GLIPIZIDE tablet, extended release

United States - English - NLM (National Library of Medicine)

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Active ingredient:
GLIPIZIDE (UNII: X7WDT95N5C) (GLIPIZIDE - UNII:X7WDT95N5C)
Available from:
A-S Medication Solutions
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Glipizide extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Glipizide extended-release tablets are not recommended for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. Glipizide is contraindicated in patients with: - Known hypersensitivity to glipizide or any of the product's ingredients. - Hypersensitivity to sulfonamide derivatives. Risk Summary Available data from a small number of published studies and postmarketing experience with glipizide extended-release tablets use in pregnancy over decades have not identified any drug associated risks for major birth defects, miscarriage, or adverse maternal outcomes. However, sulfonylureas (including glipizide) cross the placenta and have been associated with neonatal adverse reactions such as hypoglycemia. Therefore, glipizide extended-release tablets should be discontinued at least two weeks before expected delivery (see Clinical Consideration
Product summary:
Product: 50090-5377 NDC: 50090-5377-0 30 TABLET, EXTENDED RELEASE in a BOTTLE NDC: 50090-5377-2 90 TABLET, EXTENDED RELEASE in a BOTTLE
Authorization status:
Abbreviated New Drug Application
Authorization number:
50090-5377-0, 50090-5377-2

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GLIPIZIDE- glipizide tablet, extended release

A-S Medication Solutions

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use GLIPIZIDE EXTENDED-

RELEASE TABLETS safely and effectively. See full prescribing information for GLIPIZIDE

EXTENDED-RELEASE TABLETS.

GLIPIZIDE extended-release tablets, for oral use

Initial U.S. Approval: 1994

INDICATIONS AND USAGE

Glipizide extended-release tablets is a sulfonylurea indicated as an adjunct to diet and exercise to improve

glycemic control in adults with type 2 diabetes mellitus Limitations of Use: Not for treatment of type 1

diabetes or diabetic ketoacidosis. (1)

DOSAGE AND ADMINISTRATION

Recommended starting dose is 5 mg once daily. Dose adjustment can be made based on the patient's

glycemic control. Maximum recommended dose is 20 mg once daily (2.1).

Administer with breakfast or the first meal of the day (2.1).

For combination therapy with other blood-glucose-lowering agents, initiate the agent at the lowest

recommended dose, and observe patients for hypoglycemia (2.2).

DOSAGE FORMS AND STRENGTHS

Tablets: 2.5 mg, 5 mg, 10 mg (3).

CONTRAINDICATIONS

Known hypersensitivity to glipizide or any of the product's ingredients (4)

Hypersensitivity to sulfonamide derivatives (4)

WARNINGS AND PRECAUTIONS

Hypoglycemia: May be severe. Ensure proper patient selection, dosing, and instructions, particularly in

at-risk populations (e.g., elderly, renally impaired) and when used with other anti-diabetic medications

(5.1).

Hemolytic Anemia: Can occur if glucose 6-phosphate dehydrogenase (G6PD) deficient. Consider a non-

sulfonylurea alternative (5.2).

Potential Increased Risk of Cardiovascular Mortality with Sulfonylureas: Inform patient of risks, benefits

and treatment alternatives (5.3).

Macrovascular Outcomes: No clinical studies have established conclusive evidence of macrovascular

risk reduction with glipizide extended-release tablets or any other anti-diabetic drug (5.4).

ADVERSE REACTIONS

Most common adverse reactions (incidence > 3%) are dizziness, diarrhea, nervousness, tremor,

hypoglycemia and flatulence (6.1).

To report SUSPECTED ADVERSE REACTIONS, contact Northstar Rx LLC at 1-800-206-7821 or

FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Certain medications may affect glucose metabolism, requiring glipizide extended-release tablets dose

adjustment and close monitoring of blood glucose (7.1)

Miconazole: Monitor patients closely. Severe hypoglycemia can occur when glipizide and oral

miconazole are used concomitantly (7.1, 12.3).

Fluconazole: Monitor patients closely. An increase in glipizide AUC was seen after fluconazole

administration (7.3, 12.3).

Colesevelam: Glipizide extended-release tablets should be administered at least 4 hours prior to

colesevelam (7.4, 12.3).

USE IN SPECIFIC POPULATIONS

Geriatric, Hepatically Impaired Patients: At risk for hypoglycemia with glipizide extended-release tablets.

Use caution in dose selection and titration, and monitor closely (8.5, 8.6).

