Glipizide ER 5mg Tablets

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 closure of ATP-sensitive potassium channels, depolarization of the membrane, and opening of voltage-gated calcium channels. The influx of calcium triggers the exocytosis of insulin-containing granules. Glipizide also has extrapancreatic effects, including increased peripheral glucose utilization and decreased hepatic glucose production, though these are considered minor compared to its insulinotropic effect.

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

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 some fruit juices.

Other Possible Side Effects

Most people do not experience significant side effects, but some may occur. 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.

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 those that affect your blood's pH balance.
* 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. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.

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 work is crucial, so follow your doctor's recommendations for check-ups and discuss any concerns with them. Be aware that this medication may interfere with certain lab tests, so notify all 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, avoid driving, as it increases the risk of accidents. Additionally, refrain from consuming alcohol while taking this medication. If you are also taking colesevelam, take it at least 4 hours after taking this drug.

Be mindful 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. If you have low levels of the enzyme G6PD, exercise caution, as you may be more prone to anemia. This condition is more common in individuals of African, South Asian, Middle Eastern, and Mediterranean descent.

This medication may increase the risk of heart disease-related death, so discuss this with your doctor. 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 experience any concerns.

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding, as you will need to discuss the benefits and risks to you and your 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 take this medication during pregnancy, you may 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 to determine the best course of action.

• Bosentan (increased risk of hepatotoxicity)
• Miconazole (oral, IV, topical) - significantly enhances hypoglycemic effect
• Alcohol (acute ingestion - disulfiram-like reaction, chronic ingestion - enhanced hypoglycemia)

• Beta-blockers (mask symptoms of hypoglycemia, impair glucose counter-regulation)
• 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 (enhance hypoglycemic effect)
• Coumarin derivatives (e.g., warfarin - enhance hypoglycemic effect)
• Probenecid (enhance hypoglycemic effect)
• MAO inhibitors (enhance hypoglycemic effect)
• Fluconazole, Ketoconazole (inhibit CYP2C9, increasing glipizide levels)
• Cimetidine (increases glipizide levels)
• Thiazide diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blockers, isoniazid (may cause hyperglycemia, requiring dose adjustment of glipizide)
• Rifampin (induces CYP2C9, decreasing glipizide levels)

• Chromium supplements (may enhance glucose lowering)

• Symptoms of hypoglycemia: sweating, tremor, dizziness, confusion, hunger, irritability, headache, blurred vision, rapid heartbeat, anxiety, weakness, slurred speech, seizures, coma.
• Symptoms of hyperglycemia (less common with sulfonylureas alone): increased thirst, increased urination, fatigue, blurred vision.

Glipizide is Pregnancy Category C. It is generally not recommended for use during pregnancy. Insulin is the preferred treatment for diabetes during pregnancy due to better glycemic control and lower risk of fetal adverse effects.

Glipizide is excreted into breast milk. Due to the potential for hypoglycemia in the breastfed infant, Glipizide is generally not recommended during breastfeeding. Insulin is the preferred treatment for diabetes in lactating women.

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

Elderly patients are more susceptible to the hypoglycemic effects of sulfonylureas due to age-related decline in renal function, hepatic function, and glucose counter-regulation. Start with a lower dose (e.g., 2.5 mg) and titrate cautiously. Monitor blood glucose closely and educate patients and caregivers on hypoglycemia symptoms and management. Avoid in frail elderly or those with multiple comorbidities.

• Always take Glipizide ER with breakfast to minimize the risk of hypoglycemia and ensure consistent drug absorption.
• Glipizide ER is designed for once-daily dosing; do not crush, chew, or divide the tablets, as this will destroy the extended-release properties and can lead to rapid absorption and hypoglycemia.
• Patients should be educated on the symptoms of hypoglycemia and how to treat it immediately.
• Be cautious when prescribing to patients with renal or hepatic impairment, as the risk of prolonged hypoglycemia is significantly increased.
• Consider the patient's lifestyle and adherence capabilities; sulfonylureas require consistent meal patterns.
• The 'ghost tablet' (empty shell) may be seen in the stool, which is normal and does not mean the medication was not absorbed.

• Metformin (first-line for most Type 2 DM 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)
• Meglitinides (e.g., repaglinide, nateglinide - shorter acting insulin secretagogues)
• Insulin therapy

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 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.