Colistimethate sodium

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]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

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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)

Indications

• Colistimethate for injection is indicated for the treatment of acute or chronic infections due to sensitive strains of certain gram-negative bacilli. It is particularly indicated when the infection is caused by sensitive strains of Pseudomonas aeruginosa. This antibiotic is not indicated for infections due to Proteus or Neisseria. Colistimethate for injection has proven clinically effective in treatment of infections due to the following gram-negative organisms: Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae and Pseudomonas aeruginosa.

• Colistimethate for injection may be used to initiate therapy in serious infections that are suspected to be due to gram-negative organisms and in the treatment of infections due to susceptible gram-negative pathogenic bacilli.

• To reduce the development of drug-resistant bacteria and maintain the effectiveness of colistimethate for injection and other antibacterial drugs, colistimethate for injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

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

• The use of colistimethate for injection is contraindicated for patients with a history of sensitivity to the drug or any of its components.

Warnings

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

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

Adverse Reactions

Clinical Trials Experience

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

Postmarketing Experience

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

Drug Interactions

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

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Colistimethate sodium in women who are pregnant.
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

• Intravenous

Monitoring

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

IV Compatibility

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

Overdosage

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

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

Structure

• Colistimethate for Injection, USP is a sterile parenteral antibiotic product which, when reconstituted, is suitable for intramuscular or intravenous administration.

• Each vial contains colistimethate sodium or pentasodium colistinmethanesulfonate (150 mg colistin base activity). The sodium content is approximately 0.099 mg (0.0043 mEq) of sodium per milligram of colistin.

• Colistimethate Sodium, USP is pentasodium 4-3-hydroxy-1-1-3-(1-hydroxyethyl)-12,15-bis(2-methylpropyl)-2,5,8,11,14,17,20-heptaoxo-6,9,18-tris2-(sulfonatomethylamino)ethyl-1,4,7,10,13,16,19-heptazacyclotricos-21-ylamino-1-oxo-4-(sulfonatomethylamino)butan-2-ylamino-1-oxobutan-2-yl]amino-3-(6-methyloctanoylamino)-4-oxobutylaminomethanesulfonate.

• Colistimethate Sodium, USP is a polypeptide antibiotic with an approximate molecular weight of 1750. The molecular formula is C58H105N16Na5O28S5 and the structural formula is represented below:

This image is provided by the National Library of Medicine.

• Colistimethate for Injection, USP is a white to slightly yellow lyophilized cake. The color of the reconstituted solution is clear colorless to pale yellow and essentially free from particles.

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

• Typical serum and urine levels following a single 150 mg dose of colistimethate for injection IM or IV in normal adult subjects are shown in figure1.

This image is provided by the National Library of Medicine.

• Higher serum levels were obtained at 10 minutes following IV administration. Serum concentration declined with a half-life of 2 to 3 hours following either intravenous or intramuscular administration in adults and in the pediatric population, including premature infants.

• Average urine levels ranged from about 270 mcg/mL at 2 hours to about 15 mcg/mL at 8 hours after intravenous administration and from 200 to about 25 mcg/mL during a similar period following intramuscular administration.

Microbiology

• 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 following microorganisms, both in vitro and in clinical infections:

Aerobic gram-negative microorganisms

• Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae and Pseudomonas aeruginosa.

Susceptibility Tests

• Colistimethate sodium is no longer listed as an antimicrobial for routine testing and reporting by clinical microbiology laboratories.

How Supplied

Storage

There is limited information regarding Colistimethate sodium 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 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

• A® — B®

Drug Shortage Status

Price

References

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

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