Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/2509
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Zosyn (Injection, Powder, Lyophilized, For Solution)
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Zosyn should be administered by intravenous infusion
over 30 minutes. The usual daily dose of Zosyn
for adults is 3.375 g every six hours totaling 13.5 g (12.0 g piperacillin/1.5 g
tazobactam).<br/>Nosocomial Pneumonia: Initial presumptive treatment of patients with nosocomial
pneumonia should start with 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). 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. Due to the in vitro inactivation of the aminoglycoside
by beta-lactam antibiotics, Zosyn and the aminoglycoside are recommended for
separate administration. Zosyn and the aminoglycoside should be reconstituted,
diluted, and administered separately when concomitant therapy with aminoglycosides
is indicated. (See PRECAUTIONS,
Drug Interactions.) In circumstances
where co-administration via Y-site is necessary, reformulated Zosyn containing
EDTA supplied in vials or bulk pharmacy containers is compatible for simultaneous
coadministration via Y-site infusion only with the following aminoglycosides
under the following conditions: The
following compatibility information does not apply to the Zosyn (piperacillin/tazobactam)
formulation not containing EDTA. This information does not apply to Zosyn
in Galaxy containers. Refer to the package insert for Zosyn
Galaxy containers for instructions. Zosyn is not compatible with
tobramycin for simultaneous coadministration via Y-site infusion. Compatibility
of Zosyn with other aminoglycosides has not been established. Only the concentration
and diluents for amikacin or gentamicin with the dosages of 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 aminoglycosideby Zosyn.<br/>Renal Insufficiency: In patients with renal insufficiency (Creatinine
Clearance���40 mL/min), the intravenous dose of Zosyn (piperacillin
and tazobactam for injection) 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
Zosyn for patients with renal insufficiency are as follows: 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 Zosyn should be administered following each dialysis period
on hemodialysis days. No additional dosage of Zosyn is necessary for CAPD
patients.<br/>Duration of Therapy: The usual duration of Zosyn treatment is from seven
to ten days. However, the recommended duration of Zosyn 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.<br/>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 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 Zosyn 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 Zosyn in pediatric patients with impaired renal function.<br/>Directions for Reconstitution and Dilution for Use:<br/>Intravenous Administration: RECONSTITUTED STOCK SOLUTION MUST BE TRANSFERRED AND FURTHER
DILUTED FOR I.V. 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.<br/>Compatible Reconstitution Diluents: 0.9% Sodium Chloride for InjectionSterile
Water for InjectionDextrose 5%Bacteriostatic
Saline/ParabensBacteriostatic Water/ParabensBacteriostatic Saline/Benzyl
AlcoholBacteriostatic Water/Benzyl Alcohol Reconstituted
Zosyn solution 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.<br/>Compatible Intravenous Solutions: 0.9% Sodium Chloride for InjectionSterile
Water for InjectionDextran 6% in SalineDextrose
5%Lactated Ringer's Solution (Compatible only with reformulated Zosyn containing EDTA) Maximum
recommended volume per dose of Sterile Water for Injection is 50 mL. Zosyn should not be mixed with other drugs in a syringe
or infusion bottle since compatibility has not been established. Zosyn is not chemically stable in solutions that contain
only sodium bicarbonate and solutions that significantly alter the pH. Zosyn should not be added to blood products or albumin
hydrolysates. Zosyn can be used
in ambulatory intravenous infusion pumps.<br/>Stability of Zosyn Following Reconstitution: Zosyn 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]). 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. Zosyn contains no preservatives. Appropriate consideration of
aseptic technique should be used. Stability
of Zosyn (piperacillin and tazobactam for injection) 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 Zosyn is not affected when administered using an
ambulatory intravenous infusion pump. Parenteral
drug products should be inspected visually for particulate matter or discoloration
prior to administration, whenever solution and container permit.
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Package: The PHARMACY BULK VIAL is a container of sterile
preparation which contains many single doses for parenteral use. The contents
are intended for use in a pharmacy admixture program and are restricted to
the preparation of admixtures for intravenous infusion.<br/>Product: Zosyn (piperacillin and tazobactam for injection)
is an injectable antibacterial combination product consisting of the semisynthetic
antibiotic piperacillin sodium and the��-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-1-azabicyclo[3.2.0]heptane-
2-carboxylate. The chemical formula is CHNNaOS
and the molecular weight is 539.5. The chemical structure of piperacillin
sodium is: 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.
The chemical formula is CHNNaOS
and the molecular weight is 322.3. The chemical structure of tazobactam sodium
is: Zosyn, piperacillin/tazobactam parenteral
combination, is a white to off-white sterile, cryodesiccated powder consisting
of piperacillin and tazobactam as their sodium salts packaged in glass vials.
The formulation also contains 9 mg of edetate disodium dihydrate (EDTA) and
sodium citrate. Each Zosyn 40.5 g pharmacy
bulk vial contains piperacillin sodium equivalent to 36 grams of piperacillin
and tazobactam sodium equivalent to 4.5 g of tazobactam sufficient for
delivery of multiple doses. Zosyn is a monosodium
salt of piperacillin and a monosodium salt of tazobactam containing a total
of 2.79 mEq (64 mg) of Naper gram of piperacillin in
the combination product.
