Glimepiride

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];

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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

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of 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

A® — B®^[1]

Drug Shortage Status

Price

References

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

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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
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Convert pounds to Kilograms
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Publication Resources
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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
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