See 17 for PATIENT COUNSELING INFORMATION, FDA-approved patient labeling and FDA-

See 17 for PATIENT COUNSELING INFORMATION, FDA-approved patient labeling and FDA-

approved patient labeling.

Revised: 3/2021

FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

1.1 Limitations of Use

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosing

2.2 Use with Other Glucose Lowering Agents

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Hypoglycemia

5.2 Hemolytic Anemia

5.3 Increased Risk of Cardiovascular Mortality with Sulfonylureas

5.4 Macrovascular Outcomes

5.5 Gastrointestinal Obstruction

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Postmarketing Experience

7 DRUG INTERACTIONS

7.1 Drugs Affecting Glucose Metabolism

7.2 Miconazole

7.3 Fluconazole

7.4 Colesevelam

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.2 Lactation

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Hepatic Impairment

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

15 REFERENCES

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

Sections or subsections omitted from the full prescribing information are not listed.

FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

Glipizide extended-release tablets are indicated as an adjunct to diet and exercise to

improve glycemic control in adults with type 2 diabetes mellitus.

1.1 Limitations of Use

Glipizide extended-release tablets are not recommended for the treatment of type 1

diabetes mellitus or diabetic ketoacidosis.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosing

Glipizide extended-release tablets should be administered orally with breakfast or the

first main meal of the day.

The recommended starting dose of glipizide extended-release tablets is 5 mg once daily.

Start patients at increased risk for hypoglycemia (e.g. the elderly or patients with hepatic

insufficiency) at 2.5 mg [see Use in Specific Population (8.5, 8.6)].

Dosage adjustment can be made based on the patient's glycemic control. The maximum

recommended dose is 20 mg once daily.

Patients receiving immediate-release glipizide may be switched to glipizide extended-

release tablets once daily at the nearest equivalent total daily dose.

2.2 Use with Other Glucose Lowering Agents

When adding glipizide extended-release tablets to other anti-diabetic drugs, initiate

glipizide extended-release tablets at 5 mg once daily. Start patients at increased risk for

hypoglycemia at a lower dose.

When colesevelam is coadministered with glipizide extended-release tablets, maximum

plasma concentration and total exposure to glipizide is reduced. Therefore, glipizide

extended-release tablets should be administered at least 4 hours prior to colesevelam.

3 DOSAGE FORMS AND STRENGTHS

Glipizide extended-release tablets, 2.5 mg are yellow colored, round, biconvex film-

coated tablets imprinted with "2" on one side with black ink and plain on the other side.

Glipizide extended-release tablets, 5 mg are orange colored, round, biconvex film-coated

tablets imprinted with "3" on one side with black ink and plain on the other side.

Glipizide extended-release tablets, 10 mg are white colored, round, biconvex film-coated

tablets imprinted with "4" on one side and plain on the other side.

4 CONTRAINDICATIONS

Glipizide is contraindicated in patients with:

Known hypersensitivity to glipizide or any of the product's ingredients.

Hypersensitivity to sulfonamide derivatives.

5 WARNINGS AND PRECAUTIONS

5.1 Hypoglycemia

All sulfonylurea drugs, including glipizide extended-release tablets, are capable of

producing severe hypoglycemia [see Adverse Reactions (6)]. Concomitant use of

glipizide extended-release tablets with other anti-diabetic medication can increase the

risk of hypoglycemia. A lower dose of glipizide extended-release tablets may be required

to minimize the risk of hypoglycemia when combining it with other anti-diabetic

medications.

Educate patients to recognize and manage hypoglycemia. When initiating and increasing

glipizide extended-release tablets in patients who may be predisposed to hypoglycemia

(e.g., the elderly, patients with renal impairment, patients on other anti-diabetic

medications) start at 2.5 mg. Debilitated or malnourished patients, and those with

adrenal, pituitary, or hepatic impairment are particularly susceptible to the hypoglycemic

action of anti-diabetic medications. Hypoglycemia is also more likely to occur when

caloric intake is deficient, after severe or prolonged exercise, or when alcohol is

ingested.

The patient's ability to concentrate and react may be impaired as a result of

hypoglycemia. Early warning symptoms of hypoglycemia may be different or less

pronounced in patients with autonomic neuropathy, the elderly, and in patients who are

taking beta-adrenergic blocking medications or other sympatholytic agents. These

situations may result in severe hypoglycemia before the patient is aware of the

hypoglycemia.

These impairments may present a risk in situations where these abilities are especially

important, such as driving or operating other machinery. Severe hypoglycemia can lead

to unconsciousness or convulsions and may result in temporary or permanent

impairment of brain function or death.

