NDC 0003-2230 Azactam


NDC Product Code 0003-2230

NDC Product Information

Azactam with NDC 0003-2230 is a a human prescription drug product labeled by E.r. Squibb & Sons, L.l.c.. The generic name of Azactam is aztreonam. The product's dosage form is injection, solution and is administered via intravenous form.

Labeler Name: E.r. Squibb & Sons, L.l.c.

Dosage Form: Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.

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NDC Package CodePackage Description
0003-2230-1124 CONTAINER in 1 PACKAGE > 50 mL in 1 CONTAINER

Azactam Active Ingredient(s)

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This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • AZTREONAM 1 g/50mL

Administration Route(s)

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  • Intravenous - Administration within or into a vein or veins.

Pharmacological Class(es)

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These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Monobactam Antibacterial - [EPC] (Established Pharmacologic Class)
  • Monobactams - [Chemical/Ingredient]

Product Labeler Information

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Information for Patients

Aztreonam Injection

Aztreonam Injection is pronounced as (az' tree oh nam)

Why is aztreonam injection medication prescribed?
Aztreonam injection is used to treat certain infections that are caused by bacteria, including respiratory tract (including pneumonia and bronchitis), urinary tract, bloo...
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Azactam Product Label Images

Azactam Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index


AZACTAM® (aztreonam
injection) 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:C13H17N5O8S2       MW
435.44AZACTAM in the GALAXY plastic container (PL 2040) is a
frozen, iso-osmotic, sterile, sodium-free, nonpyrogenic intravenous solution.
Each 50 mL of solution contains 1 g, or 2 g aztreonam with approximately 1.7
g, or 700 mg Dextrose Hydrous, USP added to adjust osmolality,
and approximately 780 mg, or 1.6 g of arginine added for pH adjustment, respectively.
Thawed solutions have a pH in the range of 4.5 to 7.5. The solution is for
intravenous administration following thawing at room temperature or under
refrigeration.This GALAXY container is fabricated
from a specially designed multilayer plastic (PL 2040). Solutions are in contact
with the polyethylene layer of this container and can leach out certain chemical
components of the plastic in very small amounts within the expiration period.
The suitability of the plastic has been confirmed in tests in animals according
to the USP biological tests for plastic containers as well as by tissue culture
toxicity studies.

Clinical Pharmacology

Single 30-minute intravenous infusions
of 500 mg, 1 g, and 2 g doses of AZACTAM in healthy subjects produced aztreonam
peak serum levels of 54 mcg/mL, 90 mcg/mL, and 204 mcg/mL,
respectively, immediately after administration; at 8 hours, serum levels were
1 mcg/mL, 3 mcg/mL, and 6 mcg/mL, respectively
(Figure 1). Single 3-minute intravenous injections of the same doses resulted
in serum levels of 58 mcg/mL, 125 mcg/mL, and 242 mcg/mL at 5 minutes following
completion of injection.Serum concentrations of aztreonam
following completion of single intravenous infusions of 500 mg, 1 g, and 2
g doses are depicted in Figure 1.FIGURE 1The serum levels of aztreonam following single 500 mg,
1 g, or 2 g intravenous doses of AZACTAM exceed the MIC90 for 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 MIC90 for approximately 4 to 6 hours. All of the
above doses of AZACTAM result in average urine levels of aztreonam that exceed
the MIC90 for 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 (1.5-2.0) in subjects with normal renal function,
independent of the dose. 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.1-4 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
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 mcg/mL, 3500 mcg/mL,
and 6600 mcg/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 to 120 mcg/mL. 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
dose was recovered in the urine by 8 hours. Urinary excretion of a single
intravenous dose was essentially complete by 12 hours after injection. About
12% of a single intravenous radiolabeled 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
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.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-β-glucosaminidase, alanine
aminopeptidase, and β2-microglobulin) were used. No
abnormal results were obtained.Aztreonam achieves
measurable concentrations in the following body fluids and tissues:Table 1:  Extravascular Concentrations of Aztreonam After a Single Intravenous Dose (IV)aFluid or TissueDose(g)RouteHoursPost-injectionNumberofPatientsMeanConcentration(mcg/mL
or mcg/g)a Tissue penetration
is regarded as essential to therapeutic efficacy, but specific tissue levels
have not been correlated with specific therapeutic effects.Fluids   bile1IV21039   blister
fluid1IV1620   bronchial
secretion2IV475   cerebrospinal
fluid    (inflamed
meninges)2IV0.9-4.3163   pericardial
fluid2IV1633   pleural
fluid2IV1.1-3.0351   synovial
fluid2IV0.8-1.91183Tissues   atrial
appendage2IV0.9-1.61222   endometrium2IV0.7-1.949   fallopian
tube2IV0.7-1.9812   fat2IV1.3-2.0105   femur2IV1.0-2.11516   gallbladder2IV0.8-1.3423   kidney2IV2.4-5.6567   large
intestine2IV0.8-1.9912   liver2IV0.9-2.0647   lung2IV1.2-2.1622   myometrium2IV0.7-1.9911   ovary2IV0.7-1.9713   skeletal
muscle2IV0.3-0.7616   skin2IV0.0-1.0825   sternum2IV166 The concentration of aztreonam in saliva at 30 minutes
after a single 1 g intravenous dose (9 patients) was 0.2 mcg/mL; in human
milk at 2 hours after a single 1 g intravenous dose (6 patients), 0.2 mcg/mL;
in amniotic fluid at 6 to 8 hours after a single 1 g intravenous dose (5 patients),
2 mcg/mL. The concentration of aztreonam in peritoneal fluid obtained 1 to
6 hours after multiple 2 g intravenous doses ranged between 12 mcg/mL and
90 mcg/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 aztreonam 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.


