Glipizide XL 5mg Tablets

Manufacturer GREENSTONE Active Ingredient Glipizide Extended-Release Tablets(GLIP i zide) Pronunciation GLIP-i-zide
It is used to help control blood sugar in people with type 2 diabetes.
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Drug Class
Antidiabetic Agent
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Pharmacologic Class
Sulfonylurea
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Pregnancy Category
Category C
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FDA Approved
Sep 1994
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Glipizide XL is a medication used to help control high blood sugar in people with type 2 diabetes. It works by helping your body release more insulin from your pancreas, which then helps lower your blood sugar. It's an extended-release tablet, meaning it releases the medicine slowly over the day.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take your medication with your first meal of the day. Swallow the tablet whole - do not chew, break, crush, or dissolve it.

If you have any changes in your eating habits, such as skipping a meal or not eating as much as usual, be sure to discuss this with your doctor to determine the best course of action.

Storing and Disposing of Your Medication

To maintain the quality and safety of your medication, store it at room temperature in a dry place, away from the bathroom. Keep your medication in its original container to ensure it remains intact and effective. Store all medications in a safe and secure location, out of the reach of children and pets.

What to Do If You Miss a Dose

If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed dose.
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Lifestyle & Tips

  • Take Glipizide XL once daily with breakfast or the first main meal of the day.
  • Do not crush, chew, or divide the extended-release tablets; swallow them whole.
  • Follow your doctor's instructions regarding diet and exercise. These are crucial for managing diabetes.
  • Monitor your blood sugar levels regularly as advised by your doctor.
  • Be aware of the symptoms of low blood sugar (hypoglycemia) and know how to treat it (e.g., consume 15-20 grams of simple carbohydrates like glucose tablets, fruit juice, or hard candy).
  • Carry a source of fast-acting sugar with you at all times.
  • Inform all healthcare providers, including dentists, that you are taking glipizide.
  • Avoid excessive alcohol consumption, as it can increase the risk of hypoglycemia.

Dosing & Administration

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Adult Dosing

Standard Dose: 5 mg orally once daily with breakfast or the first main meal
Dose Range: 2.5 - 20 mg

Condition-Specific Dosing:

initialDose: 5 mg once daily
maintenanceDose: Adjust in increments of 2.5 mg to 5 mg at 3-7 day intervals based on blood glucose response
maximumDose: 20 mg once daily
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment, monitor closely
Moderate: Consider lower initial dose (e.g., 2.5 mg) and titrate cautiously; increased risk of hypoglycemia
Severe: Not recommended; increased risk of hypoglycemia
Dialysis: Not recommended; increased risk of hypoglycemia

Hepatic Impairment:

Mild: Consider lower initial dose (e.g., 2.5 mg) and titrate cautiously; increased risk of hypoglycemia
Moderate: Consider lower initial dose (e.g., 2.5 mg) and titrate cautiously; increased risk of hypoglycemia
Severe: Not recommended; increased risk of hypoglycemia

Pharmacology

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Mechanism of Action

Glipizide, a sulfonylurea, lowers blood glucose by stimulating the release of insulin from the pancreatic beta cells. It binds to the sulfonylurea receptor (SUR1) on the beta-cell membrane, leading to closure of ATP-sensitive potassium channels, depolarization of the membrane, and opening of voltage-gated calcium channels. The resulting influx of calcium triggers insulin secretion. It also may increase peripheral glucose utilization and decrease hepatic glucose production.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 100%
Tmax: 6-12 hours (extended-release formulation)
FoodEffect: Absorption is not significantly affected by food for the extended-release formulation, but it should be taken with breakfast or the first main meal to optimize blood glucose control.

Distribution:

Vd: Approximately 10-11 liters
ProteinBinding: >98% (primarily to albumin)
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 10-14 hours (extended-release formulation)
Clearance: Not available
ExcretionRoute: Mainly renal (80% as metabolites, <10% as unchanged drug), some fecal (10%)
Unchanged: <10%
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Pharmacodynamics

OnsetOfAction: 1-3 hours
PeakEffect: 6-12 hours
DurationOfAction: 24 hours
Confidence: Medium

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Changes in eyesight
Slurred speech
Tingling
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak

Additionally, low blood sugar (hypoglycemia) can occur, especially when this medication is used with other diabetes medications. If you experience any of the following symptoms, contact your doctor right away:

Dizziness
Headache
Feeling sleepy or weak
Shaking
Fast heartbeat
Confusion
Hunger
Sweating

Follow your doctor's instructions for managing low blood sugar, which may include taking glucose tablets, liquid glucose, or consuming certain fruit juices.

