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Glyburide (glibenclamide): Drug information

Copyright 1978-2019 Lexicomp, Inc. All rights reserved.

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

For abbreviations and symbols that may be used in Lexicomp (show table)

Brand Names: US
Diabeta [DSC]; Glynase

Brand Names: Canada

APO-GlyBURIDE
Diabeta
DOM-GlyBURIDE
Euglucon
MYLAN-Glybe [DSC]
NTP-GlyBURIDE [DSC]
PMS-GlyBURIDE
PRO-Glyburide [DSC]
RIVA-GlyBURIDE
SANDOZ GlyBURIDE [DSC]
TEVA-GlyBURIDE
TRIA-GlyBURIDE

Pharmacologic Category
Antidiabetic Agent, Sulfonylurea

Dosing: Adult
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. When converting

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to glyburide from other oral hypoglycemic agents with a long half-life (eg, chlorpropamide),
observe patient carefully for 2 weeks due to overlapping hypoglycemic effects.

Diabetes mellitus, type 2: Oral:

Note : Sulfonylureas may be considered as adjunctive or alternative monotherapy for

patients who have suboptimal response to or cannot take metformin; however,
sulfonylureas are known to have a relatively high risk of hypoglycemia as compared to
other noninsulin antidiabetic agents due to their mechanism of action. If a sulfonylurea
is chosen, agents other than glyburide are preferred (AACE/ACE [Garber 2019]; ADA
2019).

Conventional tablets (Diaβeta):

Initial: 2.5 to 5 mg/day, administered with breakfast or the first main meal of the
day. In patients who are more sensitive to hypoglycemic drugs, start at 1.25
mg/day.

Dosage adjustment: Increase in increments of no more than 2.5 mg/day at weekly

intervals based on the patient's blood glucose response

Maintenance: 1.25 to 20 mg/day given as single or divided doses. Some patients

(especially those receiving >10 mg/day) may have a more satisfactory response
with twice-daily dosing. Maximum: 20 mg/day

Micronized tablets (Glynase PresTab):

Initial: 1.5 to 3 mg/day, administered with breakfast or the first main meal of the
day. In patients who are more sensitive to hypoglycemic drugs, start at 0.75
mg/day

Dosage adjustment: Increase in increments of no more than 1.5 mg/day in weekly

intervals based on the patient's blood glucose response.

Maintenance: 0.75 to 12 mg/day given as a single dose or in divided doses. Some

patients (especially those receiving >6 mg/day) may have a more satisfactory
response with twice-daily dosing. Maximum: 12 mg/day

Management of noninsulin-dependent diabetes mellitus in patients previously

maintained on insulin: Oral: Initial dosage dependent upon current insulin dosage, see
table.

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Dose Conversion: Insulin to Glyburide

Initial Glyburide Initial Glyburide

Current Dosage Dosage
Daily Insulin Insulin Dosage Change
Dosage Conventional Micronized
Formulation Formulation (after glyburide started)
(units daily)
(mg daily) (mg daily)

<20 2.5 to 5 1.5 to 3 Discontinue

20 to 40 5 3 Discontinue

5 3 Reduce insulin dosage by

(increase in increments (increase in increments 50% (gradually taper off

>40
of 1.25 to 2.5 mg every 2 of 0.75 to 1.5 mg every insulin as glyburide dosage

to 10 days) 2 to 10 days) increased)

Dosing: Renal Impairment: Adult

There are no specific dosage adjustments provided in the manufacturer's labeling; however,
glyburide is generally not recommended in chronic kidney disease; if sulfonylurea therapy is
needed, other agents are preferred (ADA [Tuttle 2014]; Alsahli 2015; KDOQI [Nelson 2012]).

Dosing: Hepatic Impairment: Adult

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

Dosing: Geriatric
Avoid use (Beers Criteria [AGS 2015]).

Manufacturer’s recommendations:

Conventional tablets (Diaβeta): Oral: Initial: 1.25 mg once daily. Conservative initial
and maintenance doses are recommended to avoid hypoglycemic reactions.

