Glucotrol XL 10mg 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 resulting calcium influx triggers insulin secretion. It also has some extrapancreatic effects, including increased peripheral glucose utilization and decreased hepatic glucose production.

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 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 may include:
+ Dizziness
+ Headache
+ Feeling sleepy or weak
+ Shaking
+ Fast heartbeat
+ Confusion
+ Hunger
+ Sweating

If you experience any of these symptoms, contact your doctor immediately. 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 many people may not experience any or may only have mild symptoms. If you are bothered by any of the following side effects or if they 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:

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 you 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.

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 should discuss the benefits and risks of this medication with their doctor. If you are planning to become pregnant, inform your doctor, as you will need to weigh the advantages and disadvantages of taking this medication.

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 to minimize the risk of low blood sugar in your infant. Consult your doctor for guidance on managing this risk.

• Bosentan (increased risk of hepatotoxicity)
• Miconazole (oral, IV, topical) - significantly increases glipizide levels and risk of severe hypoglycemia
• Alcohol (acute ingestion) - increased risk of hypoglycemia and disulfiram-like reaction

• Beta-blockers (mask hypoglycemia symptoms, impair glucose recovery)
• NSAIDs (enhance hypoglycemic effect)
• Salicylates (high doses, enhance hypoglycemic effect)
• Sulfonamides (enhance hypoglycemic effect)
• Chloramphenicol (enhance hypoglycemic effect)
• Fluconazole (enhance hypoglycemic effect)
• Probenecid (enhance hypoglycemic effect)
• Coumarin derivatives (potentiate anticoagulant effect)
• 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)

• Not available

• Sweating
• Tremor
• Palpitations
• Anxiety
• Hunger
• Confusion
• Dizziness
• Headache
• Irritability
• Blurred vision
• Slurred speech
• Weakness
• Seizures
• Loss of consciousness

Generally not recommended during pregnancy. Insulin is the preferred treatment for diabetes during pregnancy due to better glycemic control and lower risk of fetal hypoglycemia. Glipizide may cause severe neonatal hypoglycemia.

Not recommended during breastfeeding. Glipizide is excreted into breast milk and may cause hypoglycemia in the nursing infant. Insulin is generally preferred for managing diabetes in lactating mothers.

Safety and effectiveness have not been established in pediatric patients. Use is not recommended.

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) and titrate slowly. Monitor blood glucose closely.

• Always instruct patients to take Glucotrol XL with their first main meal of the day (usually breakfast) to optimize absorption and reduce the risk of hypoglycemia.
• Emphasize the importance of consistent meal times and carbohydrate intake to prevent blood sugar fluctuations.
• Educate patients thoroughly on the signs and symptoms of hypoglycemia and how to treat it promptly.
• Be aware of drug interactions, especially with medications that can potentiate or diminish glipizide's hypoglycemic effect (e.g., beta-blockers, NSAIDs, fluconazole, corticosteroids).
• Consider alternative agents in patients with significant renal or hepatic impairment, or use with extreme caution and close monitoring.
• Glipizide ER tablets are designed to be swallowed whole and should not be chewed, crushed, or divided, as this can alter the extended-release properties and lead to rapid drug release and potential hypoglycemia.

• Metformin
• Other sulfonylureas (e.g., glimepiride, glyburide)
• DPP-4 inhibitors (e.g., sitagliptin, saxagliptin)
• SGLT2 inhibitors (e.g., empagliflozin, dapagliflozin)
• GLP-1 receptor agonists (e.g., liraglutide, semaglutide)
• Thiazolidinediones (e.g., pioglitazone)
• Insulin therapy

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 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 details about the medication taken, the amount, and the time it happened.