Brimonidine (topical): Difference between revisions

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{{DrugProjectFormSinglePage
{{DrugProjectFormSinglePage
|aOrAn=a
|authorTag={{KS}}
|genericName=brimonidine tartrate
|aOrAn=an
|drugClass=alpha adrenergic agonist
|indicationType=treatment
|indicationType=treatment
|hasBlackBoxWarning=Yes
|indication=facial [[erythema]] of [[rosacea]]
|adverseReactions=<!--Black Box Warning-->
|adverseReactions=[[erythema]], [[flushing]], skin burning sensation, and [[contact dermatitis]].
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
Line 12: Line 15:


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


* Dosing Information
* MIRVASO (brimonidine) topical gel, 0.33% is an alpha adrenergic agonist indicated for the topical treatment of persistent (nontransient) [[erythema]] of [[rosacea]] in adults 18 years of age or older.


:* Dosage
==Dosage==


=====Condition2=====
* Apply a pea-size amount once daily to each of the five areas of the face: central forehead, chin, nose, each cheek. MIRVASO topical gel should be applied smoothly and evenly as a thin layer across the entire face avoiding the eyes and lips.


* Dosing Information
==DOSAGE FORMS AND STRENGTHS==


:* Dosage
* MIRVASO (brimonidine) topical gel, 0.33% is a white to light yellow opaque aqueous gel. Each gram of gel contains 5 mg of brimonidine tartrate, equivalent to 3.3 mg of brimonidine free base.


=====Condition3=====
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


* Dosing Information


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


=====Condition4=====


* Dosing Information


:* Dosage
|fdaLIADPed=There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.


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


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


* Developed by:
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.


* Class of Recommendation:


* Strength of Evidence:
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.


* Dosing Information


:* Dosage
|contraindications=* None
|warnings='''Potentiation of Vascular Insufficiency'''


=====Condition2=====
* MIRVASO topical gel should be used with caution in patients with [[depression]], cerebral or [[coronary insufficiency]], [[Raynaud’s phenomenon]], [[orthostatic hypotension]], [[thrombangiitis obliterans]], [[scleroderma]], or [[Sjögren’s syndrome]].


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


<!--Non–Guideline-Supported Use (Adult)-->
* Alpha-2 adrenergic agonists can lower blood pressure. MIRVASO topical gel should be used with caution in patients with severe or unstable or uncontrolled cardiovascular disease.
|offLabelAdultNoGuideSupport======Condition1=====


* Dosing Information
'''Serious Adverse Reactions Following Ingestion of MIRVASO topical gel'''


:* Dosage
* Two young children of a subject in a clinical trial experienced serious adverse reactions following accidental ingestion of MIRVASO topical gel. Adverse reactions experienced by one or both children included [[lethargy]], respiratory distress with apneic episodes (requiring intubation), sinus [[bradycardia]], [[confusion]], psychomotor hyperactivity, and [[diaphoresis]]. Both children were hospitalized overnight and discharged the following day without sequelae.


=====Condition2=====
* Keep MIRVASO topical gel out of reach of children.


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


<!--Pediatric Indications and Dosage-->
* Some subjects in the clinical trials discontinued use of MIRVASO topical gel because of erythema or flushing.


<!--FDA-Labeled Indications and Dosage (Pediatric)-->
* The effect of MIRVASO topical gel may begin to diminish hours after application. For some subjects in the clinical trials, erythema was reported to return worse compared to the severity at baseline [see Adverse Reactions (6)].
|fdaLIADPed======Condition1=====


* Dosing Information
* Intermittent flushing occurred in some subjects treated with MIRVASO topical gel. The onset of flushing relative to application of MIRVASO topical gel varied, ranging from approximately 30 minutes to several hours.


:* Dosage
* Erythema and flushing appeared to resolve after discontinuation of MIRVASO topical gel.
 
=====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)-->
|offLabelPedGuideSupport======Condition1=====
 
* Developed by:
 
* Class of Recommendation:
 
* Strength of Evidence:
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Non–Guideline-Supported Use (Pediatric)-->
|offLabelPedNoGuideSupport======Condition1=====
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Contraindications-->
|contraindications=* Condition1
 
<!--Warnings-->
|warnings=* Description
 
====Precautions====
 
* Description
 
<!--Adverse Reactions-->
 
<!--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=====




=====Cardiovascular=====
=====Digestive=====
=====Endocrine=====
=====Hematologic and Lymphatic=====
=====Metabolic and Nutritional=====
=====Musculoskeletal=====
=====Neurologic=====
=====Respiratory=====
=====Skin and Hypersensitivy Reactions=====
=====Special Senses=====
=====Urogenital=====
=====Miscellaneous=====
<!--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=====
=====Cardiovascular=====
=====Digestive=====
=====Endocrine=====
=====Hematologic and Lymphatic=====
=====Metabolic and Nutritional=====
=====Musculoskeletal=====
=====Neurologic=====
=====Respiratory=====
=====Skin and Hypersensitivy Reactions=====
=====Special Senses=====
=====Urogenital=====
=====Miscellaneous=====