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Adults: Peak plasma concentrations of piperacillin and tazobactam
are attained immediately after completion of an intravenous infusion of Zosyn
(piperacillin and tazobactam for injection). Piperacillin plasma concentrations,
following a 30-minute infusion of Zosyn (piperacillin and tazobactam for injection),
were similar to those attained when equivalent doses of piperacillin were
administered alone, with mean peak plasma concentrations of approximately
134��g/mL, 242��g/mL, and 298��g/mL for the
2.25 g, 3.375 g, and 4.5 g Zosyn (piperacillin and tazobactam
for injection) doses, respectively. The corresponding mean peak plasma concentrations
of tazobactam were 15��g/mL, 24��g/mL, and 34��g/mL,
respectively. Following a 30-minute I.V. infusion
of 3.375 g Zosyn (piperacillin and tazobactam for injection) every 6
hours, steady-state plasma concentrations of piperacillin and tazobactam were
similar to those attained after the first dose. In like manner, steady-state
plasma concentrations were not different from those attained after the first
dose when 2.25 g or 4.5 g doses of Zosyn (piperacillin and tazobactam
for injection) were administered via 30-minute infusions every 6 hours. Steady-state
plasma concentrations after 30-minute infusions every 6 hours are provided
in Table 1. Following single or multiple Zosyn
doses to healthy subjects, the plasma half-life of piperacillin and of tazobactam
ranged from 0.7 to 1.2 hours and was unaffected by dose or duration of infusion. Piperacillin is metabolized to a minor microbiologically active
desethyl metabolite. Tazobactam is metabolized to a single metabolite that
lacks pharmacological and antibacterial activities. Both piperacillin and
tazobactam are eliminated via the kidney by glomerular filtration and tubular
secretion. Piperacillin is excreted rapidly as unchanged drug with 68% of
the administered dose excreted in the urine. Tazobactam and its metabolite
are eliminated primarily by renal excretion with 80% of the administered dose
excreted as unchanged drug and the remainder as the single metabolite. Piperacillin,
tazobactam, and desethyl piperacillin are also secreted into the bile. Both piperacillin and tazobactam are approximately 30% bound
to plasma proteins. The protein binding of either piperacillin or tazobactam
is unaffected by the presence of the other compound. Protein binding of the
tazobactam metabolite is negligible. Piperacillin
and tazobactam are widely distributed into tissues and body fluids including
intestinal mucosa, gallbladder, lung, female reproductive tissues (uterus,
ovary and fallopian tube), interstitial fluid, and bile. Mean tissue concentrations
are generally 50% to 100% of those in plasma. Distribution of piperacillin
and tazobactam into cerebrospinal fluid is low in subjects with non-inflamed
meninges, as with other penicillins. After the
administration of single doses of piperacillin/tazobactam to subjects with
renal impairment, the half-life of piperacillin and of tazobactam increases
with decreasing creatinine clearance. At creatinine clearance below 20 mL/min,
the increase in half-life is twofold for piperacillin and fourfold for tazobactam
compared to subjects with normal renal function. Dosage adjustments for Zosyn
are recommended when creatinine clearance is below 40 mL/min in patients
receiving the usual recommended daily dose of Zosyn. (See DOSAGE AND ADMINISTRATION section
for specific recommendations for the treatment of patients with renal insufficiency.) Hemodialysis removes 30 to 40% of a piperacillin/tazobactam
dose with an additional 5% of the tazobactam dose removed as the tazobactam
metabolite. Peritoneal dialysis removes approximately 6% and 21% of the piperacillin
and tazobactam doses, respectively, with up to 16% of the tazobactam dose
removed as the tazobactam metabolite. For dosage recommendationsfor patients
undergoing hemodialysis, see DOSAGE
AND ADMINISTRATION section. The
half-life of piperacillin and of tazobactam increases by approximately 25%
and 18%, respectively, in patients with hepatic cirrhosis compared to healthy
subjects. However, this difference does not warrant dosage adjustment of Zosyn
due to hepatic cirrhosis.<br/>Pediatrics: Piperacillin and tazobactam pharmacokinetics were studied
in pediatric patients 2 months of age and older. The clearance of both compounds
is slower in the younger patients compared to older children and adults. In
a population PK analysis, estimated clearance for 9 month-old to 12 year-old
patients was comparable to adults, with a population mean (SE) value of 5.64
(0.34) mL/min/kg. The piperacillin clearance estimate is 80% of this value
for pediatric patients 2 - 9 months old. In patients younger than 2 months
of age, clearance of piperacillin is slower compared to older children; however,
it is not adequately characterized for dosing recommendations. The population
mean (SE) for piperacillin distribution volume is 0.243 (0.011) L/kg and is
independent of age.<br/>Microbiology: Piperacillin sodium exerts bactericidal activity
by inhibiting septum formation and cell wall synthesis of susceptible bacteria.
In vitro, piperacillin is active against a variety of gram-positive and gram-negative
aerobic and anaerobic bacteria. Tazobactam sodium has little clinically relevant
in vitro activity against bacteria due to its reduced affinity to penicillin-binding
proteins. It is, however, a��-lactamase inhibitor of the Richmond-Sykes
class III (Bush class 2b&2b') penicillinases and cephalosporinases.
It varies in its ability to inhibit class II and IV (2a&4) penicillinases.
Tazobactam does not induce chromosomally-mediated��-lactamases at tazobactam
concentrations achieved with the recommended dosage regimen. Piperacillin/tazobactam has been shown to be active against
most strains of the following microorganisms both in vitro and in clinical
infections as described in the INDICATIONS
AND USAGE section.<br/>Aerobic and facultative Gram-positive microorganisms:: Staphylococcus
aureus (excluding methicillin and oxacillin-resistant isolates)<br/>Aerobic and facultative Gram-negative microorganisms:: Acinetobacter
baumaniiEscherichia coliHaemophilus influenzae (excluding��-lactamase negative, ampicillin-resistant isolates)Klebsiella pneumoniaePseudomonas aeruginosa (given
in combination with an aminoglycoside to which the isolate is susceptible)<br/>Gram-negative anaerobes:: Bacteroides
fragilis group (B. fragilis,B. ovatus,B. thetaiotaomicron, and B. vulgatus) The following in vitro data are available, but
their clinical significance is unknown. At
least 90% of the following microorganisms exhibit in vitro minimum inhibitory
concentration (MIC) less than or equal to the susceptible breakpoint for piperacillin/tazobactam.
