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Glyburide

    Brands

    DEA Class; Rx

    Common Brand Names; Diabeta, Glynase, Glynase PresTab

    • Antidiabetics, Sulfonylureas

    Second-generation sulfonylurea; twice as potent as glipizide and longer duration of action
    Used primarily in adults for the treatment of type 2 diabetes mellitus
    Due to longer duration of action, not a preferred sulfonylurea in the elderly

    Indicated for the treatment of type 2 diabetes mellitus as an adjunct to diet and exercise.

    For the treatment of gestational diabetes or pregnant females with pre-existing type 2 diabetes mellitus (T2DM).

    Hypersensitivity; sulfa allergy

    Type 1 diabetes

    Diabetic ketoacidosis with or without coma

    Coadministration with bosentan; increased risk of hepatotoxicity

    • Angioedema
    • Urticaria
    • Rash
    • Morbilliform eruptions
    • Pruritus
    • Photosensitivity reaction
    • Heartburn
    • Vasculitis
    • Disulfiram-like reaction
    • Hyponatremia
    • Nocturia
    • Agranulocytosis
    • Hemolytic anemia
    • Pancytopenia
    • Thrombocytopenia
    • Porphyria cutanea tarda
    • Arthralgia
    • Paresthesia
    • Myalgia
    • Blurred vision
    • Diuretic effect (minor)
    • Hypoglycemia
    • Nausea/vomiting
    • Cholestatic jaundice and hepatitis, which occur only rarely, may progress to liver failure
    • Weight gain
    • Bullous reactions, erythema multiforme, and exfoliative dermatitis

    Risk of hypoglycemia increases when caloric intake is deficient, when more than one glucose-lowering agent used, when ethanol is ingested, or after severe or prolonged exercise; hypoglycemia is also morelikely to occur in elederly patients, malnourished or debilitated patients, and in patients with adrenal and/or pituitary insufficiency, and patients with severe hepatic and hepatic impairment

    Concerns for cross-reactivity between agents containing sulfonamide products has been reported for patients with prior allergic reactions to any compound with the sulfonamide structure SO2NH2; an expanding understanding of allergic mechanisms suggest that cross-reactivity between antibiotic sulfonamides and nonantibiotic sulfonamides may not occur or at the very least the potential is extremely low

    Caution in pregnancy/lactation

    Administration of oral hypoglycemic drugs has been reported to be associated with increased cardiovascular mortality as compared to treatment with diet alone or diet plus insulin; latest studies, however, do not support association

    Hemolytic anemia may occur with glucose 6-phosphate dehydrogenase (G6PD) deficiency when treated with sulfonylurea agents; use caution and consider a nonsulfonylurea alternative in patients with G6PD deficiency

    There are no clinical studies establishing conclusive evidence of macrovascular risk reduction with anti-diabetic drugs

    Use of glyburide not recommended in chronic kidney disease; metabolism and excretion of glyburide may be slowed in aptients with renal impairment and its active metabolites, causing accumulation in advanced renal insufficiency; prolonged hypoglycemia could occur

    It may be necessary to discontinue therapy and administer insulin if patient exposed to stress

    Micronized tablet formulation is not bioequivalent to conventional glyburide tablets; when transferring patient to a different glyburide formulation, retitrate the dose

    Beta cell destruction may occur following prolonged use of therapy, which may result in loss of treatment efficacy in type 2 diabetes mellitus; discontinue therapy if loss of efficacy occurs in patients who were previously responding to treatment and no contributing factors can be identified

    All sulfonylureas are capable of producing severe hypoglycemia

    Pregnancy category: C

    Lactation: Not known if crosses into breast milk; avoid use in nursing women

    Adults

    20 mg/day PO for conventional glyburide (e.g., Diabeta); 12 mg/day PO for micronized glyburide (e.g., Glynase).

    Geriatric

    20 mg/day PO for conventional glyburide (e.g., Diabeta); 12 mg/day PO for micronized glyburide (e.g., Glynase).

    Adolescents

    Safety and efficacy have not been established; off-label use has been reported with a maximum of 10 mg/day PO.

    Children

    9 years and older: Safety and efficacy have not been established; off-label use has been reported with a maximum of 10 mg/day PO.
    1 to 8 years: Safety and efficacy have not been established; off-label use has been reported for selected monogenic diabetes syndromes.

    Infants

    Safety and efficacy have not been established; off-label use has been reported for monogenic diabetes syndromes.

    Neonates

    Safety and efficacy have not been established.

    Glyburide

    tablet

    • 1.25mg
    • 2.5mg
    • 5mg

    tablet, micronized

    • 1.5mg
    • 3mg
    • 5mg
    • 6mg