Glyburide and Metformin hydrochloride: Difference between revisions

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{{DrugProjectFormSinglePage
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|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=<span style="color:#FF0000;">WARNING:Lactic acidosis</span>
|blackBoxWarningBody=<i><span style="color:#FF0000;">Lactic acidosis: </span></i>


* 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.


<!--Overview-->
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).


|genericName=
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).


|aOrAn=
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.
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* Description


===Chronic Overdose===


There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.


<!--Pharmacology-->


=====Miscellaneous=====
<!--Drug box 2-->


|drugBox=




<!--Postmarketing Experience-->


|postmarketing=
<!--Mechanism of Action-->


There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
|mechAction=


=====Body as a Whole=====
*


<!--Structure-->


|structure=


=====Cardiovascular=====
*


: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]


<!--Pharmacodynamics-->


=====Digestive=====
|PD=


There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.


<!--Pharmacokinetics-->


=====Endocrine=====
|PK=


There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.


<!--Nonclinical Toxicology-->


=====Hematologic and Lymphatic=====
|nonClinToxic=


There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.


<!--Clinical Studies-->


=====Metabolic and Nutritional=====
|clinicalStudies=


There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.


<!--How Supplied-->


=====Musculoskeletal=====
|howSupplied=


*


<!--Patient Counseling Information-->


=====Neurologic=====
|fdaPatientInfo=


There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.


<!--Precautions with Alcohol-->


=====Respiratory=====
|alcohol=


* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.


<!--Brand Names-->


=====Skin and Hypersensitivy Reactions=====
|brandNames=


* ®<ref>{{Cite web | title =  | url =  }}</ref>


<!--Look-Alike Drug Names-->


=====Special Senses=====
|lookAlike=


* A® — B®<ref name="www.ismp.org">{{Cite web  | last =  | first =  | title = http://www.ismp.org | url = http://www.ismp.org | publisher =  | date =  }}</ref>


<!--Drug Shortage Status-->


=====Urogenital=====
|drugShortage=
}}


<!--Pill Image-->




=====Miscellaneous=====


<!--Label Display Image-->




<!--Drug Interactions-->


|drugInteractions=


* Drug
:* Description


<!--Use in Specific Populations-->
<!--Category-->
 
[[Category:Drug]]{{DrugProjectFormSinglePage
|authorTag=


|useInPregnancyFDA=
* '''Pregnancy Category'''


|useInPregnancyAUS=
<!--Overview-->
* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''


There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
|genericName=


|useInLaborDelivery=
There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.


|useInNursing=
There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.


|useInPed=
|aOrAn=
There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.


|useInGeri=
a
There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.


|useInGender=
|drugClass=
There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.


|useInRace=
There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.


|useInRenalImpair=
There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment.


|useInHepaticImpair=
|indication=
There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment.


|useInReproPotential=
There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.


|useInImmunocomp=
There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.


<!--Administration and Monitoring-->
|hasBlackBoxWarning=


|administration=
Yes


* Oral
|adverseReactions=


* Intravenous


|monitoring=


There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
<!--Black Box Warning-->


* Description
|blackBoxWarningTitle=
Title


<!--IV Compatibility-->
|blackBoxWarningBody=
<i><span style="color:#FF0000;">ConditionName: </span></i>


|IVCompat=
* Content


There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
<!--Adult Indications and Dosage-->


<!--Overdosage-->
<!--FDA-Labeled Indications and Dosage (Adult)-->


|overdose=
|fdaLIADAdult=


===Acute Overdose===
=====Condition1=====


====Signs and Symptoms====
* Dosing Information


* Description
:* Dosage


====Management====
=====Condition2=====


* Description
* Dosing Information


===Chronic Overdose===
:* Dosage


There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.
=====Condition3=====


<!--Pharmacology-->
* Dosing Information


<!--Drug box 2-->
:* Dosage


|drugBox=
=====Condition4=====


* Dosing Information


:* Dosage


<!--Mechanism of Action-->
<!--Off-Label Use and Dosage (Adult)-->


|mechAction=
<!--Guideline-Supported Use (Adult)-->


*
|offLabelAdultGuideSupport=


<!--Structure-->
=====Condition1=====


|structure=
* Developed by:


*  
* Class of Recommendation:


: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
* Strength of Evidence:  


<!--Pharmacodynamics-->
* Dosing Information


|PD=
:* Dosage


There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.
=====Condition2=====


<!--Pharmacokinetics-->
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


|PK=
<!--Non–Guideline-Supported Use (Adult)-->


There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
|offLabelAdultNoGuideSupport=


