Source: FDA, National Drug Code (US) Revision Year: 2018
Coly-Mycin M Parenteral 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. Coly-Mycin M Parenteral has proven clinically effective in treatment of infections due to the following gram-negative organisms: Enterobacter aerogenes, Escherichia coli, Klebsiella pneumoniae and Pseudomonas aeruginosa.
Coly-Mycin M Parenteral 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 Coly-Mycin M and other antibacterial drugs, Coly-Mycin M 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.
Important: Coly-Mycin M Parenteral is supplied in vials containing colistimethate sodium equivalent to 150 mg colistin base activity per vial.
The 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.
During reconstitution swirl gently to avoid frothing.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If these conditions are observed, the product should not be used.
The dose of Coly-Mycin M Parenteral should be 2.5 to 5 mg/kg per day of colistin base in 2 to 4 divided doses for patients with normal renal function, depending on the severity of the infection.
In obese individuals, dosage should be based on ideal body weight.
The daily dose and frequency should be reduced for the patients with renal impairment. Suggested modifications of dosage schedule for patients with renal impairment are presented in Table 1.
TABLE 1. Suggested Modification of Dosage Schedules of Coly-Mycin M Parenteral for Adults with Impaired Renal Function:
| Degree of Renal Impairment | ||||
|---|---|---|---|---|
| Normal | Mild | Moderate | Severe | |
| Creatinine Clearance (mL/min) | ≥80 | 50-79 | 30-49 | 10-29 |
| Dosage Schedule | 2.5–5 mg/kg, divided into 2 to 4 doses per day | 2.5–3.8 mg/kg, divided into 2 doses per day | 2.5 mg/kg, once daily or divided into 2 doses per day | 1.5 mg/kg every 36 hours |
Note: The suggested total daily dose is calculated from colistin base activity.
INTRAVENOUS ADMINISTRATION:
1. Direct Intermittent Administration—Slowly inject one-half of the total daily dose over a period of 3 to 5 minutes every 12 hours.
2. Continuous Infusion—Slowly inject one-half of the total daily dose over 3 to 5 minutes. Add the remaining half of the total daily dose of Coly-Mycin M Parenteral to one of the following:
0.9% NaCI
5% dextrose in 0.9% NaCl
5% dextrose in water
5% dextrose in 0.45% NaCl
5% dextrose in 0.225% NaCl
lactated Ringer’s solution
10% invert sugar solution
There are not sufficient data to recommend usage of Coly-Mycin M Parenteral with other drugs or other than the above listed infusion solutions.Administer the second half of the total daily dose by slow intravenous infusion, starting 1 to 2 hours after the initial dose, over the next 22 to 23 hours. In the presence of impaired renal function, reduce the infusion rate depending on the degree of renal impairment.
The choice of intravenous solution and the volume to be employed are dictated by the requirements of fluid and electrolyte management.
Any final intravenous infusion solution containing colistimethate sodium should be freshly prepared and used for no longer than 24 hours.
INTRAMUSCULAR ADMINISTRATION:
1. For intramuscular Injection, administer by deep intramuscular injection into a large muscle mass (such as the gluteal muscles or lateral part of the thigh).
Store reconstituted solution for intramuscular injection in a refrigerator 2° to 8°C (36° to 46°F) or between 20° to 25°C (68° to 77°F) and use within 7 days.
Overdosage with colistimethate sodium can cause neuromuscular blockade characterized by paresthesia, lethargy, confusion, dizziness, ataxia, nystagmus, disorders of speech and apnea. Respiratory muscle paralysis may lead to apnea, respiratory arrest and death. Overdosage with the drug can also cause acute renal failure, manifested as decreased urine output and increases in serum concentrations of BUN and creatinine.
As in any case of overdose, colistimethate sodium therapy should be discontinued and general supportive measures should be utilized.
It is unknown whether colistimethate sodium can be removed by hemodialysis or peritoneal dialysis in overdose cases.
Store unreconstituted product between 20° to 25°C (68° to 77°F). (See USP Controlled Room Temperature.)
Store reconstituted solution in refrigerator 2° to 8°C (36° to 46°F) or between 20° to 25°C (68° to 77°F) and use within 7 days.
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