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Glyburide and metformin: Drug information

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

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
ALERT: US Boxed Warning
Lactic acidosis:

Post-marketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (greater than 5 mmol/L), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate:pyruvate ratio; and metformin plasma levels generally greater than 5 mcg/mL.

Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (eg, carbonic anhydrase inhibitors such as topiramate), age 65 years or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (eg, acute heart failure), excessive alcohol intake, and hepatic impairment.

Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided in the full prescribing information.

If metformin-associated lactic acidosis is suspected, immediately discontinue glyburide/metformin and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended.

Pharmacologic Category
  • Antidiabetic Agent, Biguanide;
  • Antidiabetic Agent, Sulfonylurea
Dosing: Adult
Diabetes mellitus, type 2, treatment

Diabetes mellitus, type 2, treatment:

Patients with inadequate glycemic control on diet and exercise alone: Oral: Initial: Glyburide 1.25 mg/metformin 250 mg once or twice daily with meals.

Patients with inadequate glycemic control on metformin or glyburide (or another sulfonylurea) monotherapy: Oral: Initial: Glyburide 2.5 mg/metformin 500 mg or glyburide 5 mg/metformin 500 mg twice daily with meals.

Patients already receiving a combination of metformin and glyburide (or another sulfonylurea) as individual components: Oral: Initial: Do not exceed the daily dose of metformin and glyburide (or equivalent dose of other sulfonylurea) being taken.

Dosage adjustments: Oral: Increase dose gradually per glycemic control and tolerability up to a maximum dose of glyburide 20 mg/metformin 2 g per day.

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

Note: Glyburide is generally not recommended for use in patients with chronic kidney disease; if sulfonylurea therapy is needed, other agents are preferred (ADA [Tuttle 2014]; Alsahli 2015; KDOQI [Nelson 2012]).

eGFR ≥60 mL/minute/1.73 m2: No dosage adjustment necessary. Monitor kidney function at least annually.

eGFR >45 to <60 mL/minute/1.73 m2: No dosage adjustment necessary; for the metformin component, a maximum dose of 1.5 g/day in 2 divided doses (eg, 500 mg in the morning, 1 g in the evening) has been suggested (Lalau 2018). Increase monitoring of kidney function (eg, every 6 months) (ADA [Lipska 2011]; Lalau 2018).

eGFR 30 to 45 mL/minute/1.73 m2:

Initiation of therapy: Use of glyburide/metformin is not recommended for initiation of therapy. Refer also to individual agents.

Continuation of existing therapy: If eGFR falls between 30 to <45 mL/minute/1.73 m2 during therapy, consider benefits/risks of continuing therapy. If continuing therapy, a metformin dosage reduction of 50% (maximum: metformin 1 g/day) with close monitoring of kidney function is recommended (ADA [Lipska 2011]; Lalau 2018).

eGFR <30 mL/minute/1.73 m2: Use is contraindicated.

Dosing: Hepatic Impairment: Adult

The manufacturer recommends avoiding metformin because liver disease is considered a risk factor for the development of lactic acidosis during metformin therapy. However, continued use of metformin in patients with diabetes and chronic liver disease with impaired hepatic function may be associated with a survival benefit in carefully selected patients; use cautiously in patients at risk for lactic acidosis (eg, renal impairment, alcohol use) (Brackett 2010; Crowley 2017; Zhang 2014). Glyburide undergoes hepatic metabolism and use of conservative initial and maintenance doses should be considered.

Dosing: Older Adult

Note: Avoid use due to increased risk of hypoglycemia with glyburide. Agents other than sulfonylureas are preferred in older adults; if a sulfonylurea is needed, one with a lower relative risk of hypoglycemia (eg, glipizide, glimepiride) is preferred (Ref).