5.2 Hemolytic Anemia

Treatment of patients with glucose 6-phosphate dehydrogenase (G6PD) deficiency with

sulfonylurea agents, including glipizide extended-release tablets, can lead to hemolytic

anemia. Avoid use of glipizide extended-release tablets in patients with G6PD deficiency.

In post marketing reports, hemolytic anemia has also been reported in patients who did

not have known G6PD deficiency.

5.3 Increased Risk of Cardiovascular Mortality with Sulfonylureas

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 mellitus. The study involved 823 patients who were

randomly assigned to one of four treatment groups.

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.

5.4 Macrovascular Outcomes

There have been no clinical studies establishing conclusive evidence of macrovascular

risk reduction with glipizide extended-release tablets or any other anti-diabetic drug.

5.5 Gastrointestinal Obstruction

There have been reports of obstructive symptoms in patients with known strictures in

association with the ingestion of another drug with this non-dissolvable extended release

formulation. Avoid use of glipizide extended-release tablets in patients with preexisting

severe gastrointestinal narrowing (pathologic or iatrogenic).

The 2.5 mg tablets contain FD&C Yellow No.5 (tartrazine) which may cause allergic-type

reactions (including bronchial asthma) in certain susceptible persons. Although the

overall incidence of FD&C Yellow No.5 (tartrazine) sensitivity in the general population is

low, it is frequently seen in patients who also have aspirin hypersensitivity.

6 ADVERSE REACTIONS

The following serious adverse reactions are discussed in more detail below and

elsewhere in the labeling:

Hypoglycemia [see Warnings and Precautions (5.1) ]

Hemolytic anemia [see Warnings and Precautions (5.2) ]

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction

rates observed in the clinical trials of a drug cannot be directly compared to rates in the

clinical trials of another drug and may not reflect the rates observed in practice.

In clinical trials, 580 patients from 31 to 87 years of age received glipizide extended-

release tablets in doses from 5 mg to 60 mg in both controlled and open trials. The

dosages above 20 mg are not recommended dosages. In these trials, approximately

180 patients were treated with glipizide extended-release tablets for at least 6 months.

Table 1 summarizes the incidence of adverse reactions, other than hypoglycemia, that

were reported in pooled double-blind, placebo-controlled trials in ≥3% of glipizide

extended-release tablets-treated patients and more commonly than in patients who

received placebo.

Table 1 Incidence (%) of Adverse Reactions Reported in ≥3%

of Patients Treated in Placebo-Controlled Clinical Trials and

More Commonly in Patients Treated with glipizide extended-

release tablets(Excluding Hypoglycemia)

Glipizide extended-release

tablets (%)

Placebo (%)

( N=278)

(N=69)

Adverse Effect

Dizziness

Diarrhea

Nervousness

Tremor

Flatulence

Hypoglycemia: Of the 580 patients that received glipizide extended-release tablets in

clinical trials, 3.4% had hypoglycemia documented by a blood-glucose measurement

<60 mg/dL and/or symptoms believed to be associated with hypoglycemia and 2.6% of

patients discontinued for this reason. Hypoglycemia was not reported for any placebo

patients.

Gastrointestinal Reactions: In clinical trials, the incidence of gastrointestinal (GI) side

effects (nausea, vomiting, constipation, dyspepsia), occurred in less than 3% of glipizide

extended-release tablets-treated patients and were more common in glipizide extended-

release tablets-treated patients than those receiving placebo.

Dermatologic Reactions

In clinical trials, allergic skin reactions, i.e., urticaria occurred in less than 1.5% of treated

patients and were more common in glipizide extended-release tablets treated patients

than those receiving placebo. These may be transient and may disappear despite

continued use of glipizide extended-release tablets; if skin reactions persist, the drug

should be discontinued.

Laboratory Tests

Mild to moderate elevations of ALT, LDH, alkaline phosphatase, BUN and creatinine have

been noted. The relationship of these abnormalities to glipizide is uncertain.

6.2 Postmarketing Experience

The following adverse reactions have been identified during post approval use of glipizide

extended-release tablets. Because these reactions are reported voluntarily from a

population of uncertain size, it is not always possible to reliably estimate their frequency

or establish a causal relationship to drug exposure.

