Glipizide 10mg Tablets

Manufacturer APOTEX USA Active Ingredient Glipizide 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
Jun 1984
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Glipizide is a medication used to treat type 2 diabetes. It helps your body release more insulin, which lowers your blood sugar levels. It's important to take this medication exactly as prescribed, usually 30 minutes before your first meal of the day, to help control your blood sugar.
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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 30 minutes before eating, preferably 30 minutes before your first meal of the day if you are taking it once daily. 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

Store your medication at room temperature in a dry location, avoiding the bathroom. Keep all medications in a secure place, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about the best way to dispose of your medication, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.

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 to make up for a missed one.
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Lifestyle & Tips

  • 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.
  • Be aware of the symptoms of low blood sugar (hypoglycemia) and know how to treat it (e.g., consume 15-20 grams of fast-acting carbohydrate like glucose tablets, fruit juice, or hard candy).
  • Carry a source of fast-acting sugar with you at all times.
  • Limit or avoid alcohol consumption, as it can increase the risk of low blood sugar and cause a disulfiram-like reaction.
  • Inform all healthcare providers, including dentists, that you are taking glipizide.

Dosing & Administration

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Adult Dosing

Standard Dose: 5 mg once daily, 30 minutes before breakfast. Doses >15 mg/day should be divided.
Dose Range: 2.5 - 40 mg

Condition-Specific Dosing:

initialDose: 2.5-5 mg once daily
maintenanceDose: 5-20 mg daily, adjusted in 2.5-5 mg increments based on blood glucose response
maximumDose: 40 mg daily (divided doses for >15 mg/day)
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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: Initiate with lower dose (e.g., 2.5 mg daily), titrate carefully. Monitor for hypoglycemia.
Severe: Use with extreme caution or avoid. Significant risk of hypoglycemia. Consider alternative agents.
Dialysis: Not recommended due to high risk of prolonged hypoglycemia. Glipizide is not significantly removed by dialysis.

Hepatic Impairment:

Mild: Initiate with lower dose (e.g., 2.5 mg daily), titrate carefully. Monitor for hypoglycemia.
Moderate: Initiate with lower dose (e.g., 2.5 mg daily), titrate carefully. Monitor for hypoglycemia. Increased risk of prolonged hypoglycemia.
Severe: Use with extreme caution or avoid. Significant risk of prolonged and severe hypoglycemia. Consider alternative agents.

Pharmacology

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Mechanism of Action

Glipizide is a second-generation sulfonylurea that lowers blood glucose primarily by stimulating the release of insulin from the beta cells of the pancreatic islets. It binds to the sulfonylurea receptor (SUR1) on the pancreatic beta-cell membrane, leading to the closure of ATP-sensitive potassium channels. This depolarizes the cell, opening voltage-gated calcium channels, and the 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: 2-4 hours (immediate release)
FoodEffect: Food delays absorption and decreases peak plasma concentrations, but the total amount absorbed is not significantly affected. Administer 30 minutes before a meal for optimal effect.

Distribution:

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

Elimination:

HalfLife: 2-4 hours
Clearance: Not available
ExcretionRoute: Mainly renal (80%) as inactive metabolites, with a small amount (10%) excreted in feces.
Unchanged: <1%
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Pharmacodynamics

OnsetOfAction: Within 30 minutes
PeakEffect: 2-3 hours
DurationOfAction: Up to 24 hours (though half-life is shorter, clinical effect can persist)

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while 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. While 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:

Dizziness
Diarrhea
Feeling nervous and excitable
* Gas

This is not an exhaustive list of possible side effects. If you have questions or concerns, contact 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 severe hypoglycemia (e.g., confusion, seizures, loss of consciousness) - seek immediate medical attention.
  • Symptoms of allergic reaction (e.g., rash, hives, swelling of face/lips/tongue, difficulty breathing) - seek immediate medical attention.
  • Unusual bruising or bleeding, persistent sore throat, fever (may indicate blood dyscrasias, rare but serious side effects).
  • Yellowing of skin or eyes, dark urine, severe stomach pain (may indicate liver problems).
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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, including any symptoms that occurred.
A known sulfa allergy, as this may affect your ability to take this medication safely.
Acidic blood problems, such as those related to diabetic ketoacidosis or other conditions that affect blood acidity.
Type 1 diabetes, as this medication is not intended to treat this condition. If you have type 1 diabetes, your doctor will need to discuss alternative treatment options with you.

