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Wednesday, September 28, 2016

glyburide and metformin

GLYE-bure-ide, met-FOR-min hye-droe-KLOR-ide

Oral route(Tablet)

Lactic acidosis is a rare, but serious, metabolic complication that can occur due to metformin accumulation during treatment with glyburide/metformin hydrochloride; when it occurs, it is fatal in approximately 50% of cases. The risk of lactic acidosis increases with renal impairment, increased age, diabetes mellitus, congestive heart failure, hepatic insufficiency, and other conditions whenever there is significant tissue hypoperfusion and hypoxemia. Treatment with glyburide/metformin hydrochloride should not be initiated in patients 80 years of age or older unless measurement of creatinine clearance demonstrates that renal function is normal. Therapy should temporarily be discontinued prior to any intravascular radiocontrast study or surgical procedure. Avoid excessive alcohol use since alcohol potentiates the effects of metformin on lactate metabolism. Discontinue therapy immediately and institute supportive measures promptly for suspected lactic acidosis .

Commonly used brand name(s)

In the U.S.

Glucovance

Available Dosage Forms:

Tablet

Therapeutic Class: Hypoglycemic, Biguanide/Sulfonylurea Combination

Chemical Class: 2nd Generation Sulfonylurea

Uses For glyburide and metformin

Glyburide and metformin combination is used to treat high blood sugar levels caused by a type of diabetes mellitus (sugar diabetes) called type 2 diabetes. Normally, after you eat, your pancreas releases insulin to help your body store excess sugar for later use. This process occurs during normal digestion of food. 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. With two actions, the combination of glyburide and metformin helps your body cope with high blood sugar. Glyburide causes your pancreas to release more insulin into the bloodstream. Metformin reduces the absorption of sugar, reduces the release of stored sugar from the liver, and helps your body's cells use sugar better.

glyburide and metformin is available only with your doctor's prescription.

Before Using glyburide and metformin

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 glyburide and metformin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to glyburide and metformin 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 and metformin combination 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 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.

Pregnancy

	Pregnancy Category	Explanation
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.

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 glyburide and metformin, 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 glyburide and metformin 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

Bosentan

Diatrizoate

Ethiodized Oil

Iobenzamic Acid

Iobitridol

Iocarmic Acid

Iocetamic Acid

Iodamide

Iodipamide

Iodixanol

Iodohippuric Acid

Iodopyracet

Iodoxamic Acid

Ioglicic Acid

Ioglycamic Acid

Iohexol

Iomeprol

Iopamidol

Iopanoic Acid

Iopentol

Iophendylate

Iopromide

Iopronic Acid

Ioseric Acid

Iosimide

Iotasul

Iothalamate

Iotrolan

Iotroxic Acid

Ioversol

Ioxaglate

Ioxitalamic Acid

Ipodate

Metrizamide

Metrizoic Acid

Tyropanoate Sodium

Using glyburide and metformin 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

Acetazolamide

Alatrofloxacin

Balofloxacin

Cimetidine

Ciprofloxacin

Clinafloxacin

Dichlorphenamide

Disopyramide

Dofetilide

Enoxacin

Fleroxacin

Flumequine

Gatifloxacin

Gemifloxacin

Grepafloxacin

Levofloxacin

Lomefloxacin

Moxifloxacin

Norfloxacin

Ofloxacin

Pefloxacin

Prulifloxacin

Rufloxacin

Sparfloxacin

Temafloxacin

Topiramate

Tosufloxacin

Trovafloxacin Mesylate

Zonisamide

Using glyburide and metformin 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

Aceclofenac

Acemetacin

Alclofenac

Alprenolol

Apazone

Aspirin

Atenolol

Benoxaprofen

Betaxolol

Bevantolol

Bisoprolol

Bitter Melon

Bromfenac

Bucindolol

Bufexamac

Carprofen

Carteolol

Carvedilol

Celiprolol

Cephalexin

Clarithromycin

Clometacin

Clonixin

Clorgyline

Colesevelam

Cyclosporine

Dexketoprofen

Diclofenac

Diflunisal

Dilevalol

Dipyrone

Droxicam

Enalaprilat

Enalapril Maleate

Esmolol

Etodolac

Etofenamate

Felbinac

Fenbufen

Fenoprofen

Fentiazac

Fenugreek

Floctafenine

Flufenamic Acid

Flurbiprofen

Gemfibrozil

Glucomannan

Guar Gum

Ibuprofen

Indomethacin

Indoprofen

Iproniazid

Isocarboxazid

Isoxicam

Ketoprofen

Ketorolac

Labetalol

Levobunolol

Lornoxicam

Meclofenamate

Mefenamic Acid

Meloxicam

Mepindolol

Metipranolol

Metoprolol

Moclobemide

Nabumetone

Nadolol

Naproxen

Nebivolol

Nialamide

Niflumic Acid

Nimesulide

Oxaprozin

Oxprenolol

Oxyphenbutazone

Pargyline

Penbutolol

Phenelzine

Phenylbutazone

Pindolol

Pirazolac

Piroxicam

Pirprofen

Procarbazine

Propranolol

Propyphenazone

Proquazone

Psyllium

Rifampin

Rifapentine

Selegiline

Sotalol

Sulfamethoxazole

Sulindac

Suprofen

Talinolol

Tenidap

Tenoxicam

Tertatolol

Tiaprofenic Acid

Timolol

Tolmetin

Toloxatone

Tranylcypromine

Trospium

Voriconazole

Warfarin

Zomepirac

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 glyburide and metformin 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 glyburide and metformin, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol

Proper Use of glyburide and metformin

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.

glyburide and metformin 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.

Dosing

The dose of glyburide and metformin 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 glyburide and metformin. 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 two 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.

Missed Dose

If you miss a dose of glyburide and metformin, 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 and metformin

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

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; shortness of breath; sweating; or vomiting while you are using glyburide and metformin. These may be symptoms of a serious heart problem, and could be a heart attack.

Glyburide and metformin combination can cause low blood sugar. However, it also can occur if you delay or miss a meal or snack, drink alcohol, exercise more than usual, cannot eat because of nausea or vomiting, take certain medicines, or take glyburide and metformin combination with another type of diabetes medicine. Symptoms of low blood sugar must be treated before they lead to unconsciousness (passing out). Different people 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 healthcare 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 with 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. The members of your household also should know how to use it.

Symptoms of hyperglycemia (high blood sugar) include blurred vision; drowsiness; dry mouth; flushed, dry skin; fruit-like breath odor; increased urination (frequency and volume); ketones in urine; loss of appetite; sleepiness; stomachache, nausea, or vomiting; tiredness; troubled breathing (rapid and deep); unconsciousness; or unusual thirst.

High blood sugar may occur if you do not exercise as much as usual, have a fever or infection, do not take enough or skip a dose of your diabetes medicine, or overeat or do not follow your meal plan.

