Glipizide XL 10mg 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
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 pancreas release more insulin, which lowers 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

To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your dose with your first meal of the day. Swallow the tablet whole - do not chew, break, crush, or dissolve it. If you have a change in your eating habits or skip a meal, be sure to understand how to adjust your medication schedule accordingly.

Storing and Disposing of Your Medication

Keep your medication at room temperature in a dry place, avoiding storage in a bathroom. Store the medication in its original container to maintain its effectiveness. It is essential to keep all medications in a safe location, out of the reach of children and pets, to prevent accidental ingestion.

Missing 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, as this may increase the risk of side effects.
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Lifestyle & Tips

  • Take Glipizide XL once daily with breakfast to help it work best and reduce the risk of low blood sugar.
  • Follow a healthy diet plan recommended by your doctor or dietitian.
  • Engage in regular physical activity as advised by your healthcare provider.
  • Monitor your blood sugar levels regularly as instructed by your doctor.
  • Carry a source of fast-acting sugar (e.g., glucose tablets, hard candy, fruit juice) to treat low blood sugar.
  • Limit or avoid alcohol consumption, as it can increase the risk of low blood sugar and other side effects.

Dosing & Administration

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Adult Dosing

Standard Dose: Initial: 5 mg orally once daily with breakfast. Maintenance: 5-20 mg orally once daily.
Dose Range: 5 - 20 mg

Condition-Specific Dosing:

type2Diabetes: Initial 5 mg once daily with breakfast. Titrate in 5 mg increments at weekly intervals based on blood glucose response. Maximum recommended daily dose is 20 mg.
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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, but monitor closely.
Moderate: Consider starting with 2.5 mg once daily and titrate cautiously. Increased risk of hypoglycemia.
Severe: Use with extreme caution or avoid. Consider starting with 2.5 mg once daily and monitor closely for hypoglycemia. Not recommended for eGFR < 30 mL/min/1.73m².
Dialysis: Not recommended due to high risk of prolonged hypoglycemia. Insulin is generally preferred.

Hepatic Impairment:

Mild: Consider starting with 2.5 mg once daily and titrate cautiously.
Moderate: Consider starting with 2.5 mg once daily and titrate cautiously. Increased risk of hypoglycemia.
Severe: Use with extreme caution or avoid. Not recommended due to increased risk of severe and prolonged hypoglycemia.

Pharmacology

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Mechanism of Action

Glipizide, a sulfonylurea, lowers blood glucose primarily 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, influx of calcium, and subsequent exocytosis of insulin granules. It also has some extrapancreatic effects, including increased peripheral glucose utilization and decreased hepatic glucose production.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 100%
Tmax: 6-12 hours (for extended-release formulation)
FoodEffect: Food (especially high-fat meals) may delay absorption but does not significantly affect the extent of absorption. Should be taken with breakfast to optimize blood glucose control and minimize hypoglycemia risk.

Distribution:

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

Elimination:

HalfLife: 10-14 hours (effective half-life for extended-release formulation)
Clearance: Not available
ExcretionRoute: Mainly urine (80%), small amount in feces (10%)
Unchanged: <1%
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Pharmacodynamics

OnsetOfAction: 1-3 hours (for extended-release formulation)
PeakEffect: 6-12 hours (for extended-release formulation)
DurationOfAction: 24 hours (for extended-release formulation)

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 medical attention immediately:

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
Symptoms of low blood sugar, which may include:
+ Dizziness
+ Headache
+ Feeling sleepy or weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating

If you experience any of these symptoms, follow your doctor's instructions for managing low blood sugar, which may include taking glucose tablets, liquid glucose, or some 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 symptoms that bother you or do not go away, contact your doctor or seek medical help:

