PIPERACILLIN+TAZOBACTAM Powder for solution for infusion Ref.[116769] Active ingredients: Piperacillin and Tazobactam

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 eight hours. For nosocomial pneumonia and bacterial infections in neutropenic patients, the recommended dose is 4 g piperacillin / 0.5 g tazobactam administered every six 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:

Renal impairment

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

For patients on haemodialysis, one additional dose of Piperacillin/Tazobactam 2g/0.25g should be administered following each dialysis period, because haemodialysis removes 30%-50% of piperacillin in four hours.

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:

^* 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):

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 2 g / 0.25 g is administered by intravenous infusion (over 30 minutes).

Piperacillin/Tazobactam 4 g / 0.5 g is administered by intravenous infusion (over 30 minutes).

For reconstitution instructions, see section 6.6.

Symptoms

There have been post-marketing reports of overdose with Piperacillin/Tazobactam. The majority of those events experienced including nausea, vomiting, and diarrhoea have also been reported with the usual recommended dose. Patients may experience neuromuscular excitability or convulsions if higher than recommended doses are given intravenously (particularly in the presence of renal failure).

Treatment

In the event of an overdose, Piperacillin/Tazobactam treatment should be discontinued. No specific antidote is known.

Treatment should be supportive and symptomatic according to the patient's clinical presentation.

Excessive serum concentrations of either piperacillin or tazobactam may be reduced by haemodialysis (see section 4.4).

Unopened - 3 years.

When reconstituted with water for injections or saline, reconstituted solutions will remain stable for 24 hours at 25°C and for 48 hours at 4°C.

From a microbiological point of view, once opened, the product should be used immediately. If not used immediately, in- use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C, unless reconstitution has taken place in controlled and validated aseptic conditions.

Unopened: Do not store above 25°C.

After reconstitution: Store at 2-8°C (see 6.3 Shelf Life).

Packs of one two, five and ten* Type II glass vial with butyl rubber stopper and aluminium/plastic seal.

^* Not all pack sizes may be marketed.

Intravenous use:

Each vial of Piperacillin/Tazobactam 4 g/0.5 g Powder for Solution for Infusion should be reconstituted with 20 ml of one of the following diluents:

• Sterile water for injections
• 0.9% sodium chloride for injection
• Glucose 5%

To achieve effective reconstitution, invert and shake the vial thoroughly to detach any powder adhering to the walls prior to addition of the diluent. Add the solvent and shake until complete dissolution is achieved.

If the vial has been reconstituted using sterile water for injections or 0.9% sodium chloride then it should be further diluted to at least 50 ml with sterile water for injections or 0.9% sodium chloride for injection. If the vial has been reconstituted using glucose 5% then it should be further diluted to 50 ml with sterile water for injections or to 150 ml with 0.9% sodium chloride for injection.

Displacement Volume:

Each gram of Piperacillin/Tazobactam 4 g/0.5 g Powder for Solution for Infusion has a displacement volume of 0.7 ml.

Piperacillin/Tazobactam 4 g/0.5 g Powder for Solution for Infusion will displace 3.15 ml.

The reconstitution/dilution is to be made under aseptic conditions. The solution is to be inspected visually for particulate matter and discoloration prior to administration. The solution should only be used if the solution is clear and free from particles.

Any unused product or waste material should be disposed of in accordance with local requirements.