If symptoms of high blood sugar occur, check your blood sugar level and then call your doctor for instructions.

glyburide and metformin 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.

Do not take glyburide and metformin if you are also using bosentan (Tracleer®). Also, make sure your doctor knows about all other medicines you are using for diabetes, including insulin.

glyburide and metformin Side Effects

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:

More common

Anxious feeling

behavior change similar to being drunk

blurred vision

cold sweats

confusion

convulsions (seizures)

cool pale skin

cough

difficulty in concentrating

drowsiness

excessive hunger

fast heartbeat

fever

headache (continuing)

nausea

nervousness

nightmares

restless sleep

shakiness

slurred speech

sneezing

sore throat

unconsciousness

unusual tiredness or weakness

Rare

Abdominal or stomach discomfort

decreased appetite

diarrhea

fast shallow breathing

general feeling of discomfort

muscle pain or cramping

unusual sleepiness

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:

More common

Dizziness

headache

vomiting

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.

See also: glyburide and metformin side effects (in more detail)

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More glyburide and metformin resources

Glyburide and metformin Side Effects (in more detail)
Glyburide and metformin Dosage
Glyburide and metformin Use in Pregnancy & Breastfeeding
Drug Images
Glyburide and metformin Drug Interactions
Glyburide and metformin Support Group
3 Reviews for Glyburide and metformin - Add your own review/rating

Compare glyburide and metformin with other medications

Diabetes, Type 2

Tamsulosiinhydrokloridi Copyfarm

Tamsulosiinhydrokloridi Copyfarm may be available in the countries listed below.

Ingredient matches for Tamsulosiinhydrokloridi Copyfarm

Tamsulosin

Tamsulosin is reported as an ingredient of Tamsulosiinhydrokloridi Copyfarm in the following countries:

Finland

International Drug Name Search

Glyburide

Pronunciation: GLYE-bure-ide
Generic Name: Glyburide
Brand Name: DiaBeta

Glyburide is used for:

Treating type 2 diabetes. It is used along with diet and exercise. It may be used alone or with other antidiabetic medicines.

Glyburide is a sulfonylurea antidiabetic medicine. It works by causing the pancreas to release insulin, which helps to lower blood sugar.

Do NOT use Glyburide if:

you are allergic to any ingredient in Glyburide

you have type 1 diabetes or certain severe problems associated with diabetes (eg, diabetic ketoacidosis, diabetic coma)

you have moderate to severe burns or very high blood acid levels (acidosis)

you are pregnant and are within 2 weeks of the expected delivery date

you are taking bosentan

Contact your doctor or health care provider right away if any of these apply to you.

Before using Glyburide:

Some medical conditions may interact with Glyburide. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have had a severe allergic reaction (eg, a severe rash, hives, itching, breathing difficulties, dizziness) to any other sulfonamide medicine, such as acetazolamide, celecoxib, certain diuretics (eg, hydrochlorothiazide), glipizide, probenecid, sulfamethoxazole, valdecoxib, or zonisamide

if you have a history of liver, kidney, thyroid, or heart problems

if you have stomach or bowel problems (eg, stomach or bowel blockage, stomach paralysis), drink alcohol, or have had poor nutrition

if you have a certain nerve problem (autonomic neuropathy), very poor health, a high fever, a severe infection, severe diarrhea, or high blood acid levels, or have had a severe injury

if you have a history of certain hormonal problems (eg, adrenal or pituitary problems, syndrome of inappropriate secretion of antidiuretic hormone [SIADH]), low blood sodium levels, anemia, or glucose-6-phosphate dehydrogenase (G6PD) deficiency

if you will be having surgery

Some MEDICINES MAY INTERACT with Glyburide. Tell your health care provider if you are taking any other medicines, especially any of the following:

Bosentan because liver problems may occur and the effectiveness of both medicines may be decreased

Beta-blockers (eg, propranolol) because the risk of low blood sugar may be increased. They may also hide certain signs of low blood sugar and make it more difficult to notice

Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), anticoagulants (eg, warfarin), azole antifungals (eg, ketoconazole, miconazole), chloramphenicol, clarithromycin, clofibrate, disopyramide, fenfluramine, fluoxetine, insulin, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen), phenylbutazone, probenecid, quinolone antibiotics (eg, ciprofloxacin), salicylates (eg, aspirin), or sulfonamides (eg, sulfamethoxazole) because the risk of low blood sugar may be increased

Calcium channel blockers (eg, diltiazem), corticosteroids (eg, prednisone), decongestants (eg, pseudoephedrine), diazoxide, diuretics (eg, furosemide, hydrochlorothiazide), estrogens, hormonal contraceptives (eg, birth control pills), hydantoins (eg, phenytoin), isoniazid, niacin, phenothiazines (eg, promethazine), rifamycins (eg, rifampin), sympathomimetics (eg, albuterol, epinephrine, terbutaline), or thyroid supplements (eg, levothyroxine) because they may decrease Glyburide's effectiveness, resulting in high blood sugar

Gemfibrozil because blood sugar may be increased or decreased

Cyclosporine because the risk of its side effects may be increased by Glyburide

This may not be a complete list of all interactions that may occur. Ask your health care provider if Glyburide may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Glyburide:

Use Glyburide as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take Glyburide by mouth with food as directed by your doctor.

If you are taking 1 dose daily, take Glyburide with breakfast or the first main meal of the day unless your doctor tells you otherwise.

High amounts of dietary fiber may decrease Glyburide's effectiveness, resulting in high blood sugar. If you have questions about fiber in your diet while you are taking Glyburide, talk with your doctor.

Glyburide works best if it is taken at the same time each day.

Continue to take Glyburide even if you feel well. Do not miss any doses.

If you miss a dose of Glyburide, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Glyburide.

Important safety information:

Glyburide may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Glyburide with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Do not drink large amounts of alcohol while you use Glyburide. Alcohol may increase the risk of Glyburide's side effects. Also, alcohol may rarely interact with Glyburide and cause a serious reaction with symptoms such as flushing, nausea, vomiting, dizziness, or stomach pain. Talk with your doctor or health care provider before you drink alcohol while you use Glyburide.

Carry an ID card at all times that says you have diabetes. Check your blood sugar levels as directed by your doctor. If they are often higher or lower than they should be and you take Glyburide exactly as prescribed, tell your doctor.

Proper diet, regular exercise, and regular blood sugar testing are important for best results with Glyburide. Follow the diet and exercise program given to you by your health care provider.

It may be harder to control your blood sugar during times of stress such as fever, infection, injury, or surgery. Talk with your doctor about how to control your blood sugar if any of these occur. Do not change the dose of your medicine without checking with your doctor.

Glyburide may cause low blood sugar levels. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your heart beat faster; make your vision change; give you a headache, chills, or tremors; or make you more hungry. It is a good idea to carry a reliable source of glucose (eg, tablets or gel) to treat low blood sugar. If this is not available, you should eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or non-diet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens. To prevent low blood sugar, eat meals at the same time each day and do not skip meals.

