Choletec

Choletec Manufacturers

• Bracco Diagnostics Inc.
  

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  Choletec | Sagent Pharmaceuticals

  

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  An infusion rate of 10 mg/min or less is associated with fewer infusion-related events (see ADVERSE REACTIONS). Infusion-related events are related to both the concentration and the rate of administration of vancomycin. Concentrations of no more than 5 mg per mL and rates of no more than 10 mg/min are recommended in adults (see also age-specific recommendations). In selected patients in need of fluid restriction, a concentration up to 10 mg per mL may be used; use of such higher concentrations may increase the risk of infusion-related events. Infusion-related events may occur, however, at any rate or concentration.

  Patients with Normal Renal Function Adults

  The usual daily intravenous dose is 2 grams divided either as 500 mg every six hours or 1 gram every 12 hours. Each dose should be administered at no more than 10 mg/min, or over a period of at least 60 minutes, whichever is longer. Other patients factors, such as age or obesity, may call for modification of the usual intravenous daily dose.

  Pediatric patients

  The usual intravenous dosage of vancomycin is 10 mg/kg per dose given every 6 hours. Each dose should be administered over a period of at least 60 minutes. Close monitoring of serum concentrations of vancomycin may be warranted in these patients.

  Neonates

  In pediatric patients up to the age of 1 month, the total daily intravenous dosage may be lower. In neonates, an initial dose of 15 mg/kg is suggested, followed by 10 mg/kg every 12 hours for neonates in the 1st week of life and every 8 hours thereafter up to the age of 1 month. Each dose should be administered over 60 minutes. In premature infants, vancomycin clearance decreases as postconceptional age decreases. Therefore, longer dosing intervals may be necessary in premature infants. Close monitoring of serum concentrations of vancomycin is recommended in these patients.

  Patients with Impaired Renal Function and Elderly Patients

  Dosage adjustment must be made in patients with impaired renal function. In the elderly, greater dosage reductions than expected may be necessary because of decreased renal function. Measurement of vancomycin serum concentrations can be helpful in optimizing therapy, especially in seriously ill patients with changing renal function. Vancomycin serum concentrations can be determined by use of microbiologic assay, radioimmunoassay, fluorescence polarization immunoassay, fluorescence immunoassay, or high-pressure liquid chromatography.

  If creatinine clearance can be measured or estimated accurately, the dosage for most patients with renal impairment can be calculated using the following table. The dosage of vancomycin per day in mg is about 15 times the glomerular filtration rate in mL/min: (see table).

  DOSAGE TABLE FOR VANCOMYCIN IN PATIENTS WITH IMPAIRED RENAL FUNCTION (Adapted from Moellering et al.4) Creatinine Clearance
  mL/min Vancomycin Dose
  mg/24 hr 100 1545 90 1390 80 1235 70 1080 60 925 50 770 40 620 30 465 20 310 10 155

  The initial dose should be no less than 15 mg/kg, even in patients with mild to moderate renal insufficiency.

  The table is not valid for functionally anephric patients. For such patients, an initial dose of 15 mg/kg of body weight should be given to achieve prompt therapeutic serum concentrations. The dose required to maintain stable concentrations is 1.9 mg/kg/24 hr. In patients with marked renal impairment, it may be more convenient to give maintenance doses of 250 to 1000 mg once every several days rather than administering the drug on a daily basis. In anuria, a dose of 1000 mg every 7 to 10 days has been recommended.

  When only the serum creatinine concentration is known, the following formula (based on sex, weight and age of the patient) may be used to calculate creatinine clearance. Calculated creatinine clearances (mL/min) are only estimates. The creatinine clearance should be measured promptly.

  The serum creatinine must represent a steady state of renal function. Otherwise, the estimated value for creatinine clearance will not be valid. Such a calculated clearance is an overestimate of actual clearance in patients with conditions:

  (1) characterized by decreasing renal function, such as shock, severe heart failure or oliguria;
  (2) in which a normal relationship between muscle mass and total body weight is not present, such as in obese patients or those with liver disease, edema or ascites; and
  (3) accompanied by debilitation, malnutrition or inactivity.

  The safety and efficacy of vancomycin administration by the intrathecal (intralumbar or intraventricular) route have not been assessed.

  Intermittent infusion is the recommended method of administration.

  Compatibility with Other Drugs and IV Fluids

  The following diluents are physically and chemically compatible (with 4 g/L vancomycin hydrochloride):

    5% Dextrose Injection, USP   5% Dextrose Injection and 0.9% Sodium Chloride Injection, USP   Lactated Ringer's Injection, USP   5% Dextrose and Lactated Ringer's Injection   Normosol ®-M and 5% Dextrose   0.9% Sodium Chloride Injection, USP   Isolyte ® E

  Good professional practice suggests that compounded admixtures should be administered as soon after preparation as is feasible.

  Vancomycin solution has a low pH and may cause physical instability of other compounds.

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