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Tazocin EF (Zosyn) 2.25 G Iv 1 Vial

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FULL PRESCRIBING INFORMATION: CONTENTS*

1 INDICATIONS AND USAGE

1.1 Intra-abdominal Infections

1.2 Skin and Skin Structure Infections

1.3 Female Pelvic Infections

1.4 Community-acquired Pneumonia

1.5 Nosocomial Pneumonia

2 DOSAGE AND ADMINISTRATION

2.1 Adult Patients

2.2 Nosocomial Pneumonia

2.3 Renal Impairment

2.4 Pediatric Patients

2.5 Reconstitution and Dilution of Powder Formulations

2.6 Directions for Use of TAZOCIN EF (ZOSYN) in GALAXY Containers

2.7 Compatibility with Aminoglycosides

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity Reactions

5.2 Serious Skin Reactions

5.3 Clostridium difficile Associated Diarrhea

5.4 Hematologic Effects

5.5 Central Nervous System Effects

5.6 Electrolyte Effects

5.7 Development of Drug-Resistant Bacteria

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

6.2 Post-Marketing Experience

6.3 Additional Experience with piperacillin

7 DRUG INTERACTIONS

7.1 Aminoglycosides

7.2 Probenecid

7.3 Anticoagulants

7.4 Vecuronium

7.5 Methotrexate

7.6 Effects on Laboratory Tests

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

8.3 Nursing Mothers

8.4 Pediatric Use

8.5 Geriatric Use

8.6 Renal Impairment

8.7 Hepatic Impairment

8.8 Patients with Cystic Fibrosis

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

12.2 Pharmacodynamics

12.3 Pharmacokinetics

12.4 Microbiology

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

15 REFERENCES

16 HOW SUPPLIED/STORAGE AND HANDLING

17 PATIENT COUNSELING INFORMATION

*Sections or subsections omitted from the full prescribing information are not listed.

 

FULL PRESCRIBING INFORMATION

To reduce the development of drug-resistant bacteria and maintain the effectiveness of TAZOCIN EF (ZOSYN) (piperacillin/tazobactam) injection and other antibacterial drugs, TAZOCIN EF (ZOSYN) (piperacillin/tazobactam) should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

1 INDICATIONS AND USAGE

TAZOCIN EF (ZOSYN) is a combination product consisting of a penicillin-class antibacterial, piperacillin, and a β-lactamase inhibitor, tazobactam, indicated for the treatment of patients with moderate to severe infections caused by susceptible isolates of the designated bacteria in the conditions listed below.

1.1 Intra-abdominal Infections

Appendicitis (complicated by rupture or abscess) and peritonitis caused by β-lactamase producing isolates of Escherichia coli or the following members of the Bacteroides fragilis group: B. fragilisB. ovatusB. thetaiotaomicron, or B. vulgatus. The individual members of this group were studied in fewer than 10 cases.

1.2 Skin and Skin Structure Infections

Uncomplicated and complicated skin and skin structure infections, including cellulitis, cutaneous abscesses and ischemic/diabetic foot infections caused by β-lactamase producing isolates of Staphylococcus aureus.

1.3 Female Pelvic Infections

Postpartum endometritis or pelvic inflammatory disease caused by β-lactamase producing isolates of Escherichia coli.

1.4 Community-acquired Pneumonia

Community-acquired pneumonia (moderate severity only) caused by β-lactamase producing isolates of Haemophilus influenzae.

1.5 Nosocomial Pneumonia

Nosocomial pneumonia (moderate to severe) caused by β-lactamase producing isolates of Staphylococcus aureus and by piperacillin/tazobactam-susceptible Acinetobacter baumanniiHaemophilus influenzaeKlebsiella pneumoniae, andPseudomonas aeruginosa (Nosocomial pneumonia caused by P. aeruginosa should be treated in combination with an aminoglycoside) [see Dosage and Administration (2)].

To reduce the development of drug-resistant bacteria and maintain the effectiveness of TAZOCIN EF (ZOSYN) and other antibacterial drugs, TAZOCIN EF (ZOSYN) should be used only to treat infections that are proven or strongly suspected to be caused by 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.

2 DOSAGE AND ADMINISTRATION

TAZOCIN EF (ZOSYN) should be administered by intravenous infusion over 30 minutes.

2.1 Adult Patients

The usual total daily dose of TAZOCIN EF (ZOSYN) for adults is 3.375 g every six hours totaling 13.5 g (12.0 g piperacillin/1.5 g tazobactam). The usual duration of TAZOCIN EF (ZOSYN) treatment is from 7 to 10 days.