<!--Nonclinical Toxicology-->
=====Condition1=====


|nonClinToxic=
* Dosing Information


There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
:* Dosage


<!--Clinical Studies-->
=====Condition2=====


|clinicalStudies=
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
<!--Pediatric Indications and Dosage-->


<!--How Supplied-->
<!--FDA-Labeled Indications and Dosage (Pediatric)-->


|howSupplied=
|fdaLIADPed=


*
=====Condition1=====


<!--Patient Counseling Information-->
* Dosing Information


|fdaPatientInfo=
:* Dosage


There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
=====Condition2=====


<!--Precautions with Alcohol-->
There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.


|alcohol=
<!--Off-Label Use and Dosage (Pediatric)-->


* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
<!--Guideline-Supported Use (Pediatric)-->


<!--Brand Names-->
|offLabelPedGuideSupport=


|brandNames=
=====Condition1=====


* ®<ref>{{Cite web | title =  | url =  }}</ref>
* Developed by:


<!--Look-Alike Drug Names-->
* Class of Recommendation:


|lookAlike=
* Strength of Evidence:


* A® — B®<ref name="www.ismp.org">{{Cite web  | last =  | first =  | title = http://www.ismp.org | url = http://www.ismp.org | publisher =  | date =  }}</ref>
* Dosing Information


<!--Drug Shortage Status-->
:* Dosage


|drugShortage=
=====Condition2=====
}}


<!--Pill Image-->
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.


{{PillImage
<!--Non–Guideline-Supported Use (Pediatric)-->
|fileName=No image.jpg|This image is provided by the National Library of Medicine.
|drugName=
|NDC=
|drugAuthor=
|ingredients=
|pillImprint=
|dosageValue=
|dosageUnit=
|pillColor=
|pillShape=
|pillSize=
|pillScore=
}}


<!--Label Display Image-->
|offLabelPedNoGuideSupport=


{{LabelImage
=====Condition1=====
|fileName={{PAGENAME}}11.png|This image is provided by the National Library of Medicine.
}}


{{LabelImage
* Dosing Information
|fileName={{PAGENAME}}11.png|This image is provided by the National Library of Medicine.
}}


<!--Category-->
:* Dosage


[[Category:Drug]]{{DrugProjectFormSinglePage
=====Condition2=====
|authorTag=


There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.


<!--Overview-->
<!--Contraindications-->


|genericName=
|contraindications=


* Condition1


<!--Warnings-->


|aOrAn=
|warnings=


a
* Description


|drugClass=
====Precautions====


* Description


<!--Adverse Reactions-->


|indication=
<!--Clinical Trials Experience-->


|clinicalTrials=


There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.


|hasBlackBoxWarning=
=====Body as a Whole=====


Yes


|adverseReactions=




=====Cardiovascular=====


<!--Black Box Warning-->


|blackBoxWarningTitle=
Title


|blackBoxWarningBody=
<i><span style="color:#FF0000;">ConditionName: </span></i>


* Content
=====Digestive=====


<!--Adult Indications and Dosage-->


<!--FDA-Labeled Indications and Dosage (Adult)-->


|fdaLIADAdult=


=====Condition1=====
=====Endocrine=====


* Dosing Information


:* Dosage


=====Condition2=====


* Dosing Information
=====Hematologic and Lymphatic=====


:* Dosage


=====Condition3=====


* Dosing Information


:* Dosage
=====Metabolic and Nutritional=====


=====Condition4=====


* Dosing Information


:* Dosage


<!--Off-Label Use and Dosage (Adult)-->
=====Musculoskeletal=====


<!--Guideline-Supported Use (Adult)-->


|offLabelAdultGuideSupport=


=====Condition1=====


* Developed by:
=====Neurologic=====


* Class of Recommendation:


* Strength of Evidence:


* Dosing Information


:* Dosage
=====Respiratory=====


=====Condition2=====


There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


<!--Non–Guideline-Supported Use (Adult)-->


|offLabelAdultNoGuideSupport=
=====Skin and Hypersensitivy Reactions=====


=====Condition1=====


* Dosing Information


:* Dosage


=====Condition2=====
=====Special Senses=====


There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


<!--Pediatric Indications and Dosage-->


<!--FDA-Labeled Indications and Dosage (Pediatric)-->


|fdaLIADPed=
=====Urogenital=====


=====Condition1=====


* Dosing Information


:* Dosage


=====Condition2=====
=====Miscellaneous=====


There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.


