Glyburide and Metformin Hydrochloride Tablets – Consumer Medicine Information
|Condition:||Diabetes, Type 2|
|Ingredients:||Glyburide, Metformin Hydrochloride, Ammonio Methacrylate Copolymer (type B), Croscarmellose Sodium, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polydextrose, Polyethylene Glycol, Povidone, Sodium Hydroxide, Sorbic Acid, Titanium Dioxide, Triacetin|
WARNING: A small number of people who have taken metformin hydrochloride have developed a serious condition called lactic acidosis. Properly functioning kidneys are needed to help prevent lactic acidosis. Most people with kidney problems should not take Glyburide and Metformin Hydrochloride tablets. (See Question Nos. 9-13.)
Q1.Why do I need to take Glyburide and Metformin Hydrochloride?
Your doctor has prescribed Glyburide and Metformin Hydrochloride to treat your type 2 diabetes. This is also known as non-insulin-dependent diabetes mellitus.
Q2. What is type 2 diabetes?
People with diabetes are not able to make enough insulin and/or respond normally to the insulin their body does make. When this happens, sugar (glucose) builds up in the blood. This can lead to serious medical problems including kidney damage, amputations, and blindness. Diabetes is also closely linked to heart disease. The main goal of treating diabetes is to lower your blood sugar to a normal level
Q3. Whyis it important to control type 2 diabetes?
The main goal of treating diabetes is to lower your blood sugar to a normal level. Studies have shown that good control of blood sugar may prevent or delay complications such as heart disease, kidney disease, or blindness.
Q4. How is type 2 diabetes usually controlled?
High blood sugar can be lowered by diet and exercise, by a number of oral medications, and insulin injections. Before taking Glyburide and Metformin Hydrochloride you should first try to control your diabetes by exercise and weight loss. Even if you are taking Glyburide and Metformin Hydrochloride, you should still exercise and follow the diet recommended for your diabetes.
Q5.Does Glyburide and Metformin Hydrochloride work differently from other glucose-control medications?
Yes it does. The Glyburide and Metformin Hydrochloride product combines two glucose-lowering drugs, glyburide and metformin. These two drugs work together to improve the different metabolic defects found in type 2 diabetes. Glyburide lowers blood sugar primarily by causing more of the body’s own insulin to be released, and metformin lowers blood sugar, in part, by helping your body use your own insulin more effectively. Together, they are efficient in helping you achieve better glucose control.
Q6. What happens if my blood sugar is still too high?
When blood sugar cannot be lowered enough by Glyburide and Metformin Hydrochloride your doctor may prescribe injectable insulin or take other measures to control your diabetes.
Q7.Can Glyburide and Metformin Hydrochloride cause side effects?
Glyburide and Metformin Hydrochloride, like all blood sugar-lowering medications, can cause side effects in some patients. Most of these side effects are minor. However, there are also serious, but rare, side effects related to Glyburide and Metformin Hydrochloride (see Q9 - Q13).
Q8.What are the most common side effects of Glyburide and Metformin Hydrochloride?
The most common side effects of Glyburide and Metformin Hydrochloride are normally minor ones such as diarrhea, nausea, and upset stomach. If these side effects occur, they usually occur during the first few weeks of therapy. Taking your Glyburide and Metformin Hydrochloride with meals can help reduce these side effects.
Less frequently, symptoms of hypoglycemia (low blood sugar), such as lightheadedness, dizziness, shakiness, or hunger may occur. The risk of hypoglycemic symptoms increases when meals are skipped, too much alcohol is consumed, or heavy exercise occurs without enough food. Following the advice of your doctor can help you to avoid these symptoms.
Q9. Are there any serious side effects that Glyburide and Metformin Hydrochloride can cause?
People who have a condition known as glucose-6-phosphate dehydrogenase (G6PD) deficiency and who take Glyburide and Metformin Hydrochloride may develop hemolytic anemia (fast breakdown of red blood cells). G6PD deficiency usually runs in families. Tell your doctor if you or any members of your family have been diagnosed with G6PD deficiency before you start taking Glyburide and Metformin Hydrochloride.
Glyburide and Metformin Hydrochloride rarely causes serious side effects. The most serious side effect that Glyburide and Metformin Hydrochloride can cause is called lactic acidosis.
