Colistimethate Sodium

Colistimethate Sodium Manufacturers

• Heritage Pharmaceuticals Inc.
  

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  Colistimethate Sodium | Heritage Pharmaceuticals Inc.

  

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  Important: Colistimethate 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.

  Dosage
  

  Adults 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
  50-79
  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 form colistin base activity.

  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, USPto 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 solution
  There are not sufficient data to recommend usage of Colistimethate for Injection, USPwith 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.
  

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