Colistimethate
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Questions & Answers
Side Effects & Adverse Reactions
Maximum daily dose should not exceed 5 mg/kg/day (2.3 mg/lb) 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 (see OVERDOSAGE section). See PRECAUTIONS , Drug Interactions subsection for use concomitantly with other antibiotics and curariform drugs.
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. See DOSAGE AND ADMINISTRATION section for use in renal impairment.
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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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.
History
There is currently no drug history available for this drug.
Other Information
Colistimethate for Injection USP is a sterile parenteral antibiotic product which, when reconstituted (see Reconstitution), is suitable for intramuscular or intravenous administration.
Each vial contains colistimethate sodium or pentasodium colistinmethanesulfonate (150 mg colistin base activity).
Colistimethate sodium is a polypeptide antibiotic with an approximate molecular weight of 1750. The empirical formula is C58H105N16Na5O28S5 and the structural formula is represented below:
Sources
Colistimethate Manufacturers
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X-gen Pharmaceuticals, Inc.
![Colistimethate Injection, Powder, Lyophilized, For Solution [X-gen Pharmaceuticals, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Colistimethate | X-gen Pharmaceuticals, Inc.
Important: Colistimethate for Injection is supplied in vials containing colistimethate sodium equivalent to 150 mg colistin base activity per vial.
Reconstitution: 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.
DosageAdults and pediatric patients—Intravenous or Intramuscular Administration: Colistimethate for Injection 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.
In obese individuals, dosage should be based on ideal body weight.
The daily dose should be reduced in the presence of renal impairment. Modifications of dosage in the presence of renal impairment are presented in Table 1.
TABLE 1. Suggested Modification of Dosage Schedules of Colistimethate for Injection for Adults with impaired Renal Function. Renal Function Degree of Impairment Normal Mild Moderate Considerable 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. Plasma creatinine, mg/100 mL 0.7-1.2 1.3-1.5 1.6-2.5 2.6-4.0 Urea clearance, % of normal 80-100 40-70 25-40 10-25 Dosage
Unit dose of Colistimethate for Injection, mg 100-150 75-115 66-150 100-150 Frequency, times/day 4 to 2 2 2 or 1 Every 36 hr Total daily dose, mg 300 150-230 133-150 100 Approximate daily dose, mg/kg/day 5.0 2.5-3.8 2.5 1.5 INTRVENOUS ADMINISTRATION 1 Direct Intermittent Administration – Slowly inject one-half of the daily dose over a period of 3-5 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 Colistimethate for Injection to one of the following: 0.9% NaCl 5% dextrose in water 5% dextrose in 45% NaCl 5% dextrose in 0.225% NaCl Lactated Ringer’s solution 10% invert sugar solution
There is not sufficient data to recommend the usage of Colistimethate for Injection with other drugs or other than the above listed infusion solutions.
Administer the second half of the daily dose by slow intravenous infusion, starting 1 to 2 hours after the initial dose, over the next 22-23 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 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. -
Jhp Pharmaceuticals, Llc
Colistimethate | Jhp Pharmaceuticals, Llc
Important: Colistimethate for injection is supplied in vials containing colistimethate sodium equivalent to 150 mg colistin base activity per vial.
Reconstitution for Intravenous or Intramuscular Administration: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.
DosageAdults and Pediatric Patients—Intravenous or Intramuscular Administration:
The dose of Colistimethate for injection 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 Colistimethate for Injection for Adults with Impaired Renal Function Degree of Renal Impairment Normal Mild Moderate Severe Note: The suggested total daily dose is calculated from colistin base activity. 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 INTRAVENOUS ADMINISTRATION Direct Intermittent Administration—Slowly inject one-half of the total daily dose over a period of 3 to 5 minutes every 12 hours. 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 colistimethate for injection to one of the following:
0.9% NaCI
5% dextrose in 0.9% NaCI
5% dextrose in water
5% dextrose in 0.45% NaCI
5% dextrose in 0.225% NaCI
lactated Ringer's solution
10% invert sugar solution There are not sufficient data to recommend usage of colistimethate for injection 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 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. -
Fresenius Kabi Usa, Llc
Colistimethate | Fresenius Kabi Usa, Llc
ImportantColistimethate for Injection, USP is supplied in vials containing colistimethate sodium equivalent to 150 mg colistin base activity per vial.
Reconstitution for Intravenous or Intramuscular Administration
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.
DosageAdults and Pediatric Patients-Intravenous or Intramuscular Administration
The dose of Colistimethate for Injection, USP 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 Colistimethate for Injection, USP for Adults with Impaired Renal Function
Degree of Renal Impairment
Normal
Mild
Moderate
Severe
Creatinine Clearance (mL/min)
≥ 80
50 to 79
30 to 49
10 to 29
Dosage Schedule
2.5 to 5 mg/kg, divided into 2 to 4 doses per day
2.5 to 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.
ImportantColistimethate for Injection, USP is supplied in vials containing colistimethate sodium equivalent to 150 mg colistin base activity per vial.
Reconstitution for Intravenous or Intramuscular Administration
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.
DosageAdults and Pediatric Patients-Intravenous or Intramuscular Administration
The dose of Colistimethate for Injection, USP 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 Colistimethate for Injection, USP for Adults with Impaired Renal Function
Degree of Renal Impairment
Normal
Mild
Moderate
Severe
Creatinine Clearance (mL/min)
≥ 80
50 to 79
30 to 49
10 to 29
Dosage Schedule
2.5 to 5 mg/kg, divided into 2 to 4 doses per day
2.5 to 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.
-
Paddock Laboratories, Llc
Colistimethate | Paddock Laboratories, Llc
Important:Colistimethate for injection is supplied in vials containing colistimethate sodium equivalent to 150 mg colistin base activity per vial.
Reconstitution for Intravenous or Intramuscular Administration: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.
Dosage Adults and pediatric patients – Intravenous or Intramuscular Administration:The dose of Colistimethate for injection 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.
INTRAVENOUS ADMINISTRATION1. 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 colistimethate for injection to one of the following:
0.9% NaCl 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 solutionThere are not sufficient data to recommend usage of colistimethate for injection 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° (68° to 77°F) and use within 7 days.
![Colistimethate (Colistimethate Sodium) Injection [Jhp Pharmaceuticals, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=dddcd6e6-09dd-4523-802e-21765e7abb5d&name=colistimethate-03.jpg)
![Colistimethate (Colistimethate Sodium) Injection, Powder, Lyophilized, For Solution [Fresenius Kabi Usa, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=ab241809-0d2f-44ba-829c-26be67ee623f&name=colistimethate-for-injection,-usp-figure-4-309306-vial.jpg)
![Colistimethate (Colistimethate Sodium) Injection, Powder, Lyophilized, For Solution [Paddock Laboratories, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=91c7f6d0-d056-42de-9f0b-97e30c1279f9&name=5ee0a217-5009-4f6a-ae18-72dc0857be34-04.jpg)
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