Mirabegron: Difference between revisions

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{{DrugProjectFormSinglePage
{{DrugProjectFormSinglePage
|authorTag={{DB}}
|authorTag={{DB}}
|genericName=Mirabegron
|aOrAn=a
|aOrAn=a
|drugClass=beta-3 adrenergic agonist
|indicationType=treatment
|indication=overactive bladder (OAB) with symptoms of urge [[urinary incontinence]], [[urgency]], and [[urinary frequency]]
|adverseReactions=[[hypertension]], [[nasopharyngitis]], [[urinary tract infection]] and [[headache]]
|adverseReactions=[[hypertension]], [[nasopharyngitis]], [[urinary tract infection]] and [[headache]]
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
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<!--Guideline-Supported Use (Adult)-->
<!--Guideline-Supported Use (Adult)-->
|offLabelAdultGuideSupport======Condition1=====
|offLabelAdultGuideSupport=* There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
 
* 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 adult patients.


<!--Non–Guideline-Supported Use (Adult)-->
<!--Non–Guideline-Supported Use (Adult)-->
|offLabelAdultNoGuideSupport======Condition1=====
|offLabelAdultNoGuideSupport=* There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


<!--Pediatric Indications and Dosage-->
<!--Pediatric Indications and Dosage-->
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<!--Brand Names-->
<!--Brand Names-->
|brandNames=* ®<ref>{{Cite web | title =  | url =  }}</ref>
|brandNames=Myrbetriq
 
<!--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 21:13, 22 January 2015

Mirabegron
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

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Overview

Mirabegron is a beta-3 adrenergic agonist that is FDA approved for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. Common adverse reactions include hypertension, nasopharyngitis, urinary tract infection and headache.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Bladder muscle dysfunction - overactive, With symptoms of urge urinary incontinence, urgency, and urinary frequency
  • Dosing Information
  • The recommended starting dose of Myrbetriq is 25 mg once daily with or without food. Myrbetriq 25 mg is effective within 8 weeks. Based on individual patient efficacy and tolerability the dose may be increased to 50 mg once daily.
  • Myrbetriq should be taken with water, swallowed whole and should not be chewed, divided, or crushed.
  • Dose Adjustments in Specific Populations
  • The daily dose of Myrbetriq should not exceed 25 mg once daily in the following populations:
  • Patients with severe renal impairment (CL cr 15 to 29 mL/min or eGFR 15 to 29 mL/min/1.73 m 2).
  • Patients with moderate hepatic impairment (Child-Pugh Class B).
  • Myrbetriq is not recommended for use in patients with end stage renal disease (ESRD), or in patients with severe hepatic impairment (Child-Pugh Class C).

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

  • There is limited information regarding Off-Label Guideline-Supported Use of Mirabegron in adult patients.

Non–Guideline-Supported Use

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

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Contraindications

  • Condition1

Warnings

  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Mirabegron 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 Mirabegron 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 Mirabegron in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

Dosing Information

  • The recommended starting dose of Myrbetriq is 25 mg once daily with or without food. Myrbetriq 25 mg is effective within 8 weeks. Based on individual patient efficacy and tolerability the dose may be increased to 50 mg once daily.
  • Myrbetriq should be taken with water, swallowed whole and should not be chewed, divided, or crushed.

Dose Adjustments in Specific Populations

  • The daily dose of Myrbetriq should not exceed 25 mg once daily in the following populations:
  • Patients with severe renal impairment (CL cr 15 to 29 mL/min or eGFR 15 to 29 mL/min/1.73 m 2).
  • Patients with moderate hepatic impairment (Child-Pugh Class B).
  • Myrbetriq is not recommended for use in patients with end stage renal disease (ESRD), or in patients with severe hepatic impairment (Child-Pugh Class C).

DOSAGE FORMS AND STRENGTHS

  • Myrbetriq extended-release tablets are supplied in two different strengths as described below:
  • 25 mg oval, brown, film coated tablet, debossed with the Astellas logo (Astellas logo) and “325”
  • 50 mg oval, yellow, film coated tablet, debossed with theAstellas logo (Astellas logo) and "355"

Monitoring

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

  • Description

IV Compatibility

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

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

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

Pharmacology

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

Mechanism of Action

Structure

File:Mirabegron01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

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

Images

Drug Images

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

Patient Counseling Information

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

Precautions with Alcohol

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

Brand Names

Myrbetriq

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)

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