Glucovance contains a combination of glyburide and metformin. Glyburide and metformin are both oral diabetes medicines that help control blood sugar levels.

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

Glucovance is not for treating type 1 diabetes.

You should not use Glucovance if you have severe kidney disease, if you also take bosentan (Tracleer), or if you have metabolic acidosis or diabetic ketoacidosis (call your doctor for treatment).

If you need to have any type of x-ray or CT scan using a dye that is injected into your veins, you may need to temporarily stop taking Glucovance.

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. Call your doctor or get emergency medical help if you have unusual muscle pain, trouble breathing, stomach pain, dizziness, feeling cold, or feeling very weak or tired.

Before taking this medicine

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

• severe kidney disease;

• metabolic acidosis or diabetic ketoacidosis (call your doctor for treatment); or

• if you are also using bosentan (to treat pulmonary arterial hypertension).

If you need to have any type of x-ray or CT scan using a dye that is injected into your veins, you may need to temporarily stop taking Glucovance.

Tell your doctor if you have ever had:

• kidney disease;

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

• liver disease; or

• heart disease, heart attack, or stroke.

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. This may be more likely if you have other medical conditions, a severe infection, chronic alcoholism, or if you are 65 or older. Ask your doctor about your risk.

Follow your doctor's instructions about using this medicine 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. However, you may need to stop taking Glucovance for a short time just before your due date.

Metformin may stimulate ovulation in a premenopausal woman and may increase the risk of unintended pregnancy. Talk to your doctor about your risk.

You should not breastfeed while taking Glucovance.

Take Glucovance exactly as prescribed by your doctor. 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.

Take Glucovance with meals.

Drink plenty of liquids while you are taking Glucovance.

Call your doctor if you are sick with vomiting, diarrhea, or a fever. These conditions can lead to severe dehydration, which could be dangerous while you are taking Glucovance.

You may have low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).

Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Be sure your family or 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.

Glucovance is only part of a complete treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor's instructions very closely.

Your doctor may have you take extra vitamin B12 while you are taking glyburide and metformin. Take only the amount of vitamin B12 that your doctor has prescribed.

Store at room temperature away from moisture, heat, and light.

Usual Adult Dose for Diabetes Type 2:

Doses provided as glyburide-metformin

-As Initial Therapy in Patients with Inadequate Glycemic Control on Diet and Exercise Alone:
Starting dose: 1.25 mg-250 mg orally once a day
-Consider a starting dose of 1.25 mg-250 mg orally twice a day for patients with fasting blood glucose (FBG) greater than 200 mg/dL or HbA1c greater than 9%
Maintenance Dose: Increase in increments of 1.25 mg-250 mg per day every 2 weeks up to the minimum effective dose to achieve glycemic control
Maximum Initial Dose: 10 mg-2000 mg per day

-Patients with Inadequate Glycemic Control on a Glyburide (or another Sulfonylurea) and/or Metformin:
Initial dose: 2.5 mg-500 mg or 5 mg-500 mg orally twice a day
Maintenance Dose: Increase in increments of no more than 5 mg-500 mg to the minimum effective dose to achieve adequate blood glucose control
Maximum Dose: 20 mg-2000 mg per day

Comments:
-Give with meals; 5 mg-500 mg dose should not be used as initial therapy due to an increased risk of hypoglycemia; initial doses should be conservative to avoid hypoglycemia largely due to glyburide and gastrointestinal side effects largely due to metformin.
-For patients who are switching to combination therapy, initial doses should not exceed the daily dose of glyburide (or equivalent sulfonylurea) and metformin already being taken; the decision to switch to the nearest equivalent dose should be based on clinical judgement.
-Addition of thiazolidinedione may be appropriate for patients not adequately controlled on glyburide-metformin; in patients experiencing hypoglycemia, consider reducing the dose of the glyburide component.
-Monitor patients closely for signs and symptoms of hypoglycemia.

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

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

• severe kidney disease;

• metabolic acidosis or diabetic ketoacidosis (call your doctor for treatment); or

• if you are also using bosentan (to treat pulmonary arterial hypertension).

If you need to have any type of x-ray or CT scan using a dye that is injected into your veins, you may need to temporarily stop taking Glucovance.

Tell your doctor if you have ever had:

• kidney disease;

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

• liver disease; or

• heart disease, heart attack, or stroke.

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. This may be more likely if you have other medical conditions, a severe infection, chronic alcoholism, or if you are 65 or older. Ask your doctor about your risk.

Follow your doctor's instructions about using this medicine 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. However, you may need to stop taking Glucovance for a short time just before your due date.

Metformin may stimulate ovulation in a premenopausal woman and may increase the risk of unintended pregnancy. Talk to your doctor about your risk.

You should not breastfeed while taking Glucovance.

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. An overdose can cause severe hypoglycemia or lactic acidosis.

Avoid drinking alcohol. It lowers blood sugar and may increase your risk of lactic acidosis.

If you also take colesevelam, avoid taking it within 4 hours after you take Glucovance.

Get emergency medical help if you have signs of an allergic reaction to Glucovance: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• heart problems - swelling, rapid weight gain, feeling short of breath;

• severe hypoglycemia - extreme weakness, blurred vision, sweating, trouble speaking, tremors, stomach pain, confusion, seizure; or

• lactic acidosis - unusual muscle pain, trouble breathing, stomach pain, vomiting, irregular heart rate, dizziness, feeling cold, or feeling very weak or tired.

Common Glucovance side effects may include:

• low blood sugar;

• nausea, diarrhea, upset stomach; or

• headache.

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.

Many drugs can interact with glyburide and metformin, making this medicine less effective or increasing your risk of lactic acidosis. 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.