Glyburide micronized

Class
Hypoglycemic agents
Subclass
Sulfonylureas
Substance name
Glyburide micronized, glibenclamide
Brand names
Glynase PresTab®
Common formulations
Tablet
Dosage and administration
Adults patients
Treatment of diabetes mellitus type 2
•
Start at: 1.5-3 mg PO daily
•
Maintenance: 0.75-12 mg PO daily, in a single or divided doses
•
Maximum: 12 mg per day
Taken with breakfast or the first main meal. Titrate in 1.5 mg increments weekly to target blood glucose level.
Indications for use
Labeled indications
Adults
•
Treatment of diabetes mellitus type 2
Safety risks
Contraindications
Hypersensitivity to glyburide or its components
T1DM or diabetic ketoacidosis
Concomitant use of bosentan
Warnings and precautions
Cardiovascular mortality
•
Maintain a high level of suspicion, as the risk of increased cardiovascular mortality observed with tolbutamide may also apply to other sulfonylureas.
Decreased blood glucose
•
Use caution in patients at risk for hypoglycemia, including elderly patients, concomitant use of other hypoglycemic medications or alcohol, patients with renal, hepatic, adrenal, or pituitary impairment, malnutrition, calorie deficit, or after severe or prolonged exercise.
Decreased serum glyburide levels
•
Use caution in patients taking colesevelam. Advise taking glyburide at least 4 hours before colesevelam.
Hemolytic anemia
•
Use caution in patients with G6PD deficiency.
Specific populations
Renal impairment
eGFR 0-90 mL/min/1.73 m²
•
Use with caution. Start at dose of 0.75 mg daily. Monitor for hypoglycemia.
Renal replacement therapy
Continuous renal replacement
•
Use with caution. Start at a dose of 0.75 mg daily. Monitor for hypoglycemia.
Intermittent hemodialysis
•
Use with caution. Start at a dose of 0.75 mg daily. Monitor for hypoglycemia.
Peritoneal dialysis
•
Use with caution. Start at a dose of 0.75 mg daily. Monitor for hypoglycemia.
Hepatic impairment
Any severity
•
Use with caution. Start at dose of 0.75 mg daily. Monitor for hypoglycemia.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: C
•
Consider safer alternatives. Monitor neonates for hypoglycemia. Insulin is the preferred first-line treatment for diabetes in pregnancy.
•
Glyburide can be considered as a third-line option for gestational diabetes mellitus. Discontinue glyburide, if being used during pregnancy, at least 2 weeks before the expected delivery date to decrease the risk of neonatal hypoglycemia.
Breastfeeding
Do not use during breastfeeding.
•
The Endocrine Society guidelines recommend that breastfeeding patients with overt diabetes, who have successfully used glyburide during pregnancy, continue to use glyburide during breastfeeding if necessary.
Very low levels in breastfed infants (< 5%).
May potentially cause adverse effects in breastfed infants.
Adverse reactions
Common 1-10%
•
Nausea, heartburn, bloating, urticaria, pruritus, skin erythema, morbilliform rash, maculopapular rash
Rare < 0.1%
•
Hepatitis, cholestasis, acute liver failure, jaundice
Unknown frequency
•
↓ WBC count, ↓ platelet count, pancytopenia, blurred vision, angioedema, arthralgia, myalgia, ↓ blood glucose, ↓ serum sodium, ↑ serum transaminases, ↑ liver enzymes, porphyria cutanea tarda, hemolytic anemia, aplastic anemia, hepatic porphyria, disulfiram-like reaction, syndrome of inappropriate antidiuretic hormone secretion, vasculitis
Interactions
Drug(s)
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