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FEATURED PRODUCTS : PIPERACILLIN SODIUM & TAZOBACTAM FOR INJECTION (2G + 225MG & 4G + 500MG)

PIPTAZIN

Piperacillin Sodium and Tazobactam for Injection (2g+225mg and 4g+500mg)

DESCRIPTION:

Piperacillin and Tazobactam for injection is an injectable antibacterial combination product consisting of the semisynthetic antibiotic piperacillin sodium and the beta-lactamase inhibitor tazobactam sodium for intravenous administration.

Piperacillin sodium is derived from D(-)aminobenzyl-penicillin. The chemical name of piperacillin sodium is sodium (2S,5R,6R)-6-[(R)-2-(4-ethyl-2,3-dioxo-1-piperazine-carboxamido)-2-phenylacetamido]-3,3-dimethyl-7-oxo-4-thia-1azabicyclo[3.2.0]heptane-2-carboxylate.

Tazobactam sodium, a derivative of the penicillin nucleus, is a penicillanic acid sulfone. Its chemical name is sodium (2S,3S,5R)-3-methyl-7-oxo-3-(1H-1,2,3-triazol-1-ylmethyl)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylate-4,4-dioxide.

MECHANISM OF ACTION:

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.

INDICATIONS:

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)
DOSAGE AND ADMINISTRATION:

PIPTAZIN should be administered by intravenous infusion over 30 minutes.

Adults: The usual total daily dose of PIPTAZIN 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 PIPTAZIN treatment is from seven to ten days. However, the recommended duration of PIPTAZIN 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 PIPTAZIN 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 PIPTAZIN for patients with renal insufficiency are as follows:

Adults:

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

Renal Function (Creatinine Clearance, mL/min) All Indications (except nosocomial pneumonia) Nosocomial Pneumonia
> 40 mL/min 3.375 q 6 h 4.5 q 6 h
> 20-40 mL/min * 2.25 q 6 h 3.375 q 6 h
< 20 mL/min * 2.25 q 8 h 2.25 q 8 h
Haemodialysis ** 2.25 q 12 h 2.25 q 8 h
CAPD 2.25 q 12 h 2.25 q 8 h
* Creatinine clearance for patients not receiving haemodialysis
** 0.75 g should be administered following each haemodialysis session on haemodialysis days


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 PIPTAZIN 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 PIPTAZIN per gram of piperacillin with 5 mL of a compatible reconstitution diluent from the list provided below.

1.25 g, 2.25 g and 4.5 g PIPTAZIN should be reconstituted with 5 mL, 10 mL and 20 mL respectively. 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).

COMPATIABLE RECONSTRUCTION DILUENTS:
  • 0.9% Sodium Chloride for Injection
  • Sterile Water for Injection
  • Dextrose 5%
  • Bacteriostatic Saline/Parabens
  • Bacteriostatic Water/Parabens
  • Bacteriostatic Saline/Benzyl Alcohol
  • Bacteriostatic Water/Benzyl Alcohol
Reconstituted PIPTAZIN solution should be further diluted (recommended volume per dose of 50 mL to 150 mL) in a compatible intravenous diluent solution listed below. Administer by infusion over a period of at least 30 minutes. During the infusion it is desirable to discontinue the primary infusion solution.

COMPATIABLE INTRAVENOUS DILUENT SOLUTIONS:
  • 0.9% Sodium Chloride for Injection
  • Sterile Water for Injection
  • Dextrose 5%
  • Dextran 6% in Saline
  • Maximum recommended volume per dose of Sterile Water for Injection is 50 mL.
Adverse Effects: 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.

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

Presentation: PIPTAZIN is available as 2g + 225mg- 15ml Vial + 10ml Amp, 4g + 500mg injection is available as 30ml Vial + 2x10ml Amp


Important: The drug information on this Web page is meant to be educational. It is not a substitute for medical advice. Please see your health care professional for more information about your specific medical condition and the use of the above mentioned drug.
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