Glimepiride: Difference between revisions

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<small>'''''Synonyms / Brand Names:''''' Glimepirid, Glimepirida, Glimepiridum, Glimepride, Amarel, Amaryl, Endial, Novo-glimepiride, PMS-glimepiride, Ratio-glimepiride, Sandoz glimepiride
{{DrugProjectFormSinglePage
</small>
|authorTag=<!--Overview-->
 
|aOrAn=a
{{CMG}}
|hasBlackBoxWarning=Yes
 
|adverseReactions=Endocrine metabolic: Hypoglycemia (adults, 4% to 19.7%; pediatrics, 4% )
==Dosing and Administration==
Gastrointestinal: Nausea (5% )
The usual starting dose of Glimepiride as in{{DrugProjectFormSinglePage
Neurologic: Asthenia, Dizziness (5% ), Headache (8.2% )
|authorTag=
|blackBoxWarningTitle=Title
 
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
 
<!--Overview-->
 
|genericName=
 
 
 
|aOrAn=
 
a
 
|drugClass=
 
 
 
|indication=
 
 
 
|hasBlackBoxWarning=
 
Yes
 
|adverseReactions=
 
 
 
<!--Black Box Warning-->
 
|blackBoxWarningTitle=
Title
 
|blackBoxWarningBody=
<i><span style="color:#FF0000;">ConditionName: </span></i>


* Content
* Content
Line 48: Line 14:


<!--FDA-Labeled Indications and Dosage (Adult)-->
<!--FDA-Labeled Indications and Dosage (Adult)-->
 
|fdaLIADAdult======Condition1=====
|fdaLIADAdult=
 
=====Condition1=====


* Dosing Information
* Dosing Information
Line 78: Line 41:


<!--Guideline-Supported Use (Adult)-->
<!--Guideline-Supported Use (Adult)-->
 
|offLabelAdultGuideSupport======Condition1=====
|offLabelAdultGuideSupport=
 
=====Condition1=====


* Developed by:  
* Developed by:  
Line 98: Line 58:


<!--Non–Guideline-Supported Use (Adult)-->
<!--Non–Guideline-Supported Use (Adult)-->
 
|offLabelAdultNoGuideSupport======Condition1=====
|offLabelAdultNoGuideSupport=
 
=====Condition1=====


* Dosing Information
* Dosing Information
Line 114: Line 71:


<!--FDA-Labeled Indications and Dosage (Pediatric)-->
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
 
|fdaLIADPed======Condition1=====
|fdaLIADPed=
 
=====Condition1=====


* Dosing Information
* Dosing Information
Line 130: Line 84:


<!--Guideline-Supported Use (Pediatric)-->
<!--Guideline-Supported Use (Pediatric)-->
 
|offLabelPedGuideSupport======Condition1=====
|offLabelPedGuideSupport=
 
=====Condition1=====


* Developed by:  
* Developed by:  
Line 150: Line 101:


<!--Non–Guideline-Supported Use (Pediatric)-->
<!--Non–Guideline-Supported Use (Pediatric)-->
 
|offLabelPedNoGuideSupport======Condition1=====
|offLabelPedNoGuideSupport=
 
=====Condition1=====


* Dosing Information
* Dosing Information
Line 164: Line 112:


<!--Contraindications-->
<!--Contraindications-->
 
|contraindications=* Condition1
|contraindications=
 
* Condition1


<!--Warnings-->
<!--Warnings-->
 
|warnings=* Description
|warnings=
 
* Description


====Precautions====
====Precautions====
Line 182: Line 124:


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


=====Body as a Whole=====
=====Body as a Whole=====
Line 252: Line 191:


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


=====Body as a Whole=====
=====Body as a Whole=====
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<!--Drug Interactions-->
<!--Drug Interactions-->
 
|drugInteractions=* Drug
|drugInteractions=
 
* Drug
:* Description
:* Description


<!--Use in Specific Populations-->
<!--Use in Specific Populations-->
 
|useInPregnancyFDA=* '''Pregnancy Category'''
|useInPregnancyFDA=
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
* '''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.
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
 
|useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|useInLaborDelivery=
|useInNursing=There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|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.
|useInNursing=
|useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
|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.
|useInPed=
|useInHepaticImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment.
There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
|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.
|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=
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.
 
|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 and Monitoring-->
 
|administration=* Oral
|administration=
 
* Oral


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


* Description
* Description


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


<!--Overdosage-->
<!--Overdosage-->
 
|overdose====Acute Overdose===
|overdose=
 
===Acute Overdose===


====Signs and Symptoms====
====Signs and Symptoms====
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<!--Drug box 2-->
<!--Drug box 2-->
 
|drugBox=<!--Mechanism of Action-->
|drugBox=
|mechAction=*  
 
 
 
<!--Mechanism of Action-->
 
|mechAction=
 
*  


<!--Structure-->
<!--Structure-->
 
|structure=*  
|structure=
 
*  


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


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


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


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


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


<!--How Supplied-->
<!--How Supplied-->
 
|howSupplied=*  
|howSupplied=
 
*  


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


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


<!--Brand Names-->
<!--Brand Names-->
|brandNames=Amaryl
|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>


|brandNames=
<!--Drug Shortage Status-->
|drugShortage=
}}
{{PillImage
|fileName=No image.jpg
}}
{{LabelImage
|fileName={{PAGENAME}}11.png
}}
{{LabelImage
|fileName={{PAGENAME}}11.png
}}
<small>'''''Synonyms / Brand Names:''''' Glimepirid, Glimepirida, Glimepiridum, Glimepride, Amarel, Amaryl, Endial, Novo-glimepiride, PMS-glimepiride, Ratio-glimepiride, Sandoz glimepiride
</small>


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


<!--Look-Alike Drug Names-->
==Dosing and Administration==
The usual starting dose of Glimepiride as in


|lookAlike=
<!--Pill Image-->


* 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=
<!--Label Display Image-->
}}
 
<!--Pill Image-->


{{PillImage
|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-->


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


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


<!--Category-->
<!--Category-->

Revision as of 23:17, 10 October 2014

Glimepiride
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];

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

Glimepiride is a {{{drugClass}}} that is FDA approved for the {{{indicationType}}} of {{{indication}}}. There is a Black Box Warning for this drug as shown here. Common adverse reactions include Endocrine metabolic: Hypoglycemia (adults, 4% to 19.7%; pediatrics, 4% ) Gastrointestinal: Nausea (5% ) Neurologic: Asthenia, Dizziness (5% ), Headache (8.2% ).