<!--Off-Label Use and Dosage (Pediatric)-->


<!--Guideline-Supported Use (Pediatric)-->
<!--Postmarketing Experience-->


|offLabelPedGuideSupport=
|postmarketing=


=====Condition1=====
There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.


* Developed by:
=====Body as a Whole=====


* Class of Recommendation:


* Strength of Evidence:


* Dosing Information
=====Cardiovascular=====


:* Dosage


=====Condition2=====


There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
=====Digestive=====


<!--Non–Guideline-Supported Use (Pediatric)-->


|offLabelPedNoGuideSupport=


=====Condition1=====
=====Endocrine=====


* Dosing Information


:* Dosage


=====Condition2=====
=====Hematologic and Lymphatic=====


There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.


<!--Contraindications-->


|contraindications=
=====Metabolic and Nutritional=====


* Condition1


<!--Warnings-->


|warnings=
=====Musculoskeletal=====


* Description


====Precautions====


* Description
=====Neurologic=====


<!--Adverse Reactions-->


<!--Clinical Trials Experience-->


|clinicalTrials=
=====Respiratory=====


There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.


=====Body as a Whole=====


=====Skin and Hypersensitivy Reactions=====






=====Cardiovascular=====
=====Special Senses=====






=====Urogenital=====


=====Digestive=====




=====Miscellaneous=====




=====Endocrine=====


<!--Drug Interactions-->


|drugInteractions=


* Drug
:* Description


=====Hematologic and Lymphatic=====
<!--Use in Specific Populations-->


|useInPregnancyFDA=
* '''Pregnancy Category'''


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


There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.


=====Metabolic and Nutritional=====
|useInLaborDelivery=
There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.


|useInNursing=
There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.


|useInPed=
There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.


|useInGeri=
There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.


=====Musculoskeletal=====
|useInGender=
There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.


|useInRace=
There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.


|useInRenalImpair=
There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment.


|useInHepaticImpair=
There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment.


=====Neurologic=====
|useInReproPotential=
There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.


|useInImmunocomp=
There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.


<!--Administration and Monitoring-->


|administration=


=====Respiratory=====
* Oral


* Intravenous


|monitoring=


There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.


=====Skin and Hypersensitivy Reactions=====
* Description


<!--IV Compatibility-->


|IVCompat=


There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.


=====Special Senses=====
<!--Overdosage-->


|overdose=


===Acute Overdose===


====Signs and Symptoms====


=====Urogenital=====
* Description


====Management====


* Description


===Chronic Overdose===


=====Miscellaneous=====
There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.


<!--Pharmacology-->


<!--Drug box 2-->


<!--Postmarketing Experience-->
|drugBox=


|postmarketing=


There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.


=====Body as a Whole=====
<!--Mechanism of Action-->


|mechAction=


*


=====Cardiovascular=====
<!--Structure-->


|structure=


*


=====Digestive=====
: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]


<!--Pharmacodynamics-->


|PD=


=====Endocrine=====
There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.


<!--Pharmacokinetics-->


|PK=


=====Hematologic and Lymphatic=====
There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.


<!--Nonclinical Toxicology-->


|nonClinToxic=


=====Metabolic and Nutritional=====
There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.


<!--Clinical Studies-->


|clinicalStudies=


=====Musculoskeletal=====
There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.


<!--How Supplied-->


|howSupplied=


=====Neurologic=====
*


<!--Patient Counseling Information-->


|fdaPatientInfo=


=====Respiratory=====
There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.


<!--Precautions with Alcohol-->


|alcohol=


=====Skin and Hypersensitivy Reactions=====
* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.


<!--Brand Names-->


|brandNames=


=====Special Senses=====
* ®<ref>{{Cite web | title = | url = }}</ref>


<!--Look-Alike Drug Names-->


|lookAlike=


=====Urogenital=====
* A® — B®<ref name="www.ismp.org">{{Cite web  | last = | first = | title = http://www.ismp.org | url = http://www.ismp.org | publisher = | date = }}</ref>


<!--Drug Shortage Status-->


|drugShortage=
}}


=====Miscellaneous=====
<!--Pill Image-->






<!--Drug Interactions-->
<!--Label Display Image-->


|drugInteractions=


* Drug
:* Description


<!--Use in Specific Populations-->


|useInPregnancyFDA=
* '''Pregnancy Category'''


|useInPregnancyAUS=
<!--Category-->
* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''


There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
[[Category:Drug]]{{DrugProjectFormSinglePage
|authorTag=


|useInLaborDelivery=
There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.


|useInNursing=
<!--Overview-->
There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.


|useInPed=
|genericName=
There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.


|useInGeri=
There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.


|useInGender=
There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.


|useInRace=
|aOrAn=
There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.


|useInRenalImpair=
a
There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment.


|useInHepaticImpair=
|drugClass=
There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment.


|useInReproPotential=
There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.


|useInImmunocomp=
There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.