Other Possible Side Effects

Like all medications, this drug can cause side effects. Although many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor for advice:

Dizziness
Diarrhea
Feeling nervous and excitable
* Gas

This is not an exhaustive list of possible side effects. If you have questions or concerns, don't hesitate to reach out to your doctor.

Reporting Side Effects

To report side effects, you can contact the FDA at 1-800-332-1088 or visit their website at https://www.fda.gov/medwatch. Your doctor is also available to provide guidance on managing side effects.
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Seek Immediate Medical Attention If You Experience:

  • Symptoms of hypoglycemia (low blood sugar): sweating, shakiness, dizziness, confusion, hunger, irritability, headache, blurred vision, rapid heartbeat, weakness, slurred speech. Seek immediate medical attention if severe.
  • Symptoms of allergic reaction: rash, itching, swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. Seek immediate medical attention.
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced.
A known sulfa allergy.
Any narrowing of the gastrointestinal (GI) tract or a history of bowel blockage.
Acidic blood problems, such as acidosis.
* If you have type 1 diabetes, as this medication is not intended to treat this condition.

This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions.

Remember, do not start, stop, or change the dosage of any medication without first consulting your doctor to ensure your safety.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before engaging in activities that require alertness, such as driving, wait until you understand how this drug affects you. Monitor your blood sugar levels as instructed by your doctor.

Regular blood work is crucial, so follow your doctor's schedule for check-ups and discuss the results with them. Be aware that this medication may interfere with certain laboratory tests, so notify all your healthcare providers and lab personnel that you are taking this drug.

Adhere to the diet and exercise plan recommended by your doctor to maintain optimal health. If you experience low blood sugar, avoid driving, as it increases the risk of accidents. Additionally, refrain from consuming alcohol while taking this medication.

If you are also taking colesevelam, ensure you take it at least 4 hours after taking this drug. Be aware that stress, such as fever, infection, injury, or surgery, can affect blood sugar control. Changes in physical activity, exercise, or diet may also impact blood sugar levels.

Individuals with low levels of the enzyme G6PD should exercise caution, as they may be more prone to anemia. This enzyme deficiency is more common in patients of African, South Asian, Middle Eastern, and Mediterranean descent.

There is an increased risk of death from heart disease associated with this medication, so discuss this with your doctor. Low blood sugar is a potential side effect, and severe cases can lead to seizures, loss of consciousness, long-term brain damage, and even death. Consult your doctor if you experience any symptoms.

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. Pregnant or breastfeeding women, or those planning to become pregnant, should discuss the benefits and risks of this medication with their doctor.

You may notice the tablet shell in your stool, but this is a normal occurrence and not a cause for concern. However, if you are taking this medication during pregnancy, you may need to stop taking it before your due date, as low blood sugar has been reported in infants born to mothers who took similar medications. Consult your doctor to determine the best course of action.
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Overdose Information

Overdose Symptoms:

  • Severe hypoglycemia (extremely low blood sugar)
  • Confusion
  • Slurred speech
  • Tremor
  • Seizures
  • Loss of consciousness
  • Coma

What to Do:

Call 911 or your local emergency number immediately. If the person is conscious, administer oral glucose (e.g., glucose tablets, sugar-sweetened beverage). If unconscious, administer glucagon if available and trained, then seek emergency medical care. Call 1-800-222-1222 for Poison Control advice.

Drug Interactions

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Major Interactions

  • Bosentan (increased risk of hepatotoxicity)
  • Miconazole (oral, IV, topical - increased risk of hypoglycemia)
  • Alcohol (increased risk of hypoglycemia, disulfiram-like reaction)
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Moderate Interactions

  • Beta-blockers (mask hypoglycemia symptoms, impair glucose recovery)
  • NSAIDs (enhance hypoglycemic effect)
  • Salicylates (high doses, enhance hypoglycemic effect)
  • Sulfonamides (enhance hypoglycemic effect)
  • Chloramphenicol (enhance hypoglycemic effect)
  • Probenecid (enhance hypoglycemic effect)
  • Coumarin derivatives (potentiate or diminish anticoagulant effect)
  • Fluconazole (increase glipizide levels, increased hypoglycemia risk)
  • Corticosteroids (decrease hypoglycemic effect)
  • Thiazide diuretics (decrease hypoglycemic effect)
  • Thyroid hormones (decrease hypoglycemic effect)
  • Sympathomimetics (decrease hypoglycemic effect)
  • Phenytoin (decrease hypoglycemic effect)
  • Rifampin (decrease glipizide levels, reduced efficacy)
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Minor Interactions

  • Cimetidine (may increase glipizide levels slightly)
  • Ranitidine (may increase glipizide levels slightly)

Monitoring

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Baseline Monitoring

HbA1c

Rationale: To establish baseline glycemic control and guide initial dosing.