Abdominal pain

Cholestatic and hepatocellular forms of liver injury accompanied by jaundice

Leukopenia, agranulocytosis, thrombocytopenia, hemolytic anemia [see Warnings and

Leukopenia, agranulocytosis, thrombocytopenia, hemolytic anemia [see Warnings and

Precautions (5.2) ], aplastic anemia, pancytopenia

Hepatic porphyria and disulfiram-like reactions

Hyponatremia and the syndrome of inappropriate antidiuretic hormone (SIADH)

secretion

Rash

There have been reports of gastrointestinal irritation and gastrointestinal bleeding

with use of another drug with this non-dissolvable extended release formulation.

7 DRUG INTERACTIONS

7.1 Drugs Affecting Glucose Metabolism

A number of medications affect glucose metabolism and may require glipizide extended-

release tablets dose adjustment and close monitoring for hypoglycemia or worsening

glycemic control.

The following are examples of medication that may increase the glucose lowering effect

of glipizide extended-release tablets, increase the susceptibility to and/or intensity of

hypoglycemia: antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking

agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline,

pramlintide, propoxyphene, salicylates, somatostatin analogs (e.g., octreotide),

sulfonamide antibiotics, nonsteroidal anti-inflammatory agents, chloramphenicol,

probenecid, coumarins, voriconazole, H2 receptor antagonists, and quinolones. When

these medications are administered to a patient receiving glipizide extended-release

tablets, monitor the patient closely for hypoglycemia. When these medications are

discontinued from a patient receiving glipizide extended-release tablets, monitor the

patient closely for worsening glycemic control.

The following are examples of medication that may reduce the glucose-lowering effect of

glipizide extended-release tablets, leading to worsening glycemic control: atypical

antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics,

estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines,

progestogens (e.g., in oral contraceptives), protease inhibitors, somatropin,

sympathomimetic agents (e.g., albuterol, epinephrine, terbutaline), thyroid hormones,

phenytoin, nicotinic acid, and calcium channel blocking drugs. When such drugs are

administered to patients receiving glipizide extended-release tablets, monitor the patients

closely for worsening glycemic control. When these medications are discontinued from

patients receiving glipizide extended-release tablets, monitor the patient closely for

hypoglycemia.

Alcohol, beta-blockers, clonidine, and reserpine may lead to either potentiation or

weakening of the glucose-lowering effect. Increased frequency of monitoring may be

required when glipizide extended-release tablets is co-administered with these drugs.

The signs of hypoglycemia may be reduced or absent in patients taking sympatholytic

drugs such as beta-blockers, clonidine, guanethidine, and reserpine. Increased

frequency of monitoring may be required when glipizide extended-release tablets is co-

administered with these drugs.

7.2 Miconazole

Monitor patients closely for hypoglycemia when glipizide extended-release tablets are co-

administered with miconazole. A potential interaction between oral miconazole and oral

hypoglycemic agents leading to severe hypoglycemia has been reported [see Clinical

Phamacology (12.3)].

7.3 Fluconazole

Monitor patients closely for hypoglycemia when glipizide extended-release tablets are co-

administered with fluconazole. Concomitant treatment with fluconazole increases plasma

concentrations of glipizide, which may lead to hypoglycemia [see Clinical Pharmacology

(12.3)].

7.4 Colesevelam

Glipizide extended-release tablets should be administered at least 4 hours prior to the

administration of colesevelam. Colesevelam can reduce the maximum plasma

concentration and total exposure of glipizide when the two are coadministered [see

Clinical Pharmacology (12.3)].

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Available data from a small number of published studies and postmarketing experience

with glipizide extended-release tablets use in pregnancy over decades have not identified

any drug associated risks for major birth defects, miscarriage, or adverse maternal

outcomes. However, sulfonylureas (including glipizide) cross the placenta and have been

associated with neonatal adverse reactions such as hypoglycemia. Therefore, glipizide

extended-release tablets should be discontinued at least two weeks before expected

delivery (see Clinical Considerations). Poorly controlled diabetes in pregnancy is also

associated with risks to the mother and fetus (see Clinical Considerations). In animal

studies, there were no effects on embryofetal development following administration of

glipizide to pregnant rats and rabbits during organogenesis at doses 833 times and 8

times the human dose based on body surface area, respectively. However, increased

pup mortality was observed in rats administered glipizide from gestation day 15

throughout lactation at doses 2 times the maximum human dose based on body

surface area (see Data).

The estimated background risk of major birth defects is 6-10% in women with pre-

gestational diabetes with a HbA1c >7 and has been reported to be as high as 20 to 25%

in women with HbA1c >10. The estimated background risk of miscarriage for the

indicated population is unknown. In the U.S. general population, the estimated

background risk of major birth defects and miscarriage in clinically recognized

pregnancies is 2 to 4% and 15 to 20%, respectively.