However, the safety and effectiveness of piperacillin/tazobactam in treating
clinical infections due to these bacteria have not been established in adequate
and well-controlled clinical trials.<br/>Aerobic and facultative Gram-positive microorganisms:: Enterococcus
faecalis (ampicillin or penicillin-susceptible isolates only)Staphylococcus epidermidis (excluding methicillin
and oxacillin-resistant isolates)Streptococcus
agalactiaeStreptococcus
pneumoniae(penicillin-susceptible isolates only)Streptococcus pyogenesViridans
group streptococci<br/>Aerobic and facultative Gram-negative microorganisms:: Citrobacter koseriMoraxella catarrhalisMorganella morganiiNeisseria gonorrhoeaeProteus mirabilisProteus vulgarisSerratia marcescensProvidencia stuartiiProvidencia rettgeriSalmonella enterica<br/>Gram-positive anaerobes:: Clostridium perfringens<br/>Gram-negative anaerobes:: Bacteroides distasonisPrevotella melaninogenica These
are not��-lactamase producing bacteria and, therefore, are susceptible
to piperacillin alone.<br/>Susceptibility Testing Methods: As is recommended with all antimicrobials, the
results of in vitro susceptibility tests, when available, should be provided
to the physician as periodic reports, which describe the susceptibility profile
of nosocomial and community acquired pathogens. These reports should aid the
physician in selecting the most effective antimicrobial.<br/>Dilution Techniques:: Quantitative methods are used to determine antimicrobial
minimum inhibitory concentrations (MICs). These MICs provide estimates of
the susceptibility of bacteria to antimicrobial compounds. The MICs should
be determined using a standardized procedure. Standardized procedures are
based on a dilution method (broth or agar) or equivalent with standardized
inoculum concentrations and standardized concentrations of piperacillin and
tazobactam powders.1,2 MIC values should
be determined using serial dilutions of piperacillin combined with a fixed
concentration of 4��g/mL tazobactam. The MIC values obtained should
be interpreted according to criteria provided in Table 2.<br/>Diffusion Technique:: Quantitative methods that require measurement
of zone diameters also provide reproducible estimates of the susceptibility
of bacteria to antimicrobial compounds. One such standardized procedure1,3 requires the use of standardized inoculum
concentrations. This procedure uses paper disks impregnated with 100��g
of piperacillin and 10��g of tazobactam to test the susceptibility
of microorganisms to piperacillin/tazobactam. The disk diffusion interpreted
criteria are provided in Table
2.<br/>Anaerobic Techniques: For anaerobic bacteria, the susceptibility to piperacillin/tazobactam
can be determined by the reference agar dilution method.4 A report of S (���Susceptible���)
indicates that the pathogen is likely to be inhibited if the antimicrobial
compound in the blood reaches the concentrations usually achievable. A report
of I (���Intermediate���) indicates that the results should
be considered equivocal, and, if the microorganism is not fully susceptible
to alternative, clinically feasible drugs, the test should be repeated. This
category implies possible clinical applicability in body sites where the drug
is physiologically concentrated or in situations where high dosage of drug
can be used. This category also provides a buffer zone, which prevents small
uncontrolled technical factors from causing major discrepancies in interpretation.
A report of R (���Resistant���) indicates that the pathogen
is not likely to be inhibited if the antimicrobial compound in the blood reaches
the concentrations usually achievable; other therapy should be considered.<br/>Quality Control: Standardized susceptibility test procedures require
the use of laboratory control microorganisms to control the technical aspects
of the test procedures.1,2,3,4 Standard
piperacillin/tazobactam powder should provide the following ranges of values
noted in Table 3. Quality control microorganisms are specific strains of microorganisms
with intrinsic biological properties relating to resistance mechanisms and
their genetic expression within the microorganism; the specific strains used
for microbiological quality control are not clinically significant.
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Zosyn is contraindicated in patients with a history
of allergic reactions to any of the penicillins, cephalosporins, or��-lactamase
inhibitors.
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Zosyn (piperacillin and tazobactam
for injection) is supplied as a powder in the pharmacy bulk vial as follows: Each 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, 9 mg of edetate disodium dihydrate (EDTA) and 1800
mg of sodium citrate. Each pharmacy bulk vial contains 100.4 mEq (2,304 mg)
of sodium. NDC 0206-8859-10 Zosyn
(piperacillin and tazobactam for injection) pharmacy bulk vials should be
stored at controlled room temperature 20��C to 25��C (68��F to
77��F) prior to reconstitution.<br/>Also Available: Zosyn (piperacillin and tazobactam for injection)
is also supplied as follows: 2.25 g single-dose
vial containing piperacillin sodium equivalent to 2 g of piperacillin
and tazobactam sodium equivalent to 0.25 g of tazobactam. Each vial contains
5.58 mEq (128 mg) of sodium. Supplied 10/box���NDC 0206-8852-16 3.375 g single-dose vial containing piperacillin sodium
equivalent to 3 g of piperacillin and tazobactam sodium equivalent to
0.375 g of tazobactam. Each vial contains 8.38 mEq (192 mg) of sodium.
Supplied 10/box���NDC 0206-8854-16 4.5 g
single-dose vial containing piperacillin sodium equivalent to 4 g of
piperacillin and tazobactam sodium equivalent to 0.5 g of tazobactam.
