Special Warning : אזהרת שימוש

4.4.    Special warnings and precautions for use
The selection of piperacillin / tazobactam to treat an individual patient should take into account the appropriateness of using a broad-spectrum semi-synthetic penicillin based on factors such as the severity of the infection and the prevalence of resistance to other suitable antibacterial agents.
Before initiating therapy with TAZO-PIP AVENIR 4.5G, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, other beta-lactam agents (e.g. cephalosporin, monobactam or carbapenem) and other allergens. Serious and occasionally fatal hypersensitivity (anaphylactic/anaphylactoid [including shock]) reactions have been reported in patients receiving therapy with penicillins, including piperacillin / tazobactam. These reactions are more likely to occur in persons with a history of sensitivity to multiple allergens. Serious hypersensitivity reactions require the discontinuation of the antibiotic and may require administration of epinephrine and other emergency measures.
TAZO-PIP AVENIR 4.5G may cause severe cutaneous adverse reactions, such as Stevens -Johnson syndrome, toxic epidermal necrolysis, drug hypersensivity with eosinophilia and systemic symptoms (DRESS), and acute generalised exanthematous pustulosis (AGEP) (see section 4.8). If patients develop a skin rash they should be monitored closely and TAZO-PIP AVENIR 4.5G discontinued if lesions progress.
Haemophagocytic lymphohistiocytosis (HLH): cases of HLH have been reported in patients treated with piperacillin, often following treatment longer than 10 days. HLH is a life-threatening syndrome of pathologic immune activation characterised by clinical signs and symptoms of an excessive systemic inflammation (e.g. fever, hepatosplenomegaly, hypertriglyceridaemia, hypofibrinogenaemia, high serum ferritin, cytopenias and haemophagocytosis). Patients who develop early manifestations of pathologic immune activation should be evaluated immediately. If diagnosis of HLH is established, piperacillin treatment should be discontinued.
Antibiotic-induced pseudomembranous colitis may be manifested by severe, persistent diarrhoea which may be life-threatening. The onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment. In these cases, TAZO-PIP AVENIR 4.5G, should be discontinued.
Therapy with TAZO-PIP AVENIR 4.5G may result in the emergence of resistant organisms, which might cause super-infections.
Bleeding manifestations have occurred in some patients receiving beta-lactam antibiotics. These reactions sometimes have been associated with abnormalities of coagulation tests, such as clotting time, platelet aggregation and prothrombin time, and are more likely to occur in patients with renal failure.
If bleeding manifestations occur, the antibiotic should be discontinued, and appropriate therapy instituted.
Leukopenia and neutropenia may occur, especially during prolonged therapy; therefore, periodic assessment of haematopoietic function should be performed.
As with treatment with other penicillins, neurological complications in the form of convulsions (seizures) may occur when high doses are administered, especially in patients with impaired renal function (see section 4.8).
Each vial of TAZO-PIP AVENIR 4.5G contains 216 mg of sodium, equivalent to 10.8% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
This should be taken into account in patients on a strict low-sodium diet.
Hypokalaemia may occur in patients with low potassium reserves or those receiving concomitant medicinal products that may lower potassium levels; periodic electrolyte determinations may be advisable in such patients.
Renal Impairment
Due to its potential nephrotoxicity (see section 4.8), piperacillin/tazobactam should be used with care in patients with renal impairment or in hemodialysis patients. Intravenous dosages and administration intervals should be adjusted to the degree of renal function impairment (see section 4.2).
In a secondary analysis using data from a large multicenter, randomized-controlled trial when glomerular filtration rate (GFR) was examined after administration of frequently used antibiotics in critically ill patients, the use of piperacillin/tazobactam was associated with a lower rate of reversible GFR improvement compared with the other antibiotics. This secondary analysis concluded that piperacillin/tazobactam was a cause of delayed renal recovery in these patients.
Combined use of piperacillin/tazobactam and vancomycin may be associated with an increased incidence of acute kidney injury (see section 4.5).

Effects on Driving

4.7 Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
However, side effects may occur (see also 4.8), which may influence the ability to drive and use machines.


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