Timing: Prior to initiation

Fasting Plasma Glucose (FPG)

Rationale: To establish baseline glycemic control and guide initial dosing.

Timing: Prior to initiation

Renal Function (SCr, eGFR)

Rationale: To assess kidney function, as glipizide is primarily renally eliminated and renal impairment increases hypoglycemia risk.

Timing: Prior to initiation

Hepatic Function (ALT, AST, Bilirubin)

Rationale: To assess liver function, as glipizide is hepatically metabolized and hepatic impairment increases hypoglycemia risk.

Timing: Prior to initiation

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Routine Monitoring

HbA1c

Frequency: Every 3-6 months

Target: <7% (individualized)

Action Threshold: >7% (consider dose adjustment or additional therapy)

Fasting Plasma Glucose (FPG)

Frequency: Daily or several times per week (patient self-monitoring)

Target: 80-130 mg/dL (individualized)

Action Threshold: <70 mg/dL (hypoglycemia, requires intervention); >180 mg/dL (hyperglycemia, consider dose adjustment)

Signs and Symptoms of Hypoglycemia

Frequency: Continuously (patient education)

Target: N/A

Action Threshold: Any occurrence (requires immediate treatment and dose/regimen review)

Renal Function (SCr, eGFR)

Frequency: Annually or more frequently if clinically indicated

Target: Stable

Action Threshold: Significant decline (consider dose adjustment or alternative therapy)

Hepatic Function (ALT, AST, Bilirubin)

Frequency: Annually or more frequently if clinically indicated

Target: Stable

Action Threshold: Significant elevation (consider alternative therapy)

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Symptom Monitoring

  • Symptoms of hypoglycemia: sweating, tremor, dizziness, confusion, hunger, irritability, headache, blurred vision, rapid heartbeat, weakness, slurred speech, seizures, loss of consciousness.
  • Symptoms of hyperglycemia (less common with glipizide monotherapy): increased thirst, increased urination, fatigue, blurred vision.

Special Patient Groups

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Pregnancy

Glipizide is Pregnancy Category C. It is generally not recommended for use during pregnancy, especially near term, due to the potential for severe neonatal hypoglycemia. Insulin is typically preferred for glycemic control in pregnant women with diabetes.

Trimester-Specific Risks:

First Trimester: Potential for fetal harm not ruled out; risk vs. benefit should be carefully considered.
Second Trimester: Potential for fetal harm not ruled out; risk vs. benefit should be carefully considered.
Third Trimester: Increased risk of severe neonatal hypoglycemia if used near term. Discontinue at least one month before expected delivery.
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Lactation

Glipizide is excreted into breast milk. Due to the potential for hypoglycemia in the nursing infant, it is generally not recommended during breastfeeding. Insulin is usually preferred for glycemic control in lactating women.

Infant Risk: Risk of hypoglycemia in the infant.
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Pediatric Use

Safety and effectiveness have not been established in pediatric patients. Use is not recommended.

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Geriatric Use

Elderly patients are more susceptible to the hypoglycemic effects of glipizide due to potential age-related decline in renal and hepatic function, and often have multiple comorbidities and polypharmacy. Start with a lower initial dose (e.g., 2.5 mg) and titrate cautiously. Close monitoring for hypoglycemia is essential.

Clinical Information

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Clinical Pearls

  • Glipizide XL is an extended-release formulation, so it should be swallowed whole and not crushed, chewed, or divided.
  • Always take Glipizide XL with breakfast or the first main meal to minimize the risk of hypoglycemia and optimize efficacy.
  • Patients should be thoroughly educated on the symptoms and management of hypoglycemia.
  • Renal and hepatic impairment significantly increase the risk of hypoglycemia; dose adjustments or alternative therapies are often necessary.
  • Alcohol consumption should be limited or avoided due to increased risk of hypoglycemia and potential disulfiram-like reactions.
  • Sulfonylureas like glipizide can lose effectiveness over time (secondary failure) as beta-cell function declines.
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Alternative Therapies

  • Other sulfonylureas (e.g., glyburide, glimepiride)
  • Metformin (biguanide)
  • DPP-4 inhibitors (e.g., sitagliptin, saxagliptin)
  • SGLT2 inhibitors (e.g., empagliflozin, canagliflozin)
  • GLP-1 receptor agonists (e.g., liraglutide, semaglutide)
  • Thiazolidinediones (e.g., pioglitazone, rosiglitazone)
  • Insulin therapy
  • Meglitinides (e.g., repaglinide, nateglinide)
  • Alpha-glucosidase inhibitors (e.g., acarbose, miglitol)
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Cost & Coverage

Average Cost: $10 - $50 per 30 tablets (generic Glipizide XL 5mg)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (preferred generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.