Glucotrol XL 5mg Tablets

Glipizide, a second-generation sulfonylurea, 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 has some extrapancreatic effects, including increased peripheral glucose utilization and decreased hepatic glucose production.

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 very 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 may 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 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, 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.

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

It is essential to inform your doctor about the following conditions to ensure safe treatment:

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 problems, such as acidosis.
If you have type 1 diabetes, as this medication is not intended to treat this condition.

Additionally, this medication may interact with other health conditions or medications. Therefore, it is crucial to provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter (OTC) medications you are taking.
Any natural products or vitamins you are using.
Your complete medical history, including any health problems.

Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm it is safe to do so. This will help prevent potential interactions or adverse effects.

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 your doctor if you have concerns about low blood sugar.

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 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 your doctor for guidance on managing this risk.

• Bosentan (increased risk of hepatotoxicity)
• Miconazole (oral, IV, topical - significantly enhances hypoglycemic effect)
• Alcohol (acute ingestion can potentiate hypoglycemic effect; chronic ingestion can reduce it)

• Beta-blockers (mask symptoms of hypoglycemia, prolong recovery from hypoglycemia)
• Fluconazole (increases glipizide levels, risk of hypoglycemia)
• NSAIDs (e.g., ibuprofen, naproxen - may enhance hypoglycemic effect)
• Salicylates (high doses - may enhance hypoglycemic effect)
• Sulfonamides (may enhance hypoglycemic effect)
• Chloramphenicol (may enhance hypoglycemic effect)
• Coumarin derivatives (e.g., warfarin - may enhance hypoglycemic effect)
• MAO inhibitors (may enhance hypoglycemic effect)
• Probenecid (may enhance hypoglycemic effect)
• Corticosteroids (decrease hypoglycemic effect)
• Thiazide diuretics (decrease hypoglycemic effect)
• Thyroid hormones (decrease hypoglycemic effect)
• Sympathomimetics (e.g., decongestants - decrease hypoglycemic effect)
• Phenytoin (decrease hypoglycemic effect)
• Rifampin (decreases glipizide levels, reduces efficacy)
• CYP2C9 inhibitors (e.g., amiodarone, fluoxetine, gemfibrozil, sulfinpyrazone - may increase glipizide levels and risk of hypoglycemia)
• CYP2C9 inducers (e.g., carbamazepine, phenobarbital - may decrease glipizide levels and efficacy)

• Chromium (may enhance hypoglycemic effect)
• Fenugreek (may enhance hypoglycemic effect)

• Symptoms of hypoglycemia: sweating, tremor, dizziness, confusion, hunger, irritability, headache, blurred vision, rapid heartbeat, anxiety, weakness, slurred speech, seizures, loss of consciousness.
• Symptoms of hyperglycemia (if treatment is ineffective): increased thirst, increased urination, fatigue, blurred vision.

Glipizide is generally not recommended during pregnancy. Insulin is the preferred treatment for glycemic control in pregnant women with diabetes due to better safety data and lack of placental transfer concerns. If used, close monitoring of maternal and fetal blood glucose is essential.

Glipizide is excreted into breast milk and may cause hypoglycemia in the nursing infant. It is generally not recommended during breastfeeding. Insulin or other agents with better safety profiles during lactation are preferred.

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

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 lower doses (e.g., 2.5 mg) and titrate slowly with careful monitoring to avoid hypoglycemia. Avoid in frail elderly or those with frequent hypoglycemic episodes.

• Glipizide XL should be taken with breakfast or the first main meal of the day to ensure optimal absorption and glycemic control.
• Do not crush, chew, or divide Glucotrol XL tablets, as this will destroy the extended-release mechanism and can lead to rapid absorption and potential hypoglycemia.
• The 'ghost tablet' (empty shell) may be seen in the stool, which is normal and indicates the medication has been released.
• Hypoglycemia is the most common and serious side effect. Educate patients on symptoms and how to treat it.
• Patients should be advised to avoid or limit alcohol intake due to increased risk of hypoglycemia.
• Consider alternative agents in patients with significant renal or hepatic impairment due to increased risk of prolonged hypoglycemia.
• Weight gain is a common side effect associated with sulfonylureas.

• Metformin (first-line for most Type 2 Diabetes patients)
• 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 (various formulations)
• Meglitinides (e.g., repaglinide, nateglinide - shorter acting insulin secretagogues)
• Alpha-glucosidase inhibitors (e.g., acarbose)

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 for more information. If you have any questions or concerns about this 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 emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.