Each vial contains 11.17 mEq (256 mg) of sodium. Supplied 10/box���NDC
0206-8855-16 Zosyn (piperacillin and tazobactam
for injection) is also supplied in the ADD-Vantage Vial as
follows: 2.25 g ADD-Vantage vial
(piperacillin sodium equivalent to 2 g piperacillin and tazobactam sodium
equivalent to 0.25 g of tazobactam). Each ADD-Vantage vial
contains 5.58 mEq (128 mg) of sodium. Supplied 10/box���NDC 0206-8852-18 3.375 g ADD-Vantage vial (piperacillin
sodium equivalent to 3 g piperacillin and tazobactam sodium equivalent
to 0.375 g of tazobactam). Each ADD-Vantage vial contains
8.38 mEq (192 mg) of sodium. Supplied 10/box���NDC 0206-8854-18 4.5 g ADD-Vantage vial (piperacillin
sodium equivalent to 4 g piperacillin and tazobactam sodium equivalent
to 0.5 g of tazobactam). Each ADD-Vantage vial contains
11.17 mEq (256 mg) of sodium. Supplied 10/box���NDC 0206-8855-18<br/>Also Available: Zosyn (piperacillin and tazobactam injection) in
Galaxy Container (PL 2040 Plastic) is supplied as a frozen,
iso-osmotic, sterile, nonpyrogenic solution in single-dose plastic containers
as follows: 2.25 g (piperacillin sodium
equivalent to 2 g piperacillin/tazobactam sodium equivalent to 0.25 g tazobactam)
in 50 mL. Each container has 5.58 mEq (128 mg) of sodium. Supplied
24/box���NDC 0206-8860-02 3.375 g
(piperacillin sodium equivalent to 3 g piperacillin/tazobactam sodium
equivalent to 0.375 g tazobactam) in 50 mL. Each container has 8.38
mEq (192 mg) of sodium. Supplied 24/box���NDC 0206-8861-02 4.5 g (piperacillin sodium equivalent to 4 g piperacillin/tazobactam
sodium equivalent to 0.5 g tazobactam) in 100 mL. Each container
has 11.17 mEq (256 mg) of sodium. Supplied 12/box���NDC 0206-8862-02
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General: Bleeding manifestations have occurred in some patients
receiving��-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, Zosyn (piperacillin and tazobactam for injection) should be discontinued
and appropriate therapy instituted. The possibility
of the emergence of resistant organisms that might cause superinfections should
be kept in mind. If this occurs, appropriate measures should be taken. 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). Zosyn
is a monosodium salt of piperacillin and a monosodium salt of tazobactam and
contains a total of 2.79 mEq (64 mg) of Naper 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. As with other semisynthetic penicillins, piperacillin therapy
has been associated with an increased incidence of fever and rash in cystic
fibrosis patients. In patients with creatinine
clearance���40 mL/min and dialysis patients (hemodialysis
and CAPD), the intravenous dose should be adjusted to the degree of renal
function impairment. (See DOSAGE
AND ADMINISTRATION.) Prescribing
Zosyn (piperacillin and tazobactam) in the absence of a proven or strongly
suspected bacterial infection or a prophylactic indication is unlikely to
provide benefit to the patient and increases the risk of development of drug-resistant
bacteria.<br/>Information for Patients: Patients should be counseled that antibacterial
drugs including Zosyn should only be used to treat bacterial infections. They
do not treat viral infections (e.g., the common cold). When Zosyn is prescribed
to treat a bacterial infection, patients should be told that although it is
common to feel better early in the course of therapy, the medication should
be taken exactly as directed. Skipping doses or not completing the fullcourse
of therapy may (1) decrease the effectiveness of the immediate treatment and
(2) increase the likelihood that bacteria will develop resistance and will
not be treatable by Zosyn or other antibacterial drugs in the future. Diarrhea
is a common problem caused by antibiotics which usually ends when the antibiotic
is discontinued. Sometimes after starting treatment with antibiotics, patients
can develop watery and bloody stools (with or without stomach cramps and fever)
even as late as two or more months after having taken the last dose of the
antibiotic. If this occurs, patients should contact their physician as soon
as possible.<br/>Laboratory Tests: Periodic assessment of hematopoietic function should
be performed, especially with prolonged therapy, ie,���21 days.
(See ADVERSE REACTIONS, Adverse
Laboratory Events.)<br/>Drug Interactions:<br/>Aminoglycosides: The mixing of beta-lactam antibiotics with aminoglycosidesin vitro can result in substantial
inactivation of the aminoglycoside. However, amikacin and gentamicin have
been shown to be compatible in vitro with
reformulated Zosyn containing EDTA supplied in vials or bulk pharmacy containers
in certain diluents at specific concentrations for a simultaneous Y-site infusion.
Reformulated Zosyn containing EDTA is not compatible with tobramycin
for simultaneous co-administration via Y-site infusion. The inactivation of aminoglycosides in the presence of penicillin-class
drugs has been recognized. It has been postulated that penicillin-aminoglycoside
complexes form; these complexes are microbiologically inactive and of unknown
toxicity. Sequential administration of Zosyn with tobramycin to patients with
normal renal function and mild to moderate renal impairment has been shown
to modestly decrease serum concentrations of tobramycin but does not significantly
affect tobramycin pharmacokinetics. When aminoglycosides are administered
in combination with piperacillin to patients with end-stage renal disease
requiring hemodialysis, the concentrations of the aminoglycosides (especially
tobramycin) may be significantly altered and should be monitored. Since aminoglycosides
are not equally susceptible to inactivation by piperacillin, consideration
should be given to the choice of the aminoglycoside when administered in combination
with piperacillin to these patients.<br/>Probenecid: Probenecid administered concomitantly with Zosyn
prolongs the half-life of piperacillin by 21% and of tazobactam by 71%.<br/>Vancomycin: No pharmacokinetic interactions have been noted
between Zosyn and vancomycin.<br/>Heparin: Coagulation parameters should be tested more frequently
and monitored regularly during simultaneous administration of high doses of
heparin, oral anticoagulants, or other drugs that may affect the blood coagulation
system or the thrombocyte function.<br/>Vecuronium: Piperacillin when used concomitantly with vecuronium
has been implicated in the prolongation of the neuromuscular blockade of vecuronium.
