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Thursday, April 9, 2009

Side-Effects

Glucovance: Side Effects
Introduction to Glucovance

Licensed health care professionals may prescribe Glucovance for the treatment of type 2 diabetes. Glucovance is composed of two drugs known as glyburide and metformin. These drugs work together to attack high blood sugar levels.

Glyburide will stimulate insulin production in the pancreas. It will try to help the body use the insulin effectively. Metformin decreases sugar production and absorption. It also works to encourage the body’s effective use of insulin.
Diabetes

To understand Glucovance as a medical treatment, it is critical to understand that diabetes is an illness wherein the body is unable to control the level of sugar, (glucose) that is present in the body. Sugar is produced by the body, but may also be introduced to the human system through the consumption of starch based foods and foods that have been artificially sweetened.
Types of Diabetes

Diabetes will develop when a person’s body is unable to process sugar. This sugar will build up in the bloodstream. In most cases, patients will suffer from one of two major categories of diabetes. They are type 1 diabetes and type 2 diabetes.

Type 1 diabetes develops when the body is unable to produce insulin on its own. Patients may be treated with insulin injections, as well as modifications to diet and exercise regimes.

People who suffer from 2 diabetes usually develop the condition at 40 years of age or older. This type of diabetes occurs when the body is unable to create enough insulin to function, or is unable to process the insulin properly. This type of diabetes may also be treated with diet, exercise, and careful attention to maintenance of a healthy weight profile.
Complications of Diabetes

Medical professionals will attempt to reduce the likelihood of developing diabetes by encouraging their high risk patients to maintain a healthy weight, and adhere to diet and exercise routines. Doctors will advise patients that diabetes can negatively affect vision, and the functioning of major organs such as the heart and kidneys. Diabetic complications may also affect the feet, increase thirst, and create a feeling of extreme exhaustion.
Usage of Glucovance

Glucovance is an oral medication that may be taken up to twice per day with meals. Never take two doses at the same time, even if you have missed a dosage.
Side Effects of Glucovance

Glucovance is not a replacement for insulin treatment. This drug must be used in combination with regimes consisting of a healthy diet and adequate physical activity.

In general, usage of this drug may cause bouts of hunger, cold sweats, nausea, and dizziness. Others report generalized shakiness, development of anemia, stomach pain, vomiting, and upper respiratory infections.
Potential Complications of Glucovance

It is important to note that diabetic patients who utilize Glucovance must be aware that it can cause harmful reactions in the body. Some patients report episodes of hypoglycemia, or low blood sugar. Usage of this drug can also cause fatal complication in patients with kidney or liver deficiencies.

In some instances, Glucovance has induced lactic acidosis, which is a buildup of lactic acid in the blood. This medical emergency will require immediate professional care. Do seek attention from a physician if you notice stomach discomfort, unusual muscle pain or an irregular heartbeat.
Final Note

Glucovance may also negatively interact with medications that the patient already takes. For example, it may cause adverse reactions for patients who utilize birth control medications, cardiac prescriptions, thyroid medications, and antidepressants, among others. Given the high potential for health complications, patients must seek the advisement of a doctor prior to using, (or discontinuing the use of), Glucovance.

Metformin

Metformin hydrochloride is an oral antihyperglycemic drug used in the management of type 2 dia-betes. Metformin hydrochloride (N, N-dimethylimidodicarbonimidic diamide monohydrochloride) is not chemically or pharmacologically related to sulfonylureas, thiazolidinediones, or -glucosidase inhibitors. It is a white to off-white crystalline compound with a molecular formula of C 4 H 12 ClN 5 (monohydrochloride) and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68.

GLUCOVANCE is available for oral administration in tablets containing 1.25 mg glyburide with 250 mg metformin hydrochloride, 2.5 mg glyburide with 500 mg metformin hydrochloride, and 5 mg glyburide with 500 mg metformin hydrochloride. In addition, each tablet contains the following inactive ingredients: microcrystalline cellulose, povidone, croscarmellose sodium, and magne-sium stearate. The tablets are film coated, which provides color differentiation.