Adverse Reactions

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

>10%:

Endocrine & metabolic: Hypoglycemia (11% to 38%, effects higher when increased doses were used as initial therapy)

Gastrointestinal: Gastrointestinal symptoms (38%; combined GI effects increased to 38% in patients taking high doses as initial therapy), diarrhea (17%)

Respiratory: Upper respiratory infection (17%)

1% to 10%:

Central nervous system: Headache (9%), dizziness (6%)

Gastrointestinal: Nausea (8%), vomiting (8%), abdominal pain (7%)

<1%, postmarketing, and/or case reports: Cholestatic jaundice, hepatitis

Contraindications

Hypersensitivity to metformin, glyburide, or any component of the formulation; severe renal impairment (eGFR <30 mL/minute/1.73 m2); acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma; concomitant administration of bosentan.

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

Warnings/Precautions

Concerns related to adverse effects:

• Cardiovascular mortality: Product labeling for sulfonylureas 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 1998), have not supported an association. In patients with established atherosclerotic cardiovascular disease (ASCVD), agents other than sulfonylureas are preferred (ADA 2023).

• 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 patients ≥65 years of age, malnourished or frail patients, and in patients with impaired renal, hepatic, adrenal, and/or pituitary function; use with caution (Abbatecola 2012; manufacturer's labeling).

• Lactic acidosis:Lactic acidosis should be suspected in any patient with diabetes receiving metformin with evidence of acidosis but without evidence of ketoacidosis. Discontinue metformin in patients with conditions associated with dehydration, sepsis, or hypoxemia. The risk of accumulation and lactic acidosis increases with the degree of impairment of renal function and the patient's age.

• 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 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.

• Vitamin B12 concentrations: Long-term metformin use is associated with vitamin B12 deficiency.

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). After gastric bypass (Roux-en-Y gastric bypass [RYGB]), administration of IR tablets led to increased absorption (AUC0- increased by 21%) and bioavailability (increased by 50%) (Padwal 2011). 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 (Tandra2013). Lactate levels decrease after gastric bypass (RYGB)-induced weight loss irrespective of the use of metformin. Routinely lowering metformin dose after gastric bypass is not necessary as long as normal renal function is preserved (Deden 2018).

– 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 (G6PD) deficiency: Patients with 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. Avoid use in patients with G6PD deficiency.

• Heart failure: Metformin may be used in patients with stable heart failure; use cautiously or avoid in hypoperfusion (ADA 2023).

• Hepatic impairment: The metabolism and excretion of glyburide may be slowed in patients with hepatic impairment; if hypoglycemia should occur in such patients, it may be prolonged. Use metformin cautiously in patients at risk for lactic acidosis (Brackett 2010; Crowley 2017; Zhang 2014).

• 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]). Metformin is substantially excreted by the kidney; the risk of metformin accumulation and lactic acidosis increases with degree of renal impairment. Use of concomitant medications that may affect renal function (ie, affect tubular secretion) may also affect metformin disposition. Metformin should be withheld in patients with dehydration and/or prerenal azotemia.

• 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: Use metformin with caution; risk of metformin-associated lactic acidosis increases with age.

Other warnings/precautions:

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

• Ethanol use: Instruct patients to avoid excessive acute or chronic ethanol use; ethanol may potentiate metformin's effect on lactate metabolism.

• Iodinated contrast: Administration of iodinated contrast agents has been associated with post-contrast acute kidney injury; in patients taking metformin, acute decreases in renal function have been associated with an increased risk of lactic acidosis due to reduced metformin excretion (ACR 2021; manufacturer's labeling). Refer to Metformin monograph for additional information.

• Surgical procedures: Metformin-containing products should be withheld the day of surgery; restart after renal function is stable (ADA 2023).

Dosage Forms: US

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

Tablet, Oral:

Generic: Glyburide 1.25 mg and metformin hydrochloride 250 mg, Glyburide 2.5 mg and metformin hydrochloride 500 mg, Glyburide 5 mg and metformin hydrochloride 500 mg

Generic Equivalent Available: US

Yes

Pricing: US

Tablets (glyBURIDE-metFORMIN Oral)

1.25-250 mg (per each): $0.86 - $0.89

2.5-500 mg (per each): $1.03 - $1.06

5-500 mg (per each): $1.03 - $1.06

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.

Administration: Adult

Oral: All doses should be administered with a meal. Twice-daily dosing should be administered with the morning and evening meals. Patients that are NPO or require decreased caloric intake may need doses held to avoid hypoglycemia.