Zosyn (piperacillin/tazobactam) could produce the same phenomenon if given
along with vecuronium. Due to their similar mechanism of action, it is expected
that the neuromuscular blockade produced by any of the non-depolarizing muscle
relaxants could be prolonged in the presence of piperacillin. (See package
insert for vecuronium bromide.)<br/>Methotrexate: Limited data suggests that co-administration of
methotrexate and piperacillin may reduce the clearance of methotrexate due
to competition for renal secretion. The impact of tazobactam on the elimination
of methotrexate has not been evaluated. If concurrent therapy is necessary,
serum concentrations of methotrexate as well as the signs and symptoms of
methotrexate toxicity should be frequently monitored.<br/>Drug/Laboratory Test Interactions: As with other penicillins, the administration of
Zosyn (piperacillin and tazobactam for injection) may result in a false-positive
reaction for glucose in the urine using a copper-reduction method (CLINITEST).
It is recommended that glucose tests based on enzymatic glucose oxidase reactions
(such as DIASTIX or TES-TAPE) be used. There have been reports of positive test results using the
Bio-Rad Laboratories Platelia Aspergillus EIA
test in patients receiving piperacillin/tazobactam injection who were subsequently
found to be free of Aspergillus infection.
Cross-reactions with non-Aspergillus polysaccharides
and polyfuranoses with the Bio-Rad Laboratories Platelia Aspergillus EIA test have been reported. Therefore,
positive test results in patients receiving piperacillin/tazobactam should
be interpreted cautiously and confirmed by other diagnostic methods.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility: Long-term carcinogenicity studies in animals have
not been conducted with piperacillin/tazobactam, piperacillin, or tazobactam.<br/>Piperacillin/Tazobactam: Piperacillin/tazobactam was negative in microbial
mutagenicity assays at concentrations up to 14.84/1.86��g/plate.
Piperacillin/tazobactam was negative in the unscheduled DNA synthesis (UDS)
test at concentrations up to 5689/711��g/mL. Piperacillin/tazobactam
was negative in a mammalian point mutation (Chinese hamster ovary cell HPRT)
assay at concentrations up to 8000/1000��g/mL. Piperacillin/tazobactam
was negative in a mammalian cell (BALB/c-3T3) transformation assay at concentrations
up to 8/1��g/mL. In vivo, piperacillin/tazobactam did not induce
chromosomal aberrations in rats dosed I.V. with 1500/187.5 mg/kg; this
dose is similar to the maximum recommended human daily dose on a body-surface-area
basis (mg/m).<br/>Piperacillin: Piperacillin was negative in microbial mutagenicity
assays at concentrations up to 50��g/plate. There was no DNA damage
in bacteria (Rec assay) exposed to piperacillin at concentrations up to 200��g/disk.
Piperacillin was negative in the UDS test at concentrations up to 10,000��g/mL.
In a mammalian point mutation (mouse lymphoma cells) assay, piperacillin was
positive at concentrations���2500��g/mL. Piperacillin was
negative in a cell (BALB/c-3T3) transformation assay at concentrations up
to 3000��g/mL. In vivo, piperacillin did not induce chromosomal
aberrations in mice at I.V. doses up to 2000 mg/kg/day or rats at I.V.
doses up to 1500 mg/kg/day. These doses are half (mice) or similar (rats)
to the maximum recommended human daily dose based on body���surface area
(mg/m). In another in vivo test, there was no dominant lethal
effect when piperacillin was administered to rats at I.V. doses up to 2000 mg/kg/day,
which is similar to the maximum recommended human daily dose based on body-surface
area (mg/m). When mice were administered piperacillin at I.V.
doses up to 2000 mg/kg/day, which is half the maximum recommended human
daily dose based on body���surface area (mg/m), urine from
these animals was not mutagenic when tested in a microbial mutagenicity assay.
Bacteria injected into the peritoneal cavity of mice administered piperacillin
at I.V. doses up to 2000 mg/kg/day did not show increased mutation frequencies.<br/>Tazobactam: Tazobactam was negative in microbial mutagenicity
assays at concentrations up to 333��g/plate. Tazobactam was negative
in the UDS test at concentrations up to 2000��g/mL. Tazobactam
was negative in a mammalian point mutation (Chinese hamster ovary cell HPRT)
assay at concentrations up to 5000��g/mL. In another mammalian
point mutation (mouse lymphoma cells) assay, tazobactam was positive at concentrations���3000��g/mL. Tazobactam was negative in a cell (BALB/c-3T3)
transformation assay at concentrations up to 900��g/mL. In an in
vitro cytogenetics (Chinese hamster lung cells) assay, tazobactam was negative
at concentrations up to 3000��g/mL. In vivo, tazobactam did not
induce chromosomal aberrations in rats at I.V. doses up to 5000 mg/kg,
which is 23 times the maximum recommended human daily dose based on body���surface
area (mg/m).<br/>Pregnancy:<br/>Teratogenic effects���Pregnancy Category B:<br/>Nursing Mothers: Piperacillin is excreted in low concentrations in
human milk; tazobactam concentrations in human milk have not been studied.
