Glyburide and metformin (Oral route)
GLYE-bure-ide, met-FOR-min hye-droe-KLOR-ide
Post-marketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. Onset is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels, anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/pyruvate ratio, and elevated metformin plasma levels. Risk factors include renal impairment, concomitant use of certain drugs (eg, carbonic anhydrase inhibitors), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (eg, acute congestive heart failure), excess alcohol intake, and hepatic impairment. Immediately discontinue use if suspected and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended .
Hypoglycemic, Biguanide/Sulfonylurea Combination
2nd Generation Sulfonylurea
Uses of This Medicine:
Glyburide and metformin combination is used to treat a type of diabetes mellitus called type 2 diabetes. It is used together with a proper diet and exercise to help control blood sugar levels.
Glyburide causes your pancreas to release more insulin into the bloodstream. Metformin reduces the absorption of sugar from the stomach, reduces the release of stored sugar from the liver, and helps your body use sugar better.
This medicine is available only with your doctor's prescription.
Before Using This Medicine:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of glyburide and metformin combination in the pediatric population. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of glyburide and metformin combination in the elderly. However, elderly patients are more likely to have age-related kidney problems which may require caution and an adjustment in the dose for patients receiving glyburide and metformin combination.
|All Trimesters||B||Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Acetrizoic Acid
- Ethiodized Oil
- Iobenzamic Acid
- Iocarmic Acid
- Iocetamic Acid
- Iodohippuric Acid
- Iodoxamic Acid
- Ioglicic Acid
- Ioglycamic Acid
- Iopanoic Acid
- Iopronic Acid
- Ioseric Acid
- Iotroxic Acid
- Ioxitalamic Acid
- Metrizoic Acid
- Tyropanoate Sodium
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Thioctic Acid
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Aminolevulinic Acid
- Bitter Melon
- Guar Gum
- Methylene Blue
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
Other medical problems—
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Alcohol intoxication or
- Underactive adrenal glands or
- Underactive pituitary gland or
- Undernourished condition or
- Weakened physical condition or
- Any other condition that causes low blood sugar—Patients with these conditions may be more likely to develop low blood sugar while taking glyburide and metformin combination.
- Blood poisoning or
- Dehydration, severe or
- Heart or blood vessel disorders—Lactic acidosis can occur in these conditions and chances of it occurring are even greater with a medicine that contains metformin.
- Diabetic ketoacidosis (high ketones and acid in the blood) or
- Kidney disease, severe or
- Type I diabetes—Should not be used in patients with these conditions.
- Fever or
- Infection or
- Surgery or
- Trauma—These conditions may cause temporary problems with blood sugar control and your doctor may want to treat you temporarily with insulin.
- Glucose-6-phosphate dehydrogenase (G6PD) deficiency (an enzyme problem)—May cause hemolytic anemia (a blood disorder) in patients with this condition.
- Heart attack, acute or
- Heart disease (eg, congestive heart failure) or
- Vitamin B12 deficiency—Use with caution. May make these conditions worse.
- Kidney disease or
- Liver disease—Use with caution. Effects may be increased because of slower removal of the medicine from the body.
Proper Use of This Medicine:
Follow carefully the special meal plan your doctor gave you. This is the most important part of controlling your diabetes, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.
This medicine comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.
Glyburide and metformin combination should be taken with meals to help reduce the stomach adverse effects that may occur during the first few weeks of treatment.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (tablets):
- For type 2 diabetes:
- For first-time treatment:
- Adults—At first, 1.25 milligrams (mg) of glyburide and 250 mg of metformin one or two times a day with meals. Your doctor may increase your dose a little at a time every 2 weeks until your blood sugar is controlled. However, the dose is usually not more than 20 mg of glyburide and 2000 mg of metformin per day.
- Children—Use and dose must be determined by your doctor.