Use: Labeled Indications

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

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

Glucovance may be confused with Vyvanse

High alert medication:

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

Older Adult: High-Risk Medication:

Avoid routine use of sulfonylureas due to increased risk of hypoglycemia. If a sulfonylurea is needed, a different one with a lower relative risk of hypoglycemia (eg, gliclazide, glipizide, glimepiride) is preferred (ADA 2023; Beers Criteria [AGS 2023]; Diabetes Canada 2018).

Metabolism/Transport Effects

Refer to individual components.

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.

Abemaciclib: May increase the serum concentration of MetFORMIN. Risk C: Monitor therapy

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

Alcohol (Ethyl): May enhance the adverse/toxic effect of MetFORMIN. Specifically, excessive alcohol ingestion (acute or chronic) may potentiate the risk of lactic acidosis. Risk X: Avoid combination

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

Asciminib: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). 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

Beta-Blockers (Nonselective): May enhance the hypoglycemic effect of Antidiabetic Agents. Beta-Blockers (Nonselective) may diminish the therapeutic effect of Antidiabetic Agents. 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

Carbonic Anhydrase Inhibitors: May enhance the adverse/toxic effect of MetFORMIN. Specifically, the risk of developing lactic acidosis may be increased. Risk C: Monitor therapy

Cephalexin: May increase the serum concentration of MetFORMIN. Risk C: Monitor therapy

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

Cimetidine: May increase the serum concentration of MetFORMIN. Management: Consider alternatives to cimetidine in patients receiving metformin due to a potential for increased metformin concentrations and toxicity (including lactic acidosis). Risk D: Consider therapy modification

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

Dofetilide: MetFORMIN may increase the serum concentration of Dofetilide. Risk C: Monitor therapy

Dolutegravir: May increase the serum concentration of MetFORMIN. Management: Consider alternatives to this combination or use of lower metformin doses. Carefully weigh the risk of metformin toxicities (including lactic acidosis) against the benefit of combining dolutegravir with metformin. Risk D: Consider therapy modification

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

Erdafitinib: May increase the serum concentration of OCT2 Substrates (Clinically Relevant with Inhibitors). Management: Consider alternatives to this combination when possible. If combined, monitor for increased effects/toxicities of OCT2 substrates and consider OCT2 substrate dose reductions when appropriate. Risk D: Consider therapy modification

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

Fexinidazole: May increase the serum concentration of MATE1/2-K Substrates (Clinically Relevant with Inhibitors). Management: Avoid use of fexinidazole with MATE1/2-K substrates when possible. If combined, monitor for increased MATE1/2-K substrate toxicities. Risk D: Consider therapy modification

Fexinidazole: May increase the serum concentration of OCT2 Substrates (Clinically Relevant with Inhibitors). Management: Avoid use of fexinidazole with OCT2 substrates when possible. If combined, monitor for increased OCT2 substrate toxicities. Risk D: Consider therapy modification

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

Fludeoxyglucose F 18: MetFORMIN may diminish the diagnostic effect of Fludeoxyglucose F 18. Management: Consider holding metformin for 48 hours or longer prior to PET scans using fludeoxyglucose F18 (FDG-F18) when imaging of the colon or intestine is required. Consider increased monitoring of blood glucose when metformin is held. Risk D: Consider therapy modification

Fluvastatin: GlyBURIDE may increase the serum concentration of Fluvastatin. Fluvastatin may increase the serum concentration of GlyBURIDE. Risk C: Monitor therapy

Foslevodopa: May increase the serum concentration of MATE1/2-K Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor therapy

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

Gilteritinib: May increase the serum concentration of OCT1 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

Glycopyrrolate (Systemic): May increase the serum concentration of MetFORMIN. Risk C: Monitor therapy

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

Guar Gum (Partially Hydrolyzed): May decrease the serum concentration of MetFORMIN. 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

Iodinated Contrast Agents: May enhance the adverse/toxic effect of MetFORMIN. Renal dysfunction that may be caused by iodinated contrast agents may lead to metformin-associated lactic acidosis. Management: Management advice varies. Refer to the full drug interaction monograph content for details. Risk D: Consider therapy modification

