Details for: GLYBURIDE
Company: SANIS HEALTH INC
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02350459 | GLYBURIDE | GLYBURIDE | 2.5 MG | TABLET | ORAL |
| 02350467 | GLYBURIDE | GLYBURIDE | 5 MG | TABLET | ORAL |
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
GLYBURIDE (glyburide) is used as an adjunct to proper diet, exercise and weight reduction to lower blood glucose in adult patients with type 2 diabetes mellitus.
What it does
GLYBURIDE lowers blood sugar by stimulating the pancreas to secrete insulin. The pancreas must produce insulin for this medication to work.
People with type 2 diabetes are not able to make enough insulin or respond normally to the insulin their bodies make. When this happens, sugar (glucose) builds up in the blood. This can lead to serious medical problems including kidney damage, amputations, and blindness. Diabetes is also closely linked to heart disease. The main goal of treating diabetes is to lower
your blood sugar to a normal level and by doing so can prevent long term complications.
In addition to taking GLYBURIDE, you should continue to exercise and follow the diet recommended for you by your doctor.
When it should not be used
Do not take GLYBURIDE (glyburide):
- If you have Type 1 diabetes.
- If you have known hypersensitivity or allergy to this drug, any sulfonylurea or sulfonamides, or to any ingredient in the formulation or component of the container.
- If you have diabetic ketoacidosis (an emergency condition with high blood glucose levels, a lack of insulin and an accumulation of ketones (chemicals) in the blood and urine). This condition should be treated with insulin.
- Diabetic precoma or coma.
- During stress conditions such as severe infections, trauma or surgery.
- In the presence of liver disease or frank jaundice; or kidney disease.
- If you are being treated with bosentan.
- If you are pregnant or breastfeeding.
What the medicinal ingredient is
The medicinal ingredient for GLYBURIDE is glyburide.
What the non-medicinal ingredients are
GLYBURIDE tablets contain the following non-medicinal ingredients: colloidal silicon dioxide, magnesium stearate, sodium starch glycolate, pregelatinized starch and microcrystalline cellulose.
What dosage form it comes in
Tablets. Each tablet contains 2.5 mg or 5 mg glyburide.
Warnings and precautions
Proper diet, exercise and weight reduction are important to help you control your diabetes.
Your blood glucose may change in some situations, for example if you are stressed or suffering from other illnesses (e.g. infections). At such times, your doctor may need to modify your dose.
GLYBURIDE may cause low blood sugar (hypoglycemia), especially if you miss a meal, exercise for a long time, drink alcohol or use another antidiabetic medication with GLYBURIDE.
Elderly patients may be more likely to experience low blood sugar with GLYBURIDE.
If your blood sugar gets too low, you may feel shaky, weak, drowsy, confused, or very hungry. You may sweat or have blurred vision, abnormal heartbeats, trouble concentrating, or a headache that doesn't go away. Signs of severe hypoglycemia can include disorientation, loss of consciousness, and seizures.
You should ask your doctor, pharmacist or diabetes educator about symptoms of low blood sugar and what to do if you experience these symptoms. Teach your friends, co-workers, or family members what they can do to help you if you have low blood sugar.
You should also test your blood sugar as instructed by your doctor.
Before you use GLYBURIDE talk to your doctor or pharmacist if:
- You have or have had liver, kidney, or heart disease;
- You are pregnant or planning to get pregnant;
- You are breast-feeding.
- You have a blood disease called G6PD-deficiency anemia
- You have a heart disease.
GLYBURIDE is not recommended for use in children under 18 years of age.
Driving and Operating Machinery:
Alertness and reactions may be impaired due to low or high
blood sugar (hypo- or hyperglycemia), especially when
beginning or after changing treatment or when GLYBRUIDE is not taken regularly. This may affect your ability to drive or to operate machinery.
Interactions with this medication
Ask your doctor or pharmacist before taking any other medicine, including over-the-counter products.