Q10. What is lactic acidosis and can it happen to me?
Lactic acidosis is caused by a build-up of lactic acid in the blood. Lactic acidosis associated with metformin is rare and has occurred mostly in people whose kidneys were not working normally. Lactic acidosis has been reported in about one in 33,000 patients taking metformin over the course of a year. Although rare, if lactic acidosis does occur, it can be fatal in up to half the cases.
It’s also important for your liver to be working normally when you take Glyburide and Metformin Hydrochloride. Your liver helps remove lactic acid from your bloodstream.
Your doctor will monitor your diabetes and may perform blood tests on you from time to time to make sure your kidneys and your liver are functioning normally.
There is no evidence that Glyburide and Metformin Hydrochloride causes harm to the kidneys or liver.
Q11. Are there other risk factors for lactic acidosis?
Your risk of developing lactic acidosis from taking Glyburide and Metformin Hydrochloride is very low as long as your kidneys and liver are healthy. However, some factors can increase your risk because they can affect kidney and liver function. You should discuss your risk with your doctor.
You should not take Glyburide and Metformin Hydrochloride if:
- You have chronic kidney or liver problems
- You have congestive heart failure which is treated with medications, eg,digoxin (Lanoxin®) or furosemide (Lasix®)
- You drink alcohol excessively (all the time or short-term “binge” drinking)
- You are seriously dehydrated (have lost a large amount of body fluids)
- You are going to have certain x-ray procedures with injectable contrast agents
- You are going to have surgery
- You develop a serious condition such as a heart attack, severe infection, or stroke
- You are ≥ 80 years of age and have NOT had your kidney function tested
Q12. What are the symptoms of lactic acidosis?
Some of the symptoms include: feeling very weak, tired or uncomfortable; unusual muscle pain, trouble breathing, unusual or unexpected stomach discomfort, feeling cold, feeling dizzy or lightheaded, or suddenly developing a slow or irregular heartbeat.
If you notice these symptoms, or if your medical condition has suddenly changed, stop taking Glyburide and Metformin Hydrochloride tablets and call your doctor right away. Lactic acidosis is a medical emergency that must be treated in a hospital.
Q13. What does my doctor need to know to decrease my risk of lactic acidosis?
Tell your doctor if you have an illness that results in severe vomiting, diarrhea, and/or fever, or if your intake of fluids is significantly reduced. These situations can lead to severe dehydration, and it may be necessary to stop taking Glyburide and Metformin Hydrochloride temporarily.
You should let your doctor know if you are going to have any surgery or specialized x-ray procedures that require injection of contrast agents. Glyburide and Metformin Hydrochloride therapy will need to be stopped temporarily in such instances.
Q14. Can I take Glyburide and Metformin Hydrochloride with other medications?
Remind your doctor that you are taking Glyburide and Metformin Hydrochloride when any new drug is prescribed or a change is made in how you take a drug already prescribed. Glyburide and Metformin Hydrochloride may interfere with the way some drugs work and some drugs may interfere with the action of Glyburide and Metformin Hydrochloride.
Q15. What if I become pregnant while taking Glyburide and Metformin Hydrochloride?
Tell your doctor if you plan to become pregnant or have become pregnant. As with other oral glucose- control medications, you should not take Glyburide and Metformin Hydrochloride during pregnancy.
Usually your doctor will prescribe insulin while you are pregnant. As with all medications, you and your doctor should discuss the use of Glyburide and Metformin Hydrochloride if you are nursing a child.
Q16. How do I take Glyburide and Metformin Hydrochloride?
Your doctor will tell you how many Glyburide and Metformin Hydrochloride tablets to take and how often. This should also be printed on the label of your prescription. You will probably be started on a low dose of Glyburide and Metformin Hydrochloride and your dosage will be increased gradually until your blood sugar is controlled.
Q17.Where can I get more information about Glyburide and Metformin Hydrochloride?
This leaflet is a summary of the most important information about Glyburide and Metformin Hydrochloride. If you have any questions or problems, you should talk to your doctor or other healthcare provider about type 2 diabetes as well as Glyburide and Metformin Hydrochloride and its side effects. There is also a leaflet (package insert) written for health professionals that your pharmacist can let you read.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.