TAZOCIN EF (ZOSYN) should be administered by intravenous infusion over 30 minutes.

2.2 Nosocomial Pneumonia

Initial presumptive treatment of patients with nosocomial pneumonia should start with TAZOCIN EF (ZOSYN) 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). The recommended duration of TAZOCIN EF (ZOSYN) treatment for nosocomial pneumonia is 7 to 14 days. Treatment with the aminoglycoside should be continued in patients from whom P. aeruginosa is isolated.

2.3 Renal Impairment

In patients with renal impairment (creatinine clearance ≤ 40 mL/min) and dialysis patients (hemodialysis and CAPD), the intravenous dose of TAZOCIN EF (ZOSYN) should be reduced to the degree of actual renal function impairment. The recommended daily doses of TAZOCIN EF (ZOSYN) for patients with renal impairment are as follows:

Table 1: Recommended Dosing of TAZOCIN EF (ZOSYN) in Patients with Normal Renal Function and Renal - Impairment (As total grams piperacillin/tazobactam)

Renal Function (creatinine clearance, mL/min)

All Indications (except nosocomial pneumonia)

Nosocomial Pneumonia

* Creatinine clearance for patients not receiving hemodialysis

† 0.75 g (0.67 g piperacillin/0.08 g tazobactam) should be administered following each hemodialysis session on hemodialysis days

>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 6 h

Hemodialysis†

2.25 q 12 h

2.25 q 8 h

CAPD

2.25 q 12 h

2.25 q 8 h

For patients on hemodialysis, 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 hemodialysis removes 30% to 40% of the administered dose, an additional dose of 0.75 g TAZOCIN EF (ZOSYN) (0.67 g piperacillin/0.08 g tazobactam) should be administered following each dialysis period on hemodialysis days. No additional dosage of TAZOCIN EF (ZOSYN) is necessary for CAPD patients.

2.4 Pediatric Patients

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 TAZOCIN EF (ZOSYN) 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 TAZOCIN EF (ZOSYN) dosage based on pharmacokinetic modeling, is 80 mg piperacillin/10 mg tazobactam per kilogram of body weight, every 8 hours [see Use in Specific Populations (8.4) and Clinical Pharmacology (12.3)]. Pediatric patients weighing over 40 kg and with normal renal function should receive the adult dose.

It has not been determined how to adjust TAZOCIN EF (ZOSYN) dosage in pediatric patients with renal impairment.

2.5 Reconstitution and Dilution of Powder Formulations

Pharmacy bulk vials

Reconstituted stock solution must be transferred and further diluted for intravenous infusion.

The pharmacy bulk vial is for use in a hospital pharmacy admixture service only under a laminar flow hood. After reconstitution, entry into the vial must be made with a sterile transfer set or other sterile dispensing device, and contents should be dispensed as aliquots into intravenous solution using aseptic technique. Use entire contents of pharmacy bulk vial promptly. Discard unused portion after 24 hours if stored at room temperature (20°C to 25°C [68°F to 77°F]), or after 48 hours if stored at refrigerated temperature (2°C to 8°C [36°F to 46°F]).

Reconstitute the pharmacy bulk vial with exactly 152 mL of a compatible reconstitution diluent, listed below, to a concentration of 200 mg/mL of piperacillin and 25 mg/mL of tazobactam. Shake well until dissolved. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to and during administration whenever solution and container permit.

Single dose vials

Reconstitute TAZOCIN EF (ZOSYN) vials with a compatible reconstitution diluent from the list provided below.

2.25 g, 3.375 g, and 4.5 g TAZOCIN EF (ZOSYN) should be reconstituted with 10 mL, 15 mL, and 20 mL, respectively. Swirl until dissolved.

Compatible Reconstitution Diluents for Pharmacy and Single Dose Vials

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 TAZOCIN EF (ZOSYN) solutions for both bulk and single dose vials should be further diluted (recommended volume per dose of 50 mL to 150 mL) in a compatible intravenous 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.

Compatible Intravenous Solutions for Pharmacy and Single Dose Vials

0.9% sodium chloride for injection 
sterile water for injection1 
Dextran 6% in saline 
Dextrose 5%
Lactated Ringer's Solution (compatible only with reformulated TAZOCIN EF (ZOSYN) containing EDTA and is compatible for co-administration via a Y-site)

TAZOCIN EF (ZOSYN) should not be mixed with other drugs in a syringe or infusion bottle since compatibility has not been established.

TAZOCIN EF (ZOSYN) is not chemically stable in solutions that contain only sodium bicarbonate and solutions that significantly alter the pH.

TAZOCIN EF (ZOSYN) should not be added to blood products or albumin hydrolysates. Parenteral drug products should be inspected visually for particulate matter or discoloration prior to administration, whenever solution and container permit.


1 Maximum recommended volume per dose of sterile water for injection is 50 mL.

Stability of TAZOCIN EF (ZOSYN) Powder Formulations Following Reconstitution

TAZOCIN EF (ZOSYN) reconstituted from bulk and single vials is stable in glass and plastic containers (plastic syringes, I.V. bags and tubing) when used with compatible diluents. The pharmacy bulk vial should NOT be frozen after reconstitution. Discard unused portions after storage for 24 hours at room temperature or after storage for 48 hours at refrigerated temperature (2°C to 8°C [36°F to 46°F]).

Single dose or pharmacy vials should be used immediately after reconstitution. Discard any unused portion after 24 hours if stored at room temperature (20°C to 25°C [68°F to 77°F]), or after 48 hours if stored at refrigerated temperature (2°C to 8°C [36°F to 46°F]). Vials should not be frozen after reconstitution.

Stability studies in the I.V. bags have demonstrated chemical stability (potency, pH of reconstituted solution and clarity of solution) for up to 24 hours at room temperature and up to one week at refrigerated temperature. TAZOCIN EF (ZOSYN) contains no preservatives. Appropriate consideration of aseptic technique should be used.

TAZOCIN EF (ZOSYN) reconstituted from bulk and single vials can be used in ambulatory intravenous infusion pumps. Stability of TAZOCIN EF (ZOSYN) in an ambulatory intravenous infusion pump has been demonstrated for a period of 12 hours at room temperature. Each dose was reconstituted and diluted to a volume of 37.5 mL or 25 mL. One-day supplies of dosing solution were aseptically transferred into the medication reservoir (I.V. bags or cartridge). The reservoir was fitted to a preprogrammed ambulatory intravenous infusion pump per the manufacturer's instructions. Stability of TAZOCIN EF (ZOSYN) is not affected when administered using an ambulatory intravenous infusion pump.

2.6 Directions for Use of TAZOCIN EF (ZOSYN) in GALAXY Containers

TAZOCIN EF (ZOSYN) Injection is to be administered using sterile equipment, after thawing to room temperature.

TAZOCIN EF (ZOSYN) containing EDTA is compatible for co-administration via a Y-site intravenous tube with Lactated Ringer's injection, USP.

Do not add supplementary medication.

Unused portions of TAZOCIN EF (ZOSYN) should be discarded.

CAUTION: Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete.

Thawing of Plastic Container

Thaw frozen container at room temperature 20°C to 25°C [68°F to 77°F] or under refrigeration (2°C to 8°C [36°F to 46°F]). Do not force thaw by immersion in water baths or by microwave irradiation.

Check for minute leaks by squeezing container firmly. If leaks are detected, discard solution as sterility may be impaired.

The container should be visually inspected. Components of the solution may precipitate in the frozen state and will dissolve upon reaching room temperature with little or no agitation. Potency is not affected. Agitate after solution has reached room temperature. If after visual inspection, the solution remains cloudy or if an insoluble precipitate is noted or if any seals or outlet ports are not intact, the container should be discarded.

Administer by infusion over a period of at least 30 minutes. During the infusion it is desirable to discontinue the primary infusion solution.

Storage

Store in a freezer capable of maintaining a temperature of -20°C (-4°F).

For GALAXY containers, the thawed solution is stable for 14 days under refrigeration (2°C to 8°C [36°F to 46°F]) or 24 hours at room temperature 20°C to 25°C [68°F to 77°F]. Do not refreeze thawed TAZOCIN EF (ZOSYN).

2.7 Compatibility with Aminoglycosides

Due to the in vitro inactivation of aminoglycosides by piperacillin, TAZOCIN EF (ZOSYN) and aminoglycosides are recommended for separate administration. TAZOCIN EF (ZOSYN) and aminoglycosides should be reconstituted, diluted, and administered separately when concomitant therapy with aminoglycosides is indicated [see Drug Interactions (7.1)].

In circumstances where co-administration via Y-site is necessary, TAZOCIN EF (ZOSYN) formulations containing EDTA are compatible for simultaneous coadministration via Y-site infusion only with the following aminoglycosides under the following conditions:

Table 2: Compatibility with Aminoglycosides

Aminoglycoside

TAZOCIN EF (ZOSYN) Dose (grams)

TAZOCIN EF (ZOSYN) Diluent Volume * (mL)

Aminoglycoside Concentration Range † (mg/mL)

Acceptable Diluents

* Diluent volumes apply only to single vials and bulk pharmacy containers

† The concentration ranges in Table 2 are based on administration of the aminoglycoside in divided doses (10–15 mg/kg/day in two daily doses for amikacin and 3–5 mg/kg/day in three daily doses for gentamicin). Administration of amikacin or gentamicin in a single daily dose or in doses exceeding those stated above via Y-site with TAZOCIN EF (ZOSYN) containing EDTA has not been evaluated. See package insert for each aminoglycoside for complete Dosage and Administration instructions.

‡ TAZOCIN EF (ZOSYN) 3.375 g per 50 mL GALAXY® containers are NOT compatible with gentamicin for coadministration via a Y-site due to the higher concentrations of piperacillin and tazobactam.

Amikacin

2.25, 3.375, 4.5

50, 100, 150

1.75 – 7.5

0.9% sodium chloride or 5% dextrose

Gentamicin

2.25 
3.375‡ 
4.5

50,
100
150

0.7 – 3.32

0.9% sodium chloride or 5% dextrose

Only the concentration and diluents for amikacin or gentamicin with the dosages of TAZOCIN EF (ZOSYN) listed above have been established as compatible for coadministration via Y-site infusion. Simultaneous coadministration via Y-site infusion in any manner other than listed above may result in inactivation of the aminoglycoside by TAZOCIN EF (ZOSYN).

TAZOCIN EF (ZOSYN) is not compatible with tobramycin for simultaneous coadministration via Y-site infusion. Compatibility of TAZOCIN EF (ZOSYN) with other aminoglycosides has not been established.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

3 DOSAGE FORMS AND STRENGTHS

TAZOCIN EF (ZOSYN)® (piperacillin and tazobactam) for Injection is supplied as a white to off-white powder in vials of the following sizes:

Each TAZOCIN EF (ZOSYN) 2.25 g vial provides piperacillin sodium equivalent to 2 grams of piperacillin and tazobactam sodium equivalent to 0.25 g of tazobactam.

Each TAZOCIN EF (ZOSYN) 3.375 g vial provides piperacillin sodium equivalent to 3 grams of piperacillin and tazobactam sodium equivalent to 0.375 g of tazobactam.

Each TAZOCIN EF (ZOSYN) 4.5 g vial provides piperacillin sodium equivalent to 4 grams of piperacillin and tazobactam sodium equivalent to 0.5 g of tazobactam.

Each TAZOCIN EF (ZOSYN) 40.5 g pharmacy bulk vial contains piperacillin sodium equivalent to 36 grams of piperacillin and tazobactam sodium equivalent to 4.5 grams tazobactam.

TAZOCIN EF (ZOSYN)® (piperacillin and tazobactam) Injection is supplied in GALAXY® Containers as a frozen, iso-osmotic, sterile, non-pyrogenic solution in single-dose plastic containers:

2.25 g (piperacillin sodium equivalent to 2 g piperacillin/tazobactam sodium equivalent to 0.25 g tazobactam) in 50 mL

3.375 g (piperacillin sodium equivalent to 3 g piperacillin/tazobactam sodium equivalent to 0.375 g tazobactam) in 50 mL

4.5 g (piperacillin sodium equivalent to 4 g piperacillin/tazobactam sodium equivalent to 0.5 g tazobactam) in 100 mL

4 CONTRAINDICATIONS

TAZOCIN EF (ZOSYN) is contraindicated in patients with a history of allergic reactions to any of the penicillins, cephalosporins, or β-lactamase inhibitors.

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity Reactions

Serious and occasionally fatal hypersensitivity (anaphylactic/anaphylactoid) reactions (including shock) have been reported in patients receiving therapy with TAZOCIN EF (ZOSYN). These reactions are more likely to occur in individuals with a history of penicillin, cephalosporin, or carbapenem hypersensitivity or a history of sensitivity to multiple allergens. Before initiating therapy with TAZOCIN EF (ZOSYN), careful inquiry should be made concerning previous hypersensitivity reactions. If an allergic reaction occurs, TAZOCIN EF (ZOSYN) should be discontinued and appropriate therapy instituted.

5.2 Serious Skin Reactions

Serious skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported in patients receiving TAZOCIN EF (ZOSYN). If patients develop a skin rash they should be monitored closely and TAZOCIN EF (ZOSYN) discontinued if lesions progress.

5.3 Clostridium difficile Associated Diarrhea

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including TAZOCIN EF (ZOSYN), and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial drug use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

5.4 Hematologic Effects

Bleeding manifestations have occurred in some patients receiving β-lactam drugs, 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, TAZOCIN EF (ZOSYN) should be discontinued and appropriate therapy instituted.

The leukopenia/neutropenia associated with TAZOCIN EF (ZOSYN) administration appears to be reversible and most frequently associated with prolonged administration.

Periodic assessment of hematopoietic function should be performed, especially with prolonged therapy, ie, ≥ 21 days [see Adverse Reactions (6.1)].

5.5 Central Nervous System Effects

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).

5.6 Electrolyte Effects

TAZOCIN EF (ZOSYN) contains a total of 2.79 mEq (64 mg) of 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.

5.7 Development of Drug-Resistant Bacteria

Prescribing TAZOCIN EF (ZOSYN) in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of development of drug-resistant bacteria.

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

During the initial clinical investigations, 2621 patients worldwide were treated with TAZOCIN EF (ZOSYN) in phase 3 trials. In the key North American monotherapy clinical trials (n=830 patients), 90% of the adverse events reported were mild to moderate in severity and transient in nature. However, in 3.2% of the patients treated worldwide, TAZOCIN EF (ZOSYN) was discontinued because of adverse events primarily involving the skin (1.3%), including rash and pruritus; the gastrointestinal system (0.9%), including diarrhea, nausea, and vomiting; and allergic reactions (0.5%).

Table 3: Adverse Reactions from TAZOCIN EF (ZOSYN) Monotherapy Clinical Trials

System Organ Class
  Adverse Reaction

Gastrointestinal disorders

  Diarrhea (11.3%)

  Constipation (7.7%)

  Nausea (6.9%)

  Vomiting (3.3%)

  Dyspepsia (3.3%)

  Abdominal pain (1.3%)

  Pseudomembranous colitis (≤1%)

General disorders and administration site conditions

  Fever (2.4%)

  Injection site reaction (≤1%)

  Rigors (≤1%)

Immune system disorders

  Anaphylaxis (≤1%)

Infections and infestations

  Candidiasis (1.6%)

Metabolism and nutrition disorders

   Hypoglycemia (≤1%)

Musculoskeletal and connective tissue disorders

  Myalgia(≤1%)

  Arthralgia (≤1%)

Nervous system disorders

  Headache (7.7%)

  Insomnia (6.6%)

Skin and subcutaneous tissue disorders

  Rash (4.2%, including maculopapular, bullous, and urticarial)

  Pruritus (3.1%)

Vascular disorders

  Phlebitis (1.3%)

  Thrombophlebitis (≤1%)

  Hypotension (≤1%)

  Purpura (≤1%)

  Epistaxis (≤1%)

  Flushing (≤1%)

Nosocomial Pneumonia Trials

Two trials of nosocomial lower respiratory tract infections were conducted. In one study, 222 patients were treated with TAZOCIN EF (ZOSYN) in a dosing regimen of 4.5 g every 6 hours in combination with an aminoglycoside and 215 patients were treated with imipenem/cilastatin (500 mg/500 mg q6h) in combination with an aminoglycoside. In this trial, treatment-emergent adverse events were reported by 402 patients, 204 (91.9%) in the piperacillin/tazobactam group and 198 (92.1%) in the imipenem/cilastatin group. Twenty-five (11.0%) patients in the piperacillin/tazobactam group and 14 (6.5%) in the imipenem/cilastatin group (p > 0.05) discontinued treatment due to an adverse event.

The second trial used a dosing regimen of 3.375 g given every 4 hours with an aminoglycoside.

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Tazocin EF (Zosyn) 2.25 G Iv 1 Vial

  • Brand: Pfizer
  • Product Code: 8699502013582
  • Availability: In Stock
  • $12.00

Tags: Tazocin EF (Zosyn) 2.25 G Iv 1 Vial, Pfizer, All Products, Antibiotics

Table 4: Adverse Reactions from TAZOCIN EF (ZOSYN) Plus Aminoglycoside Clinical Trials*

System Organ Class
  Adverse Reaction

*For adverse drug reactions that appeared in both studies the higher frequency is presented.

Blood and lymphatic system disorders

  Thrombocythemia (1.4%)

  Anemia (≤1%)

  Thrombocytopenia (≤1%)

  Eosinophilia (≤1%)

Gastrointestinal disorders

  Diarrhea (20%)

  Constipation (8.4%)