Glipizide ER 2.5mg Tablets
It is used to help control blood sugar in people with type 2 diabetes.
Drug Class
Antidiabetic Agent
Pharmacologic Class
Sulfonylurea
Pregnancy Category
Category C
FDA Approved
Sep 1994
DEA Schedule
Not Controlled
Overview
What is this medicine?
Glipizide ER is a medication used to treat type 2 diabetes. It helps your body release more insulin from your pancreas, which lowers your blood sugar levels. It's an extended-release tablet, meaning it releases the medicine slowly over time, so you usually take it once a day.
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 eating less than usual or skipping a meal, be sure to discuss this with your doctor to determine the best course of action.
Storing and Disposing of Your Medication
Keep your medication at room temperature in a dry place, away from the bathroom. Store it in its original container to protect it from moisture and other environmental factors. Keep all medications in a safe location, out of the reach of children and pets, to prevent accidental ingestion.
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.
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 eating less than usual or skipping a meal, be sure to discuss this with your doctor to determine the best course of action.
Storing and Disposing of Your Medication
Keep your medication at room temperature in a dry place, away from the bathroom. Store it in its original container to protect it from moisture and other environmental factors. Keep all medications in a safe location, out of the reach of children and pets, to prevent accidental ingestion.
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.
Lifestyle & Tips
- Take Glipizide ER once daily with breakfast or the first main meal of the day to reduce the risk of upset stomach and ensure consistent absorption.
- Maintain a consistent meal plan and regular exercise routine as advised by your healthcare provider. These are crucial for managing diabetes.
- Avoid excessive alcohol consumption, as it can increase the risk of low blood sugar (hypoglycemia) and may cause a disulfiram-like reaction (flushing, nausea, vomiting, headache).
- Carry a source of fast-acting sugar (e.g., glucose tablets, hard candy, fruit juice) to treat mild to moderate low blood sugar episodes.
- Monitor your blood sugar levels regularly as instructed by your doctor. This helps you understand how the medication is working and identify potential issues.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial: 2.5 mg once daily with breakfast. Maintenance: 5-10 mg once daily.
Dose Range:
2.5 - 20 mg
Condition-Specific Dosing:
Type 2 Diabetes Mellitus:
Initial: 2.5 mg once daily with breakfast. Titrate in increments of 2.5-5 mg/day at weekly intervals based on blood glucose response. Maximum recommended dose is 20 mg once daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment needed, but monitor closely.
Moderate:
Consider lower initial dose (e.g., 2.5 mg once daily) and titrate cautiously. Monitor closely for hypoglycemia.
Severe:
Use with caution, generally not recommended due to increased risk of hypoglycemia. If used, start with 2.5 mg once daily and monitor very closely.
Dialysis:
Not recommended due to prolonged half-life and risk of hypoglycemia.
Hepatic Impairment:
Mild:
Consider lower initial dose (e.g., 2.5 mg once daily) and titrate cautiously. Monitor closely for hypoglycemia.
Moderate:
Consider lower initial dose (e.g., 2.5 mg once daily) and titrate cautiously. Monitor closely for hypoglycemia.
Severe:
Use with extreme caution or avoid due to increased risk of hypoglycemia. If used, start with 2.5 mg once daily and monitor very closely.
Pharmacology
Mechanism of Action
Glipizide is a second-generation sulfonylurea that lowers blood glucose 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 resulting calcium influx triggers insulin secretion.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 100%
Tmax:
2-3 hours (for ER formulation)
FoodEffect:
Food (especially high-fat meals) may delay absorption and Tmax, but does not significantly affect the extent of absorption. Should be taken with breakfast.
Distribution:
Vd:
Approximately 10-11 liters
ProteinBinding:
Approximately 98-99% (primarily to albumin)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 5-9 hours (for ER formulation)
Clearance:
Not available
ExcretionRoute:
Mainly urine (80%), remainder in feces (10%)
Unchanged:
Less than 10% (in urine)
Pharmacodynamics
OnsetOfAction:
1-2 hours
PeakEffect:
6-12 hours
DurationOfAction:
24 hours (for ER formulation)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
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 help right away:
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 very 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
If you have low blood sugar, follow your doctor's instructions for treatment, 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 or may only have mild symptoms. If you notice 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 a comprehensive list of all possible side effects. If you have questions or concerns about side effects, 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.