LamoTRIgine: May increase the serum concentration of MetFORMIN. Management: The lamotrigine Canadian product monograph states that coadministration of these drugs is not recommended. 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

MATE1/2-K Inhibitors: May increase the serum concentration of MetFORMIN. 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

Methylol Cephalexin: May increase the serum concentration of MetFORMIN. 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

Nonsteroidal Anti-Inflammatory Agents: May enhance the adverse/toxic effect of MetFORMIN. Risk C: Monitor therapy

Ombitasvir, Paritaprevir, and Ritonavir: May enhance the adverse/toxic effect of MetFORMIN. Specifically, the risk for lactic acidosis may be increased. Risk C: Monitor therapy

Ombitasvir, Paritaprevir, Ritonavir, and Dasabuvir: May enhance the adverse/toxic effect of MetFORMIN. Specifically, the risk for lactic acidosis may be increased. Risk C: Monitor therapy

Ondansetron: May increase the serum concentration of MetFORMIN. Risk C: Monitor therapy

Pacritinib: May increase the serum concentration of OCT1 Substrates (Clinically Relevant with Inhibitors). Risk X: Avoid combination

Patiromer: May decrease the serum concentration of MetFORMIN. Management: Administer metformin at least 3 hours before or 3 hours after patiromer. Risk D: Consider therapy modification

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

Ranolazine: May increase the serum concentration of MetFORMIN. Management: Limit the metformin dose to a maximum of 1,700 mg per day when used together with ranolazine 1,000 mg twice daily. Monitor patients for metformin toxicities, including lactic acidosis and carefully weigh the risks and benefits of this combination. Risk D: Consider therapy modification

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

Risdiplam: May increase the serum concentration of MATE1/2-K Substrates (Clinically Relevant with Inhibitors). Management: Avoid use of risdiplam with MATE substrates if possible. If the combination cannot be avoided, monitor closely for adverse effects. Consider a reduced dose of the MATE substrate according to that substrate's labeling if appropriate. Risk D: Consider therapy modification

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

Tafenoquine: May increase the serum concentration of MATE1/2-K Substrates (Clinically Relevant with Inhibitors). Management: Avoid use of MATE substrates with tafenoquine, and if the combination cannot be avoided, monitor closely for evidence of toxicity of the MATE substrate and consider a reduced dose of the MATE substrate according to that substrate's labeling. Risk D: Consider therapy modification

Tafenoquine: May increase the serum concentration of OCT2 Substrates (Clinically Relevant with Inhibitors). Management: Avoid use of OCT2 substrates with tafenoquine, and if the combination cannot be avoided, monitor closely for evidence of toxicity of the OCT2 substrate and consider a reduced dose of the OCT2 substrate according to that substrate's labeling. Risk D: Consider therapy modification

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

Topiramate: May enhance the adverse/toxic effect of MetFORMIN. Specifically, the risk for lactic acidosis may be increased. MetFORMIN may increase the serum concentration of Topiramate. Topiramate may increase the serum concentration of MetFORMIN. Risk C: Monitor therapy

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

Verapamil: May diminish the therapeutic effect of MetFORMIN. Risk C: Monitor therapy

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

Vitamin K Antagonists (eg, warfarin): MetFORMIN may diminish the anticoagulant effect of Vitamin K Antagonists. Vitamin K Antagonists may enhance the hypoglycemic effect of MetFORMIN. 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

See individual agents.

Reproductive Considerations

Metformin may increase ovulation in premenopausal anovulatory patients resulting in unintended pregnancies.

Refer to individual monographs for additional information.

Pregnancy Considerations

Glyburide and metformin cross the placenta (ADA 2023).

If exposure during pregnancy occurs, discontinue at least 2 weeks prior to expected delivery.

Refer to individual monographs for information related to the treatment of diabetes mellitus in pregnancy.

Breastfeeding Considerations

Glyburide and metformin are present in breast milk.

According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother. Refer to individual monographs for additional information.

