Glipizide

Glipizideis 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 orstroke. Glipizide belongs to the class of drugs known as sulfonylureas. It lowers blood sugar by causing the release of your body's naturalinsulin.

Glipizide is available under the following different brand names:Glucotrol,Glucotrol XL, and Minodiab.

Dosage Forms and Strengths

Tablet

• 5 mg
• 10 mg

Tablet, extended-release

• 2.5 mg
• 5 mg
• 10 mg

Dosage Considerations – Should be Given as Follows:

Type 2Diabetes Mellitus

Immediate-release tablet

• 5 mg orally once/day initially; increase by 2.5-5 mg as needed every several days based onblood glucose
• Maintenance range: 2.5-20 mg orally once/day or every 12 hours; not to exceed 40 mg/day

Extended-release tablets (Glucotrol XL)

• Initial: 5 mg/day orally given with breakfast; dose adjustment based on blood glucose should not be done more frequently than every 7 days
• Maintenance range: 5-10 mg orally once/day; not to exceed 20 mg/day

Dosing considerations

• 20 mg orally once/day; may increase by 10 mg/day every 2 weeks to 40 mg orally once/day; doses greater than 40 mg not recommended (may increase risk of QT prolongation)

Geriatric: Older than 60 years: Do not exceed 20 mg orally once/day

Dosing Modifications

• 大于15毫克剂量:口头/每12hours recommended

Geriatric

• 2.5 mg orally once/day initially; increase by 2.5-5 mg/day every 1-2 weeks as determined by blood glucose response at intervals of several days
• May switch to extended release once daily tablets at the nearest equivalent total daily dose or lower end of recommended range; not to exceed 20 mg/day

Conversion From Immediate Release to Extended Release

• Administer the nearest equivalent immediate-release daily dose as extended-release tablet once daily
• Alternatively, administer 5 mg orally initially; titrate as necessary

Conversion From Long Half-Life Agents

• Observe patients carefully for 1-2 weeks when being converted from long half-life sulfonylureas to glipizide, because of potential for overlapping ofhypoglycemiceffects

Transferring From Insulin Therapy to Glipizide IR orER

• Current insulin dose less than 20 units: Discontinue insulin and initiate glipizide therapy at recommended dose
• Current insulin dose greater than 20 units: Decrease insulin dose by 50% and initiate glipizide at recommended dose; decrease insulin dose gradually based on patient's response

Dosing Modifications

• Hepatic impairment: 2.5 mg orally once/day initially (immediate release); extended release not studied
• Renal impairment: Not studied; if GFR less than 50 mL/min, may decrease dose by 50% (suggested)
• Pediatric: Safety and efficacy not established

Dosing considerations

• Because elderly patients are susceptible to the hypoglycemic effects of glucose-lowering drugs, the question of how tightly glucose levels should be controlled in the elderly is controversial
• 认识到hypoglycemiain elderly patients may be challenging
• Monitoring other parameters associated withcardiovascular disease, such as blood pressure and cholesterol, may be more important than normalized glycemic control
• Initial and maintenance dosing should be conservative

Side effects of glipizide include:

• Dermatologicreactions
• Abdominal pain
• Diarrhea
• Lightheadednessandfainting
• Constipation
• Gas (flatulence)
• Dizziness
• Nervousness
• Headache
• Anxiety
• Depression
• Drowsiness
• Skin redness
• Heartburn
• Red, bumpy rash
• 低血糖(低血糖症)
• Nausea/vomiting
• Hives
• Cholestatic jaundice and hepatitis occur rarely but may progress toliver failure

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider or pharmacist first.

Severe Interactions of glipizide include:

• None

Serious Interactions of glipizide include:

• aminolevulinic acid
• ethanol
• lumacaftor/ivacaftor
• methyl aminolevulinate

Glipizide has moderate interactions with at least 156 different drugs.

Glipizide has mild interactions with at least 91 different drugs.

This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns or for more information about this medicine.

Warnings

• This medication contains glipizide. Do not take Glucotrol, Glucotrol XL, or Minodiab if you are allergic to glipizide or any ingredients contained in this drug
• Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately

Contraindications

• Hypersensitivity; sulfa allergy
• Type 1 diabetes
• Diabetic ketoacidosis with or without comav

Effects of Drug Abuse

• None

Short-Term Effects

• See "What Are Side Effects Associated with Using Glipizide ?"

Long-Term Effects

• Loss of efficacy following prolonged use possible; if no contributing factors, to explain loss of efficacy identified, consider discontinuing therapy; additional antidiabetic therapy will be required.
• See "What Are Side Effects Associated with Using Glipizide ?"

Cautions

• Patients with risk of severe hypoglycemia include the elderly, debilitated, or malnourished; adrenal orpituitaryinsufficiency; stress due to infection, fever,trauma, or surgery; concomitant use with beta-blockers or other sympatholytic agents may impair the patient's ability to recognize the signs and symptoms of hypoglycemia; use with caution
• If patient is exposed to stress (fever, trauma, infection, surgery), it may be necessary to discontinue glipizide and initiate insulin
• Use caution in hepatic/renal impairment
• Use with caution in pregnancy and lactation
• Increased risk ofcardiovascularmortality suggested by product labeling but data is limited
• FDA-approved product labeling for many medications have included a broadcontraindicationin patients with a prior allergic reaction tosulfonamides; however, recent studies have suggested that cross-reactivity betweenantibioticsulfonamides and non-antibiotic sulfonamides is unlikely to occur; increase in cardiovascular mortality suggested by product labeling but data is limited
• 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
• Hypoglycemia may be difficult to recognize in patients withautonomic neuropathy
• Hemolytic anemiamay occur with glucose 6-phosphate dehydrogenase (G6PD) deficiency when treated withsulfonylureaagents; consider a non-sulfonylurea alternative
• Avoid using the extended-release tablets in patients with severegastrointestinalnarrowing ofesophagealdysmotility
• Clinical studies have not found conclusive evidence that anti-diabetic drugs reducemacrovascularrisk
• Loss of efficacy following prolonged use possible; if no contributing factors, to explain loss of efficacy identified, consider discontinuing therapy; additional antidiabetic therapy will be required
• Drug interactions overview:
• The hypoglycemic action of sulfonylureas may be potentiated by certain drugs including nonsteroidal anti-inflammatory agents, some azoles, and other drugs that are highly protein bound, salicylates, sulfonamides,chloramphenicol、丙磺舒、香豆素类、单胺氧化酶抑制药ors, quinolones andbeta adrenergic blocking agents; conversely, certain drugs tend to producehyperglycemiaand may lead to loss of control, including thiazides and other diuretics, corticosteroids, phenothiazines,thyroidproducts,estrogens, oral contraceptives,phenytoin,nicotinic acid, sympathomimetics, calcium channel blocking drugs, andisoniazid; when co-administering glipizide with such drugs, patient should be observed closely for hypoglycemia or hyperglycemia; when such drugs are withdrawn, observe patient closely for loss of control

Pregnancy and Lactation

Use glipizide with caution during pregnancy if benefits outweigh risks. Animal studies show risk and human studies are not available, or neither animal nor human studies were done.

It is not known if glipizide crosses into breast milk; it is not recommended for use while breastfeeding.