Glipizide ER 10mg Tablets

Manufacturer RISING 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 ER 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, a natural substance that lowers blood sugar. Because it's an extended-release tablet, it releases the medicine slowly throughout 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 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

Store your medication at room temperature in a dry place, avoiding the bathroom. Keep it in its original container to maintain its effectiveness. It's 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's 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 the missed one.
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Lifestyle & Tips

  • Take Glipizide ER once daily with your first meal of the day (usually breakfast). Taking it with food helps reduce stomach upset and ensures proper absorption.
  • Do not crush, chew, or divide the extended-release tablets. Swallow them whole.
  • Follow your doctor's recommendations for diet and exercise. These are crucial for managing diabetes effectively.
  • Monitor your blood sugar levels regularly as instructed 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 fast-acting carbohydrates like glucose tablets, fruit juice, or hard candy).
  • Carry a source of fast-acting sugar with you at all times.
  • Inform your doctor about all other medications, supplements, and herbal products you are taking, as they can interact with glipizide.
  • Limit or avoid alcohol consumption, as it can increase the risk of low blood sugar.

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:

type2DiabetesMellitus: Initial: 5 mg orally once daily with breakfast. Titrate in increments of 2.5-5 mg/day at intervals of at least 3 days, based on blood glucose response. Maximum recommended dose is 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 dose adjustment required, but monitor closely.
Moderate: Consider lower starting dose (e.g., 2.5 mg) and titrate cautiously. Monitor closely for hypoglycemia.
Severe: Use with caution; consider alternative agents. If used, start with 2.5 mg and monitor very closely for hypoglycemia.
Dialysis: Not recommended due to risk of prolonged hypoglycemia. If used, extreme caution and close monitoring are required.

Hepatic Impairment:

Mild: Consider lower starting dose (e.g., 2.5 mg) and titrate cautiously. Monitor closely for hypoglycemia.
Moderate: Use with caution; consider alternative agents. If used, start with 2.5 mg and monitor very closely for hypoglycemia.
Severe: Contraindicated or not recommended due to increased risk of severe hypoglycemia.

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 requires functioning beta cells to be effective. It may also 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: Food delays absorption but does not significantly affect the extent of absorption (AUC) of the extended-release formulation. It should be taken with breakfast.

Distribution:

Vd: Approximately 10-13 L
ProteinBinding: >98% (primarily to albumin)
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 10-14 hours (extended-release formulation)
Clearance: Not readily available as a specific rate, but primarily hepatic metabolism and renal excretion.
ExcretionRoute: Primarily renal (approximately 80%) and fecal (approximately 10%)
Unchanged: <10%
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Pharmacodynamics

OnsetOfAction: Gradual (extended-release)
PeakEffect: 6-12 hours
DurationOfAction: 24 hours

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
Low blood sugar (hypoglycemia), which may be more likely when this medication is used with other diabetes medications. Symptoms of low blood sugar include:
+ Dizziness
+ Headache
+ Feeling sleepy or weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating

If you experience any of these symptoms, contact your doctor right away. To manage low blood sugar, follow your doctor's instructions, 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 not everyone will experience them. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or do not go away:

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, 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 hypoglycemia (low blood sugar): sweating, shakiness, dizziness, confusion, hunger, irritability, headache, blurred vision, rapid heartbeat, weakness, anxiety.
  • Symptoms of hyperglycemia (high blood sugar): increased thirst, increased urination, fatigue, blurred vision, dry mouth.
  • Allergic reaction: rash, itching, swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
  • Liver problems: persistent nausea/vomiting, severe stomach/abdominal pain, yellowing eyes/skin, dark urine.
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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 dose 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 your full attention, 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 the results of certain lab tests.

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 can 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 inform their doctor, as the benefits and risks of this medication 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, it is essential to note that low blood sugar has been reported in infants born to mothers who took a similar medication until the birth date. If you are taking this medication during pregnancy, you will need to stop taking it before your due date, as directed by your doctor.
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Overdose Information

Overdose Symptoms:

  • Severe hypoglycemia (profound weakness, confusion, seizures, loss of consciousness, coma)

What to Do:

Seek immediate medical attention. Call 911 or your local emergency number. For suspected overdose, call Poison Control at 1-800-222-1222. Treatment typically involves administration of glucose (oral or intravenous) and close monitoring.