FDA Accept Glucovance

Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration (FDA) has approved Glucovance™ (glyburide and metformin HCl tablets) for use, along with diet and exercise, as initial drug therapy for people with type 2 diabetes.

The drug was also approved as second-line therapy for patients with type 2 diabetes who are currently taking either or a sulfonylurea and a regimen of diet and exercise, but whose blood sugar levels are inadequately controlled.

Glucovance combines glyburide and glucophage -- the two most widely prescribed oral antidiabetic agents -- in a single pill. These agents work together to improve blood sugar in patients with type 2 diabetes.

"Glucovance represents a new approach to managing type 2 diabetes," said Richard J. Lane, president, Worldwide Medicines Group, Bristol-Myers Squibb. "It is our hope that the introduction of this novel agent could change the treatment paradigm for the more than 15 million patients in the U.S. with this condition."

Glucovance will be available in three dosing strengths, including 1.25 mg/250 mg (glyburide/metformin) tablets, 2.5 mg/500 mg tablets, and 5 mg/500 mg.

Glucovance has been proven safe and effective in clinical trials. In rare cases, Glucovance (or glucophage) may cause lactic acidosis, which can be fatal in up to half of the cases. Lactic acidosis occurs mainly in people whose kidneys are not functioning properly. Patients should not take these drugs if they have kidney problems, if they are 80 or older (unless they have their kidneys tested first), if they are taking medication for heart failure, if they have a history of liver disease or if they drink alcohol excessively. The most common side effects of Glucovance are normally minor ones such as diarrhea, nausea, and upset stomach. Less frequently, symptoms of hypoglycemia (low blood sugar) such as lightheadedness, dizziness, shakiness, or hunger may occur.

Uses

Glucovance Uses : This anti-diabetic medication is a combination of two drugs (a sulfonylurea and a biguanide). It is used along with a diet and exercise program to control high blood sugar in patients with type 2 diabetes (non-insulin-dependent diabetes). Glucovance works by stimulating the release of your body s natural insulin and by restoring your body s proper response to insulin. Controlling high blood sugar helps prevent heart disease, strokes, kidney disease, blindness and circulation problems, as well as sexual function problems (impotence).

How to Use Glucovance : Take Glucovance by mouth, usually twice daily with meals; or as directed by your doctor. Drink plenty of fluids while taking Glucovance. Use Glucovance regularly in order to get the most benefit from it. To help you remember, use it at the same times each day. Your dosage is based on your medical condition and response to therapy. Glucovance may come with a Patient Information Leaflet. Read it carefully and ask your doctor or pharmacist any questions you may have about your medication.

Glucovance Side Effects : Also see Warning section. Nausea, stomach upset, diarrhea, or weight gain may occur initially as your body adjusts to the medication. If stomach symptoms recur later (after you are on the same dose for several days or weeks), tell your doctor immediately. A late recurrence of stomach symptoms may be due to lactic acidosis. Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: persistent sore throat or fever, easy bleeding or bruising, severe stomach pain, yellowing eyes or skin, dark urine, unusual tiredness or weakness, unusual or sudden weight gain, mental/mood changes, swelling of the hands or feet, seizures. Glucovance can cause low blood sugar (hypoglycemia). This effect may occur if you do not consume enough calories (from food, juices, fruit, etc.). The symptoms include chills, cold sweat, blurred vision, dizziness, drowsiness, shaking, rapid heartbeat, weakness, headache, fainting, tingling of the hands or feet, or hunger. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you are in a situation where you don t have these reliable forms of glucose, eat a quick source of sugar such as table sugar, honey, or candy, or drink a glass of orange juice or non-diet soda to quickly raise your blood sugar level. Tell your doctor immediately about the reaction. To help prevent hypoglycemia, eat meals on a regular schedule and do not skip meals. Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, or fruity breath odor. If these symptoms occur, tell your doctor immediately. Your medication dosage may need to be increased. An allergic reaction to Glucovance is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching, swelling, dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

