Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3247
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AZACTAM (Injection, Powder, For Solution)
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Dosage in Adult Patients: AZACTAM may be administered intravenously or by intramuscular injection.
Dosage and route of administration should be determined by susceptibility
of the causative organisms, severity and site of infection, and the condition
of the patient. The intravenous route is recommended for patients requiring single
doses greater than 1 g or those with bacterial septicemia, localized parenchymal
abscess (eg, intra-abdominal abscess), peritonitis or other severe systemic
or life-threatening infections. The duration of therapy depends on the severity of infection. Generally,
AZACTAM should be continued for at least 48 hours after the patient becomes
asymptomatic or evidence of bacterial eradication has been obtained. Persistent
infections may require treatment for several weeks. Doses smaller than those
indicated should not be used.<br/>Renal Impairment in Adult Patients: Prolonged serum levels of aztreonam may occur in patients with
transient or persistent renal insufficiency. Therefore, the dosage of AZACTAM
should be halved in patients with estimated creatinine clearances between
10 mL/min/1.73 mand 30 mL/min/1.73 mafter
an initial loading dose of 1 g or 2 g. When only the serum creatinine concentration is available, the
following formula (based on sex, weight, and age of the patient) may be used
to approximate the creatinine clearance (Clcr). The serum creatinine should
represent a steady state of renal function. weight
(kg)��(140-age)Males: Clcr =���������������������������������������������72��serum creatinine (mg/dL) Females: 0.85��above value In patients with severe renal failure (creatinine clearance less
than 10 mL/min/1.73 m), such as those supported
by hemodialysis, the usual dose of 500 mg, 1 g or 2 g should be given initially.
The maintenance dose should be one-fourth of the usual initial dose given
at the usual fixed interval of 6, 8 or 12 hours. For serious or life-threatening
infections, in addition to the maintenance doses, one-eighth of the initial
dose should be given after each hemodialysis session.<br/>Dosage in the Elderly: Renal status is a major determinant of dosage in the elderly; these
patients in particular may have diminished renal function. Serum creatinine
may not be an accurate determinant of renal status. Therefore, as with all
antibiotics eliminated by the kidneys, estimates of creatinine clearance should
be obtained, and appropriate dosage modifications made if necessary.<br/>Dosage in Pediatric Patients: AZACTAM (aztreonam for injection, USP) should be administered intravenously
to pediatric patients with normal renal function. There are insufficient data
regarding intramuscular administration to pediatric patients or dosing in
pediatric patients with renal impairment. (See PRECAUTIONS:
Pediatric Use.) Because of the serious nature of infections due to Pseudomonas
aeruginosa, dosage of 2 g every 6 or 8 hours is recommended, at least
upon initiation of therapy, in systemic infections caused by this organism
in adults.<br/>CLINICAL STUDIES: A total of 612 pediatric patients aged 1 month to 12 years were
enrolled in uncontrolled clinical trials of aztreonam in the treatment of
serious gram-negative infections, including urinary tract, lower respiratory
tract, skin and skin-structure, and intra-abdominal infections.<br/>Preparation Of Parenteral Solutions:<br/>General: Upon the addition of the diluent to the container, contents should
be shaken immediately and vigorously. Constituted
solutions are not for multiple-dose use; should the entire volume in the container
not be used for a single dose, the unused solution must be discarded. Depending upon the concentration of aztreonam and diluent used,
constituted AZACTAM yields a colorless to light straw yellow solution which
may develop a slight pink tint on standing (potency is not affected). Parenteral
drug products should be inspected visually for particulate matter and discoloration
whenever solution and container permit.<br/>Admixtures With Other Antibiotics: Intravenous infusion solutions of AZACTAM not exceeding 2% w/v
prepared with Sodium Chloride Injection, USP 0.9% or Dextrose Injection, USP
5%, to which clindamycin phosphate, gentamicin sulfate, tobramycin sulfate,
or cefazolin sodium have been added at concentrations usually used clinically,
are stable for up to 48 hours at room temperature or 7 days under refrigeration.