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 help right away:
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 very 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
If you have low blood sugar, follow your doctor's instructions for treatment, 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 or may only have mild symptoms. If you notice 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 a comprehensive list of all possible side effects. If you have questions or concerns about side effects, 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.
Seek Immediate Medical Attention If You Experience:
- Symptoms of low blood sugar (hypoglycemia): sweating, shakiness, dizziness, confusion, hunger, irritability, rapid heartbeat, blurred vision, headache. If these occur, check blood sugar and treat immediately.
- Symptoms of allergic reaction: rash, itching, swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. Seek immediate medical attention.
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 bowel blockage.
Acidic blood conditions, 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 existing treatments and health conditions.
Remember, do not start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure your safety.
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 bowel blockage.
Acidic blood conditions, 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 existing treatments and health conditions.
Remember, do not start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure your safety.
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 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 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. 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 with your doctor about this risk.
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. Pregnant or breastfeeding women should discuss the benefits and risks of this medication with their doctor. If you are planning to become pregnant, inform your doctor, as they will need to weigh the benefits and risks to both you and the baby.
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 will 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 with your doctor to determine the best course of action.
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 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 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. 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 with your doctor about this risk.
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. Pregnant or breastfeeding women should discuss the benefits and risks of this medication with their doctor. If you are planning to become pregnant, inform your doctor, as they will need to weigh the benefits and risks to both you and the baby.
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 will 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 with your doctor to determine the best course of action.
Overdose Information
Overdose Symptoms:
- Severe hypoglycemia (extremely low blood sugar)
- Confusion
- Disorientation
- Slurred speech
- Seizures
- Loss of consciousness
- Coma
What to Do:
Immediately consume a source of fast-acting sugar (e.g., glucose tablets, sugary drink). If the person is unconscious or unable to swallow, call 911 or emergency services. Glucagon injection may be necessary. After initial treatment, consume a long-acting carbohydrate (e.g., sandwich, crackers) to prevent recurrence. Call 1-800-222-1222 (Poison Control Center) for further guidance.
Drug Interactions
Major Interactions
- Bosentan (increased risk of hepatotoxicity)
- Miconazole (oral, IV, topical - significantly enhances hypoglycemic effect)
- Alcohol (potentiates hypoglycemic effect, may cause disulfiram-like reaction)
Moderate Interactions
- Beta-blockers (mask symptoms of hypoglycemia, impair glucose counter-regulation)
- Fluconazole, Ketoconazole, Voriconazole (increase glipizide levels, enhance hypoglycemia)
- NSAIDs (e.g., ibuprofen, naproxen - enhance hypoglycemic effect)
- Salicylates (e.g., aspirin - enhance hypoglycemic effect at high doses)
- Sulfonamides (e.g., sulfamethoxazole/trimethoprim - enhance hypoglycemic effect)
- Chloramphenicol (enhances hypoglycemic effect)
- Warfarin (may alter anticoagulant effect, monitor INR)
- Corticosteroids, Thiazide diuretics, Estrogens, Oral contraceptives, Phenothiazines, Thyroid products, Sympathomimetics, Niacin, Calcium channel blockers, Isoniazid (may cause hyperglycemia, requiring dose adjustment of glipizide)
Minor Interactions
- Chromium (may enhance hypoglycemic effect)
- Garlic (may enhance hypoglycemic effect)
Monitoring
Baseline Monitoring
HbA1c (Glycated Hemoglobin)
Rationale: To establish baseline glycemic control and guide initial dosing.
Timing: Prior to initiation of therapy.
Fasting Plasma Glucose (FPG)
Rationale: To establish baseline glycemic control and guide initial dosing.
Timing: Prior to initiation of therapy.
Renal Function (e.g., SCr, eGFR)
Rationale: To assess kidney function, as glipizide is primarily renally excreted and dose adjustments may be needed in impairment.
Timing: Prior to initiation of therapy.