Caution should be exercised when Zosyn (piperacillin and tazobactam for injection)
is administered to a nursing woman.<br/>Pediatric Use: Use of Zosyn in pediatric patients 2 months of
age or older with appendicitis and/or peritonitis is supported by evidence
from well-controlled studies and pharmacokinetic studies in adults and in
pediatric patients. This includes a prospective, randomized, comparative,
open-label clinical trial with 542 pediatric patients 2-12 years of age with
complicated intra-abdominal infections, in which 273 pediatric patients received
piperacillin/tazobactam. Safety and efficacyin pediatric patients less than
2 months of age have not been established . There are no dosage recommendations for
Zosyn in pediatric patients with impaired renal function.<br/>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. In general, dose selection for
an elderly patient should be cautious, usually starting at the low end of
the dosing range, reflecting the greater frequency of decreased hepatic, renal,
or cardiac function, and of concomitant disease or other drug therapy. Zosyn contains 64 mg (2.79 mEq) of sodium per
gram of piperacillin in the combination product. At the usual recommended
doses, patients would receive between 768 and 1024 mg/day (33.5 and 44.6 mEq)
of sodium. The geriatric population may respond with a blunted natriuresis
to salt loading. This may be clinically important with regard to such diseases
as congestive heart failure. This drug is
known to be substantially excreted by the kidney, and the risk of toxic reactions
to this drug may be greater in patients with impaired renal function. Because
elderly patients are more likely to have decreased renal function, care should
be taken in dose selection, and it may be useful to monitor renal function.
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dailymed-instance:overdosag... |
There have been postmarketing reports of overdose
with piperacillin/tazobactam. The majority of those events experienced, including
nausea, vomiting, and diarrhea, have also been reported with the usual recommended
dosages. Patients may experience neuromuscular excitability or convulsions
if higher than recommended doses are given intravenously (particularly in
the presence of renal failure). Treatment should
be supportive and symptomatic according to the patient's clinical presentation.
Excessive serum concentrations of either piperacillin or tazobactam may be
reduced by hemodialysis. Following a single 3.375 g dose of piperacillin/tazobactam,
the percentage of piperacillin and tazobactam dose removed by hemodialysis
was approximately 31% and 39%, respectively.
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dailymed-instance:genericMe... |
Piperacillin sodium and Tazobactam sodium
|
dailymed-instance:fullName |
Zosyn (Injection, Powder, Lyophilized, For Solution)
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dailymed-instance:adverseRe... |
Adverse Events From Clinical Trials: During the initial clinical investigations, 2621
patients worldwide were treated with Zosyn (piperacillin and tazobactam for
injection) in phase 3 trials. In the key North American 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,
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%). Adverse local reactions that were reported, irrespective
of relationship to therapy with Zosyn, were phlebitis (1.3%), injection site
reaction (0.5%), pain (0.2%), inflammation (0.2%), thrombophlebitis (0.2%),
and edema (0.1%). Based on patients from the
North American trials (n=1063), the events with the highest incidence in patients,
irrespective of relationship to Zosyn therapy, were diarrhea (11.3%); headache
(7.7%); constipation (7.7%); nausea (6.9%); insomnia (6.6%); rash (4.2%),
including maculopapular, bullous, urticarial, and eczematoid; vomiting (3.3%);
dyspepsia (3.3%); pruritus (3.1%); stool changes (2.4%); fever (2.4%); agitation
(2.1%); pain (1.7%); moniliasis (1.6%); hypertension (1.6%); dizziness (1.4%);
abdominal pain (1.3%); chest pain (1.3%); edema (1.2%); anxiety (1.2%); rhinitis
(1.2%); and dyspnea (1.1%). Additional adverse
systemic clinical events reported in 1.0% or less of the patients in the initial
North American trials are listed below within each body system. Autonomic nervous
system���hypotension, ileus, syncope Body as a whole���rigors,
back pain, malaise Cardiovascular���tachycardia, including supraventricular and ventricular;
bradycardia; arrhythmia, including atrial fibrillation, ventricular fibrillation,
cardiac arrest, cardiac failure, circulatory failure, myocardial infarction Central nervous system���tremor, convulsions, vertigo Gastrointestinal���melena,
flatulence, hemorrhage, gastritis, hiccough, ulcerative stomatitis Pseudomembranous colitis was reported in one patient during
the clinical trials. The onset of pseudomembranous colitis symptoms may occur
during or after antibacterial treatment. Hearing and Vestibular System���tinnitus Hypersensitivity���anaphylaxis Metabolic and Nutritional���symptomatic
hypoglycemia, thirst Musculoskeletal���myalgia, arthralgia Platelets, Bleeding, Clotting���mesenteric
embolism, purpura, epistaxis, pulmonary embolism Psychiatric���confusion,
hallucination, depression Reproductive, Female���leukorrhea, vaginitis Respiratory���pharyngitis,
pulmonary edema, bronchospasm, coughing Skin and Appendages���genital
pruritus, diaphoresis Special
senses���taste perversion Urinary���retention, dysuria,
oliguria, hematuria, incontinence Vision���photophobia Vascular (extracardiac)���flushing<br/>Nosocomial Pneumonia Trials: In a completed study of nosocomial lower respiratory
tract infections, 222 patients were treated with 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. In this study of Zosyn in combination with an aminoglycoside,
adverse events that occurred in more than 1% of patients and were considered
by the investigator to be drug-related were: diarrhea (17.6%), fever (2.7%),
vomiting (2.7%), urinary tract infection (2.7%), rash (2.3%), abdominal pain
(1.8%), generalized edema (1.8%), moniliasis (1.8%), nausea (1.8%), oral moniliasis
(1.8%), BUN increased (1.8%), creatinine increased (1.8%), peripheral edema
(1.8%), abdomen enlarged (1.4%), headache (1.4%), constipation (1.4%), liver
