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Glucovance

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Glucovance

Glucovance

Glucovance Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Glucovance (glyburide and metformin HC1) is for people with type 2 diabetes who do not use daily insulin injections. This medication is not for treating type 1 diabetes. Glucovance is a combination of two oral diabetes medicines that help control blood sugar levels. This medication is available in generic form. Common side effects include nausea, stomach upset, diarrhea, or weight gain.

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

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.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Glucovance in Detail - Patient Information: Side Effects

This medication may cause lactic acidosis (a build-up of lactic acid in the body, which can be fatal). Lactic acidosis can start slowly and get worse over time. Get emergency medical help if you have even mild symptoms of lactic acidosis, such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or uneven heart rate, dizziness, or feeling very weak or tired.

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

Stop using this medicine and call your doctor at once if you have a serious side effect such as:

  • pale or yellowed skin, dark colored urine, fever, confusion or weakness; or
  • nausea, upper stomach pain, itching, loss of appetite, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • sneezing, runny nose, cough or other signs of a cold;
  • headache, mild dizziness; or
  • mild dizziness; or
  • mild nausea or vomiting, diarrhea, upset stomach.

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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Glucovance Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Nausea, stomach upset, diarrhea, or weight gain may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. If stomach symptoms return later (after you are on the same dose for several days or weeks), tell your doctor immediately. Stomach symptoms that occur after the first days of your treatment may be a sign of lactic acidosis.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but very serious side effects occur: easy bleeding/bruising, signs of infection (e.g., persistent sore throat, fever), persistent nausea, severe stomach/abdominal pain, yellowing eyes/skin, dark urine.

This medication may cause low blood sugar (hypoglycemia), especially if you take other medications for diabetes, drink large amounts of alcohol, do unusually heavy exercise, or do not consume enough calories from food. Symptoms include cold sweat, blurred vision, dizziness, drowsiness, shaking, fast heartbeat, headache, fainting, tingling of the hands/feet, and hunger. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or drink fruit juice or non-diet soda. Tell your doctor about the reaction immediately. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Check with your doctor or pharmacist to find out what you should do if you miss a meal.

Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, and fruity breath odor. If these symptoms occur, tell your doctor immediately. Your dosage may need to be increased.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Glucovance (Glyburide and Metformin)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Glucovance FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Glucovance (glyburide and metformin)

In double-blind clinical trials involving GLUCOVANCE (glyburide and metformin) as initial therapy or as second-line therapy, a total of 642 patients received GLUCOVANCE (glyburide and metformin) , 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 (glyburide and metformin) (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 (glyburide and metformin) 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 (glyburide and metformin) (n=365), 181 patients received GLUCOVANCE (glyburide and metformin) with rosiglitazone and 184 received GLUCOVANCE (glyburide and metformin) 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 (glyburide and metformin) 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 (glyburide and metformin) are summarized in Table 7.

The frequency of hypoglycemic symptoms in patients treated with GLUCOVANCE (glyburide and metformin) 1.25 mg/250 mg was highest in patients with a baseline HbA1c < 7%, lower in those with a baseline HbAic of between 7% and 8%, and was comparable to placebo and metformin in those with a baseline HbA1c > 8%. For patients with a baseline HbAic between 8% and 11% treated with GLUCOVANCE (glyburide and metformin) 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 (glyburide and metformin) experienced hypoglycemic symptoms. When rosiglitazone was added to GLUCOVANCE (glyburide and metformin) 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 (glyburide and metformin) 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 (glyburide and metformin) trials, GI symptoms were the most common adverse events with GLUCOVANCE (glyburide and metformin) and were more frequent at higher dose levels. In controlled trials, < 2% of patients discontinued GLUCOVANCE (glyburide and metformin) 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 (glyburide and metformin) as Initial Therapy

Variable Placebo
N=161
Glyburide Tablets
N=160
Metformin Tablets
N=159
GLUCOVANCE (glyburide and metformin)
1.25 mg/250 mg Tablets
N=158
GLUCOVANCE (glyburide and metformin)
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 (glyburide and metformin) should be discontinued if this occurs.

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

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Glucovance - User Reviews

Glucovance User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Glucovance sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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