<!--Administration and Monitoring-->
|indication=


|administration=


* Oral


* Intravenous
|hasBlackBoxWarning=


|monitoring=
Yes


There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
|adverseReactions=


* Description


<!--IV Compatibility-->


|IVCompat=
<!--Black Box Warning-->


There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
|blackBoxWarningTitle=
Title


<!--Overdosage-->
|blackBoxWarningBody=
<i><span style="color:#FF0000;">ConditionName: </span></i>


|overdose=
* Content


===Acute Overdose===
<!--Adult Indications and Dosage-->


====Signs and Symptoms====
<!--FDA-Labeled Indications and Dosage (Adult)-->


* Description
|fdaLIADAdult=


====Management====
=====Condition1=====


* Description
* Dosing Information


===Chronic Overdose===
:* Dosage


There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.
=====Condition2=====


<!--Pharmacology-->
* Dosing Information


<!--Drug box 2-->
:* Dosage


|drugBox=
=====Condition3=====


* Dosing Information


:* Dosage


<!--Mechanism of Action-->
=====Condition4=====


|mechAction=
* Dosing Information


*  
:* Dosage


<!--Structure-->
<!--Off-Label Use and Dosage (Adult)-->


|structure=
<!--Guideline-Supported Use (Adult)-->


*
|offLabelAdultGuideSupport=


: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
=====Condition1=====


<!--Pharmacodynamics-->
* Developed by:


|PD=
* Class of Recommendation:


There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.
* Strength of Evidence:


<!--Pharmacokinetics-->
* Dosing Information


|PK=
:* Dosage


There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
=====Condition2=====


<!--Nonclinical Toxicology-->
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


|nonClinToxic=
<!--Non–Guideline-Supported Use (Adult)-->


There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
|offLabelAdultNoGuideSupport=


<!--Clinical Studies-->
=====Condition1=====


|clinicalStudies=
* Dosing Information


There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
:* Dosage


<!--How Supplied-->
=====Condition2=====


|howSupplied=
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


*
<!--Pediatric Indications and Dosage-->


<!--Patient Counseling Information-->
<!--FDA-Labeled Indications and Dosage (Pediatric)-->


|fdaPatientInfo=
|fdaLIADPed=


There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
=====Condition1=====


<!--Precautions with Alcohol-->
* Dosing Information


|alcohol=
:* Dosage


* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
=====Condition2=====


<!--Brand Names-->
There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.


|brandNames=
<!--Off-Label Use and Dosage (Pediatric)-->


* ®<ref>{{Cite web | title =  | url =  }}</ref>
<!--Guideline-Supported Use (Pediatric)-->


<!--Look-Alike Drug Names-->
|offLabelPedGuideSupport=


|lookAlike=
=====Condition1=====


* A® — B®<ref name="www.ismp.org">{{Cite web  | last =  | first =  | title = http://www.ismp.org | url = http://www.ismp.org | publisher =  | date =  }}</ref>
* Developed by:  


<!--Drug Shortage Status-->
* Class of Recommendation:


|drugShortage=
* Strength of Evidence:
}}


<!--Pill Image-->
* Dosing Information


{{PillImage
:* Dosage
|fileName=No image.jpg|This image is provided by the National Library of Medicine.
|drugName=
|NDC=
|drugAuthor=
|ingredients=
|pillImprint=
|dosageValue=
|dosageUnit=
|pillColor=
|pillShape=
|pillSize=
|pillScore=
}}


<!--Label Display Image-->
=====Condition2=====


{{LabelImage
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
|fileName={{PAGENAME}}11.png|This image is provided by the National Library of Medicine.
}}


{{LabelImage
<!--Non–Guideline-Supported Use (Pediatric)-->
|fileName={{PAGENAME}}11.png|This image is provided by the National Library of Medicine.
}}


<!--Category-->
|offLabelPedNoGuideSupport=


[[Category:Drug]]{{DrugProjectFormSinglePage
=====Condition1=====
|authorTag=


* Dosing Information


<!--Overview-->
:* Dosage


|genericName=
=====Condition2=====


There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.