  • Mechanism of ActionAztreonam is a bactericidal agent that acts by inhibition of bacterial cell wall synthesis. Aztreonam has activity in the presence of some beta-lactamases, both penicillinases and cephalosporinases, of Gram-negative and Gram-positive bacteria.Mechanism of ResistanceResistance to aztreonam is primarily through hydrolysis by beta-lactamase, alteration of penicillin-binding proteins (PBPs), and decreased permeability.Interaction with Other AntimicrobialsAztreonam 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.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 USAGE5 section.Aerobic Gram-negative
  • Microorganisms: Citrobacter species
  • Enterobacter species
  • Escherichia coli Haemophilus influenzae (including
  • Ampicillin-resistant and other penicillinase-producing strains) Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa Serratia species,
  • Including S. marcescensThe following in vitro data are available, but
  • Their clinical significance is unknown. At least 90% of the following microorganisms exhibit an in vitro minimum inhibitory concentration (MIC) less than or equal to the susceptible breakpoint for aztreonam. However, the efficacy of aztreonam in treating clinical infections due to these microorganisms has not been established in adequate and well-controlled clinical trials.Aerobic Gram-negative microorganisms: Aeromonas hydrophila Morganella morganii Neisseria gonorrhoeae (including
  • Penicillinase-producing strains) Pasteurella multocida Proteus vulgaris Providencia stuartii Providencia rettgeri Yersinia enterocoliticaAztreonam 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. (See ADVERSE REACTIONS: Gastrointestinal.)

Susceptibility Test Methods

When available, the clinical microbiology laboratory should provide the results of in vitro susceptibility test results for antimicrobial drug products used in resident hospitals to the physician as periodic reports that describe the susceptibility profile of nosocomial and community-acquired pathogens. These reports should aid the physician in selecting an antibacterial drug product for treatment.

Dilution Techniques

methods are used to determine antimicrobial MICs.1-3 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 method6 (broth
or agar) or equivalent with standardized inoculum concentrations and standardized
concentrations of aztreonam powder. The MIC values should be interpreted according
to the criteria in Table 2.

