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Colistin (colistimethate): Drug information

Colistin (colistimethate): Drug information
(For additional information see "Colistin (colistimethate): Patient drug information" and see "Colistin (colistimethate): Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Coly-Mycin M
Brand Names: Canada
  • Coly-Mycin M
Pharmacologic Category
  • Antibiotic, Miscellaneous
Dosing: Adult

Note: Dosage expressed in terms of mg of colistin base activity (CBA). CBA 1 mg is defined to be equivalent to colistimethate sodium (CMS) 30,000 units which is equivalent to ~2.4 mg CMS (see table below) (EMA 2014; ESCMID/EUCAST [Tsuji 2019]; Falagas 2006; Kassamali 2013; Nation 2014; Nation 2017).

Colistimethate Sodium Conversion (EMA 2014)

Colistimethate Sodium

Colistimethate Sodium

Colistin-Base Activity (CBA)

12,500 units

1 mg

0.4 mg

150,000 units

12 mg

5 mg

1,000,000 units

80 mg

34 mg

4,500,000 units

360 mg

150 mg

9,000,000 units

720 mg

300 mg

Bronchiectasis, pulmonary colonization/infection with susceptible organisms in cystic fibrosis and noncystic fibrosis patients

Bronchiectasis, pulmonary colonization/infection with susceptible organisms in cystic fibrosis and noncystic fibrosis patients (off-label use/route): Inhalation: 30 to 150 mg CBA via nebulizer 1 to 2 times daily (maximum dose: 150 mg CBA 2 times daily) (Haworth 2014; Le 2010; Sabuda 2008; Steinfort 2007). Note: An optimal dosing regimen has not been determined and varies widely among studies; lower doses have been used in noncystic fibrosis patients with bronchiectasis (Steinfort 2007). Use in addition to systemic antibiotics (ESCMID/EUCAST [Tsuji 2019]).

Meningitis and ventriculitis

Meningitis and ventriculitis (susceptible gram-negative organisms; adjunct to systemic therapy) (use a preservative-free preparation): Intrathecal/intraventricular (off-label route): 4.2 mg CBA/day (equivalent to 10 mg CMS/day) (ESCMID/EUCAST [Tsuji 2019]; IDSA [Tunkel 2017]; Imberti 2012; Ziaka 2013). Note: Dose in clinical reports has ranged from 0.7 to 8.3 mg CBA/day in 1 or 2 divided doses (administered with concomitant systemic antimicrobial therapy) (Benifla 2004; De Bonis 2016; Falagas 2007; Fotakopoulos 2016; Imberti 2012; Katragkou 2005; Rodríguez Guardado 2008). When intraventricular colistimethate is administered via a ventricular drain, clamp drain for 15 to 60 minutes after administration (allows solution to equilibrate in CSF) (IDSA [Tunkel 2004]; IDSA [Tunkel 2017]). Intraventricular administration is generally reserved for use in patients who fail parenteral therapy despite removal of CSF shunt or when CSF shunt cannot be removed (Baddour 2018).

Pulmonary infection due to multidrug-resistant gram-negative bacilli

Pulmonary infection due to multidrug-resistant gram-negative bacilli (eg, P. aeruginosa, Acinetobacter spp.) (adjunctive agent) (off-label route): Inhalation for nebulization: Dose not well defined: 75 to 150 mg CBA every 12 hours (Doshi 2013; Rattanaumpawan 2010; Valachis 2015); doses up to 167 mg every 8 hours have been described (Lu 2012); however, doses are typically rounded to the nearest vial size. Note: Use in combination with systemic antimicrobial therapy (ESCMID/EUCAST [Tsuji 2019]; IDSA/ATS [Kalil 2016]).

Systemic infections

Systemic infections (eg, bacteremia, intra-abdominal infections, meningitis, pneumonia [hospital acquired or ventilator associated], sepsis) due to multidrug-resistant gram-negative bacilli [eg, P. aeruginosa, Acinetobacter spp.]) (alternative agent):

Note: Polymyxin B is preferred over CMS due to significant interpatient variability in pharmacokinetics, slower attainment of desired plasma concentrations, and increased risk of nephrotoxicity with CMS (ESCMID/EUCAST [Tsuji 2019]; IDSA [Tamma 2021]). To minimize development of resistance, use in combination with other antibiotics, depending on infection site and susceptibilities (Bergen 2015; ESCMID/EUCAST [Tsuji 2019]; Kassamali 2015).

