Uses for glyburide, micronized

Glyburide is used to treat high blood sugar levels caused by type 2 diabetes. In type 2 diabetes, your body does not work properly to store excess sugar and the sugar remains in your bloodstream. Chronic high blood sugar can lead to serious health problems in the future.

Proper diet is the first step in managing type 2 diabetes, but often medicines are needed to help your body. Glyburide belongs to a class of medicines called sulfonylureas. It causes your pancreas to release more insulin into the blood stream. This medicine may be used alone or with another oral medicine such as metformin.

This medicine is available only with your doctor's prescription.

Before using glyburide, micronized

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:

Allergies

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.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of glyburide in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of glyburide 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.

Breast Feeding

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.

Interactions with Medicines

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.

• Bosentan

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.

• Acarbose
• Aspirin
• Bexagliflozin
• Capecitabine
• Chloroquine
• Ciprofloxacin
• Darolutamide
• Delafloxacin
• Desmopressin
• Disopyramide
• Dulaglutide
• Enasidenib
• Encorafenib
• Enoxacin
• Entacapone
• Fluconazole
• Gatifloxacin
• Gemifloxacin
• Grepafloxacin
• Hydroxychloroquine
• Lanreotide
• Leflunomide
• Leniolisib
• Letermovir
• Levofloxacin
• Lixisenatide
• Lomefloxacin
• Methotrexate
• Metreleptin
• Midostaurin
• Moxifloxacin
• Norfloxacin
• Octreotide
• Ofloxacin
• Pasireotide
• Phenobarbital
• Pioglitazone
• Porfimer
• Primidone
• Semaglutide
• Simeprevir
• Sitagliptin
• Sotagliflozin
• Sparfloxacin
• Sparsentan
• Teriflunomide
• Thioctic Acid
• Trofinetide
• Trovafloxacin

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.

• Acebutolol
• Aminolevulinic Acid
• Atenolol
• Betaxolol
• Bisoprolol
• Bitter Melon
• Carteolol
• Carvedilol
• Celiprolol
• Clarithromycin
• Colesevelam
• Cyclosporine
• Eltrombopag
• Esmolol
• Fenugreek
• Fluvastatin
• Furazolidone
• Gemfibrozil
• Glucomannan
• Iproniazid
• Isocarboxazid
• Labetalol
• Levobunolol
• Linezolid
• Methylene Blue
• Metipranolol
• Metoprolol
• Moclobemide
• Nadolol
• Nebivolol
• Nialamide
• Oxprenolol
• Penbutolol
• Phenelzine
• Pindolol
• Practolol
• Procarbazine
• Propranolol
• Psyllium
• Rasagiline
• Rifampin
• Rifapentine
• Safinamide
• Saxagliptin
• Selegiline
• Sotalol
• Timolol
• Tranylcypromine
• Voriconazole
• Warfarin

Interactions with Food/Tobacco/Alcohol

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.

• Ethanol

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.

• Diabetic ketoacidosis (ketones in the blood) or
• Type I diabetes—Should not be used in patients with these conditions.

• Glucose-6-phosphate dehydrogenase (G6PD) deficiency (an enzyme problem)—May cause hemolytic anemia (a blood disorder) in patients with this condition.

• 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.

• Heart disease—Use with caution. May make this condition worse.

• Kidney disease or
• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper use of glyburide, micronized

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Carefully follow the special meal plan your doctor gave you. This is the most important part of controlling your condition, and is necessary if the medicine is to work properly. Also, exercise regularly and test for sugar in your blood or urine as directed.

Do not change to another brand without checking with your doctor. The number of tablets that you take depends on the brand and strength of the medicine. If you refill your medicine and it looks different, check with your pharmacist.

Dosing

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 type 2 diabetes:
  • For oral dosage form (micronized tablets):
    • Adults—At first, 1.5 to 3 milligrams (mg) once a day taken with breakfast or the first main meal. Some patients may start at 0.75 mg per day. Your doctor may adjust your dose if needed. However, the dose is usually not more than 12 mg per day.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

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.

Storage

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 glyburide, micronized

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

It is very important to follow carefully any instructions from your health care team about:

• Alcohol—Drinking alcohol may cause severe low blood sugar. Discuss this with your health care team.
• 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 you have diabetes and a list of all of 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, shortness of breath, sweating, or vomiting while you are using this medicine. These may be symptoms of a serious heart problem, including a heart attack.

Too much glyburide can cause low blood sugar (hypoglycemia) when it is used under certain conditions. Symptoms of low blood sugar must be treated before they lead to unconsciousness (passing out). Different people may feel different symptoms of low blood sugar. It is important that you learn which symptoms of low blood sugar you usually have so that you can treat it quickly and call someone on your health care team right away when you need advice.

Symptoms of hypoglycemia (low blood sugar) include anxiety, behavior change similar to being drunk, blurred vision, cold sweats, confusion, cool, pale skin, difficulty in thinking, drowsiness, excessive hunger, fast heartbeat, headache (continuing), nausea, nervousness, nightmares, restless sleep, shakiness, slurred speech, or unusual tiredness or weakness.

If symptoms of low blood sugar occur, eat glucose tablets or gel, corn syrup, honey, or sugar cubes, or drink fruit juice, non-diet soft drink, or sugar dissolved in water. Also, check your blood for low blood sugar. Glucagon is used in emergency situations when severe symptoms such as seizures (convulsions) or unconsciousness occur. Have a glucagon kit available, along with a syringe or needle, and know how to use it. Members of your household also should know how to use it.

Side Effects of glyburide, micronized

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:

Rare

• Abdominal or stomach pain
• chills
• clay-colored stools
• dark urine
• diarrhea
• dizziness
• fever
• headache
• itching or rash
• loss of appetite
• nausea
• unpleasant breath odor
• unusual tiredness or weakness
• vomiting of blood
• yellow eyes or skin

Incidence not known

• Anxiety
• black, tarry stools
• bleeding gums
• blood in the urine or stools
• blurred vision
• chest pain
• cold sweats
• coma
• confusion
• cool, pale skin
• cough
• depression
• fast heartbeat
• increased hunger
• nervousness
• nightmares
• painful or difficult urination
• pinpoint red spots on the skin
• seizures
• shakiness
• slurred speech
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swollen glands
• unusual bleeding or bruising

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Anxiety
• blurred vision
• chills
• cold sweats
• coma
• confusion
• cool, pale skin
• depression
• dizziness
• fast heartbeat
• headache
• increased hunger
• nausea
• nervousness
• nightmares
• seizures
• shakiness
• slurred speech
• unusual tiredness or weakness

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:

Less common

• Heartburn
• hives or welts
• redness of the skin

Incidence not known

• Increased sensitivity of the skin to sunlight
• redness or other discoloration of the skin
• severe sunburn

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.