Drug Interactions

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Contraindicated Interactions

  • Miconazole (oral)
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Major Interactions

  • Alcohol (increased risk of hypoglycemia and disulfiram-like reaction)
  • Beta-blockers (mask symptoms of hypoglycemia, potentiate hypoglycemic effect)
  • NSAIDs (potentiate hypoglycemic effect)
  • Salicylates (e.g., high-dose aspirin) (potentiate hypoglycemic effect)
  • Sulfonamides (potentiate hypoglycemic effect)
  • Warfarin (may alter anticoagulant effect)
  • Azole antifungals (e.g., fluconazole, ketoconazole) (potentiate hypoglycemic effect)
  • Chloramphenicol (potentiate hypoglycemic effect)
  • Probenecid (potentiate hypoglycemic effect)
  • Cimetidine (potentiate hypoglycemic effect)
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Moderate Interactions

  • 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

  • Chromium supplements (may enhance glucose lowering)

Monitoring

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Baseline Monitoring

HbA1c

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 (SCr, eGFR)

Rationale: To assess kidney function as glipizide is primarily renally excreted and dose adjustment may be needed in impairment.

Timing: Prior to initiation of therapy.

Hepatic function (ALT, AST, bilirubin)

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

Timing: Prior to initiation of therapy.

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Routine Monitoring

Fasting Plasma Glucose (FPG)

Frequency: Daily to weekly initially, then periodically (e.g., daily or several times per week) as needed to assess glycemic control.

Target: <130 mg/dL (individualized)

Action Threshold: >130 mg/dL (consider dose adjustment or additional therapy); <70 mg/dL (assess for hypoglycemia, consider dose reduction)

Postprandial Glucose (PPG)

Frequency: Periodically, especially if FPG is at target but HbA1c is not.

Target: <180 mg/dL (individualized)

Action Threshold: >180 mg/dL (consider dose adjustment or additional therapy)

HbA1c

Frequency: Every 3-6 months

Target: <7.0% (individualized)

Action Threshold: >7.0% (consider dose adjustment or additional therapy); <6.5% (assess for hypoglycemia, consider dose reduction)

Signs/symptoms of hypoglycemia

Frequency: Continuously (patient education is key)

Target: N/A

Action Threshold: Any occurrence of symptoms (e.g., sweating, tremor, confusion, hunger) requires immediate action (consume fast-acting carbohydrates) and re-evaluation of therapy.

Renal function (SCr, eGFR)

Frequency: Annually or more frequently if clinically indicated (e.g., with changes in health status or concomitant medications).

Target: Stable, within normal limits for age/sex

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

Hepatic function (ALT, AST, bilirubin)

Frequency: Annually or more frequently if clinically indicated.

Target: Stable, within normal limits

Action Threshold: Significant elevation (consider discontinuation or alternative therapy).

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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)
  • Unexplained weight gain or edema
  • Skin rash or itching

Special Patient Groups

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Pregnancy

Not recommended for use during pregnancy. Insulin is generally preferred for glycemic control in pregnant women with diabetes due to the risk of prolonged severe hypoglycemia in the neonate with sulfonylureas.

Trimester-Specific Risks:

First Trimester: Potential for fetal harm, though data are limited. Insulin is preferred.
Second Trimester: Risk of neonatal hypoglycemia if used near term. Insulin is preferred.
Third Trimester: High risk of severe and prolonged neonatal hypoglycemia if used, especially near delivery. Insulin is preferred.
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Lactation

Not recommended during breastfeeding. Glipizide is excreted into breast milk and can cause hypoglycemia in the nursing infant.

Infant Risk: High 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. Use is not recommended.

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Geriatric Use

Use with caution in elderly patients due to increased risk of hypoglycemia. Start with a lower dose (e.g., 2.5 mg) and titrate slowly. Monitor renal function closely. Elderly patients may be more susceptible to the hypoglycemic effects and may have difficulty recognizing symptoms of hypoglycemia.

Clinical Information

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Clinical Pearls

  • Glipizide ER must be taken with breakfast to ensure proper absorption and reduce the risk of gastrointestinal upset.
  • Do not crush, chew, or divide Glipizide ER tablets; they are designed for extended release.
  • Patients may notice a 'ghost tablet' (the tablet shell) in their stool, which is normal and does not mean the medication was not absorbed.
  • Educate patients thoroughly on the signs and symptoms of hypoglycemia and how to treat it immediately.
  • Alcohol consumption can significantly increase the risk of hypoglycemia and should be limited or avoided.
  • Regular monitoring of blood glucose and HbA1c is essential to assess efficacy and safety.
  • Consider alternative agents or significant dose reduction in patients with moderate to severe renal or hepatic impairment due to increased risk of hypoglycemia.
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Alternative Therapies

  • Other sulfonylureas (e.g., Glimepiride, Glyburide)
  • Biguanides (e.g., Metformin)
  • 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)
  • Insulin therapy
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Cost & Coverage

Average Cost: Varies, typically $10-$50 per 30 tablets (generic)
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 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'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 medication taken, the amount, and the time it occurred.