Glyburide is an oral diabetes medicine that helps control blood sugar levels.

Glyburide is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.

Glyburide is not for treating type 1 diabetes.

You should not use glyburide if you are being treated with bosentan (Tracleer), or if you have diabetic ketoacidosis (call your doctor for treatment). Glyburide is not for treating type 1 diabetes.

Before taking glyburide, tell your doctor if you are allergic to sulfa drugs, if you have been using insulin or chlorpropamide (Diabinese), or if you have hemolytic anemia (a lack of red blood cells), an enzyme deficiency (G6PD), a nerve disorder, liver disease, or kidney disease.

Take care not to let your blood sugar get too low. Low blood sugar (hypoglycemia) can occur if you skip a meal, exercise too long, drink alcohol, or are under stress. Symptoms include headache, hunger, weakness, sweating, tremor, irritability, or trouble concentrating. Carry hard candy or glucose tablets with you in case you have low blood sugar. Other sugar sources include orange juice and milk. Be sure your family and close friends know how to help you in an emergency.

Before taking this medicine

You should not use glyburide if you are allergic to it, or if:

• you are being treated with bosentan (Tracleer);

• you have type 1 diabetes; or

• you have diabetic ketoacidosis (call your doctor for treatment).

Tell your doctor if you have ever had:

• hemolytic anemia (a lack of red blood cells);

• an enzyme deficiency called glucose-6-phosphate dehydrogenase deficiency (G6PD);

• a nerve disorder affecting bodily functions;

• liver or kidney disease; or

• an allergy to sulfa drugs.

Before taking glyburide, tell your doctor if you have taken another oral diabetes medicine or used insulin during the past 2 weeks.

Glyburide may increase your risk of serious heart problems, but not treating your diabetes can also damage your heart and other organs. Talk to your doctor about the risks and benefits of this medicine.

Tell your doctor if you are pregnant or breastfeeding.

Follow your doctor's instructions about using glyburide if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby.

Glyburide is usually taken with breakfast or the first main meal of the day.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Your blood sugar may need to be checked often, and you may need other blood tests at your doctor's office.

Low blood sugar (hypoglycemia) can happen to anyone who has diabetes. Symptoms include headache, hunger, sweating, irritability, dizziness, nausea, fast heart rate, and feeling anxious or shaky. To quickly treat low blood sugar, always keep a fast-acting source of sugar with you such as fruit juice, hard candy, crackers, raisins, or non-diet soda.

Your doctor can prescribe a glucagon emergency injection kit to use in case you have severe hypoglycemia and cannot eat or drink. Be sure your family and close friends know how to give you this injection in an emergency.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

If your doctor changes your brand, strength, or type of glyburide, your dosage needs may change. Ask your pharmacist if you have any questions about the new kind of glyburide you receive at the pharmacy.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Usual Adult Dose for Diabetes Type 2:

Standard glyburide:
-Initial dose: 2.5 mg to 5 mg orally once a day
-Dose titration: Increase in increments of no more than 2.5 mg at weekly intervals based upon blood glucose response
-Maintenance dose: 1.25 to 20 mg orally as a single dose or in divided doses
-Maximum dose: 20 mg/day

Micronized glyburide:
-Initial dose: 1.5 mg to 3 mg orally once a day
-Dose titration: Increase in increments of no more than 1.5 mg at weekly intervals based upon blood glucose response
-Maintenance dose: 0.75 to 12 mg orally as a single dose or in divided doses
-Maximum dose: 12 mg/day

Comments:
-Administer with breakfast or the first main meal of the day
-Lower initial doses may be used in patients who are sensitive to hypoglycemic drugs
-Once a day therapy is generally satisfactory, however, some patients may have a more satisfactory response with twice-a-day dosing, especially those receiving higher doses.

TRANSFER FROM OTHER HYPOGLYCEMIC THERAPY:
-Oral Antidiabetic Therapy: No exact dosage relationships exists between standard glyburide, micronized glyburide, or other oral hypoglycemic agents; when transferring patients from other oral hypoglycemic therapy, the maximum starting doses should be observed.
-Insulin:
--If the insulin dose is less than 20 units per day substitute 2.5 to 5 mg (standard) OR 1.5 to 3 mg (micronized) orally once a day.
--If the insulin dose is between 20 and 40 units per day, substitute 5 mg (standard) OR 3 mg (micronized) orally once a day.
--If the insulin dose is more than 40 units per day; transition the patient by concomitantly decreasing insulin by 50% and starting glyburide at 5 mg (standard) OR 3 mg (micronized) orally once a day; as insulin is progressively withdrawn, titrate in increments of 1.25 to 2.5 mg (standard) OR 0.75 to 1.5 mg (micronized) orally once a day every 2 to 10 days.

Use: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Usual Geriatric Dose for Diabetes Type 2:

Initial dose: 1.25 to 2.5 mg (standard) orally or 0.75 to 1.5 mg (micronized) orally once a day.

You should not use glyburide if you are allergic to it, or if:

• you are being treated with bosentan (Tracleer);

• you have type 1 diabetes; or

• you have diabetic ketoacidosis (call your doctor for treatment).

Tell your doctor if you have ever had:

• hemolytic anemia (a lack of red blood cells);

• an enzyme deficiency called glucose-6-phosphate dehydrogenase deficiency (G6PD);

• a nerve disorder affecting bodily functions;

• liver or kidney disease; or

• an allergy to sulfa drugs.

Before taking glyburide, tell your doctor if you have taken another oral diabetes medicine or used insulin during the past 2 weeks.

Glyburide may increase your risk of serious heart problems, but not treating your diabetes can also damage your heart and other organs. Talk to your doctor about the risks and benefits of this medicine.

Tell your doctor if you are pregnant or breastfeeding.

Follow your doctor's instructions about using glyburide if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A glyburide overdose can cause life-threatening hypoglycemia.

Symptoms of severe hypoglycemia include extreme weakness, nausea, tremors, sweating, confusion, trouble speaking, fast heartbeats, or seizure.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian. It is important to eat a healthy diet, exercise regularly, and lose weight if necessary.

Avoid drinking alcohol. It lowers blood sugar and may interfere with your diabetes treatment.

Glyburide could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Get emergency medical help if you have signs of an allergic reaction to glyburide (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Call your doctor at once if you have:

• dark urine, jaundice (yellowing of the skin or eyes);

• severe skin rash, redness, or itching;

• pale skin, easy bruising or bleeding;

• fever, chills, sore throat, mouth sores; or

• low levels of sodium in the bodyheadache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady.

Older adults may be more likely to have low blood sugar while taking glyburide.

Common glyburide side effects may include:

• low blood sugar;

• nausea, heartburn, feeling full;

• muscle or joint pain;

• blurred vision; or

• mild rash or skin redness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

If you also take colesevelam, take your glyburide dose 4 hours before you take colesevelam.

Glyburide may not work as well when you use other medicines at the same time. Many other drugs can also affect blood sugar control. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

Keep all appointments with your doctor and the laboratory. Your fasting blood sugar levels and glycosylated hemoglobin (HbA1c) should be checked regularly to determine your response to glyburide. Your doctor may order other lab tests to check your response to glyburide. Your doctor will also tell you how to check your response to this medication by measuring your blood sugar levels at home. Follow these instructions carefully.

You should always wear a diabetic identification bracelet to be sure you get proper treatment in an emergency.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.