- Side Effects
- Side Effects List
- Drug Interactions
Does Glucovance (glyburide/metformin) cause side effects?
Glucovance (glyburide/metformin) is a combination of antidiabetic medication used as an adjunct to diet and exercise to improve blood glucose (sugar) control in adults with type 2 diabetes mellitus.
Glyburide is a second-generation oral sulfonylurea. It helps lower blood glucose by stimulating the release of insulin, the hormone responsible for regulating blood glucose.
Metformin is an oral biguanide antidiabetic agent. It decreases the production of glucose in the liver, decreases the absorption of glucose by the intestines, and increases the uptake and use of blood glucose by cells throughout the body. In clinical studies, Glucovance therapy was observed to be superior in improving fasting plasma glucose, post-meal blood glucose, and HbA1c levels versus treatment with glyburide or metformin alone.
Common side effects of Glucovance include:
- stomach pain,
- upset stomach,
- decreased appetite,
- metallic taste,
- heartburn, and
- weight loss.
Serious side effects of Glucovance include:
- hypoglycemia (low blood glucose),
- blood disorders,
- decreased blood sodium levels,
- sensitivity to the sunlight,
- liver disease,
- hypersensitivity-type reactions, and
- lactic acidosis
Drug interactions of Glucovance include drugs that cause blood glucose levels to increase such as thiazides and other diuretics, corticosteroids, phenothiazines, thyroid medications, estrogens, birth control pills, phenytoin, nicotinic acid, sympathomimetics, calcium channel blockers, and isoniazid, because these may diminish the effectiveness of Glucovance therapy. When these drugs are stopped, patients should be closely observed for signs of low blood glucose.
- Cimetidine, by decreasing the elimination of metformin from the body, can increase the amount of metformin in the blood by 40%. This may increase the frequency of side effects from metformin.
- Contrast media used for radiological procedures may reduce kidney function which reduces the elimination of metformin, leading to increased concentrations of metformin in the blood.
- Metformin should be stopped 48 hours before and after the use of contrast media. Alcohol consumption increases the effect of metformin on lactate production, increasing the risk of lactic acidosis.
- Certain drugs such as nonsteroidal anti-inflammatory medications (NSAIDs), salicylates, sulfonamides, chloramphenicol, probenecid, coumarins, ciprofloxacin, monoamine oxidase inhibitors (MAOIs), oral miconazole, and beta-blockers may increase the blood glucose lowering actions of glyburide.
- Hypoglycemia (low blood glucose) and symptoms from hypoglycemia may result.
- Coadministration of glyburide with bosentan may cause an abnormal increase in liver enzymes. Concomitant use of these agents is not recommended.
- Colesevelam may reduce blood levels of glyburide. Patients are advised to take glyburide 1 hour before or 4 hours after colesevelam administration to minimize the risk of their interaction.
Glucovance has not been adequately evaluated in pregnant women. Due to the lack of conclusive safety data, Glucovance should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is unknown if Glucovance is excreted in breast milk. Due to the lack of safety data and the potential risk for hypoglycemia (low blood glucose) in nursing infants, the use of Glucovance in breastfeeding mothers is not recommended.
What are the important side effects of Glucovance (glyburide/metformin)?
The most common side effects include:
Other commonly reported side effects with Glucovance therapy include:
- decreased appetite,
- metallic taste,
- heartburn, and
- weight loss.
Other side effects include:
- hypoglycemia (low blood glucose),
- blood disorders,
- decrease blood sodium levels,
- sensitivity to the sunlight,
- liver disease,
- hives, and
- hypersensitivity-type reactions.
Metformin can cause a rare but serious condition known as lactic acidosis, a build-up of acid in the blood. Lactic acidosis can cause death and requires immediate treatment.
Symptoms of lactic acidosis include:
- muscle pain,
- pain in the stomach,
- difficulty breathing,
- dizziness, and
- slow or irregular heartbeat.
Patients suspected of having signs or symptoms of lactic acidosis must seek emergency medical help.
Glucovance (glyburide/metformin) side effects list for healthcare professionals
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|
|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 a 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.
- 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.
- 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
|Glucovance 1.25 mg/250 mg Tablets
|Glucovance 2.5 mg/500 mg Tablets
|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)|
What drugs interact with Glucovance (glyburide/metformin)?
- Certain drugs tend to produce hyperglycemia and may lead to loss of blood glucose control.
- These drugs include thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid.
- When such drugs are administered to a patient receiving Glucovance, the patient should be closely observed for loss of blood glucose control.
- When such drugs are withdrawn from a patient receiving Glucovance, the patient should be observed closely for hypoglycemia.
- Metformin is negligibly bound to plasma proteins and is, therefore, less likely to interact with highly protein-bound drugs such as salicylates, sulfonamides, chloramphenicol, and probenecid as compared to sulfonylureas, which are extensively bound to serum proteins.
- The hypoglycemic action of sulfonylureas may be potentiated by certain drugs, including nonsteroidal anti-inflammatory agents and other drugs that are highly protein-bound, salicylates, sulfonamides, chloramphenicol, probenecid, coumarins, monoamine oxidase inhibitors, and beta-adrenergic blocking agents.
- When such drugs are administered to a patient receiving Glucovance, the patient should be observed closely for hypoglycemia.
- When such drugs are withdrawn from a patient receiving Glucovance, the patient should be observed closely for loss of blood glucose control.
- An increased risk of liver enzyme elevations was observed in patients receiving glyburide concomitantly with bosentan. Therefore concomitant administration of Glucovance and bosentan is contraindicated.
- A possible interaction between glyburide and ciprofloxacin, a fluoroquinolone antibiotic, has been reported, resulting in a potentiation of the hypoglycemic action of glyburide. The mechanism for this interaction is not known.
- A potential interaction between oral miconazole and oral hypoglycemic agents leading to severe hypoglycemia has been reported. Whether this interaction also occurs with the intravenous, topical, or vaginal preparations of miconazole is not known.
- Colesevelam: Concomitant administration of colesevelam and glyburide resulted in reductions in glyburide AUC and Cmax of 32% and 47%, respectively. The reductions in glyburide AUC and Cmax were 20% and 15%, respectively, when administered 1 hour before, and not significantly changed (-7% and 4%, respectively) when administered 4 hours before colesevelam.
- A single-dose, metformin-furosemide drug interaction study in healthy subjects demonstrated that the pharmacokinetic parameters of both compounds were affected by coadministration.
- Furosemide increased the metformin plasma and blood Cmax by 22% and blood AUC by 15%, without any significant change in metformin renal clearance.
- When administered with metformin, the Cmax and AUC of furosemide were 31% and 12% smaller, respectively, than when administered alone, and the terminal half-life was decreased by 32%, without any significant change in furosemide renal clearance.
- No information is available about the interaction of metformin and furosemide when coadministered chronically.
- A single-dose, metformin-nifedipine drug interaction study in normal healthy volunteers demonstrated that coadministration of nifedipine increased plasma metformin Cmax and AUC by 20% and 9%, respectively, and increased the amount excreted in the urine.
- Tmax and half-life were unaffected.
- Nifedipine appears to enhance the absorption of metformin. Metformin had minimal effects on nifedipine.
- Cationic drugs (eg, amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, or vancomycin) that are eliminated by renal tubular secretion theoretically have the potential for interaction with metformin by competing for common renal tubular transport systems.
- Such interaction between metformin and oral cimetidine has been observed in normal healthy volunteers in both single- and multiple-dose, metformin-cimetidine drug interaction studies, with a 60% increase in peak metformin plasma and whole blood concentrations and a 40% increase in plasma and whole blood metformin AUC.
- There was no change in the elimination half-life in the single-dose study. Metformin did not affect cimetidine pharmacokinetics.
- Although such interactions remain theoretical (except for cimetidine), careful patient monitoring and dose adjustment of Glucovance and/or the interfering drug is recommended in patients who are taking cationic medications that are excreted via the proximal renal tubular secretory system.
- In healthy volunteers, the pharmacokinetics of metformin and propranolol and metformin and ibuprofen were not affected when coadministered in single-dose interaction studies.
Glucovance (glyburide/metformin) is a combination antidiabetic medication used as an adjunct to diet and exercise to improve blood glucose (sugar) control in adults with type 2 diabetes mellitus. Common side effects of Glucovance include stomach pain, diarrhea, upset stomach, nausea, vomiting, headache, dizziness, decreased appetite, metallic taste, gas, heartburn, and weight loss. Due to the lack of conclusive safety data, Glucovance should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. It is unknown if Glucovance is excreted in breast milk.
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Related Disease Conditions
Normal Blood Sugar Levels In Adults with Diabetes
People with diabetes can manage and prevent low or high blood sugar levels (hyperglycemia or hypoglycemia) by keeping a log of your blood sugar levels when you are eating and fasting and eat foods that are high in carbohydrates and sugar, for example, buttered potatoes, candy, sugary desserts, and fatty foods. Blood tests, for example, the hemoglobin A1c test (A1c test) and urinalysis can diagnose the type of diabetes the person has. Diabetes during pregnancy, called gestational diabetes, should be managed by you and your OB/GYN or another healthcare professional. Extremely high levels of blood glucose in the blood can be dangerous and life threatening if you have type 1, type 2, or gestational diabetes. If you or someone that you are with has extremely high blood glucose levels, call 911 or go to your nearest Urgent Care or Emergency Department immediately. To prevent and manage high blood glucose levels in people with diabetes keep a log of your blood sugar levels, eat foods that are high in carbohydrates sugar, for example, buttered potatoes, candy, sugary deserts, and fatty foods that you can share with your doctor and other healthcare professionals.
