Glyburide and Metformin hydrochloride

{{DrugProjectFormSinglePage |authorTag=Deepika Beereddy, MBBS [1] |genericName=Glyburide and Metformin |aOrAn=a |drugClass=hypoglycemic agent |indicationType=treatment |indication=type 2 diabetes mellitus |hasBlackBoxWarning=Yes |adverseReactions=cobalamin deficiency, hypoglycemia, abdominal pain, diarrhea, nausea, vomiting, dizziness, headache, upper respiratory infection |blackBoxWarningTitle=WARNING:Lactic acidosis |blackBoxWarningBody=Lactic acidosis:

• Lactic acidosis is a rare, but serious, metabolic complication that can occur due to metformin accumulation during treatment with glyburide and metformin hydrochloride tablets; when it occurs, it is fatal in approximately 50% of cases. Lactic acidosis may also occur in association with a number of pathophysiologic conditions, including diabetes mellitus, and whenever there is significant tissue hypoperfusion and hypoxemia. Lactic acidosis is characterized by elevated blood lactate levels (>5 mmol/L), decreased blood pH, electrolyte disturbances with an increased anion gap, and an increased lactate/pyruvate ratio. When metformin is implicated as the cause of lactic acidosis, metformin plasma levels >5 mcg/mL are generally found.

The reported incidence of lactic acidosis in patients receiving metformin hydrochloride is very low (approximately 0.03 cases/1000 patient-years, with approximately 0.015 fatal cases/1000 patient-years). In more than 20,000 patient-years exposure to metformin in clinical trials, there were no reports of lactic acidosis. Reported cases have occurred primarily in diabetic patients with significant renal insufficiency, including both intrinsic renal disease and renal hypoperfusion, often in the setting of multiple concomitant medical/surgical problems and multiple concomitant medications. Patients with congestive heart failure requiring pharmacologic management, in particular those with unstable or acute congestive heart failure who are at risk of hypoperfusion and hypoxemia, are at increased risk of lactic acidosis. The risk of lactic acidosis increases with the degree of renal dysfunction and the patient's age. The risk of lactic acidosis may, therefore, be significantly decreased by regular monitoring of renal function in patients taking metformin and by use of the minimum effective dose of metformin. In particular, treatment of the elderly should be accompanied by careful monitoring of renal function. Glyburide and metformin hydrochloride treatment should not be initiated in patients ≥80 years of age unless measurement of creatinine clearance demonstrates that renal function is not reduced, as these patients are more susceptible to developing lactic acidosis. In addition, glyburide and metformin hydrochloride should be promptly withheld in the presence of any condition associated with hypoxemia, dehydration, or sepsis. Because impaired hepatic function may significantly limit the ability to clear lactate, glyburide and metformin hydrochloride should generally be avoided in patients with clinical or laboratory evidence of hepatic disease. Patients should be cautioned against excessive alcohol intake, either acute or chronic, when taking glyburide and metformin hydrochloride, since alcohol potentiates the effects of metformin hydrochloride on lactate metabolism. In addition, glyburide and metformin hydrochloride should be temporarily discontinued prior to any intravascular radiocontrast study and for any surgical procedure (see also PRECAUTIONS).

The onset of lactic acidosis often is subtle, and accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific abdominal distress. There may be associated hypothermia, hypotension, and resistant bradyarrhythmias with more marked acidosis. The patient and the patient's physician must be aware of the possible importance of such symptoms and the patient should be instructed to notify the physician immediately if they occur (see also PRECAUTIONS). Glyburide and metformin hydrochloride should be withdrawn until the situation is clarified. Serum electrolytes, ketones, blood glucose, and if indicated, blood pH, lactate levels, and even blood metformin levels may be useful. Once a patient is stabilized on any dose level of glyburide and metformin hydrochloride, gastrointestinal symptoms, which are common during initiation of therapy with metformin, are unlikely to be drug related. Later occurrence of gastrointestinal symptoms could be due to lactic acidosis or other serious disease.

Levels of fasting venous plasma lactate above the upper limit of normal but less than 5 mmol/L in patients taking glyburide and metformin hydrochloride do not necessarily indicate impending lactic acidosis and may be explainable by other mechanisms, such as poorly controlled diabetes or obesity, vigorous physical activity, or technical problems in sample handling.

Lactic acidosis should be suspected in any diabetic patient with metabolic acidosis lacking evidence of ketoacidosis (ketonuria and ketonemia).