Glucovance Precautions : Glucovance should not be used if you have certain medical conditions. Before using Glucovance, consult your doctor or pharmacist if you have: kidney disease, liver disease, conditions that may cause a low oxygen blood level or poor circulation (e.g., severe congestive heart failure, recent heart attack, recent stroke), metabolic conditions (e.g., diabetic ketoacidosis), serious infection, lack of body fluids (dehydration). Before using Glucovance, tell your doctor or pharmacist your medical history, especially of: severe breathing problems (e.g., obstructive lung disease, severe asthma), thyroid disease, blood problems (e.g., anemia, vitamin B-12 deficiency), scheduled upcoming surgery, scheduled upcoming x-ray or scanning procedures, alcohol use, certain hormonal conditions (adrenal/pituitary insufficiency, SIADH-syndrome of inappropriate secretion of antidiuretic hormone), electrolyte imbalance (hyponatremia), high blood pressure, fertility problems (e.g., ovulation problems), any allergies. You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar levels; use caution engaging in activities requiring alertness such as driving or using machinery. Limit alcohol while taking Glucovance because it can increase the risk of developing hypoglycemia. Rarely, alcohol can interact with glyburide and cause a serious reaction (disulfiram-like reaction) with symptoms such as facial flushing, nausea, vomiting, dizziness, or stomach pain. Consult your doctor or pharmacist about the safe use of alcohol. During times of stress, such as fever, infection, injury or surgery, it may be more difficult to control your blood sugar. Consult your doctor, as a change in your medication may be required. Glucovance may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths or sunlamps. Use a sunscreen and wear protective clothing when outdoors. Caution is advised when using Glucovance in the elderly because they may be more sensitive to the effects of Glucovance. Glucovance can cause changes in the menstrual cycle (promote ovulation) in women with certain fertility problems, increasing the risk of becoming pregnant. Consult your doctor or pharmacist about the use of reliable birth control while using Glucovance. Glucovance should be used only when clearly needed during pregnancy. It is not recommended for use for at least 2 weeks before delivery due to the potential for fetal harm. Insulin may be preferred during pregnancy. Discuss the risks and benefits with your doctor. Based on information from related drugs, Glucovance may pass into breast milk. Breast-feeding is not recommended while using Glucovance.

Glucovance Interactions : Glucovance should not be used with the following medications because very serious interactions may occur: bosentan. If you are currently using any of these medications, tell your doctor or pharmacist before starting glyburide/metformin. Before using Glucovance, tell your doctor or pharmacist of all prescription and nonprescription products you may use, especially of: other diabetes drugs (e.g., insulin, rosiglitazone), aspirin or aspirin-like drugs (e.g., salicylates, NSAIDs such as ibuprofen, phenylbutazone), azole antifungals (e.g., fluconazole), cimetidine, birth control pills, blood thinners (e.g., warfarin), chloramphenicol, clofibrate, clomiphene, corticosteroids (e.g., prednisone), decongestants (e.g., pseudoephedrine), diazoxide, diet pills, epinephrine, estrogens, high blood pressure drugs (beta-blockers -- including glaucoma eye drops such as propranolol, timolol, metoprolol; calcium channel blockers such as nifedipine; ACE inhibitors such as captopril), isoniazid, MAO inhibitors (e.g., furazolidone, linezolid, moclobemide, phenelzine procarbazine, selegiline, isocarboxazid, tranylcypromine), niacin, phenothiazines (e.g., chlorpromazine), phenytoin, probenecid, quinolone antibiotics (e.g., ciprofloxacin), rifampin, sulfonamides (e.g., sulfa antibiotics), thyroid drugs, water pills (diuretics such as hydrochlorothiazide, furosemide), fenugreek, ginseng. If you are scheduled to undergo any x-ray or scanning procedure using injectable iodinated contrast material, be sure to inform your doctor that you are taking Glucovance. You will need to temporarily stop Glucovance around the time of your procedure. Consult your doctor for further instructions. Do not start or stop any medicine without doctor or pharmacist approval.

