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Marquette General Health System Pharmacy and Therapeutics Committee Medication Guideline Drug Classification: 8:12.28.28 Polymixins Agent: Colistimethate sodium (Coly-Mycin® M) Formulary X Nonformulary Restricted X Nonstock Pharmacy and Therapeutics Committee-approved Indications for Inpatient Use: Colistimethate sodium is approved for the treatment of infections caused by multi-drug resistant gram-negative pathogens (i.e., Acinetobacter and Pseudomonas spp.). Use is restricted to the Infectious Disease Service. Dosage & Administration: Colistimethate sodium (Coly-Mycin® M Parenteral) is supplied in the US in vials containing colistimethate sodium equivalent to 150 mg colistin base activity per vial. The following dosing information is expressed in terms of the colistin base. Adults and pediatric patients: Colistin base should be given in 2 to 4 divided doses at dose levels of 2.5 to 5 mg/kg per day for patients with normal renal function, depending on the severity of the infection. The recommended maximum daily dose of colistin base is 800 mg. Obese Patients: Base dosage on ideal body weight Renally impaired patients: See table below Colistimethate sodium dosage adjustment in renal function Renal Function Normal Mild Moderate Considerable Plasma creatinine, 0.7-1.2 1.3-1.5 1.6-2.5 2.6-4 mg/100 mL Urea clearance, % 80-100 40-70 25-40 10-25 of normal Unit dose of colistin base, mg Frequency, times/day Total daily dose, mg Approximate daily dose, mg/kg/day 100-150 75-115 66-150 100-150 4 to 2 2 2 or 1 Every 36 hrs 300 150-230 133-150 100 5 2.5-3.8 2.5 1.5 Note: the suggested unit dose is 2.5-5 mg/kg; however, the time interval between injections should be increased in the presence of impaired renal function. Dialysis: Recommendations vary. Consult Lexi-Comp drug information available in Up-To-Date. Each 150 mg vial should be reconstituted with 2 mL Sterile Water for Injection, USP. The reconstituted solution provides colistimethate sodium at a concentration equivalent to 75 mg/mL colistin base activity. Doses may be given via direct intermittent administration (injected slowly over a period of 3 to 5 minutes) or diluted infusions (50-100 mL of 0.9% sodium chloride) given over 15 to 30 minutes. Document created: 07/13. Revised: None. Cross Reference: None. Marquette General Health System Marquette General Hospital Marquette, MI 49855 This is a confidential professional/peer review and quality assessment document of Marquette General Health System of Marquette, MI. It is protected from disclosure pursuant to the provisions of MCL 333.20175, MCL 333.21513, MCL 21515, MCL 331.531, MCL 331.533, MCL 330.1143a, and other state and federal laws. Unauthorized disclosure or duplication is absolutely prohibited. Marquette General Health System Pharmacy and Therapeutics Committee Medication Guideline Monitoring / Outcomes: Therapeutic Response: Improvement or resolution in clinical signs or symptoms of infection Adverse Effects: The most common treatment-emergent adverse effects reported with colistimethate sodium include tingling of extremities and tongue, parathesia, rash, nephrotoxicity (increased blood urea nitrogen, elevated creatinine and decreased creatinine clearance) and decreased urine output, and respiratory distress. Special Handling Procedures: Colistimethate Sodium is not considered a hazardous drug. Colistimethate Sodium is not considered a high-alert drug. References: 1. AHFS Drug Information. Available at STAT!Ref Web site. http://online.statref.com. Accessed June 10, 2013. 2. UpToDate Web site. http://www.uptodate.com/contents/search. Accessed June 10, 2013. 3. Package insert: Colistimethate for injection (Coly-Mycin® M Parenteral). JHP Pharmaceuticals, LLC; Rochester, MI 48307. Revised February 2011. 4. Lim LM, Ly N, Anderson D, Yang JC, et al. Resurgence of colistin: a review of resistance, toxicity, pharmacodynamics, and dosing. Pharmacotherapy. 2010 Dec;30(12):1279-91. 5. Li J, Nation RL, Turnidge JD, et al. Colistin: the re-emerging antibiotic for multidrug-resistant Gramnegative bacterial infections. Lancet Infect Dis. 2006 Sep;6(9):589-601. Document created: 07/13. Revised: None. Cross Reference: None. Marquette General Health System Marquette General Hospital Marquette, MI 49855 This is a confidential professional/peer review and quality assessment document of Marquette General Health System of Marquette, MI. It is protected from disclosure pursuant to the provisions of MCL 333.20175, MCL 333.21513, MCL 21515, MCL 331.531, MCL 331.533, MCL 330.1143a, and other state and federal laws. Unauthorized disclosure or duplication is absolutely prohibited.