Lactic acidosis is a medical emergency that must be treated in a hospital setting. In a patient with lactic acidosis who is taking glyburide and metformin hydrochloride, the drug should be discontinued immediately and general supportive measures promptly instituted. Because metformin hydrochloride is dialyzable (with a clearance of up to 170 mL/min under good hemodynamic conditions), prompt hemodialysis is recommended to correct the acidosis and remove the accumulated metformin. Such management often results in prompt reversal of symptoms and recovery. |fdaLIADAdult======Condition1=====

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|offLabelAdultGuideSupport======Condition1=====

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

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Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Glyburide and Metformin hydrochloride in adult patients.

|offLabelAdultNoGuideSupport======Condition1=====

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There is limited information regarding Off-Label Non–Guideline-Supported Use of Glyburide and Metformin hydrochloride in adult patients.

|fdaLIADPed======Condition1=====

• Dosing Information

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Condition2

There is limited information regarding FDA-Labeled Use of Glyburide and Metformin hydrochloride in pediatric patients.

|offLabelPedGuideSupport======Condition1=====

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Glyburide and Metformin hydrochloride in pediatric patients.

|offLabelPedNoGuideSupport======Condition1=====

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Glyburide and Metformin hydrochloride in pediatric patients.

|contraindications=* Condition1

|warnings=* Description

Precautions

• Description

|clinicalTrials=There is limited information regarding Clinical Trial Experience of Glyburide and Metformin hydrochloride in the drug label.

Miscellaneous

|postmarketing=There is limited information regarding Postmarketing Experience of Glyburide and Metformin hydrochloride in the drug label.

Miscellaneous

|drugInteractions=* Drug

• Description

|useInPregnancyFDA=* Pregnancy Category |useInPregnancyAUS=* Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Glyburide and Metformin hydrochloride in women who are pregnant. |useInLaborDelivery=There is no FDA guidance on use of Glyburide and Metformin hydrochloride during labor and delivery. |useInNursing=There is no FDA guidance on the use of Glyburide and Metformin hydrochloride with respect to nursing mothers. |useInPed=There is no FDA guidance on the use of Glyburide and Metformin hydrochloride with respect to pediatric patients. |useInGeri=There is no FDA guidance on the use of Glyburide and Metformin hydrochloride with respect to geriatric patients. |useInGender=There is no FDA guidance on the use of Glyburide and Metformin hydrochloride with respect to specific gender populations. |useInRace=There is no FDA guidance on the use of Glyburide and Metformin hydrochloride with respect to specific racial populations. |useInRenalImpair=There is no FDA guidance on the use of Glyburide and Metformin hydrochloride in patients with renal impairment. |useInHepaticImpair=There is no FDA guidance on the use of Glyburide and Metformin hydrochloride in patients with hepatic impairment. |useInReproPotential=There is no FDA guidance on the use of Glyburide and Metformin hydrochloride in women of reproductive potentials and males. |useInImmunocomp=There is no FDA guidance one the use of Glyburide and Metformin hydrochloride in patients who are immunocompromised.

|administration=* Oral

• Intravenous

|monitoring=There is limited information regarding Monitoring of Glyburide and Metformin hydrochloride in the drug label.

• Description

|IVCompat=There is limited information regarding IV Compatibility of Glyburide and Metformin hydrochloride in the drug label.

|overdose====Acute Overdose===

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Glyburide and Metformin hydrochloride in the drug label.

|drugBox=

File:Glyburide and metformin image.png

|mechAction=*

|structure=Glyburide and metformin hydrochloride tablets, USP contain 2 oral antihyperglycemic drugs used in the management of type 2 diabetes, glyburide USP and metformin hydrochloride USP.

Glyburide USP is an oral antihyperglycemic drug of the sulfonylurea class. The chemical name for glyburide is 1-[[p-[2-(5-chloro-o-anisamido)ethyl]phenyl]sulfonyl]-3-cyclo-hexylurea. Glyburide USP is a white to off-white crystalline compound. The structural formula is represented below.

