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Glucovance

  • Generic Name: glyburide and metformin
  • Brand Name: Glucovance

Glucovance (Glyburide and Metformin) side effects drug center

PROFESSIONAL

CONSUMER

SIDE EFFECTS

 

Glucovance Side Effects Center

What Is Glucovance?

Glucovance (glyburide and metformin HC1) is a combination of two oral diabetes medicines that help control blood sugar levels for people with type 2 diabetes who do not use daily insulin injections. Glucovance is not for treating type 1 diabetes. Glucovance is available in generic form.

What Are Side Effects of Glucovance?

Common side effects of Glucovance include:

Dosage for Glucovance

Dosage of Glucovance is individualized based on both effectiveness and tolerance.

What Drugs, Substances, or Supplements Interact with Glucovance?

The maximum recommended daily dose should not exceed 20 mg glyburide/2000 mg metformin. Drugs that can raise blood sugar such as isoniazid, diuretics (water pills), steroids, phenothiazines, thyroid medicine, birth control pills, hormones, seizure medicines, and diet pills, or medicines to treat asthma, colds or allergies can lead to hyperglycemia (high blood sugar) when taken with Glucovance. Drugs that lower blood sugar such as non-steroidal anti-inflammatory drugs (NSAIDs), aspirin or other salicylates, sulfa drugs, monoamine oxidase inhibitors (MAOIs), beta-blockers, or probenecid may lead to hypoglycemia (low blood sugar) when taken with Glucovance. Other medications that may interfere with Glucovance include ciprofloxacin, furosemide, nifedipine, cimetidine or ranitidine, amiloride or triamterene, digoxin, morphine, procainamide, quinidine, trimethoprim, or vancomycin. During pregnancy, Glucovance should be used only when prescribed.

Glucovance During Pregnancy or Breastfeeding

If you are using this medication during your pregnancy, your doctor may switch you to insulin at least 2 weeks before the expected delivery date because of the risk of low blood sugar in your newborn. This drug passes into breast milk in small amounts. Consult your doctor before breast-feeding.

Additional Information

Our Glucovance (glyburide and metformin HC1) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Glucovance Consumer Information

Get emergency medical help if you have signs of an allergic reaction: 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 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.

Read the entire detailed patient monograph for Glucovance (Glyburide and Metformin)

 

Glucovance Professional Information

SIDE EFFECTS

GLUCOVANCE

In double-blind clinical trials involving GLUCOVANCE as initial therapy or as second-line therapy, a total of 642 patients received GLUCOVANCE, 312 received metformin therapy, 324 received glyburide therapy, and 161 received placebo. The percent of patients reporting events and types of adverse events reported in clinical trials of GLUCOVANCE (all strengths) as initial therapy and second-line therapy are listed in Table 6.

Table 6: Most Common Clinical Adverse Events ( > 5%) in Double-Blind Clinical Studies of GLUCOVANCE Used as Initial or Second-Line Therapy

Adverse Event Number (%) of Patients
Placebo
N=161		 Glyburide
N=324		 Metformin
N=312		 GLUCOVANCE
N=642
Upper respiratory infection 22 (13.7) 57 (17.6) 51 (16.3) 111 (17.3)
Diarrhea 9 (5.6) 20 (6.2) 64 (20.5) 109 (17.0)
Headache 17(10.6) 37 (11.4) 29 (9.3) 57 (8.9)
Nausea/vomiting 10 (6.2) 17 (5.2) 38 (12.2) 49 (7.6)
Abdominal pain 6 (3.7) 10 (3.1) 25 (8.0) 44 (6.9)
Dizziness 7 (4.3) 18 (5.6) 12 (3.8) 35 (5.5)

In a controlled clinical trial of rosiglitazone versus placebo in patients treated with GLUCOVANCE (n=365), 181 patients received GLUCOVANCE with rosiglitazone and 184 received GLUCOVANCE with placebo.

Edema was reported in 7.7% (14/181) of patients treated with rosiglitazone compared to 2.2% (4/184) of patients treated with placebo. A mean weight gain of 3 kg was observed in rosiglitazone-treated patients.

Disulfiram-like reactions have very rarely been reported in patients treated with glyburide tablets.

Hypoglycemia

In controlled clinical trials of GLUCOVANCE there were no hypoglycemic episodes requiring medical intervention and/or pharmacologic therapy; all events were managed by the patients. The incidence of reported symptoms of hypoglycemia (such as dizziness, shakiness, sweating, and hunger), in the initial therapy trial of GLUCOVANCE are summarized in Table 7. The frequency of hypoglycemic symptoms in patients treated with GLUCOVANCE 1.25 mg/250 mg was highest in patients with a baseline HbA1c < 7%, lower in those with a baseline HbA1c of between 7% and 8%, and was comparable to placebo and metformin in those with a baseline HbA1c > 8%. For patients with a baseline HbA1c between 8% and 11% treated with GLUCOVANCE 2.5 mg/500 mg as initial therapy, the frequency of hypoglycemic symptoms was 30% to 35%. As second-line therapy in patients inadequately controlled on sulfonylurea alone, approximately 6.8% of all patients treated with GLUCOVANCE experienced hypoglycemic symptoms. When rosiglitazone was added to GLUCOVANCE therapy, 22% of patients reported 1 or more fingerstick glucose measurements ≤ 50 mg/dL compared to 3.3% of placebo-treated patients. All hypoglycemic events were managed by the patients and only 1 patient discontinued for hypoglycemia. (See PRECAUTIONS: General: Addition of Thiazolidinediones to GLUCOVANCE Therapy.)

Gastrointestinal Reactions

The incidence of gastrointestinal (GI) side effects (diarrhea, nausea/vomiting, and abdominal pain) in the initial therapy trial are summarized in Table 7. Across all GLUCOVANCE trials, GI symptoms were the most common adverse events with GLUCOVANCE and were more frequent at higher dose levels.

In controlled trials, < 2% of patients discontinued GLUCOVANCE therapy due to GI adverse events.

Table 7: Treatment Emergent Symptoms of Hypoglycemia or Gastrointestinal Adverse Events in a Placebo- and Active-Controlled Trial of GLUCOVANCE as Initial Therapy

Variable Placebo
N=161		 Glyburide Tablets
N=160		 Metformin Tablets
N=159		 GLUCOVANCE 1.25 mg/250 mg Tablets
N=158		 GLUCOVANCE 2.5 mg/500 mg Tablets
N=162
Mean Final Dose 0 mg 5.3 mg 1317 mg 2.78 mg/557 mg 4.1 mg/824 mg
Number (%) of patients with symptoms of hypoglycemia 5 (3.1) 34 (21.3) 5 (3.1) 18 (11.4) 61 (37.7)
Number (%) of patients with gastrointestinal adverse events 39 (24.2) 38 (23.8) 69 (43.3) 50 (31.6) 62 (38.3)

In postmarketing reports cholestatic jaundice and hepatitis may occur rarely which may progress to liver failure; GLUCOVANCE should be discontinued if this occurs.

Read the entire FDA prescribing information for Glucovance (Glyburide and Metformin)

&Copy; Glucovance Patient Information is supplied by Cerner Multum, Inc. and Glucovance Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.