Risk of low blood sugar may be increased by severe or prolonged exercise, drinking alcohol, or skipping meals.

Glyburide is a sulfonylurea. It may increase the risk of death from heart disease. Talk with your doctor about the benefits and risks of this or other therapies to treat your condition.

Glyburide may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Glyburide. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.

Do not change from this type of glyburide (nonmicronized) to the micronized type without checking with your doctor. Their effectiveness may not be the same.

Glyburide should not be used by itself to treat type 1 diabetes. If you have questions about using Glyburide to treat type 1 diabetes, talk with your doctor.

Tell your doctor or dentist that you take Glyburide before you receive any medical or dental care, emergency care, or surgery.

Lab tests, including fasting blood glucose and hemoglobin A_1c, may be performed while you use Glyburide. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Use Glyburide with caution in the ELDERLY; they may be more sensitive to its effects, especially low blood sugar levels.

Glyburide should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Glyburide while you are pregnant. If you take Glyburide during pregnancy, do not take it within 2 weeks of the expected delivery date without first checking with your doctor. It is not known if Glyburide is found in breast milk. Do not breast-feed while taking Glyburide.

When used for long periods of time, Glyburide may not work as well. If your blood sugar has been under control and then becomes hard to manage, contact your doctor. Do not change the dose of your medicine without checking with your doctor.

Possible side effects of Glyburide:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Feeling of stomach fullness; heartburn; nausea.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing, joint or muscle pain, tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); blisters on the skin; confusion; fainting; fever, chills, or persistent sore throat; irregular heartbeat; low blood sugar symptoms (eg, anxiety, dizziness, drowsiness, fast heartbeat, headache, lightheadedness, tremors, unusual sweating, weakness); severe or persistent blurred vision or other vision problems; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, stomach pain, yellowing of the eyes or skin); unusual bruising or bleeding; unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Glyburide side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include coma; confusion; fainting; fast heartbeat; lethargy; lightheadedness; seizures; severe dizziness or drowsiness; tremor; unusual sweating.

Proper storage of Glyburide:

Store Glyburide at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Glyburide out of the reach of children and away from pets.

General information:

If you have any questions about Glyburide, please talk with your doctor, pharmacist, or other health care provider.

Glyburide is to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Glyburide. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More Glyburide resources

Glyburide Side Effects (in more detail)
Glyburide Dosage
Glyburide Use in Pregnancy & Breastfeeding
Drug Images
Glyburide Drug Interactions
Glyburide Support Group
3 Reviews for Glyburide - Add your own review/rating

Glyburide Professional Patient Advice (Wolters Kluwer)

Glyburide Monograph (AHFS DI)

DiaBeta Prescribing Information (FDA)

Micronase Prescribing Information (FDA)

glyburide Concise Consumer Information (Cerner Multum)

glyburide Advanced Consumer (Micromedex) - Includes Dosage Information

Compare Glyburide with other medications

Diabetes, Type 2

Gly-Cort

Generic Name: hydrocortisone (Topical application route)

hye-droe-KOR-ti-sone

Commonly used brand name(s)

In the U.S.

Ala-Cort

Ala-Scalp HP

Anusol HC

Aquanil HC

Beta HC

Caldecort

Cetacort

Corta-Cap

Cortagel Extra Strength

Cortaid

CortAlo With Aloe

Corticaine

Corticool Maximum Strength

Cortizone-10

Cortizone-5

Cotacort

Delacort

Dermarest

Dermtex-HC

Foille Cort

Gly-Cort

Hydrozone Plus

Hytone

Instacort-10

Ivy Soothe

IvyStat

Keratol HC

Kericort 10

Lacticare-HC

Locoid

Locoid Lipocream

Medi-Cortisone Maximum Strength

Microcort

Mycin Scalp

Neutrogena T/Scalp

NuCort

Nupercainal HC

Nutracort

Pandel

Pediaderm HC Kit

Preparation H Hydrocortisone

Proctocream-HC

Recort Plus

Sarnol-HC Maximum Strength

Scalacort

Scalpcort

Summer's Eve Specialcare

Texacort

Therasoft Anti-Itch & Dermatitis

U-Cort

Westcort

In Canada

Barriere-Hc

Cortate

Cort-Eze

Cortoderm Mild Ointment

Cortoderm Regular Ointment

Emo-Cort

Emo-Cort Scalp Solution

Hydrocortisone Cream

Novo-Hydrocort

Novo-Hydrocort Cream

Prevex Hc

Sarna Hc

Available Dosage Forms:

Solution

Cream

Spray

Lotion

Ointment

Liquid

Gel/Jelly

Foam

Stick

Paste

Therapeutic Class: Corticosteroid, Weak

Pharmacologic Class: Adrenal Glucocorticoid

Uses For Gly-Cort

Hydrocortisone topical is used to help relieve redness, itching, swelling, or other discomfort caused by skin conditions. This medicine is a corticosteroid (cortisone-like medicine or steroid).

This medicine is available both over-the-counter (OTC) and with your doctor's prescription.

Before Using Gly-Cort

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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of hydrocortisone topical in the pediatric population. However, because of this medicine's toxicity, it should be used with caution. Children may absorb large amounts through the skin, which can cause serious side effects. If your child is using this medicine, follow your doctor's instructions very carefully.

Geriatric

No information is available on the relationship of age to the effects of hydrocortisone topical in geriatric patients.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of hydrocortisone

This section provides information on the proper use of a number of products that contain hydrocortisone. It may not be specific to Gly-Cort. Please read with care.

It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects or skin irritation.

This medicine is for use on the skin only. Do not get it in your eyes. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away with water.

This medicine should only be used for skin conditions that your doctor is treating. Check with your doctor before using it for other conditions, especially if you think that a skin infection may be present. This medicine should not be used to treat certain kinds of skin infections or conditions, such as severe burns.

To use:

Wash your hands with soap and water before and after using this medicine.

Apply a thin layer of this medicine to the affected area of the skin. Rub it in gently.

With the lotion, shake it well before using.

Do not bandage or otherwise wrap the skin being treated unless directed to do so by your doctor.

If the medicine is applied to the diaper area of an infant, do not use tight-fitting diapers or plastic pants unless directed to do so by your doctor.

If your doctor ordered an occlusive dressing or airtight covering to be applied over the medicine, make sure you know how to apply it. Occlusive dressings increase the amount of medicine absorbed through your skin, so use them only as directed. If you have any questions about this, check with your doctor.

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.

For redness, itching, and swelling of the skin:
- For topical dosage form (cream):
  - Adults—Apply to the affected area of the skin two or three times per day.
  - Children—Apply to the affected area of the skin two or three times per day.
- For topical dosage form (lotion):
  - Adults—Apply to the affected area of the skin two to four times per day.
  - Children—Apply to the affected area of the skin two to four times per day.
- For topical dosage form (ointment):
  - Adults—Apply to the affected area of the skin three or four times per day.
  - Children—Apply to the affected area of the skin three or four times per day.
- For topical dosage form (solution):
  - Adults—Apply to the affected area of the skin three or four times per day.
  - Children—Apply to the affected area of the skin three or four times per day.