Clinical Considerations

Disease-Associated Maternal and/or Embryo/Fetal Risk

Poorly-controlled diabetes in pregnancy increases the maternal risk for diabetic

ketoacidosis, pre-eclampsia, miscarriage, preterm delivery, stillbirth, and delivery

complications. Poorly controlled diabetes increases the fetal risk for major birth defects,

stillbirth, and macrosomia related morbidity.

Fetal/Neonatal Adverse Reactions

Neonates of women with gestational diabetes who are treated with sulfonylureas during

pregnancy may be at increased risk for neonatal intensive care admission and may

develop respiratory distress, hypoglycemia, birth injury, and be large for gestational age.

Prolonged severe hypoglycemia, lasting 4 to 10 days, has been reported in neonates

born to mothers receiving a sulfonylurea at the time of delivery and has been reported

with the use of agents with a prolonged half-life. Observe newborns for symptoms of

hypoglycemia and respiratory distress and manage accordingly.

Dose adjustments during pregnancy and the postpartum period

Due to reports of prolonged severe hypoglycemia in neonates born to mothers receiving

a sulfonylurea at the time of delivery, glipizide extended-release tablets should be

discontinued at least two weeks before expected delivery (see Fetal/Neonatal Adverse

Reactions).

Data

Animal Data

In teratology studies in rats and rabbits, pregnant animals received daily oral doses of

glipizide during the period of organogenesis at doses up to 2000 mg/kg/day and 10

mg/kg/day (approximately 833 and 8 times the human dose based on body surface

area), respectively. There were no adverse effects on embryo-fetal development at any

of the doses tested. In a peri-and postnatal study in pregnant rats, there was a reduced

number of pups born alive following administration of glipizide from gestation day 15

throughout lactation through weaning at doses ≥5 mg/kg/day (about 2 times the

recommended maximum human dose based on body surface area).

8.2 Lactation

Risk Summary

Breastfed infants of lactating women using glipizide extended-release tablets should be

monitored for symptoms of hypoglycemia (see Clinical Considerations). Although

glipizide was undetectable in human milk in one small clinical lactation study; this result is

not conclusive because of the limitations of the assay used in the study. There are no

data on the effects of glipizide on milk production. The developmental and health

benefits of breastfeeding should be considered along with the mother's clinical need for

glipizide extended-release tablets and any potential adverse effects on the breastfed

child from glipizide extended-release tablets or from the underlying maternal condition.

Clinical Considerations

Monitoring for adverse reactions

Monitor breastfed infants for signs of hypoglycemia (e.g., jitters, cyanosis, apnea,

hypothermia, excessive sleepiness, poor feeding, seizures).

8.4 Pediatric Use

Safety and effectiveness in children have not been established.

8.5 Geriatric Use

There were no overall differences in effectiveness or safety between younger and older

patients, but greater sensitivity of some individuals cannot be ruled out. Elderly patients

are particularly susceptible to the hypoglycemic action of anti-diabetic agents.

Hypoglycemia may be difficult to recognize in these patients. Therefore, dosing should

be conservative to avoid hypoglycemia. [see Dosage and Administration (2.1), Warnings

and Precautions (5.1) and Clinical Pharmacology (12.3)]

8.6 Hepatic Impairment

There is no information regarding the effects of hepatic impairment on the disposition of

glipizide. 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 hepatic impairment. If hypoglycemia occurs in

such patients, it may be prolonged and appropriate management should be instituted.

[see Dosage and Administration (2.1), Warnings and Precautions (5.1) and Clinical

Pharmacology (12.3)]

10 OVERDOSAGE

Overdosage of sulfonylureas including glipizide extended-release tablets can produce

severe hypoglycemia. Mild hypoglycemic symptoms without loss of consciousness or

neurologic findings should be treated with oral glucose. Severe hypoglycemic reactions

with coma, seizure, or other neurological impairment are medical emergencies requiring

immediate treatment. The patient should be treated with glucagon or intravenous

glucose. 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.

11 DESCRIPTION

Glipizide extended-release tablets are an oral sulfonylurea.

The Chemical Abstracts name of glipizide is 1-cyclohexyl-3-[[p-[2-(5-

methylpyrazinecarboxamido) ethyl] phenyl]sulfonyl]urea. The molecular formula is

N O S; the molecular weight is 445.55; the structural formula is shown below:

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