Overdose of Glucovance : If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include: rapid or trouble breathing, severe drowsiness, fast/slow/irregular heartbeat, shakiness, sweating, loss of consciousness.

Glucovance : If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storing Glucovance : Store at room temperature (77 degrees F or 25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Glucovance

Glucovance Side Effects
Also see Warning section. Nausea, stomach upset, diarrhea, or weight gain may occur initially as your body adjusts to the medication. If stomach symptoms recur later (after you are on the same dose for several days or weeks), tell your doctor immediately. A late recurrence of stomach symptoms may be due to lactic acidosis. Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: persistent sore throat or fever, easy bleeding or bruising, severe stomach pain, yellowing eyes or skin, dark urine, unusual tiredness or weakness, unusual or sudden weight gain, mental/mood changes, swelling of the hands or feet, seizures. Glucovance can cause low blood sugar (hypoglycemia). This effect may occur if you do not consume enough calories (from food, juices, fruit, etc.). The symptoms include chills, cold sweat, blurred vision, dizziness, drowsiness, shaking, rapid heartbeat, weakness, headache, fainting, tingling of the hands or feet, or hunger. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you are in a situation where you don t have these reliable forms of glucose, eat a quick source of sugar such as table sugar, honey, or candy, or drink a glass of orange juice or non-diet soda to quickly raise your blood sugar level. Tell your doctor immediately about the reaction. To help prevent hypoglycemia, eat meals on a regular schedule and do not skip meals. Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, or fruity breath odor. If these symptoms occur, tell your doctor immediately. Your medication dosage may need to be increased. An allergic reaction to Glucovance is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching, swelling, dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

Glucovance Precautions
Glucovance should not be used if you have certain medical conditions. Before using Glucovance, consult your doctor or pharmacist if you have: kidney disease, liver disease, conditions that may cause a low oxygen blood level or poor circulation (e.g., severe congestive heart failure, recent heart attack, recent stroke), metabolic conditions (e.g., diabetic ketoacidosis), serious infection, lack of body fluids (dehydration). Before using Glucovance, tell your doctor or pharmacist your medical history, especially of: severe breathing problems (e.g., obstructive lung disease, severe asthma), thyroid disease, blood problems (e.g., anemia, vitamin B-12 deficiency), scheduled upcoming surgery, scheduled upcoming x-ray or scanning procedures, alcohol use, certain hormonal conditions (adrenal/pituitary insufficiency, SIADH-syndrome of inappropriate secretion of antidiuretic hormone), electrolyte imbalance (hyponatremia), high blood pressure, fertility problems (e.g., ovulation problems), any allergies. You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar levels; use caution engaging in activities requiring alertness such as driving or using machinery. Limit alcohol while taking Glucovance because it can increase the risk of developing hypoglycemia. Rarely, alcohol can interact with glyburide and cause a serious reaction (disulfiram-like reaction) with symptoms such as facial flushing, nausea, vomiting, dizziness, or stomach pain. Consult your doctor or pharmacist about the safe use of alcohol. During times of stress, such as fever, infection, injury or surgery, it may be more difficult to control your blood sugar. Consult your doctor, as a change in your medication may be required. Glucovance may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths or sunlamps. Use a sunscreen and wear protective clothing when outdoors. Caution is advised when using Glucovance in the elderly because they may be more sensitive to the effects of Glucovance. Glucovance can cause changes in the menstrual cycle (promote ovulation) in women with certain fertility problems, increasing the risk of becoming pregnant. Consult your doctor or pharmacist about the use of reliable birth control while using Glucovance. Glucovance should be used only when clearly needed during pregnancy. It is not recommended for use for at least 2 weeks before delivery due to the potential for fetal harm. Insulin may be preferred during pregnancy. Discuss the risks and benefits with your doctor. Based on information from related drugs, Glucovance may pass into breast milk. Breast-feeding is not recommended while using Glucovance.