Missed Dose

If you miss a dose of this medicine, apply 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.

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 Gly-Cort

It is very important that your doctor check your or your child's progress at regular visits for any unwanted effects that may be caused by this medicine.

If your or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. The risk is greater for children and patients who use large amounts for a long time. Talk to your doctor right away if you or your child have more than one of these symptoms while you are using this medicine: blurred vision; dizziness or fainting; a fast, irregular, or pounding heartbeat; increased thirst or urination; irritability; or unusual tiredness or weakness.

Stop using this medicine and check with your doctor right away if you or your child have a skin rash, burning, stinging, swelling, or irritation on the skin.

Do not use cosmetics or other skin care products on the treated areas.

Gly-Cort Side Effects

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:

Incidence not known

Blistering, burning, crusting, dryness, or flaking of the skin

irritation

itching, scaling, severe redness, soreness, or swelling of the skin

redness and scaling around the mouth

thinning of the skin with easy bruising, especially when used on the face or where the skin folds together (e.g. between the fingers)

thinning, weakness, or wasting away of the skin

Incidence not known

Acne or pimples

burning and itching of the skin with pinhead-sized red blisters

burning, itching, and pain in hairy areas, or pus at the root of the hair

increased hair growth on the forehead, back, arms, and legs

lightening of normal skin color

lightening of treated areas of dark skin

reddish purple lines on the arms, face, legs, trunk, or groin

softening of the skin

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.

See also: Gly-Cort side effects (in more detail)

More Gly-Cort resources

Gly-Cort Side Effects (in more detail)
Gly-Cort Use in Pregnancy & Breastfeeding
Gly-Cort Drug Interactions
Gly-Cort Support Group
0 Reviews for Gly-Cort - Add your own review/rating

Gly-Cort Concise Consumer Information (Cerner Multum)

Anucort-HC cream, ointment, suppository Concise Consumer Information (Cerner Multum)

Anusol-HC Cream MedFacts Consumer Leaflet (Wolters Kluwer)

Carmol HC Prescribing Information (FDA)

Carmol HC Concise Consumer Information (Cerner Multum)

Carmol HC MedFacts Consumer Leaflet (Wolters Kluwer)

Cortizone-10 Cream MedFacts Consumer Leaflet (Wolters Kluwer)

Hydrocortisone Acetate Monograph (AHFS DI)

Hydrocortisone with Aloe Cream MedFacts Consumer Leaflet (Wolters Kluwer)

Hytone Prescribing Information (FDA)

Instacort Gel MedFacts Consumer Leaflet (Wolters Kluwer)

Locoid Cream MedFacts Consumer Leaflet (Wolters Kluwer)

Locoid Lipocream Prescribing Information (FDA)

Locoid Lotion Prescribing Information (FDA)

Nutracort Concise Consumer Information (Cerner Multum)

Nutracort Lotion MedFacts Consumer Leaflet (Wolters Kluwer)

Pandel Prescribing Information (FDA)

Pediaderm HC Lotion MedFacts Consumer Leaflet (Wolters Kluwer)

ProctoCream-HC Cream MedFacts Consumer Leaflet (Wolters Kluwer)

Proctocort Prescribing Information (FDA)

Texacort Prescribing Information (FDA)

U-cort Prescribing Information (FDA)

Westcort Prescribing Information (FDA)

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Tuesday, September 27, 2016

Acnifen

Acnifen may be available in the countries listed below.

Ingredient matches for Acnifen

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Monday, September 26, 2016

Ban A Worm

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Ban A Worm

Pyrantel

Pyrantel tartrate (a derivative of Pyrantel) is reported as an ingredient of Ban A Worm in the following countries:

United States

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Lisinopril Apotex Pharma

Lisinopril Apotex Pharma may be available in the countries listed below.

Ingredient matches for Lisinopril Apotex Pharma

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Friday, September 23, 2016

Glyburide

Class: Sulfonylureas
VA Class: HS502
Chemical Name: 1-[[p-[2-(5-Chloro-o-anisamido)ethyl]phenyl]sulfonyl]-3-cyclohexylurea
Molecular Formula: C₂₃H₂₈ClN₃O₅S
CAS Number: 10238-21-8
Brands: DiaBeta, Glucovance, Glycron, Glynase, Micronase

Introduction

Antidiabetic agent; sulfonylurea.¹ ² ³ ⁴

Uses for Glyburide

Diabetes Mellitus

Used alone or in fixed combination with metformin as an adjunct to diet and exercise for the management of type 2 (noninsulin-dependent) diabetes mellitus in patients whose hyperglycemia cannot be controlled by diet alone.¹ ² ³ ⁴ ⁴⁹ ⁵⁰ ⁵¹ ⁵² ⁵³ ⁵⁴ ⁵⁵ ⁵⁶ ⁵⁷ ⁵⁸ ⁵⁹ ⁶⁰ ¹⁵⁸

Used in combination with one or more other oral antidiabetic agents or insulin as an adjunct to diet and exercise in patients who do not achieve adequate glycemic control with diet, exercise, and oral antidiabetic agent monotherapy.¹ ¹²⁴ ¹²⁶ ¹⁵⁸ ¹⁶² ¹⁶⁵ ¹⁶⁶ ¹⁶⁸ ¹⁶⁹ ¹⁷⁰ ¹⁹⁵ ¹⁹⁶ ¹⁹⁷ ¹⁹⁸ ¹⁹⁹ ²⁰⁰ ²⁰¹ ²⁰² ²⁰³

Alternative therapy in some type 2 diabetic patients being treated with insulin.¹ ² ³ Useful in combination with insulin therapy to improve glycemic control and/or decrease insulin dosage in some type 2 diabetic patients.¹¹⁶ ¹¹⁷ ¹¹⁸ ¹¹⁹ ¹²⁰ ¹⁶² ¹⁶⁵ ¹⁶⁶ ¹⁶⁸ ¹⁶⁹ ¹⁷⁰

Not effective as sole therapy for patients with type 1 diabetes mellitus; ¹ ³ ⁶⁰ insulin is necessary.¹ ² ⁶⁰

Not effective as sole therapy in patients with diabetes mellitus complicated by acidosis, ketosis, or coma; insulin is necessary.¹ ² ³

Glyburide Dosage and Administration

General

Adjust dosage according to patient’s tolerance and urine and/or fasting blood glucose determinations.¹ ² Monitor glycosylated hemoglobin (hemoglobin A_1c, HbA_1c) to determine minimum effective dosage and to detect primary or secondary failure.¹ ²

During transfer from insulin therapy, patients should test their blood for glucose ² ⁶⁰ ¹⁰⁶ and their urine for glucose and/or ketones at least 3 times daily.¹ ² ¹²⁴ ¹²⁶ Persistent ketonuria with glycosuria, ¹ ² ketosis, ⁸⁶ and/or inadequate lowering or persistent elevation of blood glucose concentration ⁸⁶ during transfer from insulin indicate the need for insulin therapy.¹ ² ⁸⁶

Micronized formulations are not bioequivalent with conventional formulations; retitrate dosage when transferring patients from micronized to conventional formulations, or vice versa.¹²⁴

Administration

Oral Administration

Administer conventional or micronized formulations once daily with breakfast or first main meal.¹ ² ³ ¹²⁴ May administer in 2 divided doses in some patients (i.e., those receiving >10 mg daily [as conventional formulations]¹ ² or >6 mg [as micronized glyburide]).^b

Administer fixed combination with metformin hydrochloride once or twice daily with a meal.¹⁵⁸

Dosage

Adults

Diabetes Mellitus

Initial Dosage in Previously Untreated Patients

Oral

Conventional formulations: Initially, 2.5–5 mg daily.¹ ²

Micronized formulations: Initially, 1.5 –3 mg daily.¹²⁴

Fixed combination with metformin hydrochloride: Initially, 1.25 mg of glyburide and 250 mg of metformin hydrochloride once daily.¹⁵⁸ For severe hyperglycemia (baseline HbA_1c >9% or fasting blood glucose >200 mg/dL), 1.25 mg of glyburide and 250 mg of metformin hydrochloride twice daily, given with the morning and evening meals.¹⁵⁸

Initial Dosage in Patients Transferred from Other Oral Antidiabetic Agents

Oral

Conventional formulations: Initially, 2.5–5 mg daily.¹ ²

Micronized formulations: Initially, 1.5–3 mg daily.¹²⁴

May discontinue most other oral hypoglycemic agents (except chlorpropamide) immediately.¹ ² ³ ⁹⁶ ^b During transfer from chlorpropamide (a drug with a long elimination half-life), monitor closely for hypoglycemia during initial 2 weeks of transition period.¹ ² ^b

Fixed combination with metformin hydrochloride: Initially, 2.5 or 5 mg of glyburide and 500 mg of metformin hydrochloride twice daily with morning and evening meals in patients not adequately controlled by monotherapy with glyburide (or another sulfonylurea) or metformin.¹⁵⁸ For patients previously receiving combination therapy with glyburide (or another sulfonylurea) and metformin, initial dosage should not exceed previous individual dosages of glyburide (or equivalent dosage of another sulfonylurea) and metformin.¹⁵⁸ Titrate in increments ≤5 mg of glyburide and 500 mg of metformin hydrochloride to achieve adequate blood glucose control.¹⁵⁸

Initial Dosage in Patients Transferred from Insulin

Oral

Conventional formulations: Initially, 2.5–5 mg once daily (if insulin dosage is <20 units daily) or 5 mg once daily (if insulin dosage is 20–40 units daily); may discontinue insulin immediately.¹ ² ⁹⁶ If insulin dosage is >40 units daily, reduce insulin dosage by 50% and initiate glyburide at 5 mg daily; withdraw insulin gradually and increase glyburide dosage in increments of 1.25–2.5 mg daily every 2–10 days.¹ ²

Micronized formulations: Initially, 1.5–3 mg once daily (if insulin dosage is <20 units daily) or 3 mg once daily (if insulin dosage is 20–40 units daily); may discontinue insulin immediately.¹²⁴ ^b If insulin dosage is >40 units daily, reduce insulin dosage by 50% and initiate glyburide at 3 mg daily; withdraw insulin gradually and increase glyburide dosage in increments of 0.75–1.5 mg daily every 2–10 days.^b

Titration and Maintenance Dosage

Oral

Conventional formulations: Increase dosage in increments of ≤2.5 mg daily at weekly intervals.¹ ² Usual maintenance dosage is 1.25–20 mg daily.¹ ² ⁹⁶

Micronized formulations: Increase dosage in increments of ≤1.5 mg daily at weekly intervals.^b Usual maintenance dosage is 0.75–12 mg daily.¹²⁴

Fixed combination with metformin hydrochloride: Titrate in increments of 1.25 mg of glyburide and 250 mg of metformin hydrochloride daily at 2-week intervals to achieve adequate blood glucose control.¹⁵⁸

Prescribing Limits

Adults

Conventional formulations: Maximum 20 mg daily.¹ ² ⁹⁶

Micronized formulations: Maximum 12 mg daily.^b

Fixed combination with metformin hydrochloride: Maximum 20 mg of glyburide and 2 g of metformin hydrochloride daily.¹⁵⁸

Special Populations

Hepatic Impairment

Conventional formulations: Initially, 1.25 mg daily.¹ ²

Micronized formulations: Initially, 0.75 mg daily.¹²⁴

Renal Impairment

Conventional formulations: Initially, 1.25 mg daily.¹ ²

Micronized formulations: Initially, 0.75 mg daily.¹²⁴

Geriatric Patients

Conventional formulations: Initially, 1.25 mg daily¹ ²

Micronized formulations: Initially, 0.75 mg daily.¹²⁴

Fixed combination with metformin hydrochloride: Do not titrate to maximum recommended dosage.¹⁵⁸

Other Populations

Cautious dosing recommended in debilitated or malnourished patients or in patients with adrenal or pituitary insufficiency.¹ ² ¹²⁴ ¹⁵⁸

Conventional formulations: Initially, 1.25 mg daily¹ ²

Micronized formulations: Initially, 0.75 mg daily.¹²⁴

Fixed combination with metformin hydrochloride: Do not titrate to maximum recommended dosage.¹⁵⁸

Cautions for Glyburide

Contraindications

Known hypersensitivity to glyburide or any ingredient in the formulation.¹ ² ¹⁵⁸

Diabetic ketoacidosis, with or without coma.¹ ² ³

Monotherapy for type 1 diabetes mellitus.¹ ^a

Warnings/Precautions

Warnings

Cardiovascular Effects

Increased cardiovascular mortality reported with other sulfonylurea antidiabetic agents (i.e., tolbutamide, phenformin).¹ ² ⁶³ However, the American Diabetes Association considers the benefits of intensive glycemic control with insulin or sulfonylureas to outweigh the risks overall.¹²⁸ ¹³⁰ ¹³¹ ¹³⁸ ¹⁴⁴

Sensitivity Reactions

Dermatologic and Sensitivity Reactions

Possible allergic skin reaction (e.g., pruritus, erythema, urticaria, morbilliform or maculopapular eruptions).¹ ² Discontinue the drug if allergic reaction persists.¹ ²

Angioedema, arthralgia, myalgia, and vasculitis reported.¹²³

General Precautions

Hypoglycemia

Severe,¹ ² ⁶⁷ ⁶⁸ ⁶⁹ ⁷⁴ ¹⁰⁵ occasionally fatal,⁶⁷ ⁶⁸ ⁷⁴ ¹⁰⁵ hypoglycemia reported. Debilitated, malnourished, or geriatric patients and patients with renal or hepatic impairment or adrenal or pituitary insufficiency may be particularly susceptible.¹ ¹⁰⁵ ¹⁵⁸ Strenuous exercise, alcohol ingestion, insufficient caloric intake, or use in combination with other antidiabetic agents may increase risk.¹ ² ⁹⁶ ¹⁰⁵ Hypoglycemia may be difficult to recognize in geriatric patients or in those receiving β-adrenergic blocking agents.¹ ¹⁰⁵ ¹⁵⁸ (See Interactions.)

Concurrent Illness

Possible loss of glycemic control during periods of stress (e.g., fever, trauma, infection, surgery).¹ ²

Temporary discontinuance of glyburide and administration of insulin may be required.¹ ²

Use of Fixed Combinations

When used in fixed combination with metformin hydrochloride, consider the cautions, precautions, and contraindications associated with metformin.

Specific Populations

Pregnancy

Category B.¹

Many experts recommend that insulin be used during pregnancy.¹ ² ¹⁰⁶

Lactation

Not known whether glyburide is distributed into milk; discontinue nursing or the drug.¹ ²

Pediatric Use

Safety and efficacy not established.¹ ²

Geriatric Use

Increased risk of hypoglycemia; hypoglycemia may be difficult to recognize.¹ ¹⁰⁵ ¹⁵⁸ Cautious dosing recommended.¹ ² ¹²⁴ ¹⁵⁸ See Geriatric Patients under Dosage and Administration.

Hepatic Impairment

Increased risk of hypoglycemia.¹ ² ⁹⁶ ¹⁰⁵ ¹⁰⁶ Cautious dosing recommended.¹ ² ¹²⁴ ¹⁵⁸ (See Hepatic Impairment under Dosage and Administration.)

Renal Impairment

Increased risk of hypoglycemia.¹ ² ⁹⁶ ¹⁰⁵ ¹⁰⁶ Cautious dosing recommended.¹ ² ¹²⁴ ¹⁵⁸ (See Renal Impairment under Dosage and Administration.)

Common Adverse Effects

With conventional and micronized formulations, nausea, epigastric fullness, heartburn.¹ ² ³ ⁶²

With fixed-combination glyburide/metformin hydrochloride preparation, upper respiratory tract infection, diarrhea, headache, nausea/vomiting, abdominal pain, dizziness.¹⁵⁸

Interactions for Glyburide

When using fixed-combination preparation containing metformin hydrochloride, consider the drug interactions associated with metformin.¹⁵⁸

Protein-bound Drugs

Potential pharmacokinetic interaction and possible potentiation of hypoglycemic effects when used concomitantly with other highly protein-bound drugs.¹ ² ³⁷ ³⁸ ³⁹ ⁴⁰ ⁶² ⁸⁵

Observe for adverse effects when glyburide therapy is initiated or discontinued and vice versa.¹ ²

Specific Drugs

Drug	Interaction	Comments
Alcohol	Possible disulfiram-like reactions¹ ² ⁸⁷
Anticoagulants, oral	Possible displacement from plasma proteins and potentiation of hypoglycemic effects¹ ² ³⁷ ³⁸ ³⁹ ⁴⁰ ⁶² ⁸⁵	Observe for adverse effects when glyburide or oral anticoagulants are initiated or discontinued¹ ²
Antifungals, oral (i.e., fluconazole, miconazole)	Increased glyburide concentrations; possible hypoglycemia¹ ¹²⁴ ¹⁵⁸ ²¹⁰ ²¹¹
β-Adrenergic blocking agents	Impaired glucose tolerance⁶⁰ ⁶² ⁸⁵ or potentiation of hypoglycemic effects⁶⁰ ⁶² ⁸⁵	If concomitantly therapy is necessary, a β₁-selective adrenergic blocking agent may be preferred⁶²
Calcium-channel blocking agents	May exacerbate diabetes mellitus¹ ² ⁹⁰	Observe carefully for loss of glycemic control or for hypoglycemia when calcium-channel blocking agents are discontinued¹ ¹²⁴ ¹⁵⁸
Chloramphenicol	Potentiation of hypoglycemic effects¹ ² ⁶⁰ ⁶² ⁸⁵	Observe carefully for hypoglycemic effects or loss of glycemic control when chloramphenicol is discontinued¹ ¹²⁴ ¹⁵⁸
Contraceptives, oral	May exacerbate diabetes mellitus¹ ² ⁶² ⁸⁵	Observe carefully for loss of glycemic or for hypoglycemia when oral contraceptives are discontinued¹ ¹²⁴ ¹⁵⁸
Corticosteroids	May exacerbate diabetes mellitus¹ ² ⁶² ⁸⁵	Observe carefully for loss of glycemic control or for hypoglycemia when corticosteroids are discontinued¹ ¹²⁴ ¹⁵⁸
Diuretics	May exacerbate diabetes mellitus¹ ² ⁶² ⁸⁵	Observe carefully for loss of glycemic control or for hypoglycemia when diuretics are discontinued¹ ¹²⁴ ¹⁵⁸
Estrogens	May exacerbate diabetes mellitus¹ ² ⁶²	Observe carefully for loss of glycemic control or for hypoglycemia when estrogens are discontinued¹ ¹²⁴ ¹⁵⁸
Fluoroquinolone anti-infectives	Potentiation of hypoglycemic effects¹ ² ¹²⁶	Observe carefully for hypoglycemic effects or loss of glycemic control when fluoroquinolone anti-infectives are discontinued¹ ¹²⁴ ¹⁵⁸
Hydantoins	Possible displacement from plasma protein and potentiation of hypoglycemic effects¹ ² ³⁷ ³⁸ ³⁹ ⁴⁰ ⁶² ⁸⁵	Observe for adverse effects when glyburide or hydantoins are initiated or discontinued¹ ²
Isoniazid	May exacerbate diabetes mellitus¹ ²	Observe carefully for loss of glycemic control or for hypoglycemia when isoniazid is discontinued¹ ¹²⁴ ¹⁵⁸
MAO inhibitors	Potentiation of hypoglycemic effects¹ ² ⁶² ⁸⁵	Observe closely for hypoglycemic effects of loss of glycemic control when MAO inhibitors are discontinued¹ ¹²⁴ ¹⁵⁸
Niacin	May exacerbate diabetes mellitus¹ ² ⁶²	Observe carefully for loss of glycemic control or for hypoglycemia when nicotonic acid is discontinued¹ ¹²⁴ ¹⁵⁸
NSAIAs	Possible displacement from plasma proteins and potentiation of hypoglycemic effects¹ ² ³⁷ ³⁸ ³⁹ ⁴⁰ ⁶² ⁸⁵	Observe for adverse effects when glyburide or NSAIAs are initiated or discontinued¹ ²
Phenothiazines	May exacerbate diabetes mellitus¹ ² ⁶² ⁸⁵	Observe carefully for loss of glycemic control or for hypoglycemia when phenothiazines are discontinued¹ ¹²⁴ ¹⁵⁸
Phenylbutazone	Potentiation of hypoglycemic effects⁸⁴	Monitor blood glucose control; adjust glyburide dosage when phenylbutazone is initiated or discontinued⁸⁵
Phenytoin	May exacerbate diabetes mellitus¹ ² ⁶²	Observe carefully for loss of glycemic control or for hypoglycemia when phenytoin is discontinued¹ ¹²⁴ ¹⁵⁸
Probenecid	Potentiation of hypoglycemic effects¹ ² ⁶²	Observe closely for hypoglycemic effects or loss of glycemic control when probencid is discontinued¹ ¹²⁴ ¹⁵⁸
Rifampin	May exacerbate diabetes mellitus⁶² ⁸⁵	Observe carefully for loss of glycemic control or for hypoglycemia when rifampin is discontinued¹ ¹²⁴ ¹⁵⁸
Sulfonamides	Possible displacement from plasma proteins and potentiation of hypoglycemic effects¹ ² ³⁷ ³⁸ ³⁹ ⁴⁰ ⁶² ⁸⁵	Observe for adverse effects when glyburide or sulfonamides are initiated or discontinued¹ ²
Sympathomimetic agents	May exacerbate diabetes mellitus¹ ² ⁶²	Observe carefully for loss of glycemic control or for hypoglycemia when sympathomimetic agents are discontinued¹ ¹²⁴ ¹⁵⁸
Thyroid agents	May exacerbate diabetes mellitus¹ ² ⁶² ⁸⁵	Observe carefully for loss of glycemic control or for hypoglycemia when thyroid agents are discontinued¹ ¹²⁴ ¹⁵⁸