Dizziness
Diarrhea
Feeling nervous and excitable
Gas

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Symptoms of low blood sugar (hypoglycemia): sweating, shaking, dizziness, confusion, hunger, irritability, blurred vision, headache, rapid heartbeat. If these occur, consume a fast-acting sugar source immediately.
  • Symptoms of high blood sugar (hyperglycemia): increased thirst, increased urination, fatigue, blurred vision. Report these to your doctor.
  • Signs of allergic reaction: rash, itching, swelling (especially of the face, tongue, or throat), severe dizziness, trouble breathing. Seek immediate medical attention.
  • Unusual weight gain or swelling.
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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 symptoms you experienced.
A known sulfa allergy.
Any narrowing of the gastrointestinal (GI) tract or a history of bowel blockage.
Acidic blood conditions, such as those that affect your blood's pH balance.
* 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 you determine if it is safe to take this medication with your existing treatments and health conditions. Never start, stop, or adjust 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 tests will be necessary, as directed by your doctor. Be sure to discuss any concerns or questions with your doctor during these appointments. Additionally, inform all healthcare providers and laboratory personnel that you are taking this medication, as it may impact certain lab test results.

Adhere to the diet and exercise plan recommended by your doctor. If you experience low blood sugar, avoid driving, as this increases the risk of accidents. It is also recommended to avoid consuming alcohol while taking this medication. If you are taking colesevelam, 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. If you have a deficiency of the enzyme G6PD, exercise caution, as you may be more prone to anemia. This enzyme deficiency is more common in individuals of African, South Asian, Middle Eastern, and Mediterranean descent.

There is an increased risk of heart disease-related death associated with this medication. Discuss this risk 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 of low blood sugar.

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding, as the benefits and risks to you and the baby need to be discussed.

You may notice the tablet shell in your stool, but this is a normal occurrence and not a cause for concern. However, if you take 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 for guidance on managing this risk.
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Overdose Information

Overdose Symptoms:

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

What to Do:

In case of suspected overdose, seek immediate medical attention. For conscious patients, administer oral glucose. For unconscious patients, administer intravenous glucose (dextrose) or glucagon. Prolonged observation in a hospital setting is often required due to the extended-release nature and potential for recurrent hypoglycemia. Call 1-800-222-1222 (Poison Control).

Drug Interactions

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Contraindicated Interactions

  • Bosentan (increased risk of hepatotoxicity)
  • Miconazole (oral, severe hypoglycemia)
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Major Interactions

  • Alcohol (disulfiram-like reaction, severe hypoglycemia)
  • Beta-blockers (mask hypoglycemia symptoms, impair glucose recovery)
  • Fluconazole (increased glipizide levels, hypoglycemia)
  • NSAIDs (increased glipizide levels, hypoglycemia)
  • Sulfonamides (increased glipizide levels, hypoglycemia)
  • Chloramphenicol (increased glipizide levels, hypoglycemia)
  • Probenecid (increased glipizide levels, hypoglycemia)
  • MAOIs (increased glipizide levels, hypoglycemia)
  • Warfarin (altered anticoagulant effect, monitor INR)
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Moderate Interactions

  • Cimetidine (increased glipizide levels, hypoglycemia)
  • Diuretics (thiazides, loop diuretics - may cause hyperglycemia)
  • Corticosteroids (may cause hyperglycemia)
  • Thyroid products (may cause hyperglycemia)
  • Estrogens/Oral Contraceptives (may cause hyperglycemia)
  • Phenytoin (may cause hyperglycemia)
  • Nicotinic acid (may cause hyperglycemia)
  • Sympathomimetics (may cause hyperglycemia)
  • Calcium channel blockers (may cause hyperglycemia)
  • Isoniazid (may cause hyperglycemia)
  • Rifampin (decreased glipizide levels, hyperglycemia)
  • Colesevelam (decreased glipizide absorption, administer glipizide 4 hours before)
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

HbA1c

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

Timing: Prior to initiation of therapy.

Fasting Plasma Glucose (FPG)

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

Timing: Prior to initiation of therapy.

Renal Function (SCr, eGFR)

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

Timing: Prior to initiation of therapy.

Hepatic Function (ALT, AST)

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

Timing: Prior to initiation of therapy.