Ampicillin sodium admixtures with aztreonam in Sodium Chloride Injection,
USP 0.9% are stable for 24 hours at room temperature and 48 hours under refrigeration;
stability in Dextrose Injection, USP 5% is 2 hours at room temperature and
8 hours under refrigeration. Aztreonam-cloxacillin sodium and aztreonam-vancomycin hydrochloride
admixtures are stable in Dianeal 137 (Peritoneal Dialysis Solution) with 4.25%
Dextrose for up to 24 hours at room temperature. Aztreonam is incompatible with nafcillin sodium, cephradine, and
metronidazole. Other admixtures are not recommended since compatibility data are
not available.<br/>Intravenous (IV) Solutions:<br/>Intramuscular (IM) Solutions: The contents of an AZACTAM 15 mL capacity vial should be constituted
with at least 3 mL of an appropriate diluent per gram aztreonam. The following
diluents may be used:<br/>Stability Of IV And IM Solutions: AZACTAM solutions for IV infusion at concentrations not exceeding
2% w/v must be used within 48 hours following constitution if kept at controlled
room temperature (59��- 86��F/15��- 30��C) or within 7 days if refrigerated
(36��- 46��F/2��- 8��C). AZACTAM solutions at concentrations exceeding 2% w/v, except those
prepared with Sterile Water for Injection, USP or Sodium Chloride Injection,
USP, should be used promptly after preparation; the two excepted solutions
must be used within 48 hours if stored at controlled room temperature or within
7 days if refrigerated.<br/>Intravenous Administration:<br/>Intramuscular Administration: The dose should be given by deep injection into a large muscle
mass (such as the upper outer quadrant of the gluteus maximus or lateral part
of the thigh). Aztreonam is well tolerated and should not be admixed with
any local anesthetic agent.
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AZACTAM (aztreonam for injection, USP)
contains the active ingredient aztreonam, a monobactam. It was originally
isolated from Chromobacterium violaceum. It is a synthetic
bactericidal antibiotic. The monobactams, having a unique monocyclic beta-lactam nucleus,
are structurally different from other beta-lactam antibiotics (eg, penicillins,
cephalosporins, cephamycins). The sulfonic acid substituent in the 1-position
of the ring activates the beta-lactam moiety; an aminothiazolyl oxime side
chain in the 3-position and a methyl group in the 4-position confer the specific
antibacterial spectrum and beta-lactamase stability. Aztreonam is designated chemically as (Z)-2-[[[(2-amino-4-thiazolyl)[[(2S,3S)-2-methyl-4-oxo-1-sulfo-3-azetidinyl]carbamoyl]methylene]amino]oxy]-2-methylpropionic
acid. Structural formula: AZACTAM is a sterile, nonpyrogenic, sodium-free, white powder containing
approximately 780 mg arginine per gram of aztreonam. Following constitution,
the product is for intramuscular or intravenous use. Aqueous solutions of
the product have a pH in the range of 4.5 to 7.5.
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Single 30-minute intravenous infusions of 500 mg, 1 g, and 2 g
doses of AZACTAM (aztreonam for injection, USP) in healthy subjects produced
aztreonam peak serum levels of 54��g/mL, 90��g/mL, and 204��g/mL, respectively,
immediately after administration; at 8 hours, serum levels were 1��g/mL, 3��g/mL, and 6��g/mL, respectively (Figure 1). Single 3-minute intravenous injections
of the same doses resulted in serum levels of 58��g/mL, 125��g/mL, and 242��g/mL at 5 minutes following completion of injection. Serum concentrations of aztreonam in healthy subjects following
completion of single intramuscular injections of 500 mg and 1 g doses are
depicted in Figure 1; maximum serum concentrations occur at about 1 hour.