Diabetes (Type 1 and Type 2)
Diabetes is a chronic condition characterized by high levels of sugar (glucose) in the blood. The two types of diabetes are referred to as type 1 (insulin dependent) and type 2 (non-insulin dependent). Symptoms of diabetes include increased urine output, thirst, hunger, and fatigue. Treatment of diabetes depends on the type.
Type 2 Diabetes Diet Plan
A type 2 diabetes diet or a type 2 diabetic diet is important for blood sugar (glucose) control in people with diabetes to prevent complications of diabetes. There are a variety of type 2 diabetes diet eating plans such as the Mediterranean diet, Paleo diet, ADA Diabetes Diet, and vegetarian diets.Learn about low and high glycemic index foods, what foods to eat, and what foods to avoid if you have type 2 diabetes.
Pregnancy and Gestational Diabetes
Gestational diabetes is a form of diabetes that can occur during pregnancy. Pregnant women with gestational diabetes have not had the condition prior to becoming pregnant. Usually, gestational diabetes has no symptoms or signs and of gestational diabetes. Gestational diabetes can cause insulin resistance, hypoglycemia, hypoglycemia, and diabetic ketoacidosis. Treatment of gestational diabetes is managing the condition by checking your blood sugar as recommended, diet changes, getting enough exercise, and monitoring your baby's growth.
Diabetes-Related Dental Problems
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Type 2 Diabetes: Diagnosing Diabetes
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Diabetes Symptoms in Women
Diabetes symptoms in women include vaginal itching, pain, or discharge, loss of interest or pain after having sex, polycystic ovarian syndrome (POS), and urinary tract infections or UTIs (which are more common in women. Symptoms of diabetes that are the same in women and men are excessive thirst and hunger, bad breath, and skin infections, darkening of skin in areas of body creases (acanthosis nigricans), breath odor that is fruity, sweet, or acetone, and tingling or numbness in the hands or feet, blurred vision, fatigue, tingling or numbness in the hands or feet, wounds that heal slowly, irritability, and weight loss or gain. Complications of type 1 and type 2 diabetes are the same, for example, skin, eye, and circulation problems, low blood sugar (hypoglycemia), high blood sugar (hyperglycemia), ketoacidosis, and amputation. If diabetes is not managed a person may not survive.
Type 2 Diabetes
Type 2 diabetes is a chronic condition that may be reversible with diet and lifestyle changes. Symptoms include excessive thirst, frequent urination, weight loss, fatigue, and an unusual odor to your urine. Most people don't know they have type 2 diabetes until they have a routine blood test. Treatment options include medications, a type 2 diabetes diet, and other lifestyle changes.
Diabetes Treatment: Medication, Diet, and Insulin
The major goal in treating diabetes is controlling elevated blood sugar without causing abnormally low levels of blood sugar. Type 1 diabetes is treated with: insulin, exercise, and a diabetic diet. Type 2 diabetes is first treated with: weight reduction, a diabetic diet, and exercise. When these measures fail to control the elevated blood sugar, oral medications are used. If oral medications are still insufficient, insulin medications are considered.
Diabetes Symptoms in Men
Early symptoms of diabetes are different in men, such as low testosterone. In many cases, prediabetes that will progress to type 2 diabetes if it is not treated early.
Prediabetes is a situation where a person's blood sugar levels are higher than they should be, but aren't high enough to be diagnosed with type 2 diabetes. There are no signs or symptoms of prediabetes. Some of the risk factors for prediabetes are high blood pressure, high cholesterol, heart disease, smoking, family history, poor diet, and lack of activity. Diet changes along with other healthy lifestyle changes are important in treating prediabetes.
Type 1 vs. Type 2 Diabetes: Differences
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Diabetes and Safe Medications for Colds & Flu
If you have diabetes and catch a cold or the flu, can be more difficult to recover from infections and their complications, for example, pneumonia. Home remedies and over-the-counter (OTC) drugs used for the treatment of the signs and symptoms of colds and the flu may affect blood sugar levels in people with diabetes.Some medications are OK to take if you have diabetes get a cold or the flu include nonsteroidal anti-inflammatory drugs or NSAIDs, like acetaminophen (Tylenol) and ibuprofen (Motrin) to control symptoms of fever and pain. Most cough syrups are safe to take; however, check with your pediatrician to see what medications are safe to give your child if he or she has type 1 or 2 diabetes. If you have diabetes and are sick with a cold or flu, you need to check your blood sugar levels more frequently. Continue taking your regular medications. Eat a diabetic low-glycemic index diet rich in antioxidants. To prevent colds and the flu drink at least eight 8 ounce glasses of water a day. To replenish fluids, drink sports drinks like Gatorade and Pedialyte to replenish electrolytes. Avoid people who are sick, sneezing, coughing, or have other symptoms of a cold or flu.