function tests abnormal (1.4%), thrombocythemia (1.4%), excoriations (1.4%),
and sweating (1.4%). Drug-related adverse
events reported in 1% or less of patients in the nosocomial pneumonia study
of Zosyn with an aminoglycoside were: acidosis, acute kidney failure, agitation,
alkaline phosphatase increased, anemia, asthenia, atrial fibrillation, chest
pain, CNS depression, colitis, confusion, convulsion, cough increased, thrombocytopenia,
dehydration, depression, diplopia, drug level decreased, dry mouth, dyspepsia,
dysphagia, dyspnea, dysuria, eosinophilia, fungal dermatitis, gastritis, glossitis,
grand mal convulsion, hematuria, hyperglycemia, hypernatremia, hypertension,
hypertonia, hyperventilation, hypochromic anemia, hypoglycemia, hypokalemia,
hyponatremia, hypophosphatemia, hypoxia, ileus, injection site edema, injection
site pain, injection site reaction, kidney function abnormal, leukocytosis,
leukopenia, local reaction to procedure, melena, pain, prothrombin decreased,
pruritus, respiratory disorder, SGOT increased, SGPT increased, sinus bradycardia,
somnolence, stomatitis, stupor, tremor, tachycardia, ventricular extrasystoles,
and ventricular tachycardia. In a previous
nosocomial pneumonia study conducted with a dosing regimen of 3.375 g
given every 4 hours with an aminoglycoside, the following adverse events,
irrespective of drug relationship, were observed: diarrhea (20%); constipation
(8.4%); agitation (7.1%); nausea (5.8%); headache (4.5%); insomnia (4.5%);
oral thrush (3.9%); erythematous rash (3.9%); anxiety (3.2%); fever (3.2%);
pain (3.2%); pruritus (3.2%); hiccough (2.6%); vomiting (2.6%); dyspepsia
(1.9%); edema (1.9%); fluid overload (1.9%); stool changes (1.9%); anorexia
(1.3%); cardiac arrest (1.3%); confusion (1.3%); diaphoresis (1.3%); duodenal
ulcer (1.3%); flatulence (1.3%); hypertension (1.3%); hypotension (1.3%);
inflammation at injection site (1.3%); pleural effusion (1.3%); pneumothorax
(1.3%); rash, not otherwise specified (1.3%); supraventricular tachycardia
(1.3%); thrombophlebitis (1.3%); and urinary incontinence (1.3%). Adverse events irrespective of drug relationship observed
in 1% or less of patients in the above study with Zosyn and an aminoglycoside
included: aggressive reaction (combative), angina, asthenia, atelectasis,
balanoposthitis, cerebrovascular accident, chest pain, conjunctivitis, deafness,
dyspnea, earache, ecchymosis, fecal incontinence, gastric ulcer, gout, hemoptysis,
hypoxia, pancreatitis, perineal irritation/pain, urinary tract infection with
trichomonas, vitamin Bdeficiency anemia, xerosis, and yeast
in urine.<br/>Pediatrics: Studies of Zosyn in pediatric patients suggest a similar
safety profile to that seen in adults. In a prospective, randomized, comparative,
open-label clinical trial of pediatric patients with severe intra-abdominal
infections (including appendicitis and/or peritonitis), 273 patients were
treated with Zosyn (112.5 mg/kg every 8 hours) and 269 patients were treated
with cefotaxime (50 mg/kg) plus metronidazole (7.5 mg/kg) every 8 hours. In
this trial, treatment-emergent adverse events were reported by 146 patients,
73 (26.7%) in the Zosyn group and 73 (27.1%) in the cefotaxime/metronidazole
group. Six patients (2.2%) in the Zosyn group and 5 patients (1.9%) in the
cefotaxime/metronidazole group discontinued due to an adverse event. In
this study, adverse events that were reported in more than 1% of patients,
irrespective of relationship to therapy with Zosyn were: diarrhea (7.0%),
fever (4.8%), vomiting (3.7%), local reaction (3.3%), abscess (2.2%), sepsis
(2.2%), abdominal pain (1.8%), infection (1.8%), bloody diarrhea (1.1%), pharyngitis
(1.5%), constipation (1.1%) and SGOT increase (1.1%). Adverse
events reported in 1% or less of pediatric patients receiving Zosyn are consistent
with adverse events reported in adults. Additional controlled
studies in pediatric patients showed a similar safety profile as that described
above.<br/>Post-Marketing Experience: Additional adverse events reported from worldwide
marketing experience with Zosyn, occurring under circumstances where causal
relationship to Zosyn is uncertain: Gastrointestinal���hepatitis,
cholestatic jaundice Hematologic���hemolytic anemia, anemia,
thrombocytosis, agranulocytosis, pancytopenia Immune������hypersensitivity
reactions, anaphylactic/anaphylactoid reactions (including shock) Infections������candidal
superinfections Renal���interstitial nephritis, renal failure Skin and Appendages���erythema multiforme, Stevens-Johnson syndrome, toxic epidermal
necrolysis Post-marketing experience with Zosyn in
pediatric patients suggests a similar safety profile to that seen in adults.<br/>Adverse Laboratory Events (Seen During Clinical Trials): Of the studies reported, including that of nosocomial
lower respiratory tract infections in which a higher dose of Zosyn (piperacillin
and tazobactam for injection) was used in combination with an aminoglycoside,
changes in laboratory parameters, without regard to drug relationship, include: Hematologic���decreases
in hemoglobin and hematocrit, thrombocytopenia, increases in platelet count,
eosinophilia, leukopenia, neutropenia. The leukopenia/neutropenia associated
with Zosyn administration appears to be reversible and most frequently associated
with prolonged administration, i.e.,���21 days of therapy. These
patients were withdrawn from therapy; some had accompanying systemic symptoms
(eg, fever, rigors, chills). Coagulation���positive direct Coombs'
test, prolonged prothrombin time, prolonged partial thromboplastin time Hepatic���transient
elevations of AST (SGOT), ALT (SGPT), alkaline phosphatase, bilirubin Renal���increases
in serum creatinine, blood urea nitrogen Urinalysis���proteinuria,
hematuria, pyuria Additional laboratory events
include abnormalities in electrolytes (ie, increases and decreases in sodium,
potassium and calcium), hyperglycemia, decreases in total protein or albumin,
blood glucose decreased, gamma-glutamyltransferase increased, hypokalemia,
and bleeding time prolonged. The following
adverse reaction has also been reported for PIPRACIL (piperacillin
for injection): Skeletal���prolonged muscle relaxation Piperacillin therapy has been associated with an increased
incidence of fever and rash in cystic fibrosis patients.