Metformin hydrochloride USP is an oral antihyperglycemic drug used in the management of type 2 diabetes. Metformin hydrochloride (N,N-dimethylimidodicarbonimidic diamide monohydrochloride) is not chemically or pharmacologically related to sulfonylureas, thiazolidinediones, or α-glucosidase inhibitors. It is a white to off-white crystalline compound. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. The structural formula is as shown:

Glyburide and metformin hydrochloride tablets, USP are available for oral administration containing 1.25 mg glyburide USP with 250 mg metformin hydrochloride USP, 2.5 mg glyburide USP with 500 mg metformin hydrochloride USP, and 5 mg glyburide USP with 500 mg metformin hydrochloride USP. In addition, each film-coated tablet contains the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, povidone, magnesium stearate, hypromellose, propylene glycol, polysorbate 80, talc, titanium dioxide and FD&C Yellow#6 aluminum lake. The 1.25 mg/250 mg and 5 mg/500 mg strengths also contain D&C Yellow#10 aluminum lake; The 2.5 mg/500 mg strength also contains FD&C Red#40 aluminum lake. |PD=There is limited information regarding Pharmacodynamics of Glyburide and Metformin hydrochloride in the drug label.

|PK=There is limited information regarding Pharmacokinetics of Glyburide and Metformin hydrochloride in the drug label.

|nonClinToxic=There is limited information regarding Nonclinical Toxicology of Glyburide and Metformin hydrochloride in the drug label.

|clinicalStudies=There is limited information regarding Clinical Studies of Glyburide and Metformin hydrochloride in the drug label.

|howSupplied=*

|packLabel=

|fdaPatientInfo=

|alcohol=* Alcohol-Glyburide and Metformin hydrochloride interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

|brandNames=* ®

|lookAlike=* A® — B®

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Glyburide and Metformin hydrochloride
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [2];

Disclaimer

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.

Black Box Warning

Title See full prescribing information for complete Boxed Warning. ConditionName: Content

Overview

Glyburide and Metformin hydrochloride is a that is FDA approved for the {{{indicationType}}} of . There is a Black Box Warning for this drug as shown here. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Condition1

• Dosing Information

• Dosage

Condition2

• Dosing Information

• Dosage

Condition3

• Dosing Information

• Dosage

Condition4

• Dosing Information

• Dosage

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Glyburide and Metformin hydrochloride in adult patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Glyburide and Metformin hydrochloride in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding FDA-Labeled Use of Glyburide and Metformin hydrochloride in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Glyburide and Metformin hydrochloride in pediatric patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Glyburide and Metformin hydrochloride in pediatric patients.

Contraindications

• Condition1

Warnings

Title See full prescribing information for complete Boxed Warning. ConditionName: Content

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Glyburide and Metformin hydrochloride in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Glyburide and Metformin hydrochloride in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Glyburide and Metformin hydrochloride in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Glyburide and Metformin hydrochloride during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Glyburide and Metformin hydrochloride with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Glyburide and Metformin hydrochloride with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Glyburide and Metformin hydrochloride with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Glyburide and Metformin hydrochloride with respect to specific gender populations.

Race

There is no FDA guidance on the use of Glyburide and Metformin hydrochloride with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Glyburide and Metformin hydrochloride in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Glyburide and Metformin hydrochloride in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Glyburide and Metformin hydrochloride in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Glyburide and Metformin hydrochloride in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Glyburide and Metformin hydrochloride in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Glyburide and Metformin hydrochloride in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Glyburide and Metformin hydrochloride in the drug label.

Pharmacology

There is limited information regarding Glyburide and Metformin hydrochloride Pharmacology in the drug label.

Mechanism of Action

Structure

File:Glyburide and Metformin hydrochloride01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Glyburide and Metformin hydrochloride in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Glyburide and Metformin hydrochloride in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Glyburide and Metformin hydrochloride in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Glyburide and Metformin hydrochloride in the drug label.

How Supplied

Storage

There is limited information regarding Glyburide and Metformin hydrochloride Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Glyburide and Metformin hydrochloride |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Glyburide and Metformin hydrochloride |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Glyburide and Metformin hydrochloride in the drug label.

Precautions with Alcohol

• Alcohol-Glyburide and Metformin hydrochloride interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

Glyburide and Metformin hydrochloride
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [3];

Disclaimer

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.

Black Box Warning

Title See full prescribing information for complete Boxed Warning. ConditionName: Content

Overview

Glyburide and Metformin hydrochloride is a that is FDA approved for the {{{indicationType}}} of . There is a Black Box Warning for this drug as shown here. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Condition1

• Dosing Information

• Dosage

Condition2

• Dosing Information

• Dosage

Condition3

• Dosing Information

• Dosage

Condition4

• Dosing Information

• Dosage

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Glyburide and Metformin hydrochloride in adult patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Glyburide and Metformin hydrochloride in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding FDA-Labeled Use of Glyburide and Metformin hydrochloride in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Glyburide and Metformin hydrochloride in pediatric patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Glyburide and Metformin hydrochloride in pediatric patients.