Hepatic Function (e.g., ALT, AST)
Rationale: To assess liver function, as glipizide is extensively metabolized in the liver and dose adjustments may be needed in impairment.
Timing: Prior to initiation of therapy.
Routine Monitoring
HbA1c
Frequency: Every 3-6 months (or quarterly if glycemic goals are not met or therapy is changed)
Target: <7% (individualized based on patient factors)
Action Threshold: If HbA1c remains above target, consider dose adjustment or addition of other agents.
Fasting Plasma Glucose (FPG)
Frequency: Daily (patient self-monitoring) or as directed by physician
Target: 80-130 mg/dL (individualized)
Action Threshold: Persistent readings outside target range, especially below 70 mg/dL (hypoglycemia) or above 180 mg/dL (hyperglycemia).
Symptoms of Hypoglycemia
Frequency: Daily (patient self-monitoring)
Target: N/A
Action Threshold: Any occurrence of symptoms (e.g., sweating, tremor, confusion, hunger, dizziness) should prompt blood glucose check and appropriate action.
Renal Function (e.g., SCr, eGFR)
Frequency: Annually or more frequently if clinically indicated (e.g., in elderly or those with comorbidities)
Target: N/A
Action Threshold: Significant decline in eGFR may necessitate dose reduction or discontinuation.
Hepatic Function (e.g., ALT, AST)
Frequency: Annually or more frequently if clinically indicated
Target: N/A
Action Threshold: Significant elevation may necessitate dose reduction or discontinuation.
Symptom Monitoring
- Symptoms of hypoglycemia: sweating, tremor, palpitations, anxiety, hunger, confusion, dizziness, headache, blurred vision, slurred speech, irritability, unusual behavior, seizures, loss of consciousness.
- Symptoms of hyperglycemia (if inadequate control): increased thirst, increased urination, fatigue, blurred vision.
Special Patient Groups
Pregnancy
Glipizide is generally not recommended during pregnancy (Category C). Insulin is typically the preferred treatment for diabetes during pregnancy due to better glycemic control and lower risk of fetal hypoglycemia. If used, close monitoring of maternal blood glucose and fetal well-being is essential.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though human data are limited and conflicting. Insulin is preferred.
Second Trimester:
Risk of fetal hypoglycemia if used close to delivery. Insulin is preferred.
Third Trimester:
Increased risk of severe neonatal hypoglycemia if used near term, as glipizide can cross the placenta and stimulate fetal insulin secretion. Discontinue at least 2 weeks before expected delivery.
Lactation
Not recommended during breastfeeding (L3 - Moderately Safe, but caution advised). Glipizide is excreted into breast milk and can cause hypoglycemia in the nursing infant. Insulin is generally preferred for managing diabetes in lactating mothers.
Infant Risk:
Risk of hypoglycemia in the infant. Monitor infant for signs of hypoglycemia (e.g., lethargy, poor feeding, jitteriness).
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Use is generally not recommended.
Geriatric Use
Elderly patients are at increased risk of hypoglycemia due to age-related decline in renal function, hepatic function, and reduced awareness of hypoglycemic symptoms. Start with the lowest effective dose (2.5 mg once daily) and titrate cautiously. Monitor blood glucose levels frequently.
Clinical Information
Clinical Pearls
- Glipizide ER should be taken once daily with breakfast or the first main meal of the day to optimize absorption and reduce gastrointestinal upset.
- Patients should be educated on the signs and symptoms of hypoglycemia and how to treat it immediately.
- This medication is only effective in patients with some residual pancreatic beta-cell function, thus it is not used for Type 1 Diabetes Mellitus.
- Alcohol consumption should be limited or avoided due to increased risk of hypoglycemia and potential disulfiram-like reactions.
- Regular monitoring of blood glucose and HbA1c is crucial to assess efficacy and safety.
- Caution is advised in patients with severe renal or hepatic impairment due to increased risk of prolonged hypoglycemia.
Alternative Therapies
- Metformin (first-line for most Type 2 DM 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)
- Insulin therapy
Cost & Coverage
Average Cost:
Varies widely, typically $10-$50 per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 (Preferred Generic) or Tier 2 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not 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 medication taken, the amount, and the time it occurred.