Bedaquiline fumarate: Difference between revisions

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{{DrugProjectFormSinglePage
{{Bedaquiline}}
|authorTag=<!--Overview-->
{{CMG}}; {{AE}} {{chetan}}
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==Overview==
* Content
Bedaquiline is a [[diarylquinoline]] anti-[[tuberculosis]] drug, which was discovered by a team led by [[Koen Andries]] at [[Janssen Pharmaceutica]].<ref name="pmid17387738">{{cite journal | author = de Jonge MR, Koymans LH, Guillemont JE, Koul A, Andries K | title = A computational model of the inhibition of Mycobacterium tuberculosis ATPase by a new drug candidate R207910 | journal = Proteins | volume = 67 | issue = 4 | pages = 971–80 | year = 2007 | month = June | pmid = 17387738 | doi = 10.1002/prot.21376 | url =  }}</ref> It is the first new medicine to fight TB in more than forty years,<ref>{{cite web|title=FDA Approves 1st New Tuberculosis Drug in 40 Years|url=http://abcnews.go.com/Health/wireStory/fda-approves-tuberculosis-40-years-18100650#.UOIPT-RQWe0|publisher=ABC News|accessdate=31 December 2012}}</ref><ref>{{cite web|title=F.D.A. Approves New Tuberculosis Drug|url=http://www.nytimes.com/2013/01/01/business/fda-approves-new-tuberculosis-drug.html?_r=0|publisher=New York Times|accessdate=31 December 2012}}</ref> and is specifically approved to treat [[multi-drug-resistant tuberculosis]].


==Category==
<!--Adult Indications and Dosage-->
Antimycobacterial


==US Brand Names==
<!--FDA-Labeled Indications and Dosage (Adult)-->
SIRTURO<sup>®</sup>
|fdaLIADAdult======Condition1=====


==FDA Package Insert==
* Dosing Information
'''[[Bedaquiline description|Description]]'''
'''| [[Bedaquiline clinical pharmacology|Clinical Pharmacology]]'''
'''| [[Bedaquiline microbiology|Microbiology]]'''
'''| [[Bedaquiline indications and usage|Indications and Usage]]'''
'''| [[Bedaquiline contraindications|Contraindications]]'''
'''| [[Bedaquiline warnings and precautions|Warnings and Precautions]]'''
'''| [[Bedaquiline adverse reactions|Adverse Reactions]]'''
'''| [[Bedaquiline overdosage|Overdosage]]'''
'''| [[Bedaquiline dosage and administration|Dosage and Administration]]'''
'''| [[Bedaquiline how supplied|How Supplied]]'''
'''| [[Bedaquiline labels and packages|Labels and Packages]]'''


==Mechanisms of Action==
:* Dosage
Bedaquiline affects the [[proton pump]] for [[ATP synthase]]. This mechanism is unlike that of the [[quinolone]]s, whose target is [[DNA gyrase]].<ref name="Kotz">{{cite journal | author = Kotz  J | title = Targeting tuberculosis | journal = Nature Chemical Biology | volume = | issue = | pages =  | year = 2005  | month = June | pmid = | doi = 10.1038/nchembio002 | url =  }}</ref>


==References==
=====Condition2=====
{{Reflist|2}}


[[Category:Antibiotics]]
* Dosing Information
[[Category:Wikinfect]]
 
:* Dosage
 
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* Dosing Information
 
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|offLabelAdultGuideSupport======Condition1=====
 
* Developed by:
 
* Class of Recommendation:
 
* Strength of Evidence:
 
* Dosing Information
 
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|offLabelAdultNoGuideSupport======Condition1=====
 
* Dosing Information
 
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<!--FDA-Labeled Indications and Dosage (Pediatric)-->
|fdaLIADPed======Condition1=====
 
* Dosing Information
 
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====Signs and Symptoms====
 
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[[Category:Drug]]

Revision as of 17:35, 29 January 2015

Bedaquiline fumarate
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

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Black Box Warning

ConditionName:
See full prescribing information for complete Boxed Warning.
ConditionName:
  • Content

Overview

Bedaquiline fumarate 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 .

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 Bedaquiline fumarate in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Contraindications

  • Condition1

Warnings

ConditionName:
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 Bedaquiline fumarate 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 Bedaquiline fumarate 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 Bedaquiline fumarate in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

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

  • Description

IV Compatibility

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

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

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

Pharmacology

There is limited information regarding Bedaquiline fumarate Pharmacology in the drug label.

Mechanism of Action

Structure

File:Bedaquiline fumarate01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

There is limited information regarding Bedaquiline fumarate Storage in the drug label.

Images

Drug Images

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

Patient Counseling Information

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

Precautions with Alcohol

  • Alcohol-Bedaquiline fumarate 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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