Diffusion Techniques

methods that require measurement of zone diameters also provide reproducible
estimates of the susceptibility of bacteria to antimicrobial compounds. The zone size provides an estimate of the susceptibility of bacteria to antimicrobial compounds. The zone size should be determined using a standardized test method.6,7 This procedure uses paper disks impregnated
with 30 mcg aztreonam to test the susceptibility of microorganisms to aztreonam. The disk diffusion interpretive criteria are provided in Table 2.Table 2: Susceptibility Test Interpretive Criteria for AztreonamPathogenMinimum Inhibitory Concentrations(mcg/mL)Disk Diffusion Zone Diameters(mm)(S)Susceptible(I)Intermediate(R)Resistant(S)Susceptible(I)Intermediate(R)Resistanta The current absence of data on resistant isolates precludes defining any category other than “Susceptible.” If isolates yield MIC results other than susceptible, they should be submitted to a reference laboratory for additional testing.
Enterobacteriaceae≤48≥16≥2118-20≤17Haemophilus   influenzaea≤2--≥26--Pseudomonas   aeruginosa≤816≥32≥2216-21≤15

Quality Control

Standardized susceptibility test procedures require the use of laboratory controls to monitor and ensure the accuracy and precision of supplies and reagents used in the assay, and the techniques of the individual performing the test.6-8 Standard aztreonam powder should provide the following range of MIC values noted in Table 3. For the diffusion technique using the 30 mcg disk, the criteria in Table 3 should be achieved.Table 3: Acceptable Quality Control Ranges for AztreonamQC StrainMinimum Inhibitory Concentrations(mcg/mL)Disk Diffusion Zone Diameters(mm)Escherichia coli ATCC 259220.06-0.2528-36Haemophilus influenzae ATCC 492470.12-530-38Pseudomonas aeruginosa ATCC 278532-823-29

Indications And Usage

To reduce the development of drug-resistant
bacteria and maintain the effectiveness of AZACTAM (aztreonam injection) 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
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.AZACTAM 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.

Concurrent Therapy

Concurrent initial therapy with other
antimicrobial agents and AZACTAM 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
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.


This preparation is contraindicated
in patients with known hypersensitivity to aztreonam or any other component
in the formulation.


Both animal and human data suggest that
AZACTAM (aztreonam injection) is rarely cross-reactive with other beta-lactam
antibiotics and weakly immunogenic. Treatment with aztreonam can result in
hypersensitivity reactions in patients with or without prior exposure. (See CONTRAINDICATIONS.)Careful
inquiry should be made to determine whether the patient has any history of
hypersensitivity reactions to any allergens.While
cross-reactivity of aztreonam with other beta-lactam antibiotics is rare,
this drug should be administered with caution to any patient with a history
of hypersensitivity to beta-lactams (eg, penicillins, cephalosporins, and/or
carbapenems). Treatment with aztreonam can result in hypersensitivity reactions
in patients with or without prior exposure to aztreonam. If an allergic reaction
to aztreonam occurs, discontinue the drug and institute supportive treatment
as appropriate (eg, maintenance of ventilation, pressor amines, antihistamines,
corticosteroids). Serious hypersensitivity reactions may require epinephrine
and other emergency measures. (See ADVERSE REACTIONS.)Clostridium
difficile–associated diarrhea (CDAD) has been reported with use of
nearly all antibacterial agents, including AZACTAM, 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 2 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.Rare
cases of toxic epidermal necrolysis have been reported in association with
aztreonam in patients undergoing bone marrow transplant with multiple risk
factors including sepsis, radiation therapy, and other concomitantly administered
drugs associated with toxic epidermal necrolysis.


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.

Information For 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 2 or more months after having taken the last dose of the antibiotic.
If this occurs, patients should contact their physician as soon as possible.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Carcinogenicity studies with aztreonam have not been conducted using an intravenous route of administration. A 104-week rat inhalation toxicology study to assess the carcinogenic potential of aztreonam demonstrated no drug-related increase in the incidence of tumors. Rats were exposed to aerosolized aztreonam for up to 4 hours per day. Peak plasma levels of aztreonam averaging approximately 6.8 mcg/mL were measured in rats at the highest dose level.Genetic toxicology studies performed with aztreonam in vitro (Ames test, mouse lymphoma forward mutation assay, gene conversion assay, chromosome aberration assay in human lymphocytes) and in vivo (mouse bone marrow cytogenetic assay) did not reveal evidence of mutagenic or clastogenic potential.A two-generation reproduction study in rats at daily doses of 150, 600, or 2400 mg/kg given prior to and during gestation and lactation, revealed no evidence of impaired fertility. Based on body surface area, the high dose is 2.9-fold greater than the maximum recommended human dose (MRHD) for adults of 8 g per day. There was a slightly reduced survival rate during the lactation period in the offspring of rats that received the high dose, but not in offspring of rats that received lower doses of aztreonam.