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dailymed-instance:warning |
SERIOUS AND OCCASIONALLY FATAL HYPERSENSITIVITY (ANAPHYLACTIC/ANAPHYLACTOID)
REACTIONS (INCLUDING SHOCK) HAVE BEEN REPORTED IN PATIENTS RECEIVING THERAPY
WITH PENICILLINS INCLUDING ZOSYN. THESE REACTIONS ARE MORE LIKELY TO OCCUR
IN INDIVIDUALS WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY OR A HISTORY
OF SENSITIVITY TO MULTIPLE ALLERGENS. THERE HAVE BEEN REPORTS OF INDIVIDUALS
WITH A HISTORY OF PENICILLIN HYPERSENSITIVITY WHO HAVE EXPERIENCED SEVERE
REACTIONS WHEN TREATED WITH CEPHALOSPORINS. BEFORE INITIATING THERAPY WITH
ZOSYN, CAREFUL INQUIRY SHOULD BE MADE CONCERNING PREVIOUS HYPERSENSITIVITY
REACTIONS TO PENICILLINS, CEPHALOSPORINS, OR OTHER ALLERGENS. IF AN ALLERGIC
REACTION OCCURS, ZOSYN SHOULD BE DISCONTINUED AND APPROPRIATE THERAPY INSTITUTED. SERIOUS ANAPHYLACTIC/ ANAPHYLACTOID REACTIONS (INCLUDING
SHOCK) REQUIRE IMMEDIATE EMERGENCY TREATMENT WITH EPINEPHRINE. OXYGEN, INTRAVENOUS
STEROIDS, AND AIRWAY MANAGEMENT, INCLUDING INTUBATION, SHOULD ALSO BE ADMINISTERED
AS INDICATED. Clostridium
difficile associated diarrhea (CDAD) has been reported with use
of nearly all antibacterial agents, including 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 antibiotic
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 antibiotic use not directed against C. difficile may need to be discontinued. Appropriate
fluid and electrolyte management, protein supplementation, antibiotic treatment
of C. difficile, and surgical evaluation
should be instituted as clinically indicated.
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dailymed-instance:indicatio... |
Zosyn (piperacillin and tazobactam for injection)
is indicated for the treatment of patients with moderate to severe infections
caused by piperacillin-resistant, piperacillin/tazobactam-susceptible,��-lactamase
producing strains of the designated microorganisms in the specified conditions
listed below: Appendicitis (complicated by rupture
or abscess) and peritonitis caused by piperacillin-resistant,��-lactamase
producing strains of Escherichia coli or
the following members of the Bacteroides fragilis group: B. fragilis, B. ovatus, B. thetaiotaomicron, or B. vulgatus. The
individual members of this group were studied in less than 10 cases. Uncomplicated and complicated skin and skin structure infections,
including cellulitis, cutaneous abscesses and ischemic/diabetic foot infections
caused by piperacillin-resistant,�����lactamase producing strains
of Staphylococcus aureus. Postpartum endometritis or pelvic inflammatory disease caused
by piperacillin-resistant,�����lactamase producing strains of Escherichia coli. Community-acquired
pneumonia (moderate severity only) caused by piperacillin-resistant,�����lactamase
producing strains of Haemophilus influenzae. Nosocomial pneumonia (moderate to severe) caused by piperacillin-resistant,��-lactamase producing strains of Staphylococcus
aureus and by piperacillin/tazobactam-susceptible Acinetobacter
baumanii, Haemophilus influenzae, Klebsiella pneumoniae, and Pseudomonas
aeruginosa (Nosocomial pneumonia caused by P. aeruginosa should be treated in combination with an aminoglycoside). Zosyn (piperacillin and tazobactam
for injection) is indicated only for the specified conditions listed above.
Infections caused by piperacillin-susceptible organisms, for which piperacillin
has been shown to be effective, are also amenable to Zosyn 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 mixed infections caused by piperacillin���susceptible
organisms and piperacillin-resistant,�����lactamase producing organisms
susceptible to Zosyn should not require the addition of another antibiotic. Zosyn is useful as presumptive
therapy in the indicated conditions prior to the 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 Zosyn. Antimicrobial therapy should be adjusted, if
appropriate, once the results of culture(s) and antimicrobial susceptibility
testing are known. To reduce the development
of drug-resistant bacteria and maintain the effectiveness of Zosyn (piperacillin
and tazobactam) injection and other antibacterial drugs, Zosyn (piperacillin
and tazobactam) should be used only to treat or prevent 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.
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dailymed-instance:represent... | |
dailymed-instance:routeOfAd... | |
dailymed-instance:name |
Zosyn
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