Contraindications

• Condition1

Warnings

Title See full prescribing information for complete Boxed Warning. ConditionName: Content

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Glyburide and Metformin hydrochloride in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Glyburide and Metformin hydrochloride in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Glyburide and Metformin hydrochloride in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Glyburide and Metformin hydrochloride during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Glyburide and Metformin hydrochloride with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Glyburide and Metformin hydrochloride with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Glyburide and Metformin hydrochloride with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Glyburide and Metformin hydrochloride with respect to specific gender populations.

Race

There is no FDA guidance on the use of Glyburide and Metformin hydrochloride with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Glyburide and Metformin hydrochloride in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Glyburide and Metformin hydrochloride in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Glyburide and Metformin hydrochloride in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Glyburide and Metformin hydrochloride in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Glyburide and Metformin hydrochloride in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Glyburide and Metformin hydrochloride in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Glyburide and Metformin hydrochloride in the drug label.

Pharmacology

There is limited information regarding Glyburide and Metformin hydrochloride Pharmacology in the drug label.

Mechanism of Action

Structure

File:Glyburide and Metformin hydrochloride01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Glyburide and Metformin hydrochloride in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Glyburide and Metformin hydrochloride in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Glyburide and Metformin hydrochloride in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Glyburide and Metformin hydrochloride in the drug label.

How Supplied

Storage

There is limited information regarding Glyburide and Metformin hydrochloride Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Glyburide and Metformin hydrochloride |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Glyburide and Metformin hydrochloride |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Glyburide and Metformin hydrochloride in the drug label.

Precautions with Alcohol

• Alcohol-Glyburide and Metformin hydrochloride interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

Glyburide and Metformin hydrochloride
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [4];

Disclaimer

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.

Black Box Warning

Title See full prescribing information for complete Boxed Warning. ConditionName: Content

Overview

Glyburide and Metformin hydrochloride is a that is FDA approved for the {{{indicationType}}} of . There is a Black Box Warning for this drug as shown here. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Condition1

• Dosing Information

• Dosage

Condition2

• Dosing Information

• Dosage

Condition3

• Dosing Information

• Dosage

Condition4

• Dosing Information

• Dosage

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Glyburide and Metformin hydrochloride in adult patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Glyburide and Metformin hydrochloride in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding FDA-Labeled Use of Glyburide and Metformin hydrochloride in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Glyburide and Metformin hydrochloride in pediatric patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Glyburide and Metformin hydrochloride in pediatric patients.

Contraindications

• Condition1

Warnings

Title See full prescribing information for complete Boxed Warning. ConditionName: Content

• Description

Precautions

• Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Glyburide and Metformin hydrochloride in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Glyburide and Metformin hydrochloride in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Glyburide and Metformin hydrochloride in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Glyburide and Metformin hydrochloride during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Glyburide and Metformin hydrochloride with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Glyburide and Metformin hydrochloride with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Glyburide and Metformin hydrochloride with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Glyburide and Metformin hydrochloride with respect to specific gender populations.

Race

There is no FDA guidance on the use of Glyburide and Metformin hydrochloride with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Glyburide and Metformin hydrochloride in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Glyburide and Metformin hydrochloride in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Glyburide and Metformin hydrochloride in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Glyburide and Metformin hydrochloride in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Glyburide and Metformin hydrochloride in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Glyburide and Metformin hydrochloride in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Glyburide and Metformin hydrochloride in the drug label.

Pharmacology

There is limited information regarding Glyburide and Metformin hydrochloride Pharmacology in the drug label.

Mechanism of Action

Structure

File:Glyburide and Metformin hydrochloride01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Glyburide and Metformin hydrochloride in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Glyburide and Metformin hydrochloride in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Glyburide and Metformin hydrochloride in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Glyburide and Metformin hydrochloride in the drug label.

How Supplied

Storage

There is limited information regarding Glyburide and Metformin hydrochloride Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Glyburide and Metformin hydrochloride in the drug label.

Precautions with Alcohol

• Alcohol-Glyburide and Metformin hydrochloride interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.