IV: 300 mg CBA loading dose followed by 150 to 180 mg CBA twice daily as maintenance starting 12 hours after the loading dose (Dalfino 2012; ESCMID/EUCAST [Tsuji 2019]; Plachouras 2009). Note: This dosing is designed to target average colistin steady-state plasma concentration of 2 mg/L and is derived from analysis of pharmacokinetic data in critically ill patients (Nation 2017).

Urinary tract infection due to multidrug-resistant gram-negative bacilli

Urinary tract infection due to multidrug-resistant gram-negative bacilli (eg, P. aeruginosa, Acinetobacter spp.): Note: CMS is preferred for treatment of lower urinary tract infections because of higher urinary concentrations compared to polymyxin B (ESCMID/EUCAST [Tsuji 2019]; IDSA [Tamma 2021]). To minimize development of resistance, may use in combination with other antibiotics, depending on susceptibilities (Bergen 2015; ESCMID/EUCAST [Tsuji 2019]; Kassamali 2015).

IV: 300 mg CBA loading dose followed by 150 to 180 mg CBA twice daily as maintenance starting 12 hours after the loading dose (Dalfino 2012; ESCMID/EUCAST [Tsuji 2019]; Plachouras 2009). Note: This dosing is designed to target average colistin steady-state plasma concentration of 2 mg/L and is derived from analysis of pharmacokinetic data in critically ill patients (Nation 2017).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.

Note: Dosage expressed in terms of colistin base activity (CBA); although reported conversions have varied slightly in the literature, CBA 1 mg is defined to be equivalent to colistimethate sodium 30,000 units (EMA 2014; Falagas 2006; Kassamali 2013; Nation 2014; Nation 2017). These dosing recommendations should achieve a target average colistin steady-state plasma concentration of 2 mg/L and are derived from analysis of pharmacokinetic data in critically ill patients (Nation 2017). For inhaled, intrathecal, and intraventricular colistin, there are no specific dosage adjustments recommended (has not been studied); however, need for adjustment unlikely due to low systemic absorption (expert opinion).

Altered kidney function:

Loading dose: IV: 300 mg CBA, followed by a maintenance dose based on CrCl (ESCMID/EUCAST [Tsuji 2019]; Nation 2017), calculated using the Cockcroft-Gault equation with an adjusted body weight (ideal body weight [IBW] + 0.4 [total body weight – IBW]) (ESCMID/EUCAST [Tsuji 2019]; Nation 2017; Winter 2012).

Maintenance dose: IV: The following total daily maintenance doses (administered in 2 divided doses) are recommended (ESCMID/EUCAST [Tsuji 2019]; Nation 2017); begin maintenance dose 12 hours after the loading dose:

CrCl ≥90 mL/minute: 360 mg CBA/day.

CrCl 80 to <90 mL/minute: 340 mg CBA/day.

CrCl 70 to <80 mL/minute: 300 mg CBA/day.

CrCl 60 to <70 mL/minute: 275 mg CBA/day.

CrCl 50 to <60 mL/minute: 245 mg CBA/day.

CrCl 40 to <50 mL/minute: 220 mg CBA/day.

CrCl 30 to <40 mL/minute: 195 mg CBA/day.

CrCl 20 to <30 mL/minute: 175 mg CBA/day.

CrCl 10 to <20 mL/minute: 160 mg CBA/day.

CrCl 5 to <10 mL/minute: 145 mg CBA/day.

CrCl <5 mL/minute: 130 mg CBA/day.

Alternative renal dosing strategy (EMA 2014; Nation 2016):

IV:

For critically ill patients, a loading dose of 300 mg CBA should be administered followed by a maintenance dose based on CrCl. The following total daily maintenance doses (administered in 2 or 3 divided doses) are recommended; begin maintenance dose 12 hours after the loading dose:

CrCl ≥50 mL/minute: 300 mg CBA/day; patients with good kidney function (CrCl ≥80 mL/minute) may require higher doses >300 mg/day.

CrCl 30 to <50 mL/minute: 183 to 250 mg CBA/day.

CrCl 10 to <30 mL/minute: 150 to 183 mg CBA/day.

CrCl <10 mL/minute: 117 mg CBA/day.

Augmented renal clearance (measured urinary CrCl ≥130 mL/minute/1.73 m2): Augmented renal clearance (ARC) is a condition that occurs in certain critically ill patients without organ dysfunction and with normal serum creatinine concentrations. Young patients (<55 years of age) admitted post trauma or major surgery are at highest risk for ARC, as well as those with sepsis, burns, or hematologic malignancies. An 8- to 24-hour measured urinary CrCl is necessary to identify these patients (Bilbao-Meseguer 2018; Udy 2010)

IV: 360 mg CBA/day (expert opinion).

Note: No definitive studies have evaluated colistin pharmacokinetics in ARC. Patients with ARC receiving conventional doses required longer treatments than those without ARC (Aitullina 2019).

Hemodialysis, intermittent (thrice weekly): Dialyzable (~30%) (Jitmuang 2017):

Loading dose: IV: 300 mg CBA (Nation 2017; Tsuji 2019).

Maintenance dose: IV:

Dialysis days: 180 mg CBA on dialysis days (administer after dialysis) (ESCMID/EUCAST [Tsuji 2019]; Nation 2017; expert opinion).

Nondialysis days: 130 mg CBA on nondialysis days (ESCMID/EUCAST [Tsuji 2019]; Nation 2017).

Peritoneal dialysis: IV: Loading dose: 300 mg CBA followed by 150 to 200 mg CBA once daily as maintenance starting 24 hours after the loading dose (Koomanachai 2014).

CRRT: Drug clearance is dependent on the effluent flow rate, filter type, and method of renal replacement. Recommendations are based on high-flux dialyzers and effluent flow rates of 20 to 25 mL/kg/hour (or ~1,500 to 3,000 mL/hour), and minimal residual kidney function unless otherwise noted. Appropriate dosing requires consideration of adequate drug concentrations (eg, site of infection) and consideration of initial loading doses. Close monitoring of response and adverse reactions due to drug accumulation is important.

IV: Loading dose: 300 mg CBA followed by 220 mg CBA every 12 hours as maintenance starting 12 hours after the loading dose (ESCMID/EUCAST [Tsuji 2019]). Note: The pro-drug CMS is removed by CRRT (~10% per hour), therefore patients receiving CRRT require higher daily doses than patients with normal kidney function (ESCMID/EUCAST [Tsuji 2019]; Karaiskos 2016; Karvanen 2013).

PIRRT (eg, sustained, low-efficiency diafiltration): Drug clearance is dependent on the effluent flow rate, filter type, and method of renal replacement. Appropriate dosing requires consideration of adequate drug concentrations (eg, site of infection) and consideration of initial loading doses. Close monitoring of response and adverse reactions due to drug accumulation is important.

IV: Loading dose: 300 mg CBA followed by maintenance dose based on kidney function and duration of PIRRT session. Add 10% per 1 hour of PIRRT replacement to the recommended baseline daily dose for kidney function (eg, CrCl <5 mL/minute, 130 mg CBA/day); administer in 2 divided doses 12 hours apart starting 12 hours after the loading dose (ESCMID/EUCAST [Tsuji 2019]; Nation 2017).

For example, in a patient with a CrCl of <5 mL/minute receiving 10 hours nocturnal PIRRT session each day, the suggested CBA maintenance dose is: 130 mg + (10 hours × 13) = 260 mg CBA/day, administered as 130 mg every 12 hours. PIRRT session should begin 1 to 2 hours after the afternoon/evening dose (ESCMID/EUCAST [Tsuji 2019]; Nation 2017).

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Pediatric

(For additional information see "Colistin (colistimethate): Pediatric drug information")

Note: Due to risk of toxicity and efficacy limitations, systemic use is limited to when less toxic alternatives are not effective or not tolerated. When used, typically recommended as part of combination therapy (Aguilera-Alonso 2020; Chiotos 2020; ESCMID/EUCAST [Tsuji 2019]; IDSA [Tamma 2022a]; IDSA [Tamma 2022b]). Doses should be based on ideal body weight in obese patients; dosage primarily expressed in terms of colistin base activity (CBA). CBA 1 mg is defined to be equivalent to colistimethate sodium (CMS) 30,000 units, which is equivalent to ~2.4 mg CMS (EMA 2014; ESCMID/EUCAST [Tsuji 2019]; Falagas 2006; Kassamali 2013; Nation 2017).

General dosing: Infants, Children, and Adolescents: IM, IV: 2.5 to 5 mg CBA/kg/day divided every 6 to 12 hours (Red Book [AAP 2021]; manufacturer's labeling). Higher doses may be necessary in some instances; see dosing for specific indications.

CNS infection, multidrug resistant

CNS infection (VP-shunt infection, ventriculitis, meningitis), multidrug resistant: Variable doses reported; optimal dose not defined.

Infants and Children: Very limited data available: Intraventricular/Intrathecal: Reported range: 1 to 4.2 mg CBA/dose once daily in combination with systemic antibiotics (Dalgic 2009; Deniz 2021; IDSA [Tunkel 2017]; Ng 2006; Ozdemir 2010). Doses should be individualized based on culture/susceptibility, minimum inhibitory concentration (MIC), and tolerability, with consideration of patient size and cerebrospinal fluid volume. Case reports in patients 2 months to 4 years of age have described a titration regimen in which 1 mg CBA is administered on day 1, followed by 2 mg CBA once daily for 1 to 2 days, then 4 mg CBA once daily thereafter for a total of 8 to 18 days of therapy (Almangour 2022; Dalgic 2009; Deniz 2021; Ng 2006). In other case reports, patients aged 1 month to 5 years received intrathecal or intraventricular colistin without titration at a dose of 4.2 mg CBA once daily for 5 to 9 days (Iosifidis 2010; Ozdemir 2010). Doses as high as 10 mg CBA (after titration) have been reported to treat multidrug-resistant Acinetobacter baumannii in an infant (Dalgic 2009).

Adolescents: Very limited data available: Intraventricular/Intrathecal: 4.2 mg CBA/day (equivalent to 10 mg CMS/day) (Ayhan 2021; IDSA [Tunkel 2017]; Deniz 2021; Hiremath 2018; Sari 2021; Yagmur 2006). Reported range: 2 to 8.3 mg CBA/day in 1 or 2 divided doses; duration of 10 to 14 days most commonly reported; however, use for up to 24 days has been described; most commonly administered in a single daily dose (Ayhan 2021; Bargiacchi 2014; Deniz 2021; Fernandez-Viladrich 1999; Wang 2014). In some reports, the dose was titrated up from 2.1 mg CBA once daily to 4.2 mg CBA once daily (Deniz 2021; Yagmur 2006).

Cystic fibrosis, pulmonary infection

Cystic fibrosis, pulmonary infection: Limited data available:

IV: Acute pulmonary exacerbation: Children ≥5 years and Adolescents: IV: Usual reported range: 3 to 5 mg CBA/kg/day divided every 8 hours; maximum dose: 100 mg CBA/dose (Bosso 1991; Reed 2001; Young 2013); doses >5 mg CBA/kg/day (up to 8 mg CBA/kg/day) have been described; however, higher doses are associated with more severe toxicity (Bosso 1991; Reed 2001). Treatment duration varies and is dependent on patient-specific factors, including response to therapy; typical duration is 10 to 21 days (Abbott 2019; Nicholson 2022; VanDevanter 2016).

Inhaled: Children and Adolescents: Inhalation: Usual dose: 75 to 150 mg CBA via nebulizer every 12 hours; reported range: 33 to 150 mg CBA/dose; administration of doses ≤66 mg has been reported as frequently as every 8 hours. Duration depends on specific use (eg, maintenance therapy vs eradication therapy) and should be individualized (Greenwood 2017; Hodson 2002; Langton Hewer 2021; Le 2010; Proesmans 2013; Riethmüller 2016; Taccetti 2012; Tramper-Stranders 2010; Waters 2018).

Pulmonary infection due to multidrug-resistant gram-negative bacilli

Pulmonary infection due to multidrug-resistant gram-negative bacilli (eg, P. aeruginosa, Acinetobacter spp): Limited data available: Note: Use in combination with systemic therapy (ESCMID/EUCAST [Tsuji 2019]; Polat 2015).

Infants: Inhalation: 4 mg/kg/dose via nebulizer every 12 hours; maximum dose: 75 mg/dose (Polat 2015).

Children and Adolescents: Inhalation: 75 to 150 mg CBA via nebulizer every 12 hours (Le 2010; Polat 2015; Quon 2014); reported range: 30 to 150 mg CBA/dose every 12 hours (Atag 2021; Falagas 2010; Le 2010; Polat 2015; Quon 2014).

Systemic infections, due to multidrug-resistant gram-negative bacilli

Systemic infections (eg, bacteremia, pneumonia) due to multidrug- resistant gram-negative bacilli (alternative agent):

Note: Typically recommended as part of an appropriate combination regimen. Polymyxin B may be preferred over colistin, except for treatment of cystitis (Aguilera-Alonso 2020; Chiotos 2020; Tamma 2022a; Tamma 2022b).

Infants, Children, and Adolescents: IM, IV: Loading dose of 2.5 to 5 mg CBA/kg once (maximum dose: 300 mg CBA/dose), followed by 5 mg CBA/kg/day divided every 8 to every 12 hours (maximum dose: 180 mg/dose) (Aguilera-Alonso 2020; Chiotos 2020; Hsu 2014; Sahbudak Bal 2018; Tamma 2013; Wacharachaisurapol 2020). Population pharmacokinetic studies have suggested that higher doses may be necessary to treat severe/critical illness; doses of ~10 mg CBA/kg/day in divided doses have been described; monitor closely for toxicity (Antachopoulos 2021; Castagnola 2022; Chin 2020; Ooi 2019).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing adjustment for toxicity: Infants, Children, and Adolescents: Based on experience with other aminoglycosides, the following should be considered:

CNS toxicity: Dose reduction may reduce neurologic symptoms.

Nephrotoxicity: Withhold treatment if signs of renal impairment occur during treatment.

Dosing: Kidney Impairment: Pediatric

There are no pediatric specific recommendations in the manufacturer’s labeling; in adult patients, dosage adjustment is suggested.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Adjustment for Toxicity: Adult

CNS toxicity: Dose reduction may reduce neurologic symptoms.

Nephrotoxicity: Withhold treatment if signs of renal impairment occur during treatment.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Injection [preservative free]:

Coly-Mycin M: 150 mg (1 ea)

Generic: 150 mg (1 ea)

Generic Equivalent Available: US

Yes

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution Reconstituted, Injection:

Coly-Mycin M: 150 mg (1 ea)

Generic: 150 mg (1 ea)

Administration: Adult

IV: Infuse over 30 minutes to 1 hour (ESCMID/EUCAST [Tsuji 2019]).

Inhalation (off-label route): Administer solution via nebulizer (vibrating plate nebulizer may be preferred [Lu 2012]) promptly following preparation to decrease possibility of high concentrations of colistin from forming which may lead to potentially life-threatening lung toxicity. Consider use of a bronchodilator (eg, albuterol) within 15 minutes prior to administration (Le 2010). If patient is on a ventilator, place medicine in a T-piece at the midinspiratory circuit of the ventilator. One study in adult patients with VAP administered colistimethate over 60 minutes using a vibrating plate nebulizer positioned on the inspiratory limb 10 cm proximal to the Y-piece (Lu 2012).

Note: A case report of fatal lung toxicity implicated in vitro colistin formation from an inhalation solution as a potential etiology, but data regarding the concentration, formulation and storage of the inhaled colistin administered to the patient were not reported (FDA 2007; McCoy 2007; Wallace 2008). An acceptable limit of in vitro colistin formation to prevent potential toxicity is unknown. Limited stability data are available regarding the storage of colistin solution for inhaled administration (Healan 2012; Wallace 2008). Storing for >24 hours may increase the risk for potential lung toxicity; preparation immediately prior to administration is recommended (FDA 2007; Le 2010, Wallace 2008).

Intrathecal/intraventricular (off-label route): Administer only preservative-free solutions via intrathecal/intraventricular routes. Administer promptly after preparation. Discard unused portion of vial. When administered through a ventricular drain, clamp drain for 15 to 60 minutes before opening the drain to allow colistimethate solution to equilibrate in the CSF (IDSA [Tunkel 2004]; IDSA [Tunkel 2017]).

Administration: Pediatric

Parenteral:

IM: Administer deep into a large muscle mass (eg, gluteal muscle or lateral part of the thigh).

IV push: Administer over 3 to 5 minutes.

Intermittent IV infusion: Administer over 20 to 60 minutes; most commonly infused over 30 minutes in neonates (Antachopoulos 2021; Castagnola 2022; Hussain 2020; Ilhan 2018; Kapoor 2013; Nakwan 2016).

Inhalation: Administer solution via nebulizer promptly following preparation of solution to decrease possibility of high concentrations of colistin from forming, which may lead to potentially life-threatening lung toxicity. Consider use of a bronchodilator (eg, albuterol) within 15 minutes prior to administration (Le 2010).

Note: A case report of fatal lung toxicity implicated in vitro colistin formation from an inhalation solution as a potential etiology, but data regarding the concentration, formulation, and storage of the inhaled colistin administered to the patient were not reported (FDA 2007; McCoy 2007; Wallace 2008). An acceptable limit of in vitro colistin formation to prevent potential toxicity is unknown. Limited stability data are available regarding the storage of colistin solution for inhaled administration (Healan 2012; Wallace 2008). Storing for >24 hours may increase the risk for potential lung toxicity; preparation immediately prior to administration is recommended (FDA 2007; Le 2010; Wallace 2008).

Intraventricular/Intrathecal: Administer only preservative-free solutions via intrathecal/intraventricular routes. Administer promptly after preparation. Discard unused portion of vial. When administering via a ventricular drain, clamp the drain for 15 to 60 minutes to allow equilibration of colistin with cerebrospinal fluid prior to opening the drain (Al Yazidi 2018; Cascio 2010; Dalgic 2009; Deniz 2021; Ng 2006; Sari 2021; Tunkel [IDSA 2017]).

Use: Labeled Indications

Treatment of acute or chronic infections due to sensitive strains of certain gram-negative bacilli (particularly Pseudomonas aeruginosa) which are resistant to other antibacterials or in patients allergic to other antibacterials

Use: Off-Label: Adult

Bronchiectasis, pulmonary colonization/infection with susceptible organisms in cystic fibrosis and noncystic fibrosis patients (nebulized); Cystic fibrosis; Pneumonia, hospital-acquired or ventilator-associated due to multidrug-resistant gram-negative bacilli (eg, Pseudomonas aeruginosa or Acinetobacter baumannii [nebulized]) (alternative agent)

Medication Safety Issues
High alert medication:

The Institute for Safe Medication Practices (ISMP) includes this medication (intrathecal administration) among its list of drugs that have a heightened risk of causing significant patient harm when used in error.

Other safety concerns:

Due to the potential for dosing errors, it is recommended that prescriptions for colistimethate be expressed as mg of colistin base activity only.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Genitourinary: Nephrotoxicity (18% to 26% [Dalfino 2012; Oliveira 2009])

Renal: Acute renal failure (33% to 60% [Akajagbor 2013; Deryke 2010])

1% to 10%:

Central nervous system: Neurotoxicity (7%; higher incidence with high-dose IV use in cystic fibrosis [Bosso 1991; Koch-Weser 1970])

Frequency not defined:

Central nervous system: Dizziness, oral paresthesia, paresthesia, peripheral paresthesia, seizures, slurred speech, vertigo

Dermatologic: Pruritus, skin rash, urticaria

Gastrointestinal: Clostridioides difficile-associated diarrhea, gastric distress

Genitourinary: Decreased urine output

Hypersensitivity: Anaphylaxis

Renal: Decreased creatinine clearance, increased blood urea nitrogen, increased serum creatinine

Respiratory: Apnea, respiratory distress

Miscellaneous: Fever

Contraindications

Hypersensitivity to colistimethate, colistin, or any component of the formulation

Warnings/Precautions

Concerns related to adverse effects:

• Bronchoconstriction: Use of inhaled colistimethate (off-label route) may result in bronchoconstriction. Use with caution in patients with hyperactive airways; consider administration of a bronchodilator (eg, albuterol) within 15 minutes prior to administration (Le 2010).

• CNS toxicity: Transient, reversible neurological disturbances (eg, dizziness, numbness, paresthesia, generalized pruritus, slurred speech, tingling, vertigo) may occur. Patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving). Dose reduction may reduce neurologic symptoms; monitor closely.

• Renal toxicity: Dose-dependent nephrotoxicity has been reported, generally reversible upon discontinuation of treatment. Withhold treatment if signs of renal impairment occur during treatment.

• Respiratory arrest: Respiratory arrest has been reported with use; impaired renal function may increase the risk for neuromuscular blockade and apnea.

• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.

Disease-related concerns:

• Renal impairment: Use with caution in patients with preexisting renal impairment; dosage adjustments are recommended. Impaired renal function may increase the risk for respiratory arrest.

Other warnings/precautions:

• Appropriate use: Inhalation (off-label route): Once mixed, colistimethate begins conversion to bioactive colistin, a component of which may result in severe pulmonary toxicity (Le 2010). Solutions for inhalation must be mixed immediately prior to administration and used within 24 hours to reduce the incidence of pulmonary toxicity.

• Appropriate use: IV: Use only to prevent or treat infections strongly suspected or proven to be caused by susceptible bacteria to minimize development of bacterial drug resistance.

• Safety: Potential for dosing errors due to lack of standardization in literature when referring to product and dose; colistimethate (inactive prodrug) and colistin base strengths are not interchangeable; verify prescribed dose is expressed in terms of colistin base activity prior to dispensing.

Warnings: Additional Pediatric Considerations

Electrolyte disturbances, including hypomagnesemia, hypokalemia, hypocalcemia, and hyponatremia, have been described in neonates receiving IV colistimethate and may require supplementation. Disturbances have been reported mostly in populations mainly comprised of preterm patients, and risk may be higher in the very low-birth-weight population (weighing <1,500 g at birth); monitor electrolytes closely during therapy (Aksoy 2020; Alan 2014; Ambreen 2020; Antachopoulos 2017; Ilhan 2018; İpek 2017). Electrolyte disturbances may be mediated by renal tubulopathy and associated with other manifestations of kidney toxicity (Thomas 2019; Yurttutan 2021).

Neurotoxicity, which may occur in all ages, may present differently in the neonatal population compared to older pediatric patients; in term or preterm neonates, neurotoxicity may present as apnea or seizures; monitor closely (Alan 2014; Ambreen 2020; Çağan 2017; Nakwan 2019).

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Aminoglycosides: May enhance the nephrotoxic effect of Colistimethate. Aminoglycosides may enhance the neuromuscular-blocking effect of Colistimethate. Management: Avoid coadministration of colistimethate and aminoglycosides whenever possible due to the risk of nephrotoxicity and neuromuscular blockade. If coadministration cannot be avoided, monitor renal and neuromuscular function. Risk D: Consider therapy modification

Amphotericin B: May enhance the nephrotoxic effect of Colistimethate. Management: Avoid coadministration of colistimethate and amphotericin B whenever possible due to the potential for additive or synergistic nephrotoxicity. If coadministration cannot be avoided, closely monitor renal function. Risk D: Consider therapy modification

Bacillus clausii: Antibiotics may diminish the therapeutic effect of Bacillus clausii. Management: Bacillus clausii should be taken in between antibiotic doses during concomitant therapy. Risk D: Consider therapy modification

Bacitracin (Systemic): Colistimethate may enhance the nephrotoxic effect of Bacitracin (Systemic). Risk X: Avoid combination

BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination

BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Risk C: Monitor therapy

Capreomycin: May enhance the neuromuscular-blocking effect of Colistimethate. Risk C: Monitor therapy

Cefazedone: May enhance the nephrotoxic effect of Colistimethate. Risk C: Monitor therapy

Cephalothin: May enhance the nephrotoxic effect of Colistimethate. Risk C: Monitor therapy

Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Risk X: Avoid combination

Immune Checkpoint Inhibitors: Antibiotics may diminish the therapeutic effect of Immune Checkpoint Inhibitors. Risk C: Monitor therapy

Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Risk C: Monitor therapy

Mecamylamine: Colistimethate may enhance the neuromuscular-blocking effect of Mecamylamine. Risk X: Avoid combination

Methoxyflurane: Colistimethate may enhance the nephrotoxic effect of Methoxyflurane. Risk X: Avoid combination

Netilmicin (Ophthalmic): Colistimethate may enhance the nephrotoxic effect of Netilmicin (Ophthalmic). Risk X: Avoid combination

Neuromuscular-Blocking Agents: Colistimethate may enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Management: If possible, avoid concomitant use of these products. Monitor for deeper, prolonged neuromuscular-blocking effects (respiratory paralysis) in patients receiving concomitant neuromuscular-blocking agents and colistimethate. Risk D: Consider therapy modification

Polymyxin B: May enhance the neuromuscular-blocking effect of Colistimethate. Risk C: Monitor therapy

Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Risk D: Consider therapy modification

Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Avoid use of live attenuated typhoid vaccine (Ty21a) in patients being treated with systemic antibacterial agents. Postpone vaccination until 3 days after cessation of antibiotics and avoid starting antibiotics within 3 days of last vaccine dose. Risk D: Consider therapy modification

Vancomycin: May enhance the nephrotoxic effect of Colistimethate. Management: Avoid coadministration of colistimethate and vancomycin whenever possible due to the potential for additive or synergistic nephrotoxicity. If coadministration cannot be avoided, closely monitor renal function. Risk D: Consider therapy modification

Pregnancy Considerations

Adverse events have been observed in animal reproduction studies. Colistimethate crosses the placenta in humans.

Breastfeeding Considerations

Colistin (the active form of colistimethate sodium) and colistin sulphate (another form of colistin) are excreted in human milk. The manufacturer recommends caution if giving colistimethate sodium to a breast-feeding woman. Nondose-related effects could include modification of bowel flora.

Monitoring Parameters

Serum creatinine, BUN; urine output; signs of neurotoxicity; signs of bronchospasm (inhalation [off-label route]); colistin serum concentrations (to ensure adequate drug exposure particularly early in therapy) (ESCMID/EUCAST [Tsuji 2019]).

Reference Range

Target serum concentration is 2 mg/L for susceptible organisms (irrespective of reported MIC) (ESCMID/EUCAST [Tsuji 2019]).

Mechanism of Action

Colistimethate (or the sodium salt [colistimethate sodium]) is the inactive prodrug that is hydrolyzed to colistin, which acts as a cationic detergent and damages the bacterial cytoplasmic membrane causing leaking of intracellular substances and cell death

Pharmacokinetics

Absorption: Not absorbed from the GI tract, mucous membranes, or intact skin (Note: GI absorption has been observed in infants).

Distribution:

CSF penetration:

Infants, Children, and Adolescents ≤14 years: Colistin: 3% to 19%; may be increased in the presence of meningitis (Antachopoulos 2010).

Adults: Colistin: ~5% (Markantonis 2009).

Vd:

Neonates (GA: 29 to 41 weeks; PNA: 5 to 15 days): IV: Colistin: 7.7 ± 9.3 L/kg (Nakwan 2016).

Children ≥2 years and Adolescents <15 years: IV: Colistin: 0.6 ± 0.3 L/kg.

Adults:

Healthy volunteer: IV: Colistimethate: 8.92 L; Colistin: 12.4 L (Couet 2012).

Critically ill: IV: Colistimethate: 5.3 to 13.5 L; Colistin: 7.2 to 189 L (Couet 2012).

Cystic fibrosis: IV: Colistimethate: 10.8 to 31.3 L (Li 2003).

Protein binding: 50%.

Metabolism: Colistimethate sodium (inactive prodrug) is hydrolyzed to colistin (active form). Note: Only ~30% of colistimethate sodium is converted to colistin (Couet 2011).

Half-life elimination: IM, IV: All ages: Colistimethate: 2 to 3 hours.

Neonates (GA: 29 to 41 weeks; PNA: 5 to 15 days): IV: Colistin: 9 ± 6.5 hours (Nakwan 2016).

Children ≥2 years and Adolescents <15 years (critically ill): IV: Colistin: 2.6 ± 0.4 hours (Wacharachaisurapol 2020).

Adults:

Critically ill: IV: Colistimethate: 2.3 hours; Colistin: 14.4 hours (Plachouras 2009).

Cystic fibrosis: IV: Colistin: ~4 hours (Li 2003).

End-stage renal disease patients receiving CAPD: IV: Colistin: 13.2 hours (Koomanachai 2014).

Time to peak:

Neonates (GA: 29 to 41 weeks; PNA: 5 to 15 days): IV: Colistin: 1.3 ± 0.9 hours from end of 0.5-hour infusion (Nakwan 2016).

Children ≥2 years and Adolescents <15 years: IV: Colistin: 1.1 ± 0.3 hours from end of 5-minute injection (Wacharachaisurapol 2020).

Adults:

Healthy volunteers: IV: Colistin: 2 hours (range: 1 to 4 hours) (Couet 2011).

Critically ill: IV: Colistin: ~7 hours (Plachouras 2009).

Excretion: Primarily urine (as unchanged drug); most colistin recovered in the urine is from postexcretion hydrolysis of colistimethate sodium (Couet 2011).

Pricing: US

Solution (reconstituted) (Colistimethate Sodium (CBA) Injection)

150 mg (per each): $12.42 - $35.00

Solution (reconstituted) (Coly-Mycin M Injection)

150 mg (per each): $33.60

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Brand Names: International
  • Acostin (IN);
  • Aldreb (JP);
  • Alficetin (AR);
  • Alveoxina (AR);
  • Avagal (UY);
  • Colent (CL);
  • Colfinair (ES);
  • Colifin (CH, DE);
  • Colimex (LI, SA);
  • Colimicina (IT);
  • Colimycine (FR, SK);
  • Coliracin (IL);
  • Colis (KR);
  • Colistate (TH);
  • Colistin (CH, HK, NL, PL);
  • Colistineb (BE);
  • Colixin (PT);
  • Colmesdant (CR, DO, GT, HN, NI, PA, SV);
  • Colobreathe (BE, CZ, EE, ES, FI, GB, HU, IE, LT, NL, PL, RO, SE);
  • Colomycin (CZ, GB, GR, HK, HN, IE, MY, SG, SI, UA);
  • Damacol (LI);
  • Eskcolis (BD);
  • Kolneb (AT);
  • Kolomycin (SK);
  • Locolin (TW);
  • Mellistin (TH);
  • Promixin (DE, DK, ES, GB, IE, NO);
  • Tadim (AU, GR, NL, SE);
  • Xylistin (IN)


For country code abbreviations (show table)
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