DOSAGE AND ADMINISTRATION
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.
Dosage
Adults 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.
Tabel 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 |
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