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Routine Monitoring

HbA1c

Frequency: Every 3-6 months

Target: <7% (individualized)

Action Threshold: If target not met, consider dose adjustment or addition of other agents.

Fasting Plasma Glucose (FPG)

Frequency: Daily (self-monitoring) or weekly (clinic)

Target: 80-130 mg/dL (individualized)

Action Threshold: Persistent readings outside target range may indicate need for dose adjustment.

Symptoms of Hypoglycemia

Frequency: Daily, patient self-monitoring

Target: N/A

Action Threshold: Any symptoms of hypoglycemia (e.g., sweating, tremor, confusion) require immediate action (consume glucose) and dose review.

Renal Function (SCr, eGFR)

Frequency: Annually or as clinically indicated

Target: N/A

Action Threshold: Significant decline may necessitate dose reduction or discontinuation.

Hepatic Function (ALT, AST)

Frequency: Annually or as clinically indicated

Target: N/A

Action Threshold: Significant elevation may necessitate dose reduction or discontinuation.

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Symptom Monitoring

  • Symptoms of hypoglycemia (e.g., sweating, tremor, dizziness, confusion, hunger, irritability, blurred vision, headache, rapid heartbeat)
  • Symptoms of hyperglycemia (e.g., increased thirst, increased urination, fatigue, blurred vision)
  • Signs of allergic reaction (e.g., rash, itching, swelling)
  • Gastrointestinal upset (e.g., nausea, diarrhea, constipation)

Special Patient Groups

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Pregnancy

Category C. Not recommended for use during pregnancy. Insulin is generally preferred for glycemic control in pregnant women with diabetes due to the potential for fetal hyperinsulinemia and neonatal hypoglycemia with sulfonylureas.

Trimester-Specific Risks:

First Trimester: Potential for fetal hyperinsulinemia and neonatal hypoglycemia if used near term.
Second Trimester: Potential for fetal hyperinsulinemia and neonatal hypoglycemia if used near term.
Third Trimester: Increased risk of severe neonatal hypoglycemia if used near term, especially during the last month of pregnancy. Discontinue at least one month before expected delivery.
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Lactation

Excreted into breast milk. Not recommended during breastfeeding due to the potential for hypoglycemia in the breastfed infant.

Infant Risk: Risk of hypoglycemia in the infant. Monitor infant for signs of hypoglycemia (e.g., lethargy, poor feeding, jitteriness).
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Pediatric Use

Safety and effectiveness have not been established in pediatric patients. Not recommended for use in children.

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Geriatric Use

Use with caution in elderly patients due to increased risk of hypoglycemia, particularly in those with impaired renal or hepatic function. Start with a lower dose (e.g., 2.5 mg daily) and titrate slowly. Monitor blood glucose closely.

Clinical Information

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Clinical Pearls

  • Always take Glipizide XL with breakfast to ensure optimal absorption and reduce the risk of hypoglycemia.
  • Patients should be educated on the symptoms of hypoglycemia and how to treat it immediately.
  • Weight gain is a common side effect of sulfonylureas.
  • Not effective in patients with Type 1 diabetes or diabetic ketoacidosis (DKA) as it requires functioning pancreatic beta cells.
  • Caution is advised in patients with G6PD deficiency due to the risk of hemolytic anemia with sulfonylureas.
  • Regular monitoring of blood glucose and HbA1c is crucial to assess efficacy and safety.
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Alternative Therapies

  • Metformin (Biguanide)
  • DPP-4 inhibitors (e.g., Sitagliptin, Saxagliptin)
  • SGLT2 inhibitors (e.g., Canagliflozin, Dapagliflozin)
  • GLP-1 receptor agonists (e.g., Liraglutide, Semaglutide)
  • Thiazolidinediones (e.g., Pioglitazone, Rosiglitazone)
  • Meglitinides (e.g., Repaglinide, Nateglinide)
  • Insulin therapy
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Cost & Coverage

Average Cost: $10 - $50 per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (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 your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it occurred, to facilitate prompt and effective treatment.