This list is not exhaustive, and it is crucial to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you are experiencing. Your doctor and pharmacist need this information to ensure that it is safe for you to take this medication in conjunction with your other treatments. Never start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm that it is safe to do so.
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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. Until you understand how this drug affects you, avoid driving and other activities that require alertness.

To monitor your condition, follow your doctor's instructions for checking your blood sugar levels. Additionally, have your blood work checked as directed by your doctor, and discuss the results with them. Be aware that this medication may interfere with certain lab tests, so inform all your healthcare providers and lab personnel that you are taking this drug.

Adhere to the diet and exercise plan recommended by your doctor. If you experience low blood sugar, do not drive, as this can increase your risk of being involved in an accident. 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 your blood sugar control. Changes in physical activity, exercise, or diet can also impact your 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 people of African, South Asian, Middle Eastern, and Mediterranean descent.

There is a potential increased risk of death from heart disease associated with this medication. Discuss this with your doctor. Additionally, be aware that low blood sugar can occur, and severe cases can lead to seizures, loss of consciousness, long-term brain damage, and even death. Consult your doctor if you have concerns.

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. It is essential to note that low blood sugar has occurred in infants born to mothers who took a similar medication during pregnancy. If you are taking this medication and become pregnant, you may need to stop taking it before your due date, as directed by your doctor.
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Overdose Information

Overdose Symptoms:

  • Severe hypoglycemia (e.g., profuse sweating, tremor, anxiety, confusion, slurred speech, seizures, coma)
  • Prolonged hypoglycemia

What to Do:

Call 1-800-222-1222 (Poison Control). In case of severe hypoglycemia with altered consciousness, administer glucagon if available and call emergency services. If conscious, administer oral glucose. Hospitalization and intravenous glucose may be required for prolonged hypoglycemia.

Drug Interactions

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Major Interactions

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

  • Beta-blockers (mask hypoglycemia symptoms, prolong hypoglycemia)
  • NSAIDs (enhance hypoglycemic effect)
  • Salicylates (enhance hypoglycemic effect)
  • Sulfonamides (enhance hypoglycemic effect)
  • Chloramphenicol (enhance hypoglycemic effect)
  • Probenecid (enhance hypoglycemic effect)
  • Coumarin derivatives (enhance hypoglycemic effect)
  • MAOIs (enhance hypoglycemic effect)
  • Fluconazole (enhance hypoglycemic effect)
  • Alcohol (potentiates hypoglycemic effect, disulfiram-like reaction)
  • Corticosteroids (decrease hypoglycemic effect)
  • Thiazide diuretics (decrease hypoglycemic effect)
  • Phenothiazines (decrease hypoglycemic effect)
  • Thyroid products (decrease hypoglycemic effect)
  • Estrogens/Oral Contraceptives (decrease hypoglycemic effect)
  • Phenytoin (decrease hypoglycemic effect)
  • Nicotinic acid (decrease hypoglycemic effect)
  • Sympathomimetics (decrease hypoglycemic effect)
  • Calcium channel blockers (decrease hypoglycemic effect)
  • Isoniazid (decrease hypoglycemic effect)
  • Colesevelam (decreased glipizide absorption; administer glipizide at least 4 hours before colesevelam)
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Minor Interactions

  • Cimetidine (may increase glipizide levels)

Monitoring

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Baseline Monitoring

Fasting Plasma Glucose (FPG)

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

Timing: Prior to initiation of therapy.

Hemoglobin A1c (HbA1c)

Rationale: To establish baseline long-term glycemic control.

Timing: Prior to initiation of therapy.

Renal Function (e.g., SCr, eGFR)

Rationale: To assess kidney function, as glipizide is primarily renally eliminated and dose adjustments may be needed in impairment.