After identical single intravenous or intramuscular doses of AZACTAM, the
serum concentrations of aztreonam are comparable at 1 hour (1.5 hours from
start of intravenous infusion) with similar slopes of serum concentrations
thereafter. The serum levels of aztreonam following single 500 mg or 1 g (intramuscular
or intravenous) or 2 g (intravenous) doses of AZACTAM exceed the MICfor Neisseria sp., Haemophilus
influenzae and most genera of the Enterobacteriaceae for
8 hours (for Enterobacter sp., the 8-hour serum levels exceed
the MIC for 80% of strains). For Pseudomonas aeruginosa,
a single 2 g intravenous dose produces serum levels that exceed the MICfor
approximately 4 to 6 hours. All of the above doses of AZACTAM result in average
urine levels of aztreonam that exceed the MICfor
the same pathogens for up to 12 hours. When aztreonam pharmacokinetics were assessed for adult and pediatric
patients, they were found to be comparable (down to 9 months old). The serum
half-life of aztreonam averaged 1.7 hours (1.5 to 2.0) in subjects with normal
renal function, independent of the dose and route of administration. In healthy
subjects, based on a 70 kg person, the serum clearance was 91 mL/min and renal
clearance was 56 mL/min; the apparent mean volume of distribution at steady-state
averaged 12.6 liters, approximately equivalent to extracellular fluid volume. In elderly patients, the mean serum half-life of aztreonam increased
and the renal clearance decreased, consistent with the age-related decrease
in creatinine clearance.The dosage of AZACTAM
should be adjusted accordingly (see DOSAGE
AND ADMINISTRATION: Renal Impairment in Adult Patients). In patients with impaired renal function, the serum half-life of
aztreonam is prolonged. (See DOSAGE AND ADMINISTRATION:
Renal Impairment in Adult Patients.) The serum half-life of
aztreonam is only slightly prolonged in patients with hepatic impairment since
the liver is a minor pathway of excretion. Average urine concentrations of aztreonam were approximately 1100��g/mL, 3500��g/mL, and 6600��g/mL within the first 2 hours following single
500 mg, 1 g, and 2 g intravenous doses of AZACTAM (30-minute infusions), respectively.
The range of average concentrations for aztreonam in the 8- to 12-hour urine
specimens in these studies was 25��g/mL to 120��g/mL. After intramuscular
injection of single 500 mg and 1 g doses of AZACTAM (aztreonam for injection,
USP), urinary levels were approximately 500��g/mL and 1200��g/mL, respectively,
within the first 2 hours, declining to 180��g/mL and 470��g/mL in the 6- to
8-hour specimens. In healthy subjects, aztreonam is excreted in the urine
about equally by active tubular secretion and glomerular filtration. Approximately
60% to 70% of an intravenous or intramuscular dose was recovered in the urine
by 8 hours. Urinary excretion of a single parenteral dose was essentially
complete by 12 hours after injection. About 12% of a single intravenousradiolabeled
dose was recovered in the feces. Unchanged aztreonam and the inactive beta-lactam
ring hydrolysis product of aztreonam were present in feces and urine. Intravenous or intramuscular administration of a single 500 mg
or 1 g dose of AZACTAM every 8 hours for 7 days to healthy subjects produced
no apparent accumulation of aztreonam or modification of its disposition characteristics;
serum protein binding averaged 56% and was independent of dose. An average
of about 6% of a 1g intramuscular dose was excreted as a microbiologically
inactive open beta-lactam ring hydrolysis product (serum half-life approximately
26 hours) of aztreonam in the 0- to 8-hour urine collection on the last day
of multiple dosing. Renal function was monitored in healthy subjects given aztreonam;
standard tests (serum creatinine, creatinine clearance, BUN, urinalysis and
total urinary protein excretion) as well as special tests (excretion of N-acetyl-��-glucosaminidase,
alanine aminopeptidase and��-microglobulin) were used.
No abnormal results were obtained. Aztreonam achieves measurable concentrations in the following body
fluids and tissues: The concentration of aztreonam in saliva at 30 minutes after a
single 1 g intravenous dose (9 patients) was 0.2��g/mL; in human milk at 2
hours after a single 1 g intravenous dose (6 patients), 0.2��g/mL, and at
6 hours after a single 1 g intramuscular dose (6 patients), 0.3��g/mL; in
amniotic fluid at 6 to 8 hours after a single 1 g intravenous dose (5 patients),
2��g/mL. The concentration of aztreonam in peritoneal fluid obtained 1 to
6 hours after multiple 2 g intravenous doses ranged between 12��g/mL and 90��g/mL in 7 of 8 patients studied. Aztreonam given intravenously rapidly reaches therapeutic concentrations
in peritoneal dialysis fluid; conversely, aztreonam given intraperitoneally
in dialysis fluid rapidly produces therapeutic serum levels. Concomitant administration of probenecid or furosemide and AZACTAM
(aztreonam for injection, USP) causes clinically insignificant increases in
the serum levels of aztreonam. Single-dose intravenous pharmacokinetic studies
have not shown any significant interaction between aztreonam and concomitantly
administered gentamicin, nafcillin sodium, cephradine, clindamycin or metronidazole.
