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Each vial contains:

Piperacillin Sodium USP equivalent to Piperacillin              4g

Tazobactam Sodium equivalent to Tazobactam0.5g



Piperacillin-Tazobactam is an injectable antibacterial combination product consisting of the semi synthetic antibiotic piperacillin sodium and the -lactamase inhibitor tazobactam sodium for intravenous administration.

Piperacillin sodium exerts bactericidal activity by inhibiting cell wall synthesis. Tazobactam sodium has very little intrinsic microbiologic activity due to its very low level binding to penicillin-binding proteins, however it is a -lactamase inhibitor of the Richmond-Sykes class III penicillinases and cephalosporinases. Tazobactam does not induce chromosmomally-mediated-lactamases.



Piperacillin/tazobactam has been shown to be active aginst most strains of -lactamse producing micro-organisms both in vitro and clinical infections. It is indicated for the treatment of moderate to servere infections caused by piperacillin-resistant, piperacillin/tazobactam-susceptible,-lactamase producing strains of the microorganisms in the conditions listed below:

  • Appendicitis (complicated by rupture or abscess) and peritonitis: Due to piperacillin-resistant, -lactamase producing strains of E.coli or these members of the Bacteroides group:B. fragilis, B. thetaiotaomicron, or B. vulgatus.
  • Uncomplicated and complicated skin and skin structured infections: Those including cellulitis, cutaneous and ischemic/diabetic foot infections caused by piperacillin-resistant, -lactamse producing strains of S.aureus.
  • Postpartum endometritis or pelvic inflammatory disease: Due to piperacillin-resistant, -lactamase producing strains of E.coli.
  • Community-acquired pneumonia(moderate severity only): Due to piperacillin-resistant, -lactamase producing strains of H. influenzae.
  • Nosocomial pneumonia(moderate to severe):Due to piperacillin-resistant,-lactamase producing strains of S.aureus.


The treatment of mixed infections caused by piperacillin-susceptible organisms and piperacillin- resistant,-lactamase producing organisms susceptible to piperacillin/tazobactam should not require adding another antibiotic. An exception is in the treatment of Pseudomonas aeruginosa in nosocomial pneumonia, which should be in combination with an aminoglycoside.


Administration and Dosage

ZIFAM PTZ is administered by IV infusion over 30 minutes. The usual total daily dose for adults is 12g/1.5g for 7 to 10 days, given as 4.5g every 8 hours.

  • Nosocomial pneumonia: Start with 3.375g every 4 hours plus an aminoglycoside. The recommended duration of treatment is 7 to 14 days. Continue the aminoglycoside in patients from whom P aeruginosa is isolated. If it is isolated, the aminoglycoside may be discontinued at the discretion of the treating physician as guided by the severity of the infection and the patient’s clinical and bacteriological progress.
  • Renal function impairment: In patients with renal insufficiency (Creatinine Clearance<90ml/min) adjust the IV dose of the degree of actual renal function impairment. In patients with nosocomial pneumonia receiving concomitant aminoglcoside therapy, adjust the aminoglycoside dosage acoording to the manufacture’s recommendation


ZIFAM PTZ Dosage Recommendation
Creatinine clearance(ml/min) Recommended dosage regimen
                   20-80 12g/1.5g/day in divided doses of 4.5g every 8 hours
                     <20 8g/1g/day in divided doses of 4.5g every 12 hours


  • Hemodialysis: The maximum dose is 2.25 g every 8 hours. In addition because hemodialysis remove 30% to 40% of a dose in 4 hours, give one additional 0.75g dose following each dialysis period. Peritoneal dialysis removes 6% and 21% of the piperacillin and tazobactam doses respectively.
  • Duration of Therapy: Continue administration for a minium 48 to 72 hours after fever abates or after evidence of bacterial eradication has been obtained. A minimum of 10 days treatment is recommended for grop A- hemolytics stertococcal infections to guard against the risk of rheumatic fever or glomerulonephritis. However, the recommended duration of ZIFAM PTZ treatment for 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.
  • Intravenous Administration: For conventional vials, reconstitute ZIFAM PTZ 1 gram of piperacillin with 5ml of a compatible reconstitution diluent(given below)


 Shake well until dissolved.

  • Compatible IV diluent solution: These include 0.9% Sodium Chloride for injection, Sterile Water for Injection(maximum recommended volume per dose is 50ml), Dextrose 5%, Dextran 6% in Saline.


Storage/Stability: Reconstitute conventional vials with 5 ml of compatible diluent per gram of piperacillin. Shake well until dissolved. Use single dose via immediately after reconstitution. Discard any unused portion after 24 hours at room temperature and up to one week.

  • at refrigerated temperature. Stability in an ambulatory IV infusion pump has been demonstrated for a period of 12 hours at room temperature.



ZIFAM PTZ is contraindicated in patients with a history of allergic reactions to any of the penicillin, cephalosporins, or -lactamase inhibitors.



Serious and occasionally fatal hypersentivity (anaphylactic) reactions have been reported in patients on penicillin therapy. These reactions are more likely to occur in individuals with a history of penicillin hypersentivity or a history of sensitivity to multiple allergens.

Before initiating therapy with ZIFAM PTZ, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. If an allergic reaction occurs, ZIFAM PTZ should be discontinued and appropriate therapy instituted.