Dietary Considerations

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

Monitoring Parameters

Plasma glucose (individualize frequency based on treatment regimen, hypoglycemia risk, and other patient-specific factors (ADA 2023). Monitor renal function (eGFR) prior to therapy initiation and at least annually or at least every 3 to 6 months if eGFR is <60 mL/minute/1.73 m2 (KDIGO 2020). Monitor hematologic parameters (eg, hemoglobin/hematocrit, red blood cell indices) annually; folate if megaloblastic anemia is suspected; hepatic function. Monitor vitamin B12 serum concentrations every 1 to 2 years, particularly in patients who have been treated with metformin for ≥4 years, or in patients with peripheral neuropathy, anemia, or risk factors for vitamin B12 deficiency (eg, malabsorption syndromes, reduced dietary intake) (ADA 2023; KDIGO 2020; manufacturer's labeling).

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 2023; KDIGO 2020).

Reference Range

Recommendations for glycemic control in patients with diabetes:

Nonpregnant adults with diabetes (AACE [Samson 2023], ADA 2023):

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 2023):

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

HbA1c: <7% to 7.5% (healthy); <8% (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 2023):

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

The combination of glyburide and metformin is used to improve glycemic control in patients with type 2 diabetes mellitus by using two different, but complementary, mechanisms of action:

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

Metformin: Decreases hepatic glucose production, decreasing intestinal absorption of glucose and improves insulin sensitivity (increases peripheral glucose uptake and utilization)

Pharmacokinetics (Adult Data Unless Noted)

Glucovance:

Bioavailability: Compared to coadministration of glyburide and metformin, the bioavailability of glyburide observed with glyburide 2.5 mg/metformin 500 mg and glyburide 5 mg/metformin 500 mg combination product was 18% and 7% greater respectively; the pharmacokinetics of metformin was consistent with that observed with coadministration of the individual products.

Time to peak: 2.75 hours when taken with food

Refer also to individual agents.