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 Glimepiride in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Glimepiride 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 Glimepiride 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 Glimepiride in pediatric patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Glimepiride 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 Glimepiride 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 Glimepiride 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 Glimepiride in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Glimepiride during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Glimepiride with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Glimepiride with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Glimepiride with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Glimepiride with respect to specific gender populations.

Race

There is no FDA guidance on the use of Glimepiride with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Glimepiride in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Glimepiride in patients with hepatic impairment.

Females of Reproductive Potential and Males

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

Immunocompromised Patients

There is no FDA guidance one the use of Glimepiride in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Glimepiride in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Glimepiride in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Glimepiride in the drug label.

Pharmacology

There is limited information regarding Glimepiride Pharmacology in the drug label.

Mechanism of Action

Structure

File:Glimepiride01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Glimepiride in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Glimepiride in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Glimepiride in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Glimepiride in the drug label.

How Supplied

Storage

There is limited information regarding Glimepiride Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Glimepiride |?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::Glimepiride |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Glimepiride in the drug label.

Precautions with Alcohol

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

Brand Names

Amaryl

Look-Alike Drug Names

Drug Shortage Status

Price

References

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

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

{{#subobject: 

 |Page Name=Glimepiride
 |Pill Name=No image.jpg
 |Drug Name=
 |Pill Ingred=|+sep=;
 |Pill Imprint=
 |Pill Dosage={{{dosageValue}}} {{{dosageUnit}}}
 |Pill Color=|+sep=;
 |Pill Shape=
 |Pill Size (mm)=
 |Pill Scoring=
 |Pill Image=
 |Drug Author=
 |NDC=

}}

{{#subobject: 

 |Label Page=Glimepiride
 |Label Name=Glimepiride11.png

}}

{{#subobject: 

 |Label Page=Glimepiride
 |Label Name=Glimepiride11.png

}}

Synonyms / Brand Names: Glimepirid, Glimepirida, Glimepiridum, Glimepride, Amarel, Amaryl, Endial, Novo-glimepiride, PMS-glimepiride, Ratio-glimepiride, Sandoz glimepiride

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

Dosing and Administration

The usual starting dose of Glimepiride as initial therapy is 1 to 2 mg once daily, administered with breakfast or the first main meal. Those patients who may be more sensitive to hypoglycemic drugs should be started at 1 mg once daily, and should be titrated carefully.
No exact dosage relationship exists between Glimepiride and the other oral hypoglycemic agents. The maximum starting dose of Glimepiride should be no more than 2 mg.
Failure to follow an appropriate dosage regimen may precipitate hypoglycemia. Patients who do not adhere to their prescribed dietary and drug regimen are more prone to exhibit unsatisfactory response to therapy.


FDA Package Insert Resources
Indications, Contraindications, Side Effects, Drug Interactions, etc.

Calculate Creatine Clearance
On line calculator of your patients Cr Cl by a variety of formulas.

Convert pounds to Kilograms
On line calculator of your patients weight in pounds to Kg for dosing estimates.

Publication Resources
Recent articles, WikiDoc State of the Art Review, Textbook Information

Trial Resources
Ongoing Trials, Trial Results

Guidelines & Evidence Based Medicine Resources
US National Guidelines, Cochrane Collaboration, etc.

Media Resources
Slides, Video, Images, MP3, Podcasts, etc.

Patient Resources
Discussion Groups, Handouts, Blogs, News, etc.

International Resources
en Español





FDA Package Insert Resources

Indications

Contraindications

Side Effects

Drug Interactions

Precautions

Overdose

Instructions for Administration

How Supplied

Pharmacokinetics and Molecular Data

FDA label

FDA on Glimepiride

Return to top

Publication Resources

Most Recent Articles on Glimepiride

Review Articles on Glimepiride

Articles on Glimepiride in N Eng J Med, Lancet, BMJ

WikiDoc State of the Art Review

Textbook Information on Glimepiride

Return to top

Trial Resources

Ongoing Trials with Glimepiride at Clinical Trials.gov

Trial Results with Glimepiride

Return to top

Guidelines & Evidence Based Medicine Resources

US National Guidelines Clearinghouse on Glimepiride

Cochrane Collaboration on Glimepiride

Cost Effectiveness of Glimepiride

Return to top

Media Resources

Powerpoint Slides on Glimepiride

Images of Glimepiride

Podcasts & MP3s on Glimepiride

Videos on Glimepiride

Return to top

Patient Resources

Patient Information from National Library of Medicine

Patient Resources on Glimepiride

Discussion Groups on Glimepiride

Patient Handouts on Glimepiride

Blogs on Glimepiride

Glimepiride in the News

Glimepiride in the Marketplace

Return to top

International Resources

Glimepiride en Español

Return to top

Adapted from the FDA Package Insert.

Retrieved from "https://www.wikidoc.org/index.php?title=Glimepiride&oldid=1031618"