Glyburide 1.25mg Tablets

Glyburide 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 depolarization of the beta-cell membrane opens voltage-gated calcium channels, resulting in an influx of calcium and subsequent exocytosis of insulin granules.

Urgent Side Effects: Seek Medical Attention Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while 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
Muscle or joint pain
Low blood sugar (hypoglycemia), which may be more likely when taking this medication with other diabetes drugs. 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, call your doctor right away and follow their instructions for managing low blood sugar, which may include taking glucose tablets, liquid glucose, or some fruit juices.
Low blood cell counts, which can increase the risk of bleeding problems, infections, or anemia. If you notice any of the following symptoms, contact your doctor immediately:
+ Signs of infection, such as fever, chills, or sore throat
+ Unexplained bruising or bleeding
+ Feeling very tired or weak
Liver problems, which can be indicated by:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes

Other Possible Side Effects

Most people taking this medication will not experience severe side effects, and some may not have any side effects at all. However, if you notice any of the following symptoms, contact your doctor or seek medical help if they bother you or do not go away:

Feeling full
Upset stomach
Heartburn
* Weight gain

Reporting Side Effects

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 symptoms you experienced.
If you have a condition that affects the acidity of your blood.
If you have type 1 diabetes. Note that this medication is not intended to treat type 1 diabetes.
If you are currently taking bosentan.
* If the patient is a child, as this medication is not suitable for children.

This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Do not initiate, 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.

If you have a deficiency of the enzyme glucose-6-phosphate dehydrogenase (G6PD), you may be at a higher risk of developing anemia. This deficiency is more common in individuals of African, South Asian, Middle Eastern, and Mediterranean descent.

Follow your doctor's instructions for monitoring your blood sugar levels. Regular blood tests, as advised by your doctor, are also crucial to ensure your safety while taking this medication. Discuss any concerns or questions you have with your doctor.

Avoid driving if you have experienced low blood sugar, as it can significantly increase your risk of being involved in an accident.

Before consuming alcohol, consult with your doctor to understand the potential risks and how to manage them safely.

If you are taking colesevelam, ensure that you take it at least 4 hours after taking this medication to avoid any potential interactions.

Be aware that stress, such as from fever, infection, injury, or surgery, can affect your blood sugar control. Changes in your physical activity, exercise routine, or diet can also impact your blood sugar levels.

This medication can cause low blood sugar, which, if severe, can lead to seizures, loss of consciousness, permanent brain damage, and even death. It is crucial to discuss the risks and management of low blood sugar with your doctor.

There is an increased risk of death from heart disease associated with this medication. Discuss this risk with your doctor to understand it fully.

You may be more susceptible to sunburn while taking this medication. Take necessary precautions when exposed to the sun, and inform your doctor if you experience any unusual sunburn.

If you are 65 years or older, use this medication with caution, as you may be more prone to side effects.

If you are pregnant, planning to become pregnant, or breastfeeding, you must discuss the benefits and risks of this medication with your doctor. It is essential to weigh the potential effects on both you and your baby.

There have been cases of low blood sugar in newborns born to mothers who took a similar medication until the time of delivery. If you are taking this medication during pregnancy, your doctor will advise you on when to stop taking it before your due date to minimize risks to your baby.

• Bosentan (increased risk of hepatotoxicity)

• Alcohol (increased risk of hypoglycemia, disulfiram-like reaction)
• Beta-blockers (mask symptoms of hypoglycemia, impair glucose counter-regulation)
• Fluconazole (significantly increases glyburide plasma concentrations, leading to severe hypoglycemia)
• NSAIDs (e.g., ibuprofen, naproxen; may potentiate hypoglycemic effect)
• Sulfonamides (e.g., sulfamethoxazole/trimethoprim; may potentiate hypoglycemic effect)
• Chloramphenicol (may potentiate hypoglycemic effect)
• Warfarin (altered INR, increased risk of bleeding)
• MAOIs (may potentiate hypoglycemic effect)
• Salicylates (high doses; may potentiate hypoglycemic effect)
• Probenecid (may potentiate hypoglycemic effect)
• Corticosteroids (may decrease hypoglycemic effect)
• Thiazide diuretics (may decrease hypoglycemic effect)
• Thyroid products (may decrease hypoglycemic effect)
• Estrogens/Oral Contraceptives (may decrease hypoglycemic effect)
• Phenytoin (may decrease hypoglycemic effect)
• Sympathomimetics (e.g., decongestants; may decrease hypoglycemic effect)
• Calcium channel blockers (may decrease hypoglycemic effect)
• Isoniazid (may decrease hypoglycemic effect)

• Colesevelam (may reduce glyburide absorption; administer glyburide at least 4 hours before colesevelam)
• Cimetidine (may increase glyburide levels)
• Digoxin (potential for altered digoxin levels)

• Not available

• Symptoms of hypoglycemia: sweating, tremor, dizziness, hunger, confusion, irritability, headache, blurred vision, rapid heartbeat, slurred speech, anxiety, weakness, seizures, loss of consciousness.
• Symptoms of hyperglycemia (if glycemic control is poor): increased thirst, increased urination, increased hunger, fatigue, blurred vision, weight loss.
• Symptoms of allergic reaction: rash, itching, hives, swelling of face/lips/tongue/throat, difficulty breathing.

Glyburide is Pregnancy Category B. While insulin is generally the preferred treatment for pre-existing diabetes in pregnancy, glyburide may be considered for gestational diabetes mellitus (GDM) when diet and exercise fail, particularly if insulin therapy is not feasible or acceptable. However, some studies suggest a higher risk of neonatal hypoglycemia and macrosomia compared to insulin.

Lactation Risk Category L3 (Moderately safe, but monitor infant). Glyburide is excreted into breast milk in small amounts. While the risk of hypoglycemia in the infant is generally low, it is a concern, especially in premature or jaundiced infants. Insulin or other antidiabetic agents with lower infant exposure may be preferred.

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

Elderly patients are at increased risk of hypoglycemia due to age-related decline in renal function, polypharmacy, and reduced counter-regulatory responses. Start with the lowest effective dose (e.g., 1.25 mg daily) and titrate slowly. Avoid if possible, especially in those with significant renal impairment or frequent hypoglycemic episodes, due to the long half-life and active metabolites. Glipizide or glimepiride may be preferred if a sulfonylurea is necessary.

• Glyburide has a relatively long duration of action and active metabolites, increasing the risk of prolonged hypoglycemia, especially in elderly patients or those with renal/hepatic impairment.
• Always take glyburide with breakfast or the first main meal to reduce gastrointestinal upset and optimize glucose lowering.
• Patients should be educated on the symptoms of hypoglycemia and how to treat it promptly.
• Avoid in patients with a known sulfa allergy, as cross-reactivity can occur.
• Not effective in Type 1 diabetes or for the treatment of diabetic ketoacidosis (DKA).

• Other Sulfonylureas (e.g., Glipizide, Glimepiride)
• 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)
• Alpha-glucosidase Inhibitors (e.g., Acarbose, Miglitol)
• Insulin

If your symptoms or health issues persist or worsen, it's 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 be sure to check with your pharmacist for more information. If you have any questions or concerns about your 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 medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.