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

  • (AE) United Arab Emirates: Emivanz;
  • (AR) Argentina: Glucovance;
  • (AU) Australia: Glucovance;
  • (BE) Belgium: Glucovance;
  • (BF) Burkina Faso: Glibomet | Iscept;
  • (BR) Brazil: Glibeta | Glucovance;
  • (CH) Switzerland: Daonil m | Glucovance;
  • (CI) Côte d'Ivoire: Gliben m | Iscept;
  • (CL) Chile: Bi euglucon m | Glucovance;
  • (CN) China: An he | Bai kang | Jun fu le | Ke rui te | Li jiang | Li sheng yuan | Lian ge tang ding | Lian jiang | Metformin hydrochloride and glibenclamide | Metformin hydrochloride and glibenclamide tablets (i) | Metformin hydrochloride and glibenclamide tablets (II) | Rui lian | Shuang ge ning | Shuang li | Shuang ping le | Tang bei kang | Tang ping | Wei neng | Wu qi an | Yi ke fu;
  • (CO) Colombia: Bi euglucon | Glucovance | Mellimet g | Metformina + Glibenclamida | Metformina/glibenclamida | Sil-Norboral;
  • (CZ) Czech Republic: Glibomet | Glucovance;
  • (DE) Germany: Metformin Comp | Metgliben;
  • (DO) Dominican Republic: Clormin g | Droformin | Duoctar | Forclamin | Giglotril plus | Glibomet | Glimegen | Glubetic g | Glucodiatin g | Glucoless 2 | Glucoless 4 | Glucovance | Mediabet g | Metformina + glibenclamida | Proinsul Plus | Sil-Norboral;
  • (EC) Ecuador: Bi euglucon m | Bi-Glicem | Diaformina Plus | Glinil met | Glucovance | Hipoglucin DA | Metformina + glibenclamida;
  • (EG) Egypt: Amophage extra | Diavance | Euglumide Plus | Glimet | Gluokan | Glybformin | Glybofen | Meburide | Metclamide | Suguan m;
  • (FR) France: Glucovance;
  • (HK) Hong Kong: Glifil-M | Glucovance;
  • (HR) Croatia: Glucovance;
  • (ID) Indonesia: Glucovance;
  • (IN) India: Benclamet | Benformin | Bioformin | Combidos | Diabetrol | Diaforte | Diaglib m | Diolin m | Dior plus | Duotrol | G Formin | G Formin Plus | Glibomet | Gliconil m | Glifil-M | Glifor | Glinil-m | Glucored | Glycurb | Iscept | Iscept-l | Melitus | Metclam | Metica-g | Sugatrol;
  • (IT) Italy: Bi euglucon m | Dialinax | Glibomet | Gliconorm | Metformina Glibenclamide Sandoz | Suguan m;
  • (JO) Jordan: Bi-act;
  • (KE) Kenya: Duobet | Glibomet | Glifil m forte | Glucocip | Glucomet n | Glucored forte | Glucovance | Glybofen | Metcon | Metcon plus;
  • (KR) Korea, Republic of: Coemformin | Glibomet | Gliformin | Glimet | Gluclean | Glucovance | Gluriad | Glutrol | Glycol | Imeban duo | Metafobans | Metco;
  • (KW) Kuwait: Glucovance;
  • (LB) Lebanon: Diamet | Glibomet | Glimet | Glucovance | Glystor Plus;
  • (LU) Luxembourg: Glucovance;
  • (LV) Latvia: Glucovance;
  • (MA) Morocco: Glucovance;
  • (MX) Mexico: Apometglu | Bi dizalon | Bi euglucon m | Bi pradia | Dibenmin | Dimefor g | Dinorax c | Duo-anglucid | Espanorm | Estuvina | Glicavin ex | Glucotec | Glucovance | Glunovag G | Gluxson | Imalet | Insusym forte | Metformina/glibenclamida | Metixor G | Midapharma | Natisfar | Norfaben m | Sibet c | Sil-Norboral | Sonsimina | Wadil;
  • (MY) Malaysia: Daonil m | Diamide | Glucomide | Glucomin g | Glymet;
  • (NG) Nigeria: Benimet | Breformide | Glibenclamide + metformin sandoz | Glimefil | Glucovance | Glutowin forte | Glyformin plus | Greenhope metformin & glibenclamide;
  • (NL) Netherlands: Glucovance;
  • (PE) Peru: Bi euglucon | Bidimefor | Glibemet;
  • (PH) Philippines: Bemefor | Diacom | Glucovance | Rapartam;
  • (PK) Pakistan: Daonil m | Glimet | Glucomet plus | Mefbide | Mefbide plus | Metcon | Metcon plus | Semi metcon;
  • (PR) Puerto Rico: Glipizide and metformin hydrochloride | Glucovance | Glyburide and Metformin Hcl | Glyburide and metformin hydrochloride | Glyburide/metformin;
  • (PY) Paraguay: Istion;
  • (QA) Qatar: Bi-Act | Deux | Glucovance;
  • (RO) Romania: Glibomet | Gliformin | Glucovance;
  • (RU) Russian Federation: Bagomet plus | Glibenclamide metformin | Glibenfag | Glibenfazh | Glibomet | Gluconorm | Gluconorm plus | Glucovance | Metglib | Metglib force;
  • (SA) Saudi Arabia: Daonil m | Diamet | Glimifort | Glucovance;
  • (SG) Singapore: Glucovance;
  • (SI) Slovenia: Glucovance;
  • (SK) Slovakia: Glibomet | Glucovance;
  • (TN) Tunisia: Glucovance;
  • (TR) Turkey: Glucovance;
  • (UA) Ukraine: Duotrol | Glucovance;
  • (UG) Uganda: Diamide | Diolin m | Duotrol | Glifil m fort | Glucovance;
  • (UY) Uruguay: Bi euglucon | Bi euglucon m | Dublex | Resolut Plus;
  • (VE) Venezuela, Bolivarian Republic of: Bi euglucon m | Glimetvin | Glucenorm | Glucovance | Metformina-glibenclamida | Metformina/glibenclamida | Sulfomet;
  • (VN) Viet Nam: Hasanbest | Metovance;
  • (ZA) South Africa: Glucovance;
  • (ZM) Zambia: Gliben m | Glifil m forte
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