Gestational Diabetes (Diabetes during Pregnancy))
Learning how to avoid gestational diabetes is possible and maintaining a healthy weight and diet before and during pregnancy can help. Discover risk factors, tests and treatments for, and signs and symptoms of gestational diabetes.
How to Prevent Diabetes Naturally
Prediabetes is a condition in which a person has early symptoms of diabetes, but has not yet fully developed the condition. If prediabetes is not treated with lifestyle changes, the person could develop type 2 diabetes. Type 2 diabetes and prediabetes can be prevented with lifestyle changes, for example, eating a healthy diet, getting more exercise, reducing stress, quitting smoking, reducing or managing blood pressure and cholesterol, and managing any other health conditions or risk factors that you may have for developing type 2 diabetes.
What Are the Early Signs of Diabetes?
The early signs of diabetes depend on if one has type 1 or type 2 diabetes. Type 1 diabetes usually occurs in children, whereas type 2 diabetes is prevalent in adults.
Diabetes Foot Problems
Diabetes related foot problems can affect your health with two problems: diabetic neuropathy, where diabetes affects the nerves, and peripheral vascular disease, where diabetes affects the flow of blood. Common foot problems for people with diabetes include athlete's foot, fungal infection of nails, calluses, corns, blisters, bunions, dry skin, foot ulcers, hammertoes, ingrown toenails, and plantar warts.
Eye Problems and Diabetes
Diabetes and eye problems are generally caused by high blood sugar levels over an extended period of time. Types of eye problems in a person with diabetes include glaucoma, cataracts, and retinopathy. Examples of symptoms include blurred vision, headaches, eye aches, pain, halos around lights, loss of vision, watering eyes. Treatment for eye problems in people with diabetes depend on the type of eye problem. Prevention of eye problems include reducing blood pressure, cholesterol levels, quitting smoking, and maintaining proper blood glucose levels.
Is Diabetes Insipidus Life-Threatening?
Diabetes insipidus (DI) is an uncommon disease that manifests as a frequent urge for urination and extreme thirst. It has nothing to do with blood sugar levels. Although in both diabetes mellitus and insipidus, patients experience a large volume of urine production, the cause is completely different.
Types of Diabetes Type 2 Medications
Type 2 diabetes oral medications are prescribed to treat type 2 diabetes in conjuction with lifestyle changes like diet and exercise. There are nine classes of drugs approved for the treatment of type 2 diabetes. Examples of type 2 oral diabetes medications include acarbose (Precose), chlorpropamide (Diabinese), glipizide (Glucotrol, Glucotrol XL), and metformin (Glucophage). Side effects, drug interactions, warnings and precautions, dosage, and breastfeeding and pregnancy safety information should be reviewed prior to taking any medication.
Hypoglycemia Without Diabetes: Causes and Diet
Hypoglycemia (low blood sugar level) is a condition most seen in patients with diabetes, who are on insulin or medications. Hypoglycemia is uncommon to happen in people without diabetes.
Can Type 2 Diabetes be Cured?
Type 2 diabetes is a long-term medical condition in which the body is not able to regulate blood sugar (glucose) level because of the inability of the body to properly use insulin. An individual can get type 2 diabetes because of a number of factors that reduce insulin action or quantity in the body. The goals of diabetes management are to eliminate symptoms and prevent the development of complications. Many drugs, both oral and injectable, are available for diabetes management.
Tips for Managing Type 1 and 2 Diabetes at Home
Managing your diabetes is a full time commitment. The goal of diabetic therapy is to control blood glucose levels and prevent the complications of diabetes. Information about exercise, diet, and medication will help you manage your diabetes better. Blood glucose reagent strips, blood glucose meters, urine glucose tests, tests for urinary ketones, continuous glucose sensors, and Hemoglobin A1C testing information will enable you to mange your diabetes at home successfully.
What Are the Early Signs of Type 2 Diabetes?
Type 2 Diabetes is a chronic disease characterized by increased blood sugar (glucose) level. Type 2 Diabetes is caused by either insufficient insulin secretion or resistance to that hormone’s action. Insulin is produced by the pancreas and helps process the glucose in the blood. Thus, with inadequate insulin, the bodies can’t burn all the blood sugar for energy in an efficient way. This means the glucose level in the blood rises, causing a variety of symptoms and when severe may even lead to death.
Treatment & Diagnosis
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Medications & Supplements
- metformin solution - oral, Riomet
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- metformin - oral, Glucophage
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- Synjardy (empagliflozin and metformin)
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.
Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.