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Glyburide (glibenclamide): Drug information

Glyburide (glibenclamide): Drug information
(For additional information see "Glyburide (glibenclamide): Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Glynase
Brand Names: Canada
  • APO-GlyBURIDE;
  • Diabeta [DSC];
  • PMS-GlyBURIDE [DSC];
  • TEVA-GlyBURIDE;
  • TRIA-GlyBURIDE
Pharmacologic Category
  • Antidiabetic Agent, Sulfonylurea
Dosing: Adult

Note: Micronized glyburide tablets are not bioequivalent to conventional glyburide tablets; dosage adjustments may be required when switching between glyburide formulations.

Diabetes mellitus, type 2, treatment

Diabetes mellitus, type 2, treatment (alternative agent):

Note: May be used as an adjunctive agent or alternative monotherapy for patients in whom initial therapy with lifestyle intervention and metformin failed or who cannot take metformin. Sulfonylureas are associated with a greater risk of hypoglycemia than other noninsulin antidiabetic agents; if one is chosen, a sulfonylurea other than glyburide with a lower relative risk of hypoglycemia (eg, glipizide, glimepiride) is preferred (Ref).

Conventional tablets (Diaβeta):

Oral: Initial: 1.25 to 5 mg once daily administered with the first main meal; in patients whose glycemic levels are close to goal, use lower initial doses (eg, 1.25 to 2.5 mg once daily) to reduce the risk of hypoglycemia (Ref).

Dosage adjustment: May increase in increments of ≤2.5 mg/day every 1 to 4 weeks if needed to achieve glycemic goals; usual maintenance dose: 2.5 to 10 mg/day in 1 or 2 divided doses (maximum: 20 mg/day) (Ref). Note: For some patients, especially those receiving >10 mg/day, glycemic response may be improved with twice-daily dosing.

Micronized tablets (Glynase PresTab):

Oral: Initial: 0.75 to 3 mg once daily administered with the first main meal.

Dosage adjustment: May increase in increments of ≤1.5 mg/day every 1 to 4 weeks if needed to achieve glycemic goals; usual maintenance dose: 0.75 to 6 mg/day in 1 or 2 divided doses (maximum: 12 mg/day) (Ref). Note: For some patients, especially those receiving >6 mg/day, glycemic response may be improved by administering in 2 divided doses.

Dosage adjustment for concomitant therapy : Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.

Altered kidney function: Oral:

eGFR ≥60 mL/minute/1.73 m2: No dosage adjustment required (Ref).

eGFR <60 mL/minute/1.73 m2: Avoid use due to long duration of action and risk of accumulation of renally excreted active metabolites causing prolonged hypoglycemia. If a sulfonylurea is chosen, agents with a shorter half-life and inactive metabolites (eg, glipizide) may be preferred to reduce the risk of hypoglycemia (Ref).

Hemodialysis, intermittent (thrice weekly): Unlikely to be significantly dialyzed (highly protein bound) (Ref):

Oral: Avoid use due to long duration of action and risk of accumulation of renally excreted active metabolites causing prolonged hypoglycemia (Ref).

Peritoneal dialysis: Unlikely to be significantly dialyzed (highly protein bound) (Ref):

Oral: Avoid use due to long duration of action and risk of accumulation of renally excreted active metabolites causing prolonged hypoglycemia (Ref).

CRRT: Oral: Avoid use due to long duration of action and risk of accumulation of renally excreted active metabolites causing prolonged hypoglycemia (Ref).

PIRRT (eg, sustained, low-efficiency diafiltration): Oral: Avoid use due to long duration of action and risk of accumulation of renally excreted active metabolites causing prolonged hypoglycemia (Ref).

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling; however, use conservative initial and maintenance doses.

Dosing: Older Adult

Avoid use (Ref).

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

1% to 10%:

Gastrointestinal: Epigastric fullness (≤2%), heartburn (≤2%), nausea (≤2%)

Hypersensitivity: Hypersensitivity reaction (2%; including erythema, maculopapular rash, morbilliform rash, pruritus, urticaria)

Frequency not defined:

Central nervous system: Disulfiram-like reaction

Endocrine & metabolic: Hypoglycemia, hyponatremia, weight gain

Genitourinary: Diuresis (minor)

Hematologic & oncologic: Hemolytic anemia

Hepatic: Cholestatic jaundice, hepatic failure, hepatitis

<1%, postmarketing, and/or case reports: Accommodation disturbance, angioedema, arthralgia, blurred vision, bullous rash, erythema multiforme, exfoliative dermatitis, increased serum transaminases, myalgia, vasculitis

Contraindications

Hypersensitivity to glyburide or any component of the formulation; type 1 diabetes mellitus or diabetic ketoacidosis, with or without coma; concomitant use with bosentan.

Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to any sulfonylurea or sulfonamide; diabetic precoma or coma, stress conditions (eg, severe infections, trauma, surgery); liver disease or frank jaundice; renal impairment; pregnancy; breastfeeding.

Warnings/Precautions

Concerns related to adverse reactions:

• Cardiovascular mortality: Product labeling states oral hypoglycemic drugs may be associated with an increased cardiovascular mortality as compared to treatment with diet alone or diet plus insulin. Data to support this association are limited, and several studies, including a large prospective trial (UKPDS), have not supported an association. In patients with established atherosclerotic cardiovascular disease (ASCVD), other agents are preferred (ADA 2021).

• Hypoglycemia: All sulfonylurea drugs are capable of producing severe hypoglycemia. Hypoglycemia is more likely to occur when caloric intake is deficient, after severe or prolonged exercise, when ethanol is ingested, or when more than one glucose-lowering drug is used. It is also more likely in elderly patients, malnourished or debilitated patients, and in patients with severe renal and hepatic impairment, adrenal and/or pituitary insufficiency; use with caution.

• Sulfonamide (“sulfa”) allergy: The FDA-approved product labeling for many medications containing a sulfonamide chemical group includes a broad contraindication in patients with a prior allergic reaction to sulfonamides. There is a potential for cross-reactivity between members of a specific class (eg, two antibiotic sulfonamides). However, concerns for cross-reactivity have previously extended to all compounds containing the sulfonamide structure (SO2NH2). An expanded understanding of allergic mechanisms indicates cross-reactivity between antibiotic sulfonamides and nonantibiotic sulfonamides may not occur or at the very least this potential is extremely low (Brackett 2004; Johnson 2005; Slatore 2004; Tornero 2004). In particular, mechanisms of cross-reaction due to antibody production (anaphylaxis) are unlikely to occur with nonantibiotic sulfonamides. T-cell-mediated (type IV) reactions (eg, maculopapular rash) are less well understood and it is not possible to completely exclude this potential based on current insights. In cases where prior reactions were severe (Stevens-Johnson syndrome/TEN), some clinicians choose to avoid exposure to these classes.

Disease-related concerns:

• Bariatric surgery:

– Altered absorption: Use IR formulations after surgery to minimize the potential effects of bypassing stomach and proximal small bowel with gastric bypass or more rapid gastric emptying and proximal small bowel transit with sleeve gastrectomy (Apovian 2015). ER formulations may have altered release and absorption patterns after gastric bypass or sleeve gastrectomy (but not gastric band). Compared to control, Tmax in a gastric bypass cohort administered tolbutamide was significantly shorter (1.4 ± 1.8 vs 5.1 ± 1.7 hours; P < 0.001), while Cmax and AUC0- ∞ were not altered (Tandra 2013).

– Hypoglycemia: Use an antidiabetic agent without the potential for hypoglycemia if possible; hypoglycemia may occur after gastric bypass, sleeve gastrectomy, and gastric band (Mechanick 2020). Insulin secretion and sensitivity may be partially or completely restored after these procedures (gastric bypass is most effective, followed by sleeve and finally band) (Korner 2009; Peterli 2012). First-phase insulin secretion and hepatic insulin sensitivity have been shown to be significantly improved in the immediate days after gastric bypass and sleeve gastrectomy. The restorative effects of these procedures on peripheral insulin sensitivity may occur later in the 3- to 12-month period postsurgery (Mingrone 2016).

– Weight gain: Evaluate risk vs benefit and consider alternative therapy after gastric bypass, sleeve gastrectomy, and gastric banding; weight gain may occur (Apovian 2015).

• Glucose-6-phosphate dehydrogenase deficiency: Patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency may be at an increased risk of sulfonylurea-induced hemolytic anemia; however, cases have also been described in patients without G6PD deficiency during postmarketing surveillance. Use with caution and consider a nonsulfonylurea alternative in patients with G6PD deficiency.

• Renal impairment: The metabolism and excretion of glyburide may be slowed in patients with renal impairment and its active metabolites may accumulate in advanced renal insufficiency (Snyder 2004). If hypoglycemia should occur, it may be prolonged. Use of glyburide is generally not recommended in chronic kidney disease (ADA [Tuttle 2014]; Alsahli 2015; KDOQI [Nelson 2012]).

• Stress-related states: It may be necessary to discontinue therapy and administer insulin if the patient is exposed to stress (fever, trauma, infection, surgery).

Special populations:

• Older adult: Glyburide is a longer-duration sulfonylurea; avoid use in older adults due to potential for severe hypoglycemia (Beers Criteria [AGS 2019]). If sulfonylureas are used, those of shorter duration (eg, glipizide, glimepiride) are preferred (ADA 2021).

Dosage form specific issues:

• Glyburide tablet formulations: Micronized glyburide tablets are not bioequivalent to conventional glyburide tablets; retitration should occur if patients are being transferred to a different glyburide formulation (eg, micronized-to-conventional or vice versa) or from other hypoglycemic agents.

Other warnings/precautions:

• Appropriate use: Not for use in patients with diabetic ketoacidosis (DKA) or patients with type 1 diabetes mellitus.

• Hospitalized patients: Consider temporary discontinuation of noninsulin antidiabetic agents and initiation or continuation of insulin therapy during hospitalization (ADA 2021). In noncritically ill hospitalized patients, continued use of sulfonylureas may be considered if there are no contraindications, regular nutritional intake is expected, and blood glucose is well controlled; close monitoring and subsequent dosage adjustments are recommended (ADA/AACE [Moghissi 2009]; Bogun 2013; Inzucchi 2006). If sulfonylureas are used, those of shorter duration (eg, glipizide, glimepiride) are preferred (ADA 2021).

Dosage Forms Considerations

Micronized formulation: Glynase

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Glynase: 1.5 mg, 3 mg, 6 mg [scored]

Generic: 1.25 mg, 1.5 mg, 2.5 mg, 3 mg, 5 mg, 6 mg

Generic Equivalent Available: US

Yes

Pricing: US

Tablets (glyBURIDE Micronized Oral)

1.5 mg (per each): $0.39

3 mg (per each): $0.66

6 mg (per each): $0.92

Tablets (glyBURIDE Oral)

1.25 mg (per each): $0.28

2.5 mg (per each): $0.46

5 mg (per each): $0.78

Tablets (Glynase Oral)

1.5 mg (per each): $2.27

3 mg (per each): $3.83

6 mg (per each): $6.04

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Tablet, Oral:

Diabeta: 2.5 mg [DSC], 5 mg [DSC]

Generic: 2.5 mg, 5 mg

Administration: Adult

Oral: Administer with meals at the same time each day. Patients that are NPO or require decreased caloric intake may need doses held to avoid hypoglycemia.

Use: Labeled Indications

Diabetes mellitus, type 2, treatment: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Medication Safety Issues
Sound-alike/look-alike issues:

GlyBURIDE may be confused with glipiZIDE, Glucotrol

Diaβeta may be confused with Zebeta

Micronase may be confused with Microzide

High alert medication:

The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drugs which have a heightened risk of causing significant patient harm when used in error.

Older Adult: High-Risk Medication:

Beers Criteria: Glyburide is identified in the Beers Criteria as a potentially inappropriate medication to be avoided in patients 65 years and older (independent of diagnosis or condition) due to its higher risk of severe prolonged hypoglycemia in older adults (Beers Criteria [AGS 2019]). Note: Updates for the American Geriatrics Society 2023 AGS Beers Criteria for Potentially Inappropriate Medication Use in Older Adults are in process.

Pharmacy Quality Alliance (PQA): Glyburide is identified as a high-risk medication in patients 65 years and older on the PQA’s Use of High-Risk Medications in the Elderly (HRM) performance measure, a safety measure used by the Centers for Medicare and Medicaid Services (CMS) for Medicare plans (PQA 2017).

Metabolism/Transport Effects

Substrate of CYP2C9 (major), CYP3A4 (minor), OATP1B1/1B3 (SLCO1B1/1B3); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Ajmaline: Sulfonamides may enhance the adverse/toxic effect of Ajmaline. Specifically, the risk for cholestasis may be increased. Risk C: Monitor therapy

Alcohol (Ethyl): Sulfonylureas may enhance the adverse/toxic effect of Alcohol (Ethyl). A flushing reaction may occur. Risk C: Monitor therapy

Alpelisib: May decrease the serum concentration of CYP2C9 Substrates (High risk with Inducers). Risk C: Monitor therapy

Alpha-Glucosidase Inhibitors: May enhance the hypoglycemic effect of Sulfonylureas. Management: Consider a decrease in sulfonylurea dose when initiating therapy with an alpha-glucosidase inhibitor and monitor patients for hypoglycemia. Risk D: Consider therapy modification

Alpha-Lipoic Acid: May enhance the hypoglycemic effect of Antidiabetic Agents. Risk C: Monitor therapy

Aminolevulinic Acid (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Systemic). Risk X: Avoid combination

Aminolevulinic Acid (Topical): Photosensitizing Agents may enhance the photosensitizing effect of Aminolevulinic Acid (Topical). Risk C: Monitor therapy

Amiodarone: May enhance the hypoglycemic effect of Sulfonylureas. Risk C: Monitor therapy

Androgens: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy

Antidiabetic Agents: May enhance the hypoglycemic effect of Hypoglycemia-Associated Agents. Risk C: Monitor therapy

Beta-Blockers (Beta1 Selective): May enhance the hypoglycemic effect of Antidiabetic Agents. Risk C: Monitor therapy

Beta-Blockers (Nonselective): May enhance the hypoglycemic effect of Sulfonylureas. Beta-Blockers (Nonselective) may diminish the therapeutic effect of Sulfonylureas. Risk C: Monitor therapy

Bortezomib: May enhance the therapeutic effect of Antidiabetic Agents. Bortezomib may diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy

Bosentan: GlyBURIDE may enhance the hepatotoxic effect of Bosentan. GlyBURIDE may decrease the serum concentration of Bosentan. Bosentan may decrease the serum concentration of GlyBURIDE. Risk X: Avoid combination

Carbocisteine: Sulfonylureas may enhance the adverse/toxic effect of Carbocisteine. Specifically, sulfonylureas may enhance adverse effects of alcohol that is present in liquid formulations of carbocisteine-containing products. Risk C: Monitor therapy

Chloramphenicol (Systemic): May increase the serum concentration of Sulfonylureas. Risk C: Monitor therapy

Clarithromycin: May enhance the hypoglycemic effect of Sulfonylureas. Risk C: Monitor therapy

Colesevelam: May decrease the serum concentration of GlyBURIDE. Management: Administer glyburide at least 4 hours prior to colesevelam. Risk D: Consider therapy modification

CycloSPORINE (Systemic): May diminish the therapeutic effect of GlyBURIDE. GlyBURIDE may increase the serum concentration of CycloSPORINE (Systemic). Risk C: Monitor therapy

CYP2C9 Inducers (Moderate): May decrease the serum concentration of Sulfonylureas. Risk C: Monitor therapy

CYP2C9 Inhibitors (Moderate): May increase the serum concentration of Sulfonylureas. Risk C: Monitor therapy

Darolutamide: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy

Dexketoprofen: May enhance the adverse/toxic effect of Sulfonamides. Risk C: Monitor therapy

Dipeptidyl Peptidase-IV Inhibitors: May enhance the hypoglycemic effect of Sulfonylureas. Management: Consider a decrease in sulfonylurea dose when initiating therapy with a dipeptidyl peptidase-IV inhibitor and monitor patients for hypoglycemia. Risk D: Consider therapy modification

Direct Acting Antiviral Agents (HCV): May enhance the hypoglycemic effect of Antidiabetic Agents. Risk C: Monitor therapy

Eltrombopag: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy

Encorafenib: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy

Etilefrine: May diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy

Fibric Acid Derivatives: May enhance the hypoglycemic effect of Sulfonylureas. Risk C: Monitor therapy

Gemfibrozil: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy

Glucagon-Like Peptide-1 Agonists: May enhance the hypoglycemic effect of Sulfonylureas. Management: Consider sulfonylurea dose reductions when used in combination with glucagon-like peptide-1 agonists. Risk D: Consider therapy modification

Guanethidine: May enhance the hypoglycemic effect of Antidiabetic Agents. Risk C: Monitor therapy

Herbal Products with Glucose Lowering Effects: May enhance the hypoglycemic effect of Hypoglycemia-Associated Agents. Risk C: Monitor therapy

Hyperglycemia-Associated Agents: May diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy

Hypoglycemia-Associated Agents: May enhance the hypoglycemic effect of other Hypoglycemia-Associated Agents. Risk C: Monitor therapy

Hypoglycemia-Associated Agents: Antidiabetic Agents may enhance the hypoglycemic effect of Hypoglycemia-Associated Agents. Risk C: Monitor therapy

Leflunomide: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy

Leniolisib: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Risk X: Avoid combination

Letermovir: May increase the serum concentration of GlyBURIDE. Risk C: Monitor therapy

Lumacaftor and Ivacaftor: May decrease the serum concentration of CYP2C9 Substrates (High Risk with Inhibitors or Inducers). Lumacaftor and Ivacaftor may increase the serum concentration of CYP2C9 Substrates (High Risk with Inhibitors or Inducers). Risk C: Monitor therapy

Maitake: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy

Mecamylamine: Sulfonamides may enhance the adverse/toxic effect of Mecamylamine. Risk X: Avoid combination

Methoxsalen (Systemic): Photosensitizing Agents may enhance the photosensitizing effect of Methoxsalen (Systemic). Risk C: Monitor therapy

Metreleptin: May enhance the hypoglycemic effect of Sulfonylureas. Management: Sulfonylurea dosage adjustments (including potentially large decreases) may be required to minimize the risk for hypoglycemia with concurrent use of metreleptin. Monitor closely for signs or symptoms of hypoglycemia. Risk D: Consider therapy modification

Miconazole (Oral): May enhance the hypoglycemic effect of Sulfonylureas. Miconazole (Oral) may increase the serum concentration of Sulfonylureas. Risk C: Monitor therapy

Mitiglinide: May enhance the adverse/toxic effect of Sulfonylureas. Risk X: Avoid combination

Monoamine Oxidase Inhibitors: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy

Pegvisomant: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy

Porfimer: Photosensitizing Agents may enhance the photosensitizing effect of Porfimer. Risk C: Monitor therapy

Pretomanid: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy

Probenecid: May increase the serum concentration of Sulfonylureas. Risk C: Monitor therapy

Prothionamide: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy

Quinolones: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Quinolones may diminish the therapeutic effect of Agents with Blood Glucose Lowering Effects. Specifically, if an agent is being used to treat diabetes, loss of blood sugar control may occur with quinolone use. Risk C: Monitor therapy

RaNITIdine (Withdrawn from US Market): May enhance the hypoglycemic effect of GlyBURIDE. Risk C: Monitor therapy

Rifapentine: May decrease the serum concentration of CYP2C9 Substrates (High risk with Inducers). Risk C: Monitor therapy

Ritodrine: May diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy

Salicylates: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy

Selective Serotonin Reuptake Inhibitors: May enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy

Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitors: May enhance the hypoglycemic effect of Sulfonylureas. Management: Consider a decrease in sulfonylurea dose when initiating therapy with a sodium-glucose cotransporter 2 (SGLT2) inhibitor and monitor patients for hypoglycemia. Risk D: Consider therapy modification

SORAfenib: May enhance the hypoglycemic effect of GlyBURIDE. Risk C: Monitor therapy

Sulfonamide Antibiotics: May enhance the hypoglycemic effect of Sulfonylureas. Risk C: Monitor therapy

Teriflunomide: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy

Tetracyclines: May enhance the hypoglycemic effect of Sulfonylureas. Risk C: Monitor therapy

Thiazide and Thiazide-Like Diuretics: May diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy

Thiazolidinediones: May enhance the hypoglycemic effect of Sulfonylureas. Management: Consider sulfonylurea dose adjustments in patients taking thiazolidinediones and monitor for hypoglycemia. Risk D: Consider therapy modification

Trofinetide: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Management: Avoid concurrent use with OATP1B1/1B3 substrates for which small changes in exposure may be associated with serious toxicities. Monitor for evidence of an altered response to any OATP1B1/1B3 substrate if used together with trofinetide. Risk D: Consider therapy modification

Verteporfin: Photosensitizing Agents may enhance the photosensitizing effect of Verteporfin. Risk C: Monitor therapy

Vitamin K Antagonists (eg, warfarin): Sulfonylureas may enhance the anticoagulant effect of Vitamin K Antagonists. Vitamin K Antagonists may enhance the hypoglycemic effect of Sulfonylureas. Risk C: Monitor therapy

Voclosporin: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy

Voriconazole: May increase the serum concentration of Sulfonylureas. Risk C: Monitor therapy

Food Interactions

Ethanol may cause rare disulfiram reactions. Management: Monitor patients.

Reproductive Considerations

Sulfonylureas are not recommended for patients with type 2 diabetes mellitus planning to become pregnant. Patients who could become pregnant should use effective contraception during therapy. Transition to a preferred therapy should be initiated prior to conception and contraception should be continued until glycemic control is achieved (ADA 2021; Alexopoulos 2019; Egan 2020).

Pregnancy Considerations

Glyburide crosses the placenta.

Severe hypoglycemia lasting 4 to 10 days has been noted in infants born to mothers taking a sulfonylurea at the time of delivery. Additional adverse maternal and fetal events have been noted in some studies and may be influenced by maternal glycemic control and/or differences in study design (Bertini 2005; Ekpebegh 2007; Joy 2012; Langer 2000; Langer 2005). According to the manufacturer, if glyburide is used during pregnancy, it should be discontinued at least 2 weeks before the expected delivery date.

Due to pregnancy-induced physiologic changes, some pharmacokinetic properties of glyburide may be altered (Hebert 2009).

Poorly controlled diabetes during pregnancy can be associated with an increased risk of adverse maternal and fetal outcomes, including diabetic ketoacidosis, preeclampsia, spontaneous abortion, preterm delivery, delivery complications, major malformations, stillbirth, and macrosomia (ACOG 201 2018). To prevent adverse outcomes, prior to conception and throughout pregnancy, maternal blood glucose and HbA1c should be kept as close to target goals as possible but without causing significant hypoglycemia (ADA 2021; Blumer 2013).

Glyburide has been evaluated for the treatment of gestational diabetes mellitus; however, because glyburide crosses the placenta, long-term safety data are not available, and adverse events have been observed, glyburide should not be recommended as an initial alternative therapy (ACOG 190 2018; ADA 2021).

Agents other than glyburide are currently recommended to treat diabetes mellitus in pregnancy (ADA 2021).

Breastfeeding Considerations

Glyburide may be present in breast milk.

Using information from a case report, the relative infant dose (RID) of glyburide was calculated to be 0.08% using a milk concentration of 7.3 ng/mL, providing an estimated daily infant dose via breast milk of 0.001 mg/kg/day. This milk concentration was obtained following maternal administration of very large doses of glyburide (up to 90 mg/day) for the treatment of permanent neonatal diabetes mellitus (PNDM) caused by a KCNJ11 (Kir6.2) mutation throughout pregnancy. Glyburide was also detected in the serum of the breastfeeding infant 6 days after birth (Myngheer 2014). In general, breastfeeding is considered acceptable when the RID of a medication is <10% (Anderson 2016; Ito 2000). Glyburide was not detected in breast milk following short-term maternal use with standard doses (Feig 2005); however, chronic therapy was not evaluated.

Appropriate glycemic control is required for the establishment of lactation in patients with diabetes mellitus (Anderson 2018). Breastfeeding provides metabolic benefits to mothers with diabetes mellitus as well as their infants; therefore, breastfeeding is encouraged (ACOG 201 2018; ADA 2021; Blumer 2013). According to the manufacturer, due to the potential for hypoglycemia in the breastfeeding infant, a decision should be made whether to discontinue breastfeeding or to discontinue the drug, taking into account the importance of treatment to the mother; however, other sources note that glyburide may be used in patients who are breastfeeding; infants should be monitored for hypoglycemia (Anderson 2018; Blumer 2013; WHO 2002).

Dietary Considerations

Individualized medical nutrition therapy based on American Diabetes Association recommendations is an integral part of therapy.

Monitoring Parameters

Signs and symptoms of hypoglycemia, urine glucose test, fasting blood glucose.

HbA1c: Monitor at least twice yearly in patients who have stable glycemic control and are meeting treatment goals; monitor quarterly in patients in whom treatment goals have not been met, or with therapy change. Note: In patients prone to glycemic variability (eg, patients with insulin deficiency), or in patients whose HbA1c is discordant with serum glucose levels or symptoms, consider evaluating HbA1c in combination with blood glucose levels and/or a glucose management indicator (ADA 2021; KDIGO 2020).

Reference Range

Recommendations for glycemic control in patients with diabetes:

Nonpregnant adults with diabetes (ADA 2021):

HbA1c: <7% (a more aggressive [<6.5%] or less aggressive [<8%] HbA1c goal may be targeted based on patient-specific characteristics). Note: In patients using a continuous glucose monitoring system, a goal of time in range >70% with time below range <4% is recommended and is similar to a goal HbA1c <7%.

Preprandial capillary blood glucose: 80 to 130 mg/dL (SI: 4.4 to 7.2 mmol/L) (more or less stringent goals may be appropriate based on patient-specific characteristics).

Peak postprandial capillary blood glucose (~1 to 2 hours after a meal): <180 mg/dL (SI: <10 mmol/L) (more or less stringent goals may be appropriate based on patient-specific characteristics).

Older adults (≥65 years of age) (ADA 2021):

Note: Consider less strict targets in patients who are using insulin and/or insulin secretagogues (sulfonylureas, meglitinides) (ES [LeRoith 2019]).

HbA1c: <7% to 7.5% (healthy); <8% to 8.5% (complex/intermediate health). Note: Individualization may be appropriate based on patient and caregiver preferences and/or presence of cognitive impairment. In patients with very complex or poor health (ie, limited remaining life expectancy), consider making therapy decisions based on avoidance of hypoglycemia and symptomatic hyperglycemia rather than HbA1c level.

Preprandial capillary blood glucose: 80 to 130 mg/dL (SI: 4.4 to 7.2 mmol/L) (healthy); 90 to 150 mg/dL (SI: 5 to 8.3 mmol/L) (complex/intermediate health); 100 to 180 mg/dL (SI: 5.6 to 10 mmol/L) (very complex/poor health).

Bedtime capillary blood glucose: 80 to 180 mg/dL (SI: 4.4 to 10 mmol/L) (healthy); 100 to 180 mg/dL (SI: 5.6 to 10 mmol/L) (complex/intermediate health); 110 to 200 mg/dL (SI: 6.1 to 11.1 mmol/L) (very complex/poor health).

Classification of hypoglycemia (ADA 2021):

Level 1: 54 to 70 mg/dL (SI: 3 to 3.9 mmol/L); hypoglycemia alert value; initiate fast-acting carbohydrate (eg, glucose) treatment.

Level 2: <54 mg/dL (SI: <3 mmol/L); threshold for neuroglycopenic symptoms; requires immediate action.

Level 3: Hypoglycemia associated with a severe event characterized by altered mental and/or physical status requiring assistance.

Mechanism of Action

Stimulates insulin release from the pancreatic beta cells; reduces glucose output from the liver; insulin sensitivity is increased at peripheral target sites

Pharmacokinetics (Adult Data Unless Noted)

Onset of action: Serum insulin levels begin to increase 15-60 minutes after a single dose

Duration: ≤24 hours

Absorption: Significant within 1 hour

Protein binding, plasma: Extensive, primarily to albumin

Metabolism: Hepatic; forms metabolites (weakly active)

Bioavailability: Variable among oral dosage forms

Half-life elimination: Diaβeta: 10 hours; Glynase PresTab: ~4 hours; may be prolonged with renal or hepatic impairment

Time to peak, serum: Adults: 2-4 hours

Excretion: Feces (50%) and urine (50%) as metabolites

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Daonil | Diatab | Euglucon | Glibil | Glynase | Melix | Micronase | Mini Glynase;
  • (AR) Argentina: Benclamid | Daonil | Diabemin | Euglucon | G.o.n. | Gardoton | Glaturin | Glentor | Glibediab | Glibemida | Glibenclamida | Glibenclamida ahimsa | Glibenclamida denver farma | Glibenclamida fabra | Glibenclamida gen med | Glibenclamida puntanos | Glibenclamida vannier | Glidanil | Gliptid | Glitral | Pira;
  • (AT) Austria: Daonil | Dia-eptal | Euglucon | Glibenclamid genericon pharma | Glucobene | Glucostad | Normoglucon;
  • (AU) Australia: Daonil | Euglucon | Glimel | Semi-Daonil;
  • (BD) Bangladesh: Daonil | Daosin | Diabeles | Diacon | Diben | Dibenol | Dicon | Gilemal | Glabin | Gluban | Glucon | Gluconil | Glucotab;
  • (BE) Belgium: Bevoren | Daonil | Euglucon;
  • (BF) Burkina Faso: Daonil | Fairglib | Glibenclamide tm | Hemi-daonil;
  • (BG) Bulgaria: Glibenclamid | Maninil;
  • (BR) Brazil: Aglucil | Benclamin | Clamiben | Daonil | Diaben | Diabetty's | Diabexil | Diabinil | Euglucon | Furp glibenclamida | Glibenclamida | Glibenclamon | Glibex | Glibexil | Glicamida | Glicamin | Gliconil | Glionil | Glucosil | Iquego glibenclamida | Lisaglucon | Lqfex glibenclamida | Nilclamida | Uni gliben;
  • (CH) Switzerland: Daonil | Euglucon | Gli-basan | Gli-basan semi | Glibenclamid-cophar | Glibenorm | Glibesifar | Semi-Daonil;
  • (CI) Côte d'Ivoire: Glibenclamida Generis | Glibenclamide tm;
  • (CL) Chile: Clais | Daonil | Euglusid | Glibenclamida | Mezalit;
  • (CN) China: Glibenhexal;
  • (CO) Colombia: Euglucon | Glibenclamida | Glibenclamida MK | Glibens | Glucinex | Gluicon;
  • (CZ) Czech Republic: Betanase | Calabren aps | Daonil | Euglucon | Gilemal | Glibasan | Glibenhexal | Glucobene | Maninil;
  • (DE) Germany: Azuglucon | Bastiverit | Daonil | Dia-basf | Duraglucon n | Euglucon | Glib | Glib abz | Gliben | Gliben lich | Gliben-puren n | Glibenbeta | Glibenclamid | Glibenclamid al | Glibenclamid basic | Glibenclamid sandoz | Glibenclamid temmler | Glibendoc | Glibenhexal | Glimidstada | Glucoremed | Glukoreduct | Glukovital | Glycolande n | Humedia | Jutaglucon | Maninil | Orabetic | Praeciglucon | Semi gliben puren n | Semi-Daonil | Semi-Euglucon;
  • (DO) Dominican Republic: Armoniol | Daonil | Diabetop | Euglucon | Glibelam | Glibencil | Glibenclamid | Glibenclamida | Glibenil | Gliboral | Gluben | Glucamida | Glucoven | Lufranclamida | Nor-Clamida | Norboral | Su-Ka;
  • (EC) Ecuador: Daonil | Diabesulf | Euglucon | Gliben | Glibenclamida | Glibenclamida MK | Glicem | Libraglucil;
  • (EE) Estonia: Betanaze | Daonil | Gilemal | Glib s-ratiopharm | Glibenclamid | Glibenclamid awd | Glucobene | Maninil;
  • (EG) Egypt: Daonil | Diaben | Euglucon | Glibecon | Gliben | Gluben | Semi daonil;
  • (ES) Spain: Daonil | Euglucon | Glucolon | Norglicem;
  • (ET) Ethiopia: Clamide | Daonil | Diaben;
  • (FI) Finland: Daonil | Euglamin | Euglucon | Gilemid | Origlucon;
  • (FR) France: Daonil | Euglucan | Glibenclamide arrow | Glibenclamide eg | Hemi-daonil | Miglucan;
  • (GB) United Kingdom: Abbenclamide | Calabren | Daonil | Diabetamide | Euglucon | Glibenclamide berk | Glibenclamide cox | Glibenclamide dc | Glibenclamide kent | Lederglib | Libanil | Malix;
  • (GR) Greece: Daonil | Deroctyl | Diabefar | Euglycon;
  • (HK) Hong Kong: Apo-Glyburide | Clamide | Cp-Gliben | Daomid | Daonil | Euglucon | Gliban | Gliben | Gliboral | Glifil | Glimel | Glitisol | Glucoben | Melix | Qualibenmide | Semi-Daonil | Semi-Euglucon | Xeltic;
  • (HR) Croatia: Glibenclamid Genericon;
  • (HU) Hungary: Euglucon | Gilemal | Glucobene | Maninil;
  • (ID) Indonesia: Clamega | Condiabet | Daonil | Euglucon | Fimediab | Glidanal | Glimel | Gluconic | Gluconin | Glulo | Glyamid | Harmida | Hartmida | Latibet | Padonil | Prodiabet | Prodiamel | Renabetic | Semi-Euglucon | Tiabet | Trodeb;
  • (IE) Ireland: Daonil;
  • (IL) Israel: Daonil | Glibetic | Gluben;
  • (IN) India: Afdiex | Betanase | Codica | D-con | Daonil | Daorid | Diabentil | Diabetnil | Euglucon | G-nil | Glibet | Gliconil | Glinil | Glucosafe | Glunil | Glyboral | Glybovin | Semi codica | Semi glyboral | Semi-Daonil | Semi-Euglucon;
  • (IT) Italy: Daonil | Euglucon | Gliben | Gliboral;
  • (JO) Jordan: Daonil | Diatab | Euglucon | Glibemide | Glibesyn | Glibil | Glucana | Glucomid | Glunil | Melix | Riveclamide;
  • (JP) Japan: Benclart | Benclart taiyo | Bratogen | Cramiton | Damsel | Daonil | Entrezon | Euglucon | Euglucon chugai | Euglucon yamanouchi | Glibenclamide nichiiko | Glypinart | Margleid | Opeamin | Pamilcon | Pamilcon yamakawa | Pamilicon | Seogrumin | Seogrumin choseido;
  • (KE) Kenya: Betanase | Daonil;
  • (KR) Korea, Republic of: Dangbinol | Daonil | Daonil semi | Diabet | Euglucon | Glisulin | Glynase Prestab | Suraben;
  • (KW) Kuwait: Daonil | Diatab | Doabetic | Euglucon | Glynase | Micronase;
  • (LB) Lebanon: Apo glyburide | Daonil | Euglucon | Glibamid | Gliboral | Glidiabet | Melix;
  • (LT) Lithuania: Apo gliburid | Betanase | Daonil | Euglucon | Gilemal | Glibasan | Glibenclamid awd | Glucobene | Glyboral | Maninil;
  • (LU) Luxembourg: Daonil | Euglucon | Glibenhexal;
  • (LV) Latvia: Apo gliburid | Betanase | Daonil | Euglucon | Gilemal | Glibasan | Gliben | Glibenclamid | Glibenclamid awd | Glucobene | Maninil;
  • (MA) Morocco: Benclamid | Daonil | Glidiabet | Glipharm | Hemi-daonil;
  • (MX) Mexico: Apogly | Biojara | Brucen | Daonil | Dibetid | Diglexol | Euglucon | Glemicid | Glibenclamid brissa | Glibenclamida | Glibenclamida g.i | Glibenclamida gi s | Glibenclamida Innovare | Glibenclamida Teva | Glibenil | Glibenval | Glicavin | Glifarcal | Glihexal | Glikeyer | Glipar | Glucal | Glucoven | Insusym | Lawazin | Mibeclag | Norboral | Ocrix | Reglusan | Secrusol;
  • (MY) Malaysia: Benil | Claben | Clamide | D.B.T | Daonil | Debtan | Diabitol | Dibelet | Dyanil | Euglucon | Glibemid | Gliben | Glibenclamide Pharmaniaga | Glibesyn | Glimide | Haminil;
  • (NG) Nigeria: Adnil | Bgnil | Cladyl | Clamide | Clezide | Glanil | Glemid | Glipil | Heonil | Rotaclamide | Sanclamide | Zunabetis;
  • (NL) Netherlands: Daonil | Glibenclamide Actavis | Glibenclamide Alpharma;
  • (NO) Norway: Daonil | Euglucon | Glibenclamid | Glibenklamid recip | Hexaglucon;
  • (NZ) New Zealand: Apo-glibenclamide | Daonil | Gliben | Semi-Daonil;
  • (OM) Oman: Doabetic;
  • (PE) Peru: Daonil | Diabetglin | Euglucon | Glibefar | Glibemlip | Glibenclamida | Gliciron | Glidiabet | Gliren;
  • (PH) Philippines: Allase | Amecladin | Bendix | Benglycon | Benmide | Daonil | Debtan | Diabent | Euglamid | Euglotab | Euglucon | Eundin | Gliben | Glibenclamide Winthrop | Glimide | Gluban | Glymod | Hyporex | Insol | Lodulce | Melix | Orabetic | Sucron | Usa lab glibenclamide | Vamsler glibenclamide;
  • (PK) Pakistan: Benil | Daonil | Diabeta | Diabetone | Diamide | Dicon | Euglucon | Glabinol | Glaonil | Gliben | Glicon | Glifen | Glukil | Maclamide | Pharmide | Pligliben | Semi glicon;
  • (PL) Poland: Daonil | Euclamin | Euglucon | Gilemal | Glibenclamid al;
  • (PR) Puerto Rico: Diabeta | Glyburide | Glyburide (Micronized) | Glyburide micro | Glynase Prestab | Micronase;
  • (PT) Portugal: Daonil | Euglucon | Glibenclamida | Semi-Daonil | Semi-Euglucon;
  • (PY) Paraguay: Daonil | Diameg | Euglucon | Glibamida | Gliben | Glibencil | Glibenclamida empa | Glibenclamida pasteur | Glidanil | Glidiabet | Indoprin | Normaprol | Vincadil;
  • (RO) Romania: Gilemal | Glibenclamid arena | Glibenclamid atb | Glibenclamid lph | Glibetic | Gluben;
  • (RU) Russian Federation: Antibet | Betanase | Daonil | Diab control | Gilemal | Glamid | Glibenclamid | Glibenclamid-teva | Glibex | Glidanil | Glimidstada | Glucobene | Maniglid | Maninil | Statiglin;
  • (SA) Saudi Arabia: Apo glyburide | Daonil | Diatab | Doabetic | Euglucon | Glibemide | Glibil | Glymide | Glynase | Micronase | Novo glyburide;
  • (SE) Sweden: Daonil | Glibenclamid ratiopharm | Glibenklamid recip;
  • (SG) Singapore: Apo-Glyburide | Benil | Clamide | Daonil | Dibelet | Euglucon | Glibemid | Glibesyn | Glicon | Glimel | Glimide | Glyboral;
  • (SI) Slovenia: Daonil | Euglucon | Glibenklamid;
  • (SK) Slovakia: Glucobene | Maninil;
  • (TH) Thailand: Benclamide | Benclamin | Benlacon | Bnil-5g | Bowadon | Cytagon | Daobenes | Daonil | Daono | Debtan | Deonil | Diabenol | Dibelet | Dibenil | Dibesin | Eubemide | Euglucon | Eunil | Glamide | Glenclamide | Glibecon | Glibenam | Glibenese | Glibenil | Glibesyn | Glibetic | Glibic | Glimide | Gluben | Glucomide | Glucon | Gluzo | Locose | Manoglucon | Neogil | Pinnil | Semi-diabenol | Semi-Euglucon | Sibenax | Sinil | Sugril | T.o.nil | Unil-5 | Upcon | Xeltic | Zibenax;
  • (TN) Tunisia: Daonil | Diabenyl;
  • (TR) Turkey: Dianorm | Diyaben | Gliben;
  • (TW) Taiwan: Antiglucon | Apo-Glyburide | Daonil | Deglucon | Diaben | Diabenlyse | Diabetin | Diabitan | Diabitin | Diomin | Entrezon | Euglucon | Glamide | Gleuton | Gliben | Glibide | Glimel | Glimide | Gliucon | Gluli | Pertanzin | Semi-Euglucon | Shintan | Tantell | Yichentan;
  • (UA) Ukraine: Betanase | Gilemal | Glibamid | Glibenclamid | Glibenclamid Rivopharm | Maniglid | Manil | Maninil;
  • (UG) Uganda: Betanase | Diaben | Diabeta | Dias | Glamide | Glibex 5;
  • (UY) Uruguay: Daonil | Diabeton | Diaclamid | Euglucon | Glibenclamida | Glibexan | Glimida | Glyburide;
  • (VE) Venezuela, Bolivarian Republic of: Daonil | Euglucon | Glibenclamida | Glibenil | Gliciron | Glucamida;
  • (ZA) South Africa: Daonil | Diacare | Euglucon | Glibenclamide oethmaan | Glyben | Glycomin | Norton-glibenclamide | Rolab-glibenclamide;
  • (ZM) Zambia: Betanase | Clamide | Daonil | Diolin | Dyanil | Glamide | Glemide | Glibex | Glinil | Glycoben | Glycomin | Kaonil | Metagliben;
  • (ZW) Zimbabwe: Glamide | Glitisol | Variglyben
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Topic 8494 Version 478.0

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