Timing: Prior to initiation of therapy.

Hepatic Function (e.g., ALT, AST, bilirubin)

Rationale: To assess liver function, as glipizide is metabolized in the liver and dose adjustments may be needed in impairment.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Fasting Plasma Glucose (FPG)

Frequency: Daily or several times per week (self-monitoring), or as clinically indicated.

Target: <130 mg/dL (individualized)

Action Threshold: >180 mg/dL (consider dose adjustment), <70 mg/dL (address hypoglycemia)

Postprandial Glucose (PPG)

Frequency: Periodically (self-monitoring), or as clinically indicated.

Target: <180 mg/dL (individualized)

Action Threshold: >200 mg/dL (consider dose adjustment)

Hemoglobin A1c (HbA1c)

Frequency: Every 3-6 months

Target: <7.0% (individualized)

Action Threshold: >7.0% (consider dose adjustment or alternative therapy)

Signs and Symptoms of Hypoglycemia

Frequency: Continuously (patient education)

Target: N/A

Action Threshold: Any occurrence of symptoms (e.g., sweating, tremor, confusion, hunger, dizziness) requires immediate action (consume fast-acting carbohydrate).

Renal Function

Frequency: Annually or more frequently in patients with existing impairment or risk factors.

Target: Stable eGFR

Action Threshold: Significant decline in eGFR (consider dose adjustment or discontinuation).

Hepatic Function

Frequency: Annually or more frequently in patients with existing impairment or risk factors.

Target: Normal liver enzymes

Action Threshold: Significant elevation in liver enzymes (consider discontinuation).

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Symptom Monitoring

  • Symptoms of hypoglycemia (e.g., sweating, tremor, dizziness, confusion, hunger, irritability, headache, blurred vision, 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

Glipizide is generally not recommended during pregnancy. Insulin is the preferred treatment for diabetes during pregnancy due to better glycemic control and lower risk of fetal adverse effects. If used, close monitoring of maternal glucose and fetal well-being is essential.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity, though data are limited and conflicting. Insulin is preferred.
Second Trimester: Risk of neonatal hypoglycemia if used near term. Insulin is preferred.
Third Trimester: High risk of neonatal hypoglycemia, hyperinsulinemia, and macrosomia if used near term. Discontinue well before delivery (e.g., 2 weeks) and switch to insulin.
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Lactation

Glipizide is excreted into breast milk. Due to the potential for hypoglycemia in the breastfed infant, it is generally not recommended during breastfeeding. Insulin or other agents with better safety profiles in lactation are preferred.

Infant Risk: L3 (Moderately safe; caution advised). Potential for infant hypoglycemia. Monitor infant for signs of hypoglycemia (e.g., lethargy, poor feeding, jitteriness).
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Pediatric Use

Safety and efficacy 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 decreased renal function, polypharmacy, and altered nutritional status. Initiate with a lower dose (e.g., 2.5 mg daily) and titrate slowly. Close monitoring for hypoglycemia is crucial.

Clinical Information

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Clinical Pearls

  • Glipizide IR should be taken 30 minutes before a meal to optimize absorption and reduce the risk of postprandial hyperglycemia.
  • For doses exceeding 15 mg daily, glipizide IR should be given in divided doses to minimize side effects and maintain glycemic control.
  • Patients should be educated thoroughly on the symptoms and management of hypoglycemia.
  • Alcohol consumption should be limited or avoided due to increased risk of hypoglycemia and potential disulfiram-like reactions.
  • Glipizide is generally considered to have a lower risk of hypoglycemia compared to first-generation sulfonylureas, but it is still a significant concern, especially in patients with renal or hepatic impairment, or those who skip meals.
  • Weight gain is a common side effect of sulfonylureas, including glipizide.
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Alternative Therapies

  • Metformin (first-line for most type 2 diabetes patients)
  • Other sulfonylureas (e.g., glyburide, glimepiride)
  • 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
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Cost & Coverage

Average Cost: $10 - $30 per 30 tablets (10mg)
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. 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 seeking help, be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.