoid glipizide-induced hypoglycemia.
Concurrent Illness
Possible loss of glycemic control during periods of stress (e.g., fever of any cause, trauma, infection, surgery).1 2
Temporary discontinuance of glipizide and administration of insulin may be required.1
GI Disease
Use extended-release tablets with caution in patients with severe preexisting GI narrowing, since obstruction may occur.95
Use of Fixed Combinations
When use in fixed combination with metformin hydrochloride, consider the cautions, precautions, and contraindications associated with metformin.
Specific Populations
Pregnancy
Category C.1
Many experts recommend that insulin be used during pregnancy.1 95
Lactation
Not known whether glipizide is distributed into milk;1 discontinue nursing or the drug.1
Pediatric Use
Safety and efficacy not established.1 However, the ADA states that use may be considered in children with type 2 diabetes mellitus because of greater compliance and convenience and lack of evidence demonstrating better efficacy of insulin for type 2 diabetes mellitus.117
Geriatric Use
Increased risk of hypoglycemia.1 27 71 Cautious dosing recommended.1 27 71
Hepatic Impairment
Increased risk of hypoglycemia.1 27 71 Cautious dosing recommended.1 27 71 (See Hepatic Impairment under Dosage and Administration.)
Generally, not recommended in severe impairment.2 65 72
Renal Impairment
Increased risk of hypoglycemia.1 27 71 Cautious dosing recommended.1 27 71 (See Renal Impairment under Dosage and Administration.)
Generally, not recommended in severe impairment.2 65 72
Common Adverse Effects
With conventional tablets, nausea,1 50 anorexia,50 vomiting,50 pyrosis,50 gastralgia,1 diarrhea,1 and constipation.1 2 50
With extended-release tablets, asthenia, headache, pain, dizziness, nervousness, tremor, diarrhea, hypoglycemia, and flatulence.95 With glipizide in fixed combination with metformin hydrochloride, upper respiratory tract infection, diarrhea, dizziness, hypertension, nausea/vomiting, musculoskeletal pain, headache, abdominal pain, and urinary tract infection.153
Interactions for Glipizide
Protein-bound Drugs
Potential pharmacokinetic interaction with other protein-bound drugs.1 2 47 72 80
Use with caution with protein-bound drugs.1
Specific Drugs
|
Drug |
Interaction |
Comments |
|---|---|---|
|
Alcohol |
Rarely, disulfiram like reactions1 |
|
|
Antifungals |
Increased plasma concentrations of glipizide and hypoglycemic effect95 |
|
|
Anticoagulants, oral |
Glipizide could displace or be displaced by oral anticoagulants from plasma protein binding sites1 2 47 72 80 |
Use with caution with protein-bound drugs1 |
|
β-Adrenergic blocking agents |
Impaired glucose tolerance; increased frequency or severity of hypoglycemia and hypoglycemia-induced complications62 72 80 |
If concomitant therapy is necessary, a β1-selective adrenergic blocking agent may be preferred62 72 |
|
Calcium-channel blocking agents |
May exacerbate diabetes mellitus1 |
Observe closely when concurrent therapy is initiated or discontinued1 |
|
Chloramphenicol |
Observe closely when concurrent therapy is initiated or discontinued1 |
|
|
Cimetidine |
Inhibits the hepatic metabolism of glipizide and potentiate hypoglycemic effect83 |
Glipizide dosage adjustment may be necessary when cimetidine therapy is initated or discontinued83 |
|
Contraceptives, oral |
Observe closely when concurrent therapy is initiated or discontinued1 |
|
|
Corticosteroids |
Observe closely when concurrent therapy is initiated or discontinued1 |
|
|
Dicumarol |
Does not displace dicumarol from plasma protein binding sites1 81 82 |
Use with caution with protein-bound drugs1 |
|
Diuretics, nonthiazide |
Observe closely when concurrent therapy is initiated or discontinued1 |
|
|
Diuretics, thiazide |
||
|
Estrogens |
Observe closely when concurrent therapy is initiated or discontinued1 |
|
|
Hydantoins |
Glipizide could displace or be displaced by hydantoins from plasma protein binding sites1 2 47 72 80 |
Use with caution with protein-bound drugs1 |
|
Indoprofen |
Does not displace indoprofen from plasma protein binding sites1 81 82 |
Use with caution with protein-bound drugs1 |
|
Isoniazid |
May exacerbate diabetes mellitus1 |
Observe closely when concurrent therapy is initiated or discontinued1 |
|
MAO inhibitors |
Observe closely when concurrent therapy is initiated or discontinued1 |
|
|
Niacin |
May exacerbate diabetes mellitus1 |
Observe closely when concurrent therapy is initiated or discontinued1 |
|
NSAIAs |
Glipizide could displace or be displaced by nonsteroidal anti-inflammatory agents from plasma protein binding sites1 2 47 72 80 |
Use with caution with protein-bound drugs1 |
|
Phenothiazines |
Observe closely when concurrent therapy is initiated or discontinued1 |
|
|
Phenytoin |
Observe closely when concurrent therapy is initiated or discontinued1 |
|
|
Probenecid |
Observe closely when concurrent therapy is initiated or discontinued1 |
|
|
Rifampin |
Observe closely when concurrent therapy is initiated or discontinued1 |
|
|
Salicylate |
Does not displace salicylate from plasma protein binding sites1 81 82 |
Use with caution with protein-bound drugs1 |
|
Sulfonamides |
Glipizide could displace or be displaced by sulfonamides from plasma protein binding sites1 2 47 72 80 |