Glyburide Pharmacokinetics

Absorption

Bioavailability

Almost completely absorbed following oral administration.⁴ ²³ ²⁴ ⁹⁴

Onset

Hypoglycemic action generally begins within 45–60 minutes and is maximal within 1.5–3 hours.⁴ ²⁷ ³² ⁴⁹

Duration

In nonfasting diabetic patients, the hypoglycemic action may persist for up to 24 hours.¹ ² ³³

Food

Food does not affect rate or extent of absorption.²⁷ ²⁸ ⁹⁴

Special Populations

In patients with renal¹ ² ²⁷ or hepatic¹ ² impairment, serum concentrations may be increased.

Distribution

Extent

Distributed in substantial amounts into bile.¹ ² ³ ²⁵ ²⁶ ³⁶

Appears to cross the placenta.⁸¹ ¹⁰¹ Not known if distributed into breast milk.¹ ²

Plasma Protein Binding

>99% (for glyburide).⁷ ²⁵ ³⁷

>97% (for major metabolite 4-trans-hydroxyglyburide).²⁵

Elimination

Metabolism

Appears to be completely metabolized, ²⁵ ²⁶ ³¹ ³⁶ probably in the liver.³¹

Elimination Route

Excreted as metabolites in urine and feces in approximately equal proportions.¹ ² ²³ ²⁵ ²⁶ ³⁰ ³¹ ⁴⁷

Minimally removed by hemodialysis.⁴²

Half-life

1.4–1.8 hours (for glyburide)²⁴ ²⁷ ²⁹ ⁴¹ ⁹⁷ or approximately 10 hours (for glyburide and metabolites).²⁵ ³⁰ ³¹ ³²

Special Populations

In patients with severe renal impairment, clearance may be decreased and half-life prolonged.⁴² ⁴³

Stability

Storage

Oral

Conventional or Micronized Tablets

Well-closed containers at 15–30°C.¹ ² ¹²⁴ ¹²⁶

Fixed-combination Tablets

Light-resistant containers up to 25°C.¹⁵⁸

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Stimulates secretion of endogenous insulin from beta cells of the pancreas.¹ ² ³ ⁴ ⁸ ⁹ ¹⁰ ¹¹ ¹² Lowers blood glucose concentration in diabetic and nondiabetic individuals.³ ⁴ ⁸ ⁹ ¹⁰ ¹¹

During prolonged administration, extrapancreatic effects (e.g., enhanced peripheral sensitivity to insulin, reduction of basal hepatic glucose production) contribute to the hypoglycemic action.⁴ ⁸ ⁹ ¹⁰ ¹¹ ¹² ¹⁵ ¹⁶ ¹⁷ ¹¹⁰ ¹¹¹ ¹¹² ¹²¹

Advice to Patients

Importance of regular clinical and laboratory evaluations, including urine and/or fasting blood glucose determinations.¹ ²

Importance of adhering to diet and exercise regimen.¹ ²

Risks of hypoglycemia, the symptoms and treatment of hypoglycemic reactions, and conditions that predispose to the development of hypoglycemic reactions.¹

Understanding of primary and secondary failure to oral sulfonylurea antidiabetic agents.¹

Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.¹

Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹

Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Glyburide
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets	1.25 mg*	DiaBeta (scored)	Sanofi-Aventis
			Glyburide Tablets	Greenstone, Sandoz, Teva
			Micronase (scored)	Pfizer
		2.5 mg*	DiaBeta (scored)	Sanofi-Aventis
			Glyburide Tablets	Greenstone, Sandoz, Teva
			Micronase (scored)	Pfizer
		5 mg*	DiaBeta (scored)	Sanofi-Aventis
			Glyburide Tablets	Greenstone, Sandoz, Teva
			Micronase (scored)	Pfizer
	Tablets (micronized)	1.5 mg*	Glyburide Micronized Tablets	Amide, Greenstone, Mylan, Stada, Teva, West-Ward
			Glycron (scored)	Zoetica
			Glynase PresTab (scored)	Pfizer
		3 mg*	Glyburide Micronized Tablets	Amide, Greenstone, Mylan, Stada, Teva, West-Ward
			Glycron (scored)	Zoetica
			Glynase PresTab (scored)	Pfizer
		4.5 mg*	Glycron (scored)	Zoetica
		6 mg*	Glyburide Micronized Tablets	Amide, Greenstone, Mylan, Stada, Teva, West-Ward
			Glycron (scored)	Zoetica
			Glynase PresTab (scored)	Pfizer

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Glyburide Combinations
Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets, film-coated	1.25 mg with Metformin Hydrochloride 250 mg*	Glucovance (with povidone)	Bristol-Myers Squibb
			Glyburide with Metformin Hydrochloride Tablets	Actavis, Par, Sandoz, Teva
		2.5 mg with Metformin Hydrochloride 500 mg*	Glucovance (with povidone)	Bristol-Myers Squibb
			Glyburide with Metformin Hydrochloride Tablets	Actavis, Par, Sandoz, Teva
		5 mg with Metformin Hydrochloride 500 mg*	Glucovance (with povidone)	Bristol-Myers Squibb
			Glyburide with Metformin Hydrochloride Tablets	Actavis, Par, Sandoz, Teva