No reports of disulfiram-like reactions with alcohol ingestion have been noted;
this is not unexpected since aztreonam does not contain a methyl-tetrazole
side chain.<br/>Microbiology: Aztreonam exhibits potent and specific activity in vitro against
a wide spectrum of gram-negative aerobic pathogens including Pseudomonas
aeruginosa. The bactericidal action of aztreonam results from the
inhibition of bacterial cell wall synthesis due to a high affinity of aztreonam
for penicillin binding protein 3 (PBP3). Aztreonam, unlike the majority of
beta-lactam antibiotics, does not induce beta-lactamase activity and its molecular
structure confers a high degree of resistance to hydrolysis by beta-lactamases
(ie, penicillinases and cephalosporinases) produced by most gram-negative
and gram-positive pathogens; it is, therefore, usually active against gram-negative
aerobic microorganisms that are resistant to antibiotics hydrolyzed by beta-lactamases.
It is active against many strains that are multiply-resistant to other antibiotics,
such as certain cephalosporins, penicillin, and aminoglycosides. Aztreonam
maintains its antimicrobial activity over a pH range of 6 to 8 in
vitro, as well as in the presence of human serum and under anaerobic
conditions. Aztreonam 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. Aerobic gram-negative microorganisms: The following in vitro data are available, but
their clinical significance is unknown. Aztreonam exhibits in vitro minimal inhibitory
concentrations (MICs) of 8��g/mL or less against most (���90%) strains of the
following microorganisms; however, the safety and effectiveness of aztreonam
in treating clinical infections due to these microorganisms have not been
established in adequate and well-controlled clinical trials. Aerobic gram-negative microorganisms: Aztreonam and aminoglycosides have been shown to be synergistic in
vitro against most strains of P. aeruginosa, many
strains of Enterobacteriaceae, and other gram-negative aerobic
bacilli. Alterations of the anaerobic intestinal flora by broad spectrum
antibiotics may decrease colonization resistance, thus permitting overgrowth
of potential pathogens, eg, Candida and Clostridium species.
Aztreonam has little effect on the anaerobic intestinal microflora in in
vitro studies. Clostridium difficile and its cytotoxin
were not found in animal models following administration of aztreonam.<br/>Susceptibility Tests:
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This preparation is contraindicated in patients with known hypersensitivity
to aztreonam or any other component in the formulation.
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AZACTAM (aztreonam for injection,
USP) Single-dose 15 mL capacity vials: 1 g/vial: Packages of 10 NDC
51479-041-152 g/vial: Packages
of 10 NDC
51479-042-15<br/>Storage: Store original packages at room temperature; avoid excessive heat.<br/>ALSO SUPPLIED AS:: AZACTAM (aztreonam injection) in
GALAXY plastic container (PL 2040) as a frozen, 50 mL single-dose intravenous
solution as follows: 1 g aztreonam/50 mL container: Packages
of 24 NDC
51479-048-012 g aztreonam/50 mL container: Packages
of 24 NDC
51479-049-01
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General: Prescribing AZACTAM 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 the development of drug-resistant
bacteria. In patients with impaired hepatic or renal function, appropriate
monitoring is recommended during therapy. If an aminoglycoside is used concurrently with aztreonam, especially
if high dosages of the former are used or if therapy is prolonged, renal function
should be monitored because of the potential nephrotoxicity and ototoxicity
of aminoglycoside antibiotics. The use of antibiotics may promote the overgrowth of nonsusceptible
organisms, including gram-positive organisms (Staphylococcus aureus and Streptococcus
faecalis) and fungi. Should superinfection occur during therapy,
appropriate measures should be taken.<br/>Information for Patients: Patients should be counseled that antibacterial drugs including
AZACTAM should only be used to treat bacterial infections. They do not treat
viral infections (eg, the common cold). When AZACTAM 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 full course 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 AZACTAM 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/>Carcinogenesis, Mutagenesis, Impairment of Fertility: Carcinogenicity studies in animals have not been performed. Genetic toxicology studies performed in vivo and in
vitro with aztreonam in several standard laboratory models revealed
no evidence of mutagenic potential at the chromosomal or gene level. Two-generation reproduction studies in rats at daily doses up to
20 times the maximum recommended human dose, prior to and during gestation
and lactation, revealed no evidence of impaired fertility. There was a slightly
reduced survival rate during the lactation period in the offspring of rats
that received the highest dosage, but not in offspring of rats that received
5 times the maximum recommended human dose.<br/>Pregnancy:<br/>Pregnancy Category B: Aztreonam crosses the placenta and enters the fetal circulation. Studies in pregnant rats and rabbits, with daily doses up to 15
and 5 times, respectively, the maximum recommended human dose, revealed no
evidence of embryo- or fetotoxicity or teratogenicity. No drug induced changes
were seen in any of the maternal, fetal, or neonatal parameters that were
monitored in rats receiving 15 times the maximum recommended human dose of
aztreonam during late gestation and lactation. There are no adequate and well-controlled studies in pregnant women.
Because animal reproduction studies are not always predictive of human response,
aztreonam should be used during pregnancy only if clearly needed.<br/>Nursing Mothers: Aztreonam is excreted in human milk in concentrations that are
less than 1% of concentrations determined in simultaneously obtained maternal
serum; consideration should be given to temporary discontinuation of nursing
and use of formula feedings.<br/>Pediatric Use: The safety and effectiveness of intravenous AZACTAM (aztreonam
for injection, USP) have been established in the age groups 9 months to 16
years. Use of AZACTAM in these age groups is supported by evidence from adequate
and well-controlled studies of AZACTAM in adults with additional efficacy,
safety, and pharmacokinetic data from non-comparative clinical studiesin
pediatric patients. Sufficient data are not available for pediatric patients
under 9 months of age or for the following treatment indications/pathogens:
septicemia and skin and skin-structure infections (where the skin infection
is believed or known to be due to H. influenzae type b).
In pediatric patients with cystic fibrosis, higher doses of AZACTAM may be
warranted.<br/>Geriatric Use: Clinical studies of AZACTAM did not include sufficient numbers
of subjects aged 65 years and over to determine whether they respond differently
from younger subjects. Other reported clinical experience has not identified
differences in responses between the elderly and younger patients.In
general, dose selection for an elderly patient should be cautious, reflecting
the greater frequency of decreased hepatic, renal, or cardiac function, and
of concomitant disease or other drug therapy. In elderly patients, the mean serum half-life of aztreonam increased
and the renal clearance decreased, consistent with the age-related decrease
in creatinine clearance.Since aztreonam is
known to be substantially excreted by the kidney, 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, renal function
should be monitored and dosage adjustments made accordingly (see DOSAGE AND ADMINISTRATION: Renal Impairment in Adult
Patients and Dosage in the
Elderly). AZACTAM contains no sodium.
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If necessary, aztreonam may be cleared from the serum by hemodialysis
and/or peritoneal dialysis.