<!--Contraindications-->


|aOrAn=
|contraindications=


a
* Condition1


|drugClass=
<!--Warnings-->


|warnings=


* Description


|indication=
====Precautions====


* Description


<!--Adverse Reactions-->


|hasBlackBoxWarning=
<!--Clinical Trials Experience-->


Yes
|clinicalTrials=


|adverseReactions=
There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.


=====Body as a Whole=====




<!--Black Box Warning-->


|blackBoxWarningTitle=
Title


|blackBoxWarningBody=
=====Cardiovascular=====
<i><span style="color:#FF0000;">ConditionName: </span></i>


* Content


<!--Adult Indications and Dosage-->


<!--FDA-Labeled Indications and Dosage (Adult)-->


|fdaLIADAdult=
=====Digestive=====


=====Condition1=====


* Dosing Information


:* Dosage


=====Condition2=====
=====Endocrine=====


* Dosing Information


:* Dosage


=====Condition3=====


* Dosing Information
=====Hematologic and Lymphatic=====


:* Dosage


=====Condition4=====


* Dosing Information


:* Dosage
=====Metabolic and Nutritional=====


<!--Off-Label Use and Dosage (Adult)-->


<!--Guideline-Supported Use (Adult)-->


|offLabelAdultGuideSupport=


=====Condition1=====
=====Musculoskeletal=====


* Developed by:


* Class of Recommendation:


* Strength of Evidence:


* Dosing Information
=====Neurologic=====


:* Dosage


=====Condition2=====


There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


<!--Non–Guideline-Supported Use (Adult)-->
=====Respiratory=====


|offLabelAdultNoGuideSupport=


=====Condition1=====


* Dosing Information


:* Dosage
=====Skin and Hypersensitivy Reactions=====


=====Condition2=====


There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


<!--Pediatric Indications and Dosage-->


<!--FDA-Labeled Indications and Dosage (Pediatric)-->
=====Special Senses=====


|fdaLIADPed=


=====Condition1=====


* Dosing Information


:* Dosage
=====Urogenital=====


=====Condition2=====


There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.


<!--Off-Label Use and Dosage (Pediatric)-->


<!--Guideline-Supported Use (Pediatric)-->
=====Miscellaneous=====


|offLabelPedGuideSupport=


=====Condition1=====


* Developed by:
<!--Postmarketing Experience-->


* Class of Recommendation:
|postmarketing=


* Strength of Evidence:
There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.


* Dosing Information
=====Body as a Whole=====


:* Dosage


=====Condition2=====


There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
=====Cardiovascular=====


<!--Non–Guideline-Supported Use (Pediatric)-->


|offLabelPedNoGuideSupport=


=====Condition1=====
=====Digestive=====


* Dosing Information


:* Dosage


=====Condition2=====
=====Endocrine=====


There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.


<!--Contraindications-->


|contraindications=
=====Hematologic and Lymphatic=====


* Condition1


<!--Warnings-->


|warnings=
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|useInLaborDelivery=
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=====Musculoskeletal=====
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Revision as of 14:05, 16 October 2014

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. [1]; Associate Editor(s)-in-Chief: Deepika Beereddy, MBBS [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

WARNING:Lactic acidosis
See full prescribing information for complete Boxed Warning.
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.

Overview

Glyburide and Metformin hydrochloride is a hypoglycemic agent that is FDA approved for the treatment of type 2 diabetes mellitus. There is a Black Box Warning for this drug as shown here. Common adverse reactions include cobalamin deficiency, hypoglycemia, abdominal pain, diarrhea, nausea, vomiting, dizziness, headache, upper respiratory infection.

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

WARNING:Lactic acidosis
See full prescribing information for complete Boxed Warning.
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.
  • 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

{{#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

Drug Shortage Status

Price

References

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

  1. ↑ Empty citation (help)
  2. ↑ "http://www.ismp.org". External link in |title= (help)

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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. [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

Drug Shortage Status

Price

References

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

  1. ↑ Empty citation (help)
  2. ↑ "http://www.ismp.org". External link in |title= (help)

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

{{#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

Drug Shortage Status

Price

References

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

  1. ↑ Empty citation (help)
  2. ↑ "http://www.ismp.org". External link in |title= (help)

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. [5];

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

Drug Shortage Status

Price

References

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

  1. ↑ Empty citation (help)
  2. ↑ "http://www.ismp.org". External link in |title= (help)
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