Pseudomembranous colitis has been reported with nearly all antibacterial agents, including piperacillin/tazobactam, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.

Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is one primary cause of “antibiotic-associated colitis”.

After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against Clostridium difficile colitis.




Bleeding manifestatios have occured in some patients receiving-lactam antibiotics, including piperacillin. These reactions have sometimes been associated with abnormalities of coagulation test such as clotting time, platelet aggregation and prothrombin time, and are more likely to occur in patients with renal failure.

If bleeding manifestations occur, ZIFAM PTZ should be discontinued and appropriate therapy instituted.

As with other penicillins, patients may experience neuromuscular excitability or convulsions if higher than recommended doses are given intravenously (particularly in the presence of renal failure).

ZIFAM PTZ is a monosodium salt of piperacillin and a monosodium salt of tazobactam and contains a total of 2.35mEq(54mg) of Na+ per gram of piperacillin in the combination product. This should be considered when treating patients requiring restricted salt intake. Periodic electrolyte determinatios 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.

The possibility of the emergence of resistant organisms that might cause superinfections shuld be kept in mind.

As with other semisynthetic penicillins, piperacillin therapy has been associated with an increased incidence of fever and rash in cystic fibrosis patients.


Drug interactions


The mixing of ZIFAM PTZ with an aminoglycoside in vitro can result in substantial inactivation of the aminoglycoside. The aminoglycoside should be reconstitute and administered separately.



Probenecid administered concomitantly with ZIFAM PTZ prolongs the half-life of piperacillin by 21% and that of tazobactam by 71%



No pharmacokinetic interactions have been noted between ZIFAM PTZ and vancomycin.



Piperacillin when used concomitantly with vecuronium has been implicated in the prolongation of the neuromuscular blockade of vecuronium.



Reproduction studies have been performed in rats and have revealed no evidence of impaired fertility due to piperacillin/tazobactam administered up to a dose which is similar to the maximum recommended human daily dose based on body-surface area (mg/m2)



Piperacillin is excreted in low concentrations in human milk; tazobactam concentrations in human milk have not been studied. Caution should be exercised when ZIFAM PTZ is administered to a nursing woman.


Pediatric Use

Safety and efficacy in pediatric patients have not been established.



Geriatric Use

Patients over 65 years are not at an increased risk of developing adverse effects solely because of age. However, dosage should be adjusted in the presence of renal insufficiency.


Side Effects

General: rigors, back pain, malaise, asthenia, chest pain

Autonomic nervous system- hypotension, ileus, syncope

Cardiovascular– tachycardia, including supraventricular and ventricular; bradycardia; arrhythmia, including atrial fibrillation, ventricular filbrillation, cardiac arrest, cardiac failure, circulatory failure, myocardial infarction angina.

Central nervous system- tremor, ocnvulsions, vertigo, aggressive reaction (combative).

Gastrointestinal – melena, flatulence, hemorrhage, gastritis, hiccough, ulcerative stomatitis, fecal incontinence, gastric ulcer, pancreatitis.

Pseudomembranouls colitis was reported in one patient during the clinical trials. The onset of pseudomembranous coliits symptoms may occur during or after antibacterial tretment.

Hearing and Vestibular System- tinnitus, deafness, earache

Hypersensitivity- anaphylaxis

Metabolic and Nutritional– symptomatic hypoglycemia, thirst, gout, vitamin B12 deficiency anemia

Musculoskeletal – myalgia, arthralgia

Platelets, Bleeding, Clotting – mesenteric embolism, purpura, epistaxis, pulmonary embolism, ecchymosis, hemoptysis

Psychiatirc– confusion, hallucination, depression

Reproductive, Female – leukorrhea, vaginitis perineal irritation/pain

Respiratory– pharyngiits, pulmonary edema, bronchospasm, coughing, atelectasis, dyspnea, hypoxia

Skin and Appendages- genital pruitus, diaphoresis, conjunctivitis, xerosis

Special senses– taste perversion

Urinary- retention, dysuria, oliguria, hematuria, incontinence, urinary tract infection with trichomonas, yeast in urine

Vision- photophobia

Vascular (extracardiac)- flushing cardiovascular accident

Additional adverse events reported from worldwide marketing experience with Piperacillin and tazobactam for injection, occurring under circumstances where casual relationship to ZIFAM PTZ is uncertain;

Gastrointestinal- hepatitis, cholestatic jaundice

Hematologic- hemolytic anemia

Renal-rarely, interstitial nephritis



Information on overdosage of ZIFAM PTZ in human is not available.

Excessive serum concentrations of either piperacillin or tazobactam may be reduced by hemodialysis. No specific antidotes is known. As with other penicillins, neuromuscular excitability or convulsions have occurred following large intravenous doses, primarily in patients with impaired renal function. In the case of motor excitability or convulsions, general supportie measures, including administration of anitconvulsive agents (e.g. diazepam or barbiturates), may be considered.



Store below 25 C in a dry place, protect from light. Keep out of reach of children.

Presentation: Vial with 20 ml Sterile water for injection.

Myanmar Reg. No : 170. AA 3846


Manufactured by:

Zifam Pyrex Myanmar Co., Ltd.

Lot C6, Zone-A, Thilawa SEZ, Thanlyin and Kyaut Tan Township, Yangon, Myanmar. 


Product of

Zifam Pinnacle Pty.Ltd

The Healthcare Group


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