PIPERACILLIN AND TAZOBACTAM FOR

). To reduce the development of drug-resistant bacteria and maintain the effectiveness of Piperacillin and Tazobactam for Injection and other antibacterial drugs, Piperacillin and Tazobactam for Injection should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.

When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Piperacillin and Tazobactam for Injection Page 5 of 43 While Piperacillin and Tazobactam for Injection is indicated only for the conditions listed above, infections caused by piperacillin susceptible organisms are also amenable to Piperacillin and Tazobactam for Injection treatment due to its piperacillin content.

The tazobactam component of this combination product does not decrease the activity of the piperacillin component against piperacillin susceptible organisms. Therefore, the treatment of polymicrobial infections caused by piperacillin susceptible organisms and ß-lactamase producing organisms susceptible to Piperacillin and Tazobactam for Injection should not require the addition of another antibiotic.

Piperacillin and Tazobactam for Injection may be useful as presumptive therapy in the indicated conditions prior to identification of causative organisms because of its broad spectrum of bactericidal activity against gram-positive and gram-negative aerobic and anaerobic organisms.

Appropriate cultures should usually be performed before initiating antimicrobial treatment in order to isolate and identify the organisms causing infection and to determine their susceptibility to Piperacillin and Tazobactam for Injection.

Antimicrobial therapy should be adjusted, if appropriate, once results of culture(s) and antimicrobial susceptibility testing are known. 3 Pediatrics). 2 Geriatrics Geriatrics (> 65 years of age): Patients over 65 years of age are not at an increased risk of developing adverse effects solely because of age.

4 Geriatrics). 2 CONTRAINDICATIONS The use of Piperacillin and Tazobactam for Injection (sterile piperacillin sodium/tazobactam sodium) is contraindicated in: • Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container.

). Hematologic Bleeding manifestations or significant leukopenia following prolonged administration have occurred in some patients receiving ß-lactam antibiotics, including piperacillin. These reactions have sometimes 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 hematopoietic function should be performed (see 7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests).

5 Post- Market Adverse Reactions1). g. fever, hepatosplenomegaly, hypertriglyceridaemia, hypofibrinogenaemia, high serum ferritin, cytopenias and haemophagocytosis) and is associated with high mortality rates if not recognized early and treated.

• Immediately evaluate patients who develop early manifestations of pathologic immune activation. • If HLH is diagnosed, discontinue piperacillin-tazobactam treatment. 35 mEq (54 mg) of sodium (Na+) per gram of piperacillin in the combination product.

This should be considered when treating patients requiring restricted salt intake. Periodic electrolyte determinations should be performed in patients with low potassium reserves, and the possibility of hypokalemia should be kept in mind with patients who have potentially low potassium reserves and who are receiving cytotoxic therapy or diuretics.

4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data). Coagulation parameters should be tested more frequently and monitored regularly, during simultaneous administration of Piperacillin and Tazobactam for Injection and high doses of heparin, oral anticoagulants and/or other drugs that may affect the blood coagulation system and/or the thrombocyte function (see

, Immune 04/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .............................................................................................

2 TABLE OF CONTENTS................................................................................................................ 2 PART I: HEALTH PROFESSIONAL INFORMATION .......................................................................

4 1 INDICATIONS ................................................................................................................ 1 Pediatrics .....................................................................................................................

2 Geriatrics ..................................................................................................................... 5 2 CONTRAINDICATIONS ...................................................................................................

5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX .............................................................. 6 4 DOSAGE AND ADMINISTRATION .................................................................................. 1 Dosing Considerations .................................................................................................

2 Recommended Dose and Dosage Adjustment ............................................................ 3 Reconstitution ............................................................................................................. 4 Administration...........................................................................................................

12 5 OVERDOSAGE ............................................................................................................. 12 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................ 13 7 WARNINGS AND PRECAUTIONS..................................................................................

The use of Piperacillin and Tazobactam for Injection (sterile piperacillin sodium/tazobactam sodium) is contraindicated in: • Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container.

For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • Patients with a history of allergic reactions to any of the penicillins and/or cephalosporins or ß-lactamase inhibitors. Piperacillin and Tazobactam for Injection Page 6 of 43