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AZTREONAM
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AZACTAM (Injection, Powder, For Solution)
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Local reactions such as phlebitis/thrombophlebitis following IV
administration, and discomfort/swelling at the injection site following IM
administration occurred at rates of approximately 1.9% and 2.4%, respectively. Systemic reactions (considered to be related to therapy or of uncertain
etiology) occurring at an incidence of 1% to 1.3% include diarrhea, nausea
and/or vomiting, and rash. Reactions occurring at an incidence of less than
1% are listed within each body system in order of decreasing severity:<br/>Pediatric Adverse Reactions: Of the 612 pediatric patients who were treated with AZACTAM in
clinical trials, less than 1% required discontinuation of therapy due to adverse
events. The following systemic adverse events, regardless of drug relationship,
occurred in at least 1% of treated patients in domestic clinical trials: rash
(4.3%), diarrhea (1.4%), and fever (1.0%). These adverse events were comparable
to those observed in adult clinical trials. In 343 pediatric patients receiving intravenous therapy, the following
local reactions were noted: pain (12%), erythema (2.9%), induration (0.9%),
and phlebitis (2.1%). In the US patient population, pain occurred in 1.5%
of patients, while each of the remaining three local reactions had an incidence
of 0.5%. The following laboratory adverse events, regardless of drug relationship,
occurred in at least 1% of treated patients: increased eosinophils (6.3%),
increased platelets (3.6%), neutropenia (3.2%), increased AST (3.8%), increased
ALT (6.5%), and increased serum creatinine (5.8%). In US pediatric clinical trials, neutropenia (absolute neutrophil
count less than 1000/mm) occurred in 11.3% of
patients (8/71) younger than 2 years receiving 30 mg/kg q6h. AST and ALT elevations
to greater than 3 times the upper limit of normal were noted in 15% to 20%
of patients aged 2 years or above receiving 50 mg/kg q6h. The increased frequency
of these reported laboratory adverse events may be due to either increased
severity of illness treated or higher doses of AZACTAM (aztreonam for injection,
USP) administered.<br/>Adverse Laboratory Changes: Adverse laboratory changes without regard to drug relationship
that were reported during clinical trials were:
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To reduce the development of drug-resistant bacteria and maintain
the effectiveness of AZACTAM (aztreonam for injection,
USP) and other antibacterial drugs, AZACTAM should be used only to treat or
prevent infections that are proven or strongly suspected to be caused by susceptible
bacteria. When culture andsusceptibility 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. AZACTAM (aztreonam for injection, USP) is indicated for the treatment
of the following infections caused by susceptible gram-negative microorganisms: Urinary Tract Infections (complicated and uncomplicated),
including pyelonephritis and cystitis (initial and recurrent) caused by Escherichia
coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, Enterobacter
cloacae, Klebsiella oxytoca*, Citrobacter species*
and Serratia marcescens*. Lower Respiratory Tract Infections, including pneumonia
and bronchitis caused by Escherichia coli, Klebsiella pneumoniae,
Pseudomonas aeruginosa, Haemophilus influenzae, Proteus mirabilis, Enterobacter species
and Serratia marcescens*. Septicemia caused by Escherichia coli, Klebsiella
pneumoniae, Pseudomonas aeruginosa, Proteus mirabilis*, Serratia
marcescens* and Enterobacter species. Skin and Skin-Structure Infections, including those
associated with postoperative wounds, ulcers and burns caused by Escherichia
coli, Proteus mirabilis, Serratia marcescens, Enterobacter species, Pseudomonas
aeruginosa, Klebsiella pneumoniae and Citrobacter species*. Intra-abdominal Infections, including peritonitis
caused by Escherichia coli, Klebsiella species including K.
pneumoniae, Enterobacter species including E. cloacae*, Pseudomonas
aeruginosa, Citrobacter species* including C. freundii*
and Serratia species* including S. marcescens*. Gynecologic Infections, including endometritis and
pelvic cellulitis caused by Escherichia coli, Klebsiella pneumoniae*, Enterobacter species*
including E. cloacae* and Proteus mirabilis*. AZACTAM is indicated for adjunctive therapy to surgery in the management
of infections caused by susceptible organisms, including abscesses, infections
complicating hollow viscus perforations, cutaneous infections and infections
of serous surfaces. AZACTAM is effective against most of the commonly encountered
gram-negative aerobic pathogens seen in general surgery. *Efficacy for this organism in this organ system was studied in
fewer than 10 infections.<br/>Concurrent Therapy: Concurrent initial therapy with other antimicrobial agents and
AZACTAM (aztreonam for injection, USP) is recommended before the causative
organism(s) is known in seriously ill patients who are also at risk of having
an infection due to gram-positive aerobic pathogens. If anaerobic organisms
are also suspected as etiologic agents, therapy should be initiated using
an anti-anaerobic agent concurrently with AZACTAM (see DOSAGE
AND ADMINISTRATION). Certain antibiotics (eg, cefoxitin, imipenem)
may induce high levels of beta-lactamase in vitro in some
gram-negative aerobes such as Enterobacter and Pseudomonas species,
resulting in antagonism to many beta-lactam antibiotics including aztreonam.
These in vitro findings suggest that such beta-lactamase-inducing
antibiotics not be used concurrently with aztreonam. Following identification
and susceptibility testing of the causative organism(s), appropriate antibiotic
therapy should be continued.
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AZACTAM
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