Tazep

Inhibits bacterial cell wall synthesis by binding to one or more of the penicillin binding proteins (PBPs); which in turn inhibits the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls, thus inhibiting cell wall biosynthesis. Bacteria eventually lyse due to ongoing activity of cell wall autolytic enzymes (autolysins and murein hydrolases) while cell wall assembly is arrested. Tazobactam inhibits many beta-lactamases, including staphylococcal penicillinase and Richmond and Sykes types II, III, IV, and V, including extended spectrum enzymes; it has only limited activity against class I beta-lactamases other than class Ic types.

In adults and children over 12 years of age:

• Bacterial infections of the lungs and airways (chest or lower respiratory tract infections)
• Bacterial infections within the abdomen
• Bacterial infections of the urinary tract
• Bacterial infections of the skin
• Bacterial infections of the blood (septicaemia or blood poisoning)
• Bacterial infections in people with low white blood cell counts (neutropenia) and hence decreased ability to fight infection (used in combination with an aminoglycoside antibiotic for this purpose)

In children under 12 years of age:

• Appendicitis complicated by a burst appendix, peritonitis and/or abcess formation in children aged 2 to 12 years.
• Bacterial infections in children with low white blood cell counts (neutropenia) and hence decreased ability to fight infection (used in combination with an aminoglycoside antibiotic for this purpose)

Tazep should be administered by intravenous infusion over 30 minutes.

Adults: The usual total daily dose of Tazep is 3.375 g every six hours totaling 13.5 g (12.0 g piperacillin/1.5 g Tazobactam).

Initial presumptive treatment of patients with nosocomial pneumonia should start with PIPTAZIN at a dosage of 4.5 g every six hours plus an aminoglycoside, totaling 18.0 g (16.0 g piperacillin/2.0 g tazobactam). Treatment with the aminoglycoside should be continued in patients from whom Pseudomonas aeruginosa is isolated. If Pseudomonas aeruginosa is not isolated, the aminoglycoside may be discontinued at the discretion of the treating physician.

Pediatrics: For children with appendicitis and/or peritonitis 9 months of age or older, weighing up to 40 kg, and with normal renal function, the recommended piperacillin/tazobactam dosage is 100 mg piperacillin/12.5 mg tazobactam per kilogram of body weight, every 8 hours. For pediatric patients between 2 months and 9 months of age, the recommended piperacillin/tazobactam dosage based on pharmacokinetic modeling, is 80 mg piperacillin/10 mg tazobactam per kilogram of body weight, every 8 hours. Pediatric patients weighing over 40 kg and with normal renal function should receive the adult dose. There are no dosage recommendations for piperacillin/tazobactam in pediatric patients with impaired renal function.

Duration of Therapy:

The usual duration of Tazep treatment is from seven to ten days. However, the recommended duration of Tazep treatment of nosocomial pneumonia is 7 to 14 days. In all conditions, the duration of therapy should be guided by the severity of the infection and the patient`s clinical and bacteriological progress.

Renal Insufficiency:

In patients with renal insufficiency (creatinine clearance < 40 mL/min), the intravenous dose of Tazep should be adjusted to the degree of actual renal function impairment. In patients with nosocomial pneumonia receiving concomitant aminoglycoside therapy, the aminoglycoside dosage should be adjusted according to the recommendations of the manufacturer. The recommended daily doses of Tazep for patients with renal insufficiency are as follows: Adults:

Recommended Dosing of Tazep in Patients with Normal Renal Function and Renal Insufficiency (As total grams piperacillin/tazobactam):

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 haemodialysis removes 30% to 40% of the administered dose, an additional dose of 0.75 g PIPTAZIN should be administered following each dialysis period on haemodialysis days. No additional dosage of Tazep is necessary for CAPD patients.

Pediatrics:

There are no dosage recommendations for piperacillin/tazobactam in pediatric patients with impaired renal function.

Directions for Reconstitution and Dilution for Use

Intravenous Administration: Reconstitute Tazep per gram of piperacillin with 5 mL of a compatible reconstitution diluent from the list provided below.

4.5 g Tazep should be reconstituted with 20 mL. Swirl until dissolved.

Use immediately after reconstitution. Discard any unused portion after 24 hours if stored at room temperature (20-25 Degree Celcius), or after 48 hours if stored at refrigerated temperature (20 – 80 Degree Celcius).

Piperacillin and tazobactam may cause side effects such as upset stomach , vomiting, unpleasant or abnormal taste, diarrhea, gas ,headache, constipation, insomnia, rash, itching skin, swelling, shortness of breath, unusual bruising or bleeding.

Tazep is contraindicated in patients with a history of allergic reactions to any of the penicillins, cephalosporins, or beta-lactamase inhibitors.