<!--Drug Interactions-->
|drugInteractions=* Drug
:* Description
<!--Use in Specific Populations-->
|useInPregnancyFDA=* '''Pregnancy Category'''
|useInPregnancyFDA=* '''Pregnancy Category'''
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
Line 321: Line 147:


<!--Brand Names-->
<!--Brand Names-->
|brandNames=* ®<ref>{{Cite web | title = | url = }}</ref>
|brandNames=* MIRVASO ®<ref>{{Cite web | title =brimonidine tartrate gel|url =http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f6a4353f-ae69-4214-901f-e5d42a6fbde7 }}</ref>
 


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


Revision as of 20:05, 6 May 2015

Brimonidine (topical)
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: Kiran Singh, M.D. [2]

Disclaimer

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Overview

Brimonidine (topical) is an alpha adrenergic agonist that is FDA approved for the treatment of facial erythema of rosacea. Common adverse reactions include erythema, flushing, skin burning sensation, and contact dermatitis..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

  • MIRVASO (brimonidine) topical gel, 0.33% is an alpha adrenergic agonist indicated for the topical treatment of persistent (nontransient) erythema of rosacea in adults 18 years of age or older.

Dosage

  • Apply a pea-size amount once daily to each of the five areas of the face: central forehead, chin, nose, each cheek. MIRVASO topical gel should be applied smoothly and evenly as a thin layer across the entire face avoiding the eyes and lips.

DOSAGE FORMS AND STRENGTHS

  • MIRVASO (brimonidine) topical gel, 0.33% is a white to light yellow opaque aqueous gel. Each gram of gel contains 5 mg of brimonidine tartrate, equivalent to 3.3 mg of brimonidine free base.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Brimonidine (topical) in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Brimonidine (topical) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Brimonidine (topical) in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Brimonidine (topical) in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Brimonidine (topical) in pediatric patients.

Contraindications

  • None

Warnings

Potentiation of Vascular Insufficiency

Severe Cardiovascular Disease

  • Alpha-2 adrenergic agonists can lower blood pressure. MIRVASO topical gel should be used with caution in patients with severe or unstable or uncontrolled cardiovascular disease.

Serious Adverse Reactions Following Ingestion of MIRVASO topical gel

  • Two young children of a subject in a clinical trial experienced serious adverse reactions following accidental ingestion of MIRVASO topical gel. Adverse reactions experienced by one or both children included lethargy, respiratory distress with apneic episodes (requiring intubation), sinus bradycardia, confusion, psychomotor hyperactivity, and diaphoresis. Both children were hospitalized overnight and discharged the following day without sequelae.
  • Keep MIRVASO topical gel out of reach of children.

Erythema and Flushing

  • Some subjects in the clinical trials discontinued use of MIRVASO topical gel because of erythema or flushing.
  • The effect of MIRVASO topical gel may begin to diminish hours after application. For some subjects in the clinical trials, erythema was reported to return worse compared to the severity at baseline [see Adverse Reactions (6)].
  • Intermittent flushing occurred in some subjects treated with MIRVASO topical gel. The onset of flushing relative to application of MIRVASO topical gel varied, ranging from approximately 30 minutes to several hours.
  • Erythema and flushing appeared to resolve after discontinuation of MIRVASO topical gel.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Brimonidine (topical) in the drug label.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Brimonidine (topical) in the drug label.

Drug Interactions

There is limited information regarding Brimonidine (topical) Drug Interactions in the drug label.

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 Brimonidine (topical) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Brimonidine (topical) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Brimonidine (topical) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Brimonidine (topical) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Brimonidine (topical) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Brimonidine (topical) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Brimonidine (topical) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Brimonidine (topical) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Brimonidine (topical) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Brimonidine (topical) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Brimonidine (topical) in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Brimonidine (topical) in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Brimonidine (topical) in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Brimonidine (topical) in the drug label.

Pharmacology

There is limited information regarding Brimonidine (topical) Pharmacology in the drug label.

Mechanism of Action

Structure

File:Brimonidine (topical)01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Brimonidine (topical) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Brimonidine (topical) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Brimonidine (topical) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Brimonidine (topical) in the drug label.

How Supplied

Storage

There is limited information regarding Brimonidine (topical) Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Brimonidine (topical) |?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::Brimonidine (topical) |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Brimonidine (topical) in the drug label.

Precautions with Alcohol

  • Alcohol-Brimonidine (topical) 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. ↑ "brimonidine tartrate gel".
  2. ↑ "http://www.ismp.org". External link in |title= (help)

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