- For patients previously treated with a sulfonylurea antidiabetic agent and/or metformin:
- Adults—At first, 2.5 milligrams (mg) of glyburide and 500 mg of metformin or 5 mg of glyburide and 500 mg of metformin two times a day, with the morning and evening meals. Your doctor may increase your dose a little at a time until your blood sugar is controlled. However, the dose is usually not more than 20 mg of glyburide and 2000 mg of metformin per day.
- Children—Use and dose must be determined by your doctor.
- For first-time treatment:
- For type 2 diabetes:
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions While Using This Medicine:
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Do not take this medicine together with bosentan (Tracleer®). Also, make sure your doctor knows about all other medicines you are using for diabetes, including insulin.
Under certain conditions, too much metformin can cause lactic acidosis. The symptoms of lactic acidosis are severe and quick to appear. They usually occur when other health problems not related to the medicine are present and very severe, such as a heart attack or kidney failure. The symptoms of lactic acidosis include abdominal or stomach discomfort, decreased appetite, diarrhea, fast, shallow breathing, a general feeling of discomfort, muscle pain or cramping, and unusual sleepiness, tiredness, or weakness. If you have any symptoms of lactic acidosis, get emergency medical help right away.
It is very important to carefully follow any instructions from your health care team about:
- Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team.
- Other medicines—Do not take other medicines unless they have been discussed with your doctor. This especially includes nonprescription medicines such as aspirin, and medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems.
- Counseling—Other family members need to learn how to prevent side effects or help with side effects if they occur. Also, patients with diabetes may need special counseling about diabetes medicine dosing changes that might occur because of lifestyle changes, such as changes in exercise and diet. Furthermore, counseling on contraception and pregnancy may be needed because of the problems that can occur in patients with diabetes during pregnancy.
- Travel—Keep your recent prescription and your medical history with you. Be prepared for an emergency as you would normally. Make allowances for changing time zones and keep your meal times as close as possible to your usual meal times.
- In case of emergency—There may be a time when you need emergency help for a problem caused by your diabetes. You need to be prepared for these emergencies. It is a good idea to wear a medical identification (ID) bracelet or neck chain at all times. Also, carry an ID card in your wallet or purse that says that you have diabetes and a list of all your medicines.
Check with your doctor right away if you start having chest pain or discomfort, nausea, pain or discomfort in the arms, jaw, back, or neck, trouble breathing, sweating, or vomiting while you are using this medicine. These may be symptoms of a serious heart problem, and could be a heart attack.
This medicine may cause hypoglycemia (low blood sugar). This is more common when this medicine is taken together with certain medicines. Low blood sugar must be treated before it causes you to pass out (unconsciousness). People feel different symptoms of low blood sugar. It is important that you learn which symptoms you usually have so you can treat it quickly. Talk to your doctor about the best way to treat low blood sugar.
Hyperglycemia (high blood sugar) may occur if you do not take enough or skip a dose of your medicine, overeat or do not follow your meal plan, have a fever or infection, or do not exercise as much as usual. High blood sugar can be very serious and must be treated right away. It is important that you learn which symptoms you have in order to treat it quickly. Talk to your doctor about the best way to treat high blood sugar.
This medicine may interact with the dye used for an X-ray or CT scan. Your doctor should advise you to stop taking it before you have any medical exams or diagnostic tests that might cause less urine output than usual. You may be advised to start taking the medicine again 48 hours after the exams or tests if your kidney function is tested and found to be normal.
Side Effects of This Medicine:
- More common
- Anxious feeling
- behavior change similar to being drunk
- blurred vision
- cold sweats
- convulsions (seizures)
- cool, pale skin
- difficulty with concentrating
- excessive hunger
- fast heartbeat
- headache (continuing)
- restless sleep
- slurred speech
- sore throat
- unusual tiredness or weakness
- Abdominal or stomach discomfort
- decreased appetite
- fast shallow breathing
- general feeling of discomfort
- muscle pain or cramping
- unusual sleepiness
- More common
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Last Updated: 9/4/2017