Colistimethate sodium
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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Overview
Colistimethate sodium is a {{{drugClass}}} that is FDA approved for the treatment of {{{indication}}}. 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
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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
- Maximum daily dose calculated from colistin base activity should not exceed 5 mg/kg/day with normal renal function.
- Transient neurological disturbances may occur. These include circumoral paresthesia or numbness, tingling or formication of the extremities, generalized pruritus, vertigo, dizziness, and slurring of speech. For these reasons, patients should be warned not to drive vehicles or use hazardous machinery while on therapy. Reduction of dosage may alleviate symptoms. Therapy need not be discontinued, but such patients should be observed with particular care.
- Nephrotoxicity can occur and is probably a dose-dependent effect of colistimethate sodium. These manifestations of nephrotoxicity are reversible following discontinuation of the antibiotic.
- Overdosage can result in renal insufficiency, muscle weakness, and apnea.
- Respiratory arrest has been reported following intramuscular administration of colistimethate sodium. Impaired renal function increases the possibility of apnea and neuromuscular blockade following administration of colistimethate sodium. Therefore, it is important to follow recommended dosing guidelines.
- Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including colistimethate for injection, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
- C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
- If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
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
- Certain other antibiotics (aminoglycosides and polymyxin) have also been reported to interfere with the nerve transmission at the neuromuscular junction. Based on this reported activity, they should not be given concomitantly with colistimethate for injection except with the greatest caution.
- Curariform muscle relaxants (e.g., tubocurarine) and other drugs, including ether, succinylcholine, gallamine, decamethonium and sodium citrate, potentiate the neuromuscular blocking effect and should be used with extreme caution in patients being treated with colistimethate for injection.
- Sodium cephalothin may enhance the nephrotoxicity of colistimethate for injection. The concomitant use of sodium cephalothin and colistimethate for injection should be avoided.
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:
- 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.
- 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
- ®[1]
Look-Alike Drug Names
- A® — B®[2]
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
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- ↑ "http://www.ismp.org". External link in
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