Posology : מינונים

4.2. Posology and method of administration
Therapeutic indications for intravenous and oral administration are different. Both administration routes could not be commuted.

Intravenous administration
Solution concentrations of no more than 5 mg/ml are recommended. In selected patients in need of fluid restriction, solution concentration up to 10 mg/ml may be used; use of such higher concentrations may increase the risk of infusion-related events (see section 6.6).
Infusions should be given over at least 60 minutes. In adults, if doses exceeding 500 mg are used, a rate of infusion of no more than 10 mg/min is recommended. Infusion-related adverse events are related to both concentration and rate of administration of vancomycin.
The duration of treatment is guided by the severity of the infection and its clinical and bacteriological Progression.


Patients with normal renal and hepatic functions
Adult and adolescents above 12 years of age:
The recommended daily intravenous dose is 2000 mg (2g), divided into doses of 500mg every 6 hours or 1000mg every 12 hours.
For bacterial endocarditis, the generally accepted regimen is 1000 mg of vancomycin intravenously every 12 hours for 4 weeks either alone or in combination with other antibiotics (gentamicin plus rifampin, gentamicin, streptomycin).
Enterococcal endocarditis is treated for 6 weeks with vancomycin in combination with an Aminoglycoside – according to national recommendations.


Children 1 month to 12 years of age:
The recommended intravenous dose is 10mg/kg, every 6 hours.

Infants and newborn:
The recommended initial dose is 15 mg/kg, followed by 10 mg/kg every 12 hours during the first week of life and every 8 hours after that age and up to 1 month of age. Careful monitoring of serum concentration of vancomycin is recommended (see below).
Elderly patients:
Lower maintenance doses may be required due to the age –related reduction in renal function.


Obese patients:
Modification of the usual daily doses may be required.

Patients with impaired hepatic function
There is no evidence that the dose has to be reduced in patients with impaired hepatic function.

Patients with impaired renal function
The dose must be adjusted in patients with impaired renal function and the following nomogram can serve as guidance. Careful monitoring of serum concentration of vancomycin is recommended (see below)



If the creatine clearance is not available, the following formula may be applied to calculate the creatinine clearance from the patients age, sex and serum creatinine: 


Women: 0.85 x value calculated by the above formula.

Where possible, the creatinine clearance should always be determined.


In patients with mild or moderate renal failure, the starting dose must not be less than 15 mg/kg. In patients with severe renal failure, it is preferable to administer a maintenance dose between 250 mg and 1000 mg at a spacing of several days rather than administer lower daily doses.


Patients with anuria (with practically no renal function) should receive a dose of 15 mg/kg body weight until the therapeutic serum concentration is reached. The maintenance doses are 1.9 mg/kg body weight per 24 hours.
In order to facilitate the procedure, adult patients with strongly impaired renal function may obtain amaintenance dose of 250 - 1000 mg at intervals of several days instead of a daily dose.


Dosage in case of haemodialysis
For patients without any renal function, even under regular hemodialysis, the following dosage is also possible: Saturating dose 1000 mg, maintenance dose 1000 mg every 7 - 10 days.

If polysulfone membranes are used in haemodialysis (high flux dialysis), the half-life of vancomycin is reduced. An additional maintenance dose may be necessary in patients on regular haemodialysis.


Monitoring of vancomycin serum concentrations:
The serum concentration of vancomycin should be monitored at the second day of treatment immediately prior to the next dose, and one hour post infusion. Therapeutic vancomycin blood levels should be between 30 and 40 mg/l (maximum 50 mg/l) one hour after the end of the infusion, the minimum level (short prior to the next administration) between 5 and 10 mg/l.
The concentrations should normally be monitored twice or three times per week.

Oral administration
Treatment of colitis due to C. difficile

Adults: The usual daily dose is 0,5g to 2 g given in 4 divided doses (125 mg to 500 mg per dose) for 7 to 10 days.
Children: The usual daily dose is 40 mg/kg/day given in 4 divided doses, up to a maximum of 250 mg/dose, for 7 to 10 days.


Method of Administration
For intravenous infusion only, and not for intramuscular administration.
Parenterally vancomycin shall only be administered as slow intravenous infusion (not more than 10 mg/min – over at least 60 min) which is sufficiently diluted (at least 500 mg/100ml or at least 1000mg/200 ml).
Patients requiring fluid restriction can receive a solution of 500 mg /50 ml or 1000 mg /100 ml. With these higher concentrations the risk for infusion related side effects can be increased.


Oral administration:
For information about the preparation of the solution, please refer to section 6.6 special precautions for disposal and other handling.