Drugs that can interact with GLYBURIDE include: diuretics (water pills), corticosteroids (such as prednisone), ACE inhibitors (a drug used to treat high blood pressure (hypertension)), birth control pills, and some kinds of cold and allergy drugs.
Avoid drinking alcohol while you are taking GLYBURIDE.
Proper use of this medication
Usual dose
Take GLYBURIDE exactly as prescribed by your doctor.
The usual dose is 2.5 to 10 mg daily. Maximum daily dose is 20 mg.
A dose of more than 10 mg should be taken in two divided doses.
Tablets should be taken during or immediately after meals.
Overdose
Overdosage with this medication may result in hypoglycemia.
Missed Dose
If you forget to take GLYBURIDE tablets, do not take a double dose to make up for forgotten individual doses.
Discuss with your healthcare for dealing with such mistakes (in
particular forgetting a dose or skipping a meal) or in the event a
dose cannot be taken at the prescribed time.
Side effects and what to do about them
Side Effects:
As with any type of medication, GLYBURIDE is associated with some side effects.
The most common side effect of glyburide is low blood sugar (hypoglycemia). Please see the WARNINGS and PRECAUTIONS section above.
The following side effects have been observed with
glyburide use: nausea, heartburn, feeling “full”, vomiting,
diarrhea and abdominal pain.
Allergic skin reactions (itchiness, rash, eruption) have been
reported in a number of patients. An increased sensibility to
light has been associated with the use of oral antidiabetic
drugs.
Transient visual disturbances may occur at the beginning of
the treatment due to variations in level of blood sugar.
| Symptom / effect | Talk with your doctor or pharmacist Only if severe | Talk with your doctor or pharmacist In all cases | Stop taking the drug and call your doctor or pharmacist |
|---|---|---|---|
| Common | |||
| Low blood sugar (hypoglycemia) | ✔ | ||
| Uncommon | |||
| Skin reactions (itchiness, rash, eruption) | ✔ | ||
| Rare | |||
| Blood disorders (unusual bruising or bleeding) | ✔ | ||
| Very rare | |||
| Liver problem (yellowing of the eyes or skin) | ✔ | ||
| Allergic reaction (difficult breathing, decreased blood pressure) | ✔ | ||
| Allergic inflammation of blood vessels (vasculitis) | ✔ | ||
| Serious Skin Reactions [bullous reactions (Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis), drug rash with eosinophilia and systemic symptoms (DRESS), exfoliative dermatitis and erythema multiforme]: any combination of red itchy rash with blisters and peeling of the skin and/or of the lips, eyes, mouth, nasal passages or genitals. It often goes with fever, chills, headache, cough, body aches or joint pain. You may have less or dark urine, yellow skin or eyes | ✔ | ||
This list is not a complete list of side effects. If you have any unexpected effects while taking this GLYBURIDE, contact your doctor or pharmacist.
How to store
GLYBURIDE bottles should be stored between 15ºC -30ºC and protected from high humidity. Unit dose strips should be stored between 15 ºC -25°C and protected from high humidity.
Reporting side effects
You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.
3 ways to report:
- Online at MedEffect (hc-sc.gc.ca/dhp-mps/medeff/index-eng.php);
- By calling 1-866-234-2345 (toll-free);
- By completing a Consumer Side Effect Reporting Form and sending it by:
- Fax to 1-866-678-6789 (toll-free), or
- Mail to: Canada Vigilance Program
-
Health Canada, Postal Locator 1908C
Ottawa, ON
K1A 0K9
Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect (hc-sc.gc.ca/dhp-mps/medeff/index-eng.php).
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
This document plus the full product monograph, prepared for health professionals can be found by contacting Sanis Health Inc., at:
1-866-236-4076
or quality@sanis.com
This leaflet was prepared by:
Sanis Health Inc.
1 President's Choice Circle
Brampton, Ontario
L6Y 5S5
Last revised: September 7, 2017