Use with caution with protein-bound drugs1 |
|
Sympathomimetic agents |
Observe closely when concurrent therapy is initiated or discontinued1 |
|
|
Thyroid agents |
Observe closely when concurrent therapy is initiated or discontinued1 |
Glipizide Pharmacokinetics
Absorption
Bioavailability
Absorption is essentially complete; 1 30 31 32 33 34 35 36 37 38 80–100% of an oral dose may be absorbed.30 31 95
Onset
Duration
In nonfasting diabetic patients, the hypoglycemic action may persist for up to 24 hours.1 39 40 41 42 43 44
Food
Food delays the absorption of conventional tablets but does not affect peak serum concentrations achieved or the extent of absorption of the drug.32 33 Peak serum concentrations following administration of conventional tablets generally are delayed 20–40 minutes in the nonfasting state compared with the fasting state.1 32 33
Peak plasma concentrations of glipizide following adminsitration in fixed combination with metformin hydrochloride with food are delayed by 1 hour.153
Food does not affect the glycemic response or the time to absorption of extended-release tablets.95 Peak blood concentrations following administation of extended-release tablets and food are increased.95
Distribution
Extent
Following IV administration in mice, distributed into the liver and blood, with lower concentrations in the lungs, kidneys, adrenals, myocardium, salivary glands, and retroscapular fat.45 In humans, small amounts of glipizide are apparently distributed into bile30 34 37 and very small amounts are distributed into erythrocytes and saliva.30
Not known if glipizide is distributed into milk.1
Plasma Protein Binding
Elimination
Metabolism
Appears to be almost completely metabolized, 30 34 35 36 37 mainly in the liver.1
Elimination Route
Glipizide and its metabolites are excreted principally in urine30 34 35 36 37 (60–90%) and to a lesser extent in feces (5–20%).30 34 35 37 95
Half-life
Terminal elimination half-life of glipizide averages 3–4.7 hours following oral administration in patients with normal renal and hepatic function.9 30 31 32 33 34 35 38 39 48
Terminal elimination half-life of total glipizide metabolites ranges from 2–6 hours.37
Special Populations
Renal or hepatic impairment may increase serum glipizide concentrations and reduce elimination.1 37
Severe renal impairment may decrease the renal excretion of and increase the terminal elimination half-life of glipizide metabolites.37
Stability
Storage
Oral
Tablets (conventional)
Tight, light-resistant containers90 at a temperature <30°C.1
Tablets (extended-release)
15–30°C; protect from moisture and humidity.95
Tablets (fixed-combination)
20–25°C (may be exposed to 15–30°C).153
Actions
-
Lowers blood glucose concentration in diabetic and nondiabetic individuals.2 3 5 6 7 8 9 10 11 12 13
-
Stimulates secretion of postprandial endogenous insulin from the beta cells of the pancreas.1 2 3 5 7 8 9 10 11 12 13
-
During prolonged administration, extrapancreatic effects such as enhanced peripheral sensitivity to insulin and reduction of basal hepatic glucose production contribute to the hypoglycemic action.3 5 7 8 10 12 13 14 16 17 23 24
Advice to Patients
-
Importance of regular clinical and laboratory evaluations, including blood and urine glucose determinations.1
-
Importance of adherence to diet and exercise regimen.1
-
Understanding of primary and secondary failure to oral sulfonylurea antidiabetic agents.1
-
Risks of hypoglycemia, the symptoms and treatment of hypoglycemic reactions, and conditions that predispose to the development of hypoglycemic reactions.1
-
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.1
-
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1
-
Importance of informing patients of other important precautionary information. (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
|
Routes |
Dosage Forms |
Strengths |
Brand Names |
Manufacturer |
|---|---|---|---|---|
|
Oral |
Tablets |
5 mg* |
Glipizide Tablets |
Apotex, Mylan, Sandoz, Teva, Watson |
|
Glucotrol (scored) |
Pfizer |
|||
|
10 mg* |
Glipizide Tablets |
Apotex, Mylan, Sandoz, Teva, Watson |
||
|
Glucotrol (scored) |
Pfizer |
|||
|
Tablets, extended-release |
2.5 mg* |
Glipizide Tablets ER |
Andrx, Greenstone |
|
|
Glucotrol XL |
Pfizer |
|||
|
5 mg* |
Glipizide Tablets ER |
Andrx, Greenstone, Watson |
||
|
Glucotrol XL |
Pfizer |
|||
|
10 mg* |
Glipizide Tablets ER |
Andrx, Greenstone, Watson |
||
|
Glucotrol XL |
Pfizer |
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
|
Routes |
Dosage Forms |
Strengths |
Brand Names |
Manufacturer |
|---|---|---|---|---|
|
Oral |
Tablets, film-coated |
2.5 mg with 250 mg Metformin Hydrochloride* |
Glipizide with Metformin Hydrochloride Tablets |
CorePharma, Sandoz, Teva |
|
Metaglip |
Bristol-Myers Squibb |
|||
|
2.5 mg with 500 mg Meformin Hydrochloride* |
Glipizide with Metformin Hydrochloride Tablets |
CorePharma, Sandoz, Teva |
||
|
Metaglip |
Bristol-Myers Squibb |
|||
|
5 mg with 500 mg Metformin Hydrochloride* |
Glipizide with Metformin Hydrochloride Tablets |
CorePharma, Sandoz, Teva |
||
|
Metaglip |
Bristol-Myers Squibb |
AHFS DI Essentials. © Copyright, 2016, American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814. Review Date: September 06, 2016.
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