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Diabeta 1.25MG Tablets (SANOFI-AVENTIS U.S.): 50/$23.99 or 100/$45.97

Diabeta 2.5MG Tablets (SANOFI-AVENTIS U.S.): 30/$25.99 or 60/$49.97

Diabeta 5MG Tablets (SANOFI-AVENTIS U.S.): 30/$42.36 or 90/$117.67

Glucovance 2.5-500MG Tablets (B-M SQUIBB U.S. (PRIMARY CARE)): 60/$85.99 or 180/$249.98

Glucovance 5-500MG Tablets (B-M SQUIBB U.S. (PRIMARY CARE)): 60/$92 or 180/$246.06

GlyBURIDE 1.25MG Tablets (TEVA PHARMACEUTICALS USA): 30/$15.99 or 60/$23.98

GlyBURIDE 5MG Tablets (TEVA PHARMACEUTICALS USA): 30/$18.99 or 60/$29.98

GlyBURIDE Micronized 1.5MG Tablets (DAVA PHARMACEUTICALS): 90/$26.99 or 180/$52.97

GlyBURIDE Micronized 3MG Tablets (DAVA PHARMACEUTICALS): 90/$15.01 or 180/$17.99

GlyBURIDE Micronized 6MG Tablets (DAVA PHARMACEUTICALS): 90/$17 or 180/$21

GlyBURIDE-MetFORMIN 2.5-500MG Tablets (IVAX PHARMACEUTICALS INC.): 60/$45.99 or 180/$125.96

GlyBURIDE-MetFORMIN 5-500MG Tablets (TEVA PHARMACEUTICALS USA): 100/$83.99 or 300/$246.97

Glynase 1.5MG Tablets (PFIZER U.S.): 60/$53.99 or 180/$147.97

Glynase 3MG Tablets (PFIZER U.S.): 60/$75.99 or 180/$227.98

Glynase 6MG Tablets (PFIZER U.S.): 60/$129.99 or 180/$369.98

Micronase 1.25MG Tablets (PFIZER U.S.): 30/$22.99 or 90/$68.97

Micronase 2.5MG Tablets (PFIZER U.S.): 30/$28.99 or 90/$86.97

Micronase 5MG Tablets (PFIZER U.S.): 30/$41.99 or 90/$114.96

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

References

1. Pharmacia & Upjohn Company. Micronase (glyburide) prescribing information. Kalamazoo, MI; 2002 Mar.

2. Hoechst-Roussel Pharmaceuticals Inc. Diaβeta (glyburide) prescribing information. Somerville, NJ; 1987 Dec.

3. Anon. Glibenclamide: a review. Drugs. 1971; 1:116-40. [PubMed 5004340]

4. Jackson JE, Bressler R. Clinical pharmacology of sulphonylurea hypoglycaemic agents: part 1. Drugs. 1981; 22:211-45. [IDIS 140932] [PubMed 7021124]

5. Vomel VW, Sauer W. Zur Frage einer antimikrobiellen Wirkung des neuen oralen Antidiabeticums HB 419. (German; with English abstract) Arzneim-Forsch. 1969; 19:1491-4.

6. The British pharmacopoeia. London: Her Majesty’s Stationery Office; 1980:210.

7. Hadju VP, Kohler KF, Schmidt FH et al. Physikalisch-chemische und analytische Unter suchungen an HB 419. (German; with English abstract) Arzneim-Forsch. 1969; 19:1381-6.

8. Skillman TG, Feldman JM. The pharmacology of sulfonylureas. Am J Med. 1981; 70:361-72. [IDIS 164995] [PubMed 6781341]

9. Kolterman OG, Gray RS, Shapiro G et al. The acute and chronic effects of sulfonylurea therapy in type II diabetic subjects. Diabetes. 1984; 33:346-54. [IDIS 184146] [PubMed 6423429]

10. Duckworth WC, Solomon SS, Kitabchi AE. Effect of chronic sulfonylurea therapy on plasma insulin and proinsulin levels. J Clin Endocrinol Metab. 1972; 35:585-91. [IDIS 28916] [PubMed 5052977]

11. Feldman JM, Lebovitz HE. Endocrine and metabolic effects of glybenclamide: evidence for an extrapancreatic mechanism of action. Diabetes. 1971; 20:745-55.

12. DeFronzo RA, Ferrannini E, Koivisto V. New concepts in the pathogenesis and treatment of noninsulin-dependent diabetes mellitus. Am J Med. 1983; 74(Suppl 1A):52-81. [IDIS 164138] [PubMed 6337486]

13. Lockwood DH, Maloff BL, Nowak SM et al. Extrapancreatic effects of sulfonylureas: potentiation of insulin action through post-binding mechanisms. Am J Med. 1983; 74(Suppl 1A):102-8. [PubMed 6401922]

14. Brogden RN, Heel RC, Pakes GE et al. Glipizide: a review of its pharmacological properties and therapeutic use. Drugs. 1979; 18:329-53. [IDIS 107972] [PubMed 389600]

15. Kolterman OG, Prince MJ, Olefsky JM. Insulin resistance in noninsulin-dependent diabetes mellitus: impact of sulfonylurea agents in vivo and in vitro. Am J Med. 1983; 74(Suppl 1A):82-101. [IDIS 164139] [PubMed 6401923]

16. Beck-Nielsen H, Pedersen O, Lindskov HO. Increased insulin sensitivity and cellular insulin binding in obese diabetics following treatment with glibenclamide. Acta Endocrinol. 1979; 90:451-62. [PubMed 106617]

17. Hjollund E, Richelsen B, Beck-Nielsen H et al. The effect of glibenclamide on insulin receptors in normal man: comparative studies of insulin binding to monocytes and erythrocytes. J Clin Endocrinol Metab. 1983; 57:1257-62. [IDIS 178711] [PubMed 6415086]

18. Moses AM, Howanitz J, Miller M. Diuretic action of three sulfonylurea drugs. Ann Intern Med. 1973; 78:541

Wednesday, September 28, 2016

Commonly used brand name(s)

Uses For glyburide and metformin

Before Using glyburide and metformin

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Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

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Important safety information:

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If OVERDOSE is suspected:

General information:

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Introduction

Uses for Glyburide

Diabetes Mellitus

Glyburide Dosage and Administration

General

Administration

Oral Administration

Dosage

Adults

Diabetes Mellitus

Initial Dosage in Previously Untreated Patients

Initial Dosage in Patients Transferred from Other Oral Antidiabetic Agents

Initial Dosage in Patients Transferred from Insulin

Titration and Maintenance Dosage

Prescribing Limits

Adults

Special Populations

Hepatic Impairment

Renal Impairment

Geriatric Patients

Other Populations

Cautions for Glyburide

Contraindications

Warnings/Precautions

Warnings

Cardiovascular Effects