Micronized tablets (Glynase PresTab): Initial: 0.75 mg once daily. Conservative initial
and maintenance doses are recommended to avoid hypoglycemic reactions.

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

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Tablet, Oral:

Diabeta: 1.25 mg [DSC], 2.5 mg [DSC], 5 mg [DSC]

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

Dosage Forms Considerations

Micronized formulation: Glynase

Dosage Forms: Canada

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

Tablet, Oral:

Diabeta: 2.5 mg, 5 mg

Euglucon: 5 mg

Generic: 2.5 mg, 5 mg

Administration: Adult
Oral: Administer with meals at the same time each day (twice-daily dosing may be beneficial if
conventional glyburide doses are >10 mg or micronized glyburide doses are >6 mg). Patients
that are NPO or require decreased caloric intake may need doses held to avoid hypoglycemia.

Use: Labeled Indications

Diabetes mellitus, type 2: 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:

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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.

Geriatric Patients: 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 2015]). Note: Updates for the American Geriatrics Society
2019 Updated AGS 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.

Adverse Reactions

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

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Hypersensitivity to glyburide or any component of the formulation; type 1 diabetes mellitus

or diabetic ketoacidosis, with or without coma; concomitant use with bosentan.

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.

Documentation of allergenic cross-reactivity for sulfonylureas is limited. However, because

of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-
sensitivity cannot be ruled out with certainty.

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 2019).

• 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

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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:

• 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:

• Elderly: Glyburide is a longer-duration sulfonylurea; avoid use in older adults due to

potential for severe hypoglycemia (Beers Criteria [AGS 2015]). If sulfonylureas are
used, those of shorter duration (eg, glipizide) are preferred (ADA 2019).

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.

• Secondary failure: Loss of efficacy may be observed following prolonged use as a

result of the progression of type 2 diabetes mellitus which results in continued beta cell
destruction. In patients who were previously responding to sulfonylurea therapy,
consider additional factors which may be contributing to decreased efficacy (eg,
inappropriate dose, nonadherence to diet and exercise regimen). If no contributing

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factors can be identified, consider discontinuing use of the sulfonylurea due to

secondary failure of treatment. Additional antidiabetic therapy (eg, insulin) will be
required.

Metabolism/Transport Effects
Substrate of CYP2C9 (major); Note: Assignment of Major/Minor substrate status based on
clinically relevant drug interaction potential

Drug Interactions
(For additional information: Launch drug interactions program)

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

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

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

Antidiabetic Agents: May enhance the hypoglycemic effect of Hypoglycemia-Associated

Agents. Risk C: Monitor therapy

Beta-Blockers: May enhance the hypoglycemic effect of Sulfonylureas. Cardioselective

beta-blockers (eg, acebutolol, atenolol, metoprolol, and penbutolol) may be safer than
nonselective beta-blockers. All beta-blockers appear to mask tachycardia as an initial
symptom of hypoglycemia. Ophthalmic beta-blockers are probably associated with lower
risk than systemic agents. Exceptions: Levobunolol; Metipranolol. 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

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formulations of carbocisteine-containing products. Risk C: Monitor therapy

Chloramphenicol (Systemic): May decrease the metabolism of Sulfonylureas. Risk C:

Monitor therapy

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

therapy

Clarithromycin: May increase the serum concentration of GlyBURIDE. 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

Cyclic Antidepressants: May enhance the hypoglycemic effect of Sulfonylureas. Risk C:

Monitor therapy

CycloSPORINE (Systemic): May diminish the therapeutic effect of GlyBURIDE.