Pregnancy Category B

In pregnant women, aztreonam crosses the placenta and enters
the fetal circulation.Developmental toxicity studies in pregnant rats and rabbits with daily doses of aztreonam up to 1800 and 1200 mg/kg, respectively, revealed no evidence of embryotoxicity or fetotoxicity or teratogenicity. These doses, based on body surface area, are 2.2- and 2.9-fold greater than the MRHD for adults of 8 g per day. A peri/postnatal study in rats revealed no drug-induced changes in any maternal, fetal, or neonatal parameters. The highest dose used in this study, 1800 mg/kg/day, is 2.2 times the MRHD based on body surface area.There are no adequate and well-controlled studies of aztreonam on human pregnancy outcomes. Because animal reproduction studies are not always predictive of human response, aztreonam should be used during pregnancy only if clearly needed.

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.

Pediatric Use

The safety and effectiveness of intravenous
AZACTAM 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 noncomparative clinical studies in 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. (See CLINICAL PHARMACOLOGY, DOSAGE

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.9-12 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.1-4 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
in Adult Patients and Dosage
in the Elderly).AZACTAM contains no

Adverse Reactions

Local reactions (eg, phlebitis/thrombophlebitis;
discomfort/swelling) following intravenous administration occurred at rates
of approximately 1.9%.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:Hypersensitivity—anaphylaxis,
angioedema, bronchospasmHematologic—pancytopenia,
neutropenia, thrombocytopenia, anemia, eosinophilia, leukocytosis, thrombocytosisGastrointestinal—abdominal cramps; rare
cases of C. difficile–associated diarrhea, including pseudomembranous
colitis, or gastrointestinal bleeding have been reported. Onset of pseudomembranous
colitis symptoms may occur during or after antibiotic treatment. (See WARNINGS.)Dermatologic—toxic
epidermal necrolysis (see WARNINGS),
purpura, erythema multiforme, exfoliative dermatitis, urticaria, petechiae,
pruritus, diaphoresisCardiovascular—hypotension,
transient ECG changes (ventricular bigeminy and PVC), flushingRespiratory—wheezing,
dyspnea, chest painHepatobiliary—hepatitis,
jaundiceNervous System—seizure, confusion,
vertigo, paresthesia, insomnia, dizzinessMusculoskeletal—muscular
achesSpecial Senses—tinnitus, diplopia,
mouth ulcer, altered taste, numb tongue, sneezing, nasal congestion, halitosisOther—vaginal
candidiasis, vaginitis, breast tendernessBody
as a Whole—weakness, headache, fever, malaise

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 3 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/mm3) occurred in 11.3% of patients (8/71)
younger than 2 years receiving 30 mg/kg every 6 hours. 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 every 6 hours. The increased
frequency of these reported laboratory adverse events may be due to either
increased severity of illness treated or higher doses of AZACTAM administered.

Adverse Laboratory Changes

Adverse laboratory changes without regard
to drug relationship that were reported during clinical trials were:Hepatic—elevations
of AST (SGOT), ALT (SGPT), and alkaline phosphatase; signs or symptoms of
hepatobiliary dysfunction occurred in less than 1% of recipients (see above).Hematologic—increases
in prothrombin and partial thromboplastin times, positive Coombs’ test.Renal—increases
in serum creatinine.


necessary, aztreonam may be cleared from the serum by hemodialysis and/or
peritoneal dialysis.

Dosage In Adult Patients

AZACTAM, an intravenous solution in GALAXY
plastic containers (PL 2040), is intended for intravenous use only. Dosage
should be determined by susceptibility of the causative organisms, severity
and site of infection, and the condition of the patient.Table 4: Azactam Dosage Guidelines for Adults*Type of InfectionDoseFrequency(hours)* Maximum recommended dose is 8 g per day.
Urinