Euglucon

Name: Euglucon

Before Using Euglucon

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 liver or kidney problems, which may require an adjustment in the dose for patients receiving glyburide.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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
  • Balofloxacin
  • Besifloxacin
  • Ciprofloxacin
  • Disopyramide
  • Dulaglutide
  • Enoxacin
  • Entacapone
  • Fleroxacin
  • Flumequine
  • Gatifloxacin
  • Gemifloxacin
  • Lanreotide
  • Levofloxacin
  • Lixisenatide
  • Lomefloxacin
  • Metreleptin
  • Moxifloxacin
  • Nadifloxacin
  • Norfloxacin
  • Octreotide
  • Ofloxacin
  • Pasireotide
  • Pazufloxacin
  • Pefloxacin
  • Pioglitazone
  • Prulifloxacin
  • Rufloxacin
  • Simeprevir
  • Sparfloxacin
  • Thioctic Acid
  • Tosufloxacin

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
  • 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.
  • 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 disease—Use with caution. May make this condition worse.
  • Kidney disease or
  • Liver disease—Use with caution. Effects may be increased because of slower removal of the medicine from the body.

Euglucon 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:

Less common
  • Difficulty with swallowing
  • dizziness
  • fast heartbeat
  • hives
  • itching
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • shortness of breath
  • skin rash
  • tightness in the chest
  • unusual tiredness or weakness
  • wheezing
Rare
  • Abdominal or stomach pain
  • chills
  • clay-colored stools
  • dark urine
  • diarrhea
  • fever
  • headache
  • light-colored stools
  • loss of appetite
  • nausea and vomiting
  • rash
  • unpleasant breath odor
  • upper right abdominal pain
  • vomiting of blood
  • yellow eyes and skin
Incidence not known
  • Agitation
  • back, leg, or stomach pains
  • bleeding gums
  • blood in the urine or stools
  • bloody, black, or tarry stools
  • blurred vision
  • change in near or distance vision
  • chest pain
  • coma
  • confusion
  • convulsions
  • cough or hoarseness
  • decreased urine output
  • depression
  • difficulty in focusing eyes
  • difficulty with breathing
  • fast or irregular heartbeat
  • fluid-filled skin blisters
  • general body swelling
  • high fever
  • hostility
  • increased thirst
  • irritability
  • itching of the skin
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • lethargy
  • lower back or side pain
  • muscle pain or cramps
  • muscle twitching
  • nosebleeds
  • painful or difficult urination
  • pale skin
  • pinpoint red spots on the skin
  • rapid weight gain
  • seizures
  • sensitivity to the sun
  • skin thinness
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • stupor
  • swelling of the face, ankles, or hands
  • swollen or painful glands
  • unusual bleeding or bruising

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

Symptoms of overdose
  • Anxiety
  • cold sweats
  • cool, pale skin
  • increased hunger
  • nervousness
  • nightmares
  • shakiness
  • slurred speech

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
  • Indigestion
  • passing of gas
Incidence not known
  • Difficulty with moving
  • itching
  • joint pain
  • redness or other discoloration of the skin
  • severe sunburn
  • swollen joints

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.

What is glyburide?

Glyburide is an oral diabetes medicine that helps control blood sugar levels.

Glyburide is used to treat type 2 diabetes.

Glyburide is not for treating type 1 diabetes.

Important information

You should not use Glyburide if you are being treated with bosentan (Tracleer), or if you have diabetic ketoacidosis (call your doctor for treatment).

Before taking glyburide, tell your doctor if you are allergic to sulfa drugs, if you have been using insulin or chlorpropamide (Diabinese), or if you have hemolytic anemia (a lack of red blood cells), an enzyme deficiency (G6PD), a nerve disorder, liver disease, or kidney disease.

Take care not to let your blood sugar get too low. Low blood sugar (hypoglycemia) can occur if you skip a meal, exercise too long, drink alcohol, or are under stress. Symptoms include headache, hunger, weakness, sweating, tremor, irritability, or trouble concentrating. Carry hard candy or glucose tablets with you in case you have low blood sugar. Other sugar sources include orange juice and milk. Be sure your family and close friends know how to help you in an emergency.

What other drugs will affect glyburide?

Many other medicines can affect your blood sugar, and some medicines can increase or decrease the effects of glyburide. Some drugs can also cause you to have fewer symptoms of hypoglycemia, making it harder to tell when your blood sugar is low. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using. This includes prescription and over-the-counter medicines, vitamins, and herbal products.

For the Consumer

Applies to glyburide: oral tablet

Along with its needed effects, glyburide 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 while taking glyburide:

Less common
  • Difficulty with swallowing
  • dizziness
  • fast heartbeat
  • hives
  • itching
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • shortness of breath
  • skin rash
  • tightness in the chest
  • unusual tiredness or weakness
  • wheezing
Rare
  • Abdominal or stomach pain
  • chills
  • clay-colored stools
  • dark urine
  • diarrhea
  • fever
  • headache
  • light-colored stools
  • loss of appetite
  • nausea and vomiting
  • rash
  • unpleasant breath odor
  • upper right abdominal pain
  • vomiting of blood
  • yellow eyes and skin
Incidence not known
  • Agitation
  • back, leg, or stomach pains
  • bleeding gums
  • blood in the urine or stools
  • bloody, black, or tarry stools
  • blurred vision
  • change in near or distance vision
  • chest pain
  • coma
  • confusion
  • convulsions
  • cough or hoarseness
  • decreased urine output
  • depression
  • difficulty in focusing eyes
  • difficulty with breathing
  • fast or irregular heartbeat
  • fluid-filled skin blisters
  • general body swelling
  • high fever
  • hostility
  • increased thirst
  • irritability
  • itching of the skin
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • lethargy
  • lower back or side pain
  • muscle pain or cramps
  • muscle twitching
  • nosebleeds
  • painful or difficult urination
  • pale skin
  • pinpoint red spots on the skin
  • rapid weight gain
  • seizures
  • sensitivity to the sun
  • skin thinness
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • stupor
  • swelling of the face, ankles, or hands
  • swollen or painful glands
  • unusual bleeding or bruising

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

Symptoms of overdose
  • Anxiety
  • cold sweats
  • cool, pale skin
  • increased hunger
  • nervousness
  • nightmares
  • shakiness
  • slurred speech

Some side effects of glyburide 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
  • Indigestion
  • passing of gas
Incidence not known
  • Difficulty with moving
  • itching
  • joint pain
  • redness or other discoloration of the skin
  • severe sunburn
  • swollen joints

Precautions

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Other Comments

Administration advice:
-Take orally once a day with first main meal of the day
-When coadministered with colesevelam, this drug should be taken at least 4 hours prior
-Missed doses should not be corrected by doubling the next dose. Measures for handling events such as missing a dose or skipping a meal should be agreed upon between the patient and their doctor.

General:
-Hypoglycemia may occur, especially in the elderly, debilitated, or malnourished patient, in patients receiving combination therapy, and/or those with renal, hepatic or adrenal insufficiency; dose reduction of this drug may be necessary.
-This drug should not be used in patients with type 1 diabetes or diabetic ketoacidosis.
-Hemolytic anemia may occur in glucose 6-phosphate dehydrogenase (G6PD) deficient patients; consider a non-sulfonylurea alternative.
-When a patient stabilized on any diabetic regimen is exposed to stress such as fever, trauma infection, or surgery, it may be necessary to stop this drug and administer insulin.

Monitoring:
Regular clinical and laboratory evaluations are necessary to determine minimum effective dose and detect primary or secondary failure.
-Clinical status should be checked within the first 4 to 8 weeks and regularly, thereafter
-Laboratory monitoring including periodic fasting blood glucose, self-monitoring of blood glucose, and urine testing (i.e., glucose and ketones) should be done more frequently during drug initiation and with changing doses; glycosylated hemoglobin levels (HbA1c) should be done as clinically warranted.
-In the event of severe hypoglycemia, patients should be closely monitored for a minimum of 24 to 48 hours since hypoglycemia may recur after apparent clinical recovery.

Patient advice:
-Patients should understand the importance of exercise and dietary control in the management of their disease.
-Patients should understand that alcohol ingestion, intense or prolonged exercise, skipping meals, illness, or lifestyle changes may increase their risks for hypoglycemia; they should know how to recognize the symptoms of hypoglycemia and be prepared to treat it.
-Patients should be careful about driving and use of machinery, especially when at risk for hypoglycemia.
-Patients should speak with their health care provider during periods of stress such as fever, trauma, or illness, as their diabetes management may need to be changed.
-Advise patient to speak to physician or health care professional if pregnant, intend to become pregnant, or are breastfeeding.

(web3)