Colistimethate sodium: Difference between revisions

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__NOTOC__
{{DrugProjectFormSinglePage
{{Colistimethate sodium}}
|aOrAn=a
{{CMG}}; {{AE}} {{MM}}
|indicationType=treatment
==Overview==
|hasBlackBoxWarning=Yes
'''Colistimethate sodium''' (polymyxin E) is a [[polymyxin]] [[antibiotic]] produced by certain strains of ''[[Bacillus polymyxa]]'' var. ''colistinus''. Colistin is a mixture of [[cyclic polypeptide]]s colistin A and B. Colistin is effective against most [[Gram-negative]] bacilli and is used as a [[polypeptide antibiotic]].
|adverseReactions=<!--Black Box Warning-->
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>


Colistimethate sodium is a decades-old drug that fell out of favor due to its [[nephrotoxicity]]. It remains one of the [[Drug of last resort|last-resort antibiotics]] for multidrug-resistant ''[[Pseudomonas aeruginosa]]'', ''[[Klebsiella pneumoniae]]'', and ''[[Acinetobacter]]''.<ref>{{cite journal | last1 = Falagas | first1 = ME | last2 = Grammatikos | first2 = AP | last3 = Michalopoulos | first3 = A | title = Potential of old-generation antibiotics to address current need for new antibiotics | url = http://www.ncbi.nlm.nih.gov/pubmed/18847400 | pmid = 18847400  | author-separator =, | journal = Expert review of anti-infective therapy | author-name-separator= | doi=10.1586/14787210.6.5.593 | volume=6 | issue=5 | year=2008 | month=October | pages=593–600}}</ref> [[NDM-1 metallo-β-lactamase]] multidrug-resistant [[Enterobacteriaceae]] have also shown susceptibility to Colistin.<ref name=Kumarasamy>{{cite journal |author=Kumarasamy ''et al.'' |last2=Toleman |first2=Mark A |last3=Walsh |first3=Timothy R |last4=Bagaria |first4=Jay |last5=Butt |first5=Fafhana |last6=Balakrishnan |first6=Ravikumar |last7=Chaudhary |first7=Uma |last8=Doumith |first8=Michel |last9=Giske |first9=Christian G |title=Emergence of a new antibiotic resistance mechanism in India, Pakistan, and the UK: a molecular, biological, and epidemiological study |journal=The Lancet Infectious Diseases |volume= 10|issue= 9|pages= 597–602|year=2010 |month= |pmid= 20705517 |pmc=2933358|doi=10.1016/S1473-3099(10)70143-2 |url=}}</ref>
* Content


==Category==
<!--Adult Indications and Dosage-->
[[Polymyxin|Polymyxin antibiotic]]


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


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


==Mechanism of Action==
:* Dosage
Colistimethate sodium is a surface active agent which penetrates into and disrupts the bacterial cell membrane. It has been shown to have bactericidal activity against most strains of the microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section


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


[[Category:Antibiotics]]
* Dosing Information
[[Category:Wikinfect]]
 
:* Dosage
 
=====Condition3=====
 
* Dosing Information
 
:* Dosage
 
=====Condition4=====
 
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:* Dosage
 
<!--Off-Label Use and Dosage (Adult)-->
 
<!--Guideline-Supported Use (Adult)-->
|offLabelAdultGuideSupport======Condition1=====
 
* Developed by:
 
* Class of Recommendation:
 
* Strength of Evidence:
 
* Dosing Information
 
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* Dosing Information
 
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<!--Pediatric Indications and Dosage-->
 
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
|fdaLIADPed======Condition1=====
 
* Dosing Information
 
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There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
 
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<!--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.
 
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|offLabelPedNoGuideSupport======Condition1=====
 
* Dosing Information
 
:* Dosage
 
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|contraindications=* Condition1
 
<!--Warnings-->
|warnings=* Description
 
====Precautions====
 
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=====Body as a Whole=====
 
 
 
 
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=====Endocrine=====
 
 
 
 
=====Hematologic and Lymphatic=====
 
 
 
 
=====Metabolic and Nutritional=====
 
 
 
 
=====Musculoskeletal=====
 
 
 
 
=====Neurologic=====
 
 
 
 
=====Respiratory=====
 
 
 
 
=====Skin and Hypersensitivy Reactions=====
 
 
 
 
=====Special Senses=====
 
 
 
 
=====Urogenital=====
 
 
 
 
=====Miscellaneous=====
 
 
 
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|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=====
 
 
 
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* Description
 
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<!--Overdosage-->
|overdose====Acute Overdose===
 
====Signs and Symptoms====
 
* Description
 
====Management====
 
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===Chronic Overdose===
 
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[[Category:Drug]]

Revision as of 14:23, 17 March 2015

Colistimethate sodium
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

Colistimethate sodium is a {{{drugClass}}} that is FDA approved for the treatment 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 Colistimethate sodium in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

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

  • Description

IV Compatibility

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

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

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

Pharmacology

There is limited information regarding Colistimethate sodium Pharmacology in the drug label.

Mechanism of Action

Structure

File:Colistimethate sodium01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

There is limited information regarding Colistimethate sodium Storage in the drug label.

Images

Drug Images

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

Patient Counseling Information

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

Precautions with Alcohol

  • Alcohol-Colistimethate sodium 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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