Posology : מינונים

4.2 Posology and method of administration
Posology

The dose and frequency of piperacillin/tazobactam depends on the severity and localisation of the infection and expected pathogens.

Adult and adolescent patients
Infections
The usual dose is 4 g piperacillin / 0.5 g tazobactam given every 8 hours.

For nosocomial pneumonia and bacterial infections in neutropenic patients, the recommended dose is 4 g piperacillin / 0.5 g tazobactam administered every 6 hours.
This regimen may also be applicable to treat patients with other indicated infections when particularly severe.

The following table summarises the treatment frequency and the recommended dose for adult and adolescent patients by indication or condition:

Treatment frequency          Piperacillin/tazobactam 4 g / 0.5 g
Every 6 hours                Severe pneumonia
Neutropenic adults with fever suspected to be due to a bacterial infection.
Every 8 hours                Complicated urinary tract infections (including pyelonephritis)
Complicated intra-abdominal infections
Skin and soft tissue infections (including diabetic foot infections)
Renal impairment
The intravenous dose should be adjusted to the degree of actual renal impairment as follows (each patient must be monitored closely for signs of substance toxicity; medicinal product dose and interval should be adjusted accordingly):

Creatinine clearance (ml/min)        Piperacillin/tazobactam (recommended dose) > 40                 No dose adjustment necessary
20-40                Maximum dose suggested: 4 g / 0.5 g every 8 hours
< 20                 Maximum dose suggested: 4 g / 0.5 g every 12 hours

For patients on haemodialysis, the maximum dose is 2.25 g every twelve hours for all indications other than nosocomial pneumonia and 2.25 g every eight hours for nosocomial pneumonia. Since hemodialysis removes 30% to 40% of the administered dose, an additional dose of 0.75 g piperacillin-Tazobactam should be administered following each dialysis period on hemodialysis days.

Hepatic impairment
No dose adjustment is necessary (see section 5.2).

Dose in elderly patients
No dose adjustment is required for the elderly with normal renal function or creatinine clearance values above 40 ml/min.

Paediatric population (2-12 years of age)

Infections
The following table summarises the treatment frequency and the dose per body weight for paediatric patients 2-12 years of age by indication or condition: Dose per weight and treatment             Indication / condition frequency
80 mg Piperacillin / 10 mg                Neutropenic children with fever suspected Tazobactam per kg body weight /           to be due to bacterial infections* every 6 hours
100 mg Piperacillin / 12.5 mg             Complicated intra-abdominal infections* Tazobactam per kg body weight / every 8 hours
* Not to exceed the maximum 4 g / 0.5 g per dose over 30 minutes.

Renal impairment
The intravenous dose should be adjusted to the degree of actual renal impairment as follows (each patient must be monitored closely for signs of substance toxicity; medicinal product dose and interval should be adjusted accordingly):

Creatinine clearance (ml/min)        Piperacillin/tazobactam (recommended dose) > 50                  No dose adjustment needed.
50                  70 mg piperacillin / 8.75 mg tazobactam / kg every 8 hours.

For children on haemodialysis, one additional dose of 40 mg piperacillin / 5 mg tazobactam / kg should be administered following each dialysis period.

Use in children aged below 2 years

The safety and efficacy of piperacillin/tazobactam in children 0- 2 years of age has not been established.

No data from controlled clinical studies are available.

Treatment duration
The usual duration of treatment for most indications is in the range of 5-14 days….
However, the duration of treatment should be guided by the severity of the infection, the pathogen(s) and the patient's clinical and bacteriological progress.

Route of administration
Piperacillin/tazobactam 4 g / 0.5 g is administered by intravenous infusion (over 30 minutes).

For reconstitution instructions, see section 6.6.



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