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

Dabrafenib: May decrease the serum concentration of CYP2C9 Substrates (High risk with
Inducers). Management: Seek alternatives to the CYP2C9 substrate when possible. If
concomitant therapy cannot be avoided, monitor clinical effects of the substrate closely
(particularly therapeutic effects). Risk D: Consider therapy modification

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

Enzalutamide: May decrease the serum concentration of CYP2C9 Substrates (High risk
with Inducers). Management: Concurrent use of enzalutamide with CYP2C9 substrates
that have a narrow therapeutic index should be avoided. Use of enzalutamide and any
other CYP2C9 substrate should be performed with caution and close monitoring. Risk D:
Consider therapy modification

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

Fluconazole: May increase the serum concentration of Sulfonylureas. Management: Seek

alternatives when possible. If used together, monitor closely for increased effects of
sulfonylureas if fluconazole is initiated/dose increased, or decreased effects if fluconazole
is discontinued/dose decreased. Risk D: Consider therapy modification

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

Herbs (Hypoglycemic Properties): 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

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

Lumacaftor: May decrease the serum concentration of CYP2C9 Substrates (High Risk with
Inhibitors or Inducers). Lumacaftor 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 Blood Glucose Lowering Agents. Risk C:
Monitor therapy

Mecamylamine: Sulfonamides may enhance the adverse/toxic effect of Mecamylamine.

Risk X: Avoid combination

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.
Risk D: Consider therapy modification

Miconazole (Oral): May enhance the hypoglycemic effect of Sulfonylureas. Miconazole

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(Oral) may increase the serum concentration of Sulfonylureas. Risk C: Monitor therapy

MiFEPRIStone: May increase the serum concentration of CYP2C9 Substrates (High risk
with Inhibitors). Management: Use CYP2C9 substrates at the lowest recommended dose,
and monitor closely for adverse effects, during and in the 2 weeks following mifepristone
treatment. Risk D: Consider therapy modification

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

combination

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

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

Porfimer: Photosensitizing Agents may enhance the photosensitizing effect of Porfimer.

Risk C: Monitor therapy

Probenecid: May decrease the protein binding of Sulfonylureas. Probenecid may increase
the serum concentration of Sulfonylureas. Risk C: Monitor therapy

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

Quinolones: May enhance the hypoglycemic effect of Blood Glucose Lowering Agents.
Quinolones may diminish the therapeutic effect of Blood Glucose Lowering Agents.
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: May increase the serum concentration of Sulfonylureas. Risk C: Monitor

therapy

RifAMPin: May decrease the serum concentration of Sulfonylureas. Management: Seek

alternatives to these combinations when possible. Monitor closely for diminished
therapeutic effects of sulfonylureas if rifampin is initiated/dose increased, or enhanced
effects if rifampin is discontinued/dose decreased. Risk D: Consider therapy modification

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 Blood Glucose Lowering Agents. Risk

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C: Monitor therapy

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

Sodium-Glucose Cotransporter 2 (SLGT2) Inhibitors: May enhance the hypoglycemic

effect of Sulfonylureas. Management: Consider a decrease in sulfonylurea dose when
initiating therapy with a sodium-glucose cotransporter 2 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

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

Tolvaptan: May increase the serum concentration of GlyBURIDE. 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

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

therapy

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

Pregnancy Implications

Glyburide crosses the placenta. Some pharmacokinetic properties of glyburide may change
during pregnancy (Hebert 2009).

Severe hypoglycemia lasting 4 to 10 days has been noted in infants born to mothers taking a

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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).

In women with diabetes, maternal hyperglycemia can be associated with congenital

malformations as well as adverse effects in the fetus, neonate, and the mother (ACOG 201
2018; ADA 2019; Metzger 2007). 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 2019; Blumer 2013).

Agents other than glyburide are currently recommended to treat diabetes in pregnant women
(ADA 2019). According to the manufacturer, if glyburide is used during pregnancy, it should be
discontinued at least 2 weeks before the expected delivery date.

Breast-Feeding Considerations

Glyburide may be present in breast milk.

The relative infant dose (RID) of glyburide is 0.08% when calculated using the highest
breast milk concentration located and compared to a weight-adjusted maternal dose of 90
mg/day.

In general, breastfeeding is considered acceptable when the RID of a medication is <10%

(Anderson 2016; Ito 2000).

The RID of glyburide was calculated 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). Glyburide was not detected
in breast milk following short-term maternal use with standard doses (Feig 2005); however,
chronic therapy was not evaluated.

Current guidelines note that breastfeeding is encouraged for all women, including those
with diabetes (ACOG 201 2018; ADA 2019; Blumer 2013; Metzger 2007). A small snack
before breastfeeding may help decrease the risk of hypoglycemia in women with
pregestational diabetes (ACOG 201 2018; Reader 2004).

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

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sources note that glyburide may be used in breastfeeding women (Blumer 2013; Metzger
2007). The World Health Organization considers glyburide compatible with breastfeeding if
the infant is monitored for hypoglycemia (WHO 2002).

Dietary Considerations
Should be taken with meals at the same time each day (twice-daily dosing may be beneficial if
conventional glyburide doses are >10 mg or micronized glyburide doses are >6 mg).
Individualized medical nutrition therapy (MNT) based on ADA recommendations is an integral
part of therapy.

Monitoring Parameters
Signs and symptoms of hypoglycemia, urine glucose test, fasting blood glucose, hemoglobin
A1c (at least twice yearly in patients who have stable glycemic control and are meeting
treatment goals; quarterly in patients not meeting treatment goals or with therapy change [ADA
2019])

Reference Range

Recommendations for glycemic control in patients with diabetes:

Nonpregnant adults (ADA 2019):

HbA1c: <7% (a more aggressive [<6.5%] or less aggressive [<8%] HbA1c goal
may be targeted based on patient-specific characteristics)

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

Peak postprandial capillary blood glucose: <180 mg/dL (more or less stringent
goals may be appropriate based on patient-specific characteristics)

Older adults (≥65 years) (ADA 2019):

HbA1c: <7.5% (healthy); <8% (complex/intermediate health); <8.5% (very

complex/poor health) (individualization may be appropriate based on patient and
caregiver preferences)

Preprandial capillary blood glucose: 90 to 130 mg/dL (healthy); 90 to 150 mg/dL

(complex/intermediate health); 100 to 180 mg/dL (very complex/poor health)

Bedtime capillary blood glucose: 90 to 150 mg/dL (healthy); 100 to 180 mg/dL
(complex/intermediate health); 110 to 200 mg/dL (very complex/poor health)

Classification of hypoglycemia (ADA 2019):

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Level 1: ≥54 to ≤70 mg/dL; hypoglycemia alert value; initiate fast-acting carbohydrate
(eg, glucose) treatment

Level 2: <54 mg/dL; 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

Pharmacodynamics and Pharmacokinetics

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

Pricing: US

Tablets (glyBURIDE Micronized Oral)

1.5 mg (per each): $0.36 - $0.42

3 mg (per each): $0.60 - $0.70

6 mg (per each): $0.84 - $1.19

Tablets (glyBURIDE Oral)

1.25 mg (per each): $0.28

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2.5 mg (per each): $0.31 - $0.46

5 mg (per each): $0.24 - $0.78

Tablets (Glynase Oral)

1.5 mg (per each): $2.15

3 mg (per each): $3.63

6 mg (per each): $5.72

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.

Brand Names: International

Allase (PH); Apo-Glibenclamide (NZ); Benclamin (TH); Benil (SG); Betanase (AE, CY, EG, IQ,
IR, JO, KW, LK, LY, OM, QA, SA, SY, YE); Betanese 5 (BF, BJ, CI, ET, GH, GM, GN, KE, LR,
MA, ML, MR, MU, MW, NE, NG, SC, SD, SL, SN, TN, TZ, UG, ZM); Bevoren (LU); Brucen
(MX); Calabren (CZ); Clamiben (BR); Clamide (HK); Daonil (AE, AR, AU, BD, BE, BF, BH, BJ,
BO, BR, CH, CI, CL, CR, CY, DK, DO, EG, ES, ET, FR, GH, GM, GN, GR, GT, HK, HN, HR, ID,
IN, IQ, IR, IT, JO, JP, KE, KR, KW, LK, LR, LU, LY, MA, ML, MR, MU, MW, MY, NE, NG, NI, NO,
NZ, OM, PA, PH, PT, PY, QA, RU, SA, SC, SD, SG, SL, SN, SV, SY, TH, TN, TR, TW, TZ, UG,
UY, VE, VN, YE, ZA, ZM); Daosin (BD); Diaben (AE, CY, EG, IQ, IR, JO, KW, LY, OM, QA, SA,
SY, YE); Diabenol (TH); Diabesulf (EC); Diabetin (TW); Dibelet (MY); Dynor (BD); Euclamin
(PL); Euglucan (FR); Euglucon (AE, AR, AT, AU, BD, BF, BJ, BO, CH, CI, CO, CY, CZ, DE, EC,
EG, ET, FI, GH, GM, GN, GR, HK, HR, IN, IQ, IR, IT, JO, JP, KE, KR, KW, LR, LU, LY, MA, ML,
MR, MU, MW, MX, MY, NE, NG, NZ, OM, PH, PK, PT, PY, QA, RU, SA, SC, SD, SE, SG, SL,
SN, SY, TH, TN, TW, TZ, UG, YE, ZA, ZM, ZW); Gilemal (AT, HU); Glamide (TH, ZW); Glarin
(BD); Gliban (AE, CY, EG, IQ, IR, JO, KW, LY, OM, QA, SA, SY, YE); Glibedal (HR); Gliben (IT,
LK); Gliben-CP (HK); Glibenclamid (HR); Glibenclamid Pharmavit (HU); Glibenclamid-
ratiopharm (LU); Glibenhexal (LU); Glibesyn (MY, SG, TH); Glibet (IN); Glibetics (LK); Glibil
(AE, CY, EG, IQ, IR, JO, KW, LY, OM, QA, SA, SY, YE); Glibil-5 (SA); Gliboral (BF, BJ, CI, ET,
GH, GM, GN, KE, LB, LR, MA, ML, MR, MU, MW, NE, NG, SC, SD, SL, SN, TN, TZ, UG, ZM);

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Glidiabet (PE); Glihexal (VN); Glimel (AU, HK); Glipiz (LK); Glisulin (KR); Glitisol (ET, MT, TR);
Gluben (IL); Glucobene (HU); Glucolon (ES); Glucomid (BF, BJ, CI, ET, GH, GM, GN, KE, LR,
MA, ML, MR, MU, MW, NE, NG, SC, SD, SL, SN, TN, TZ, UG, ZM, ZW); Gluconic (ID); Gluconil
(BD); Glucoven (MX); Gluzo (TH); Glycomin (ZA); Glynase (AE, BB, BH, QA); Hemi-Daonil
(AR, FR, MA); Hipexal (CL); Lodulce (PH); Maninil (BG, EE, UA); Manoglucon (TH); Melix (AE,
BB, BF, BH, BJ, BM, BS, BZ, CI, CY, EG, ET, GH, GM, GN, GY, IQ, IR, JM, JO, KE, KW, LB,
LR, LY, MA, ML, MR, MU, MW, NE, NG, NL, OM, PR, QA, SA, SC, SD, SL, SN, SR, SY, TN,
TT, TZ, UG, YE, ZA, ZM); Miglucan (FR); Orabetic (PH); Padonil (ID); Pira (AR); Renabetic (ID);
Semi-Daonil (AE, AR, AU, CH, CY, EG, GB, IQ, IR, JO, KW, LY, MA, OM, PT, QA, SA, SY, YE);
Semi-Euglucon (AR, AT, AU, NZ); Sentionyl (PH); Sugril (TH); Variglyben (ZW)

For country abbreviations used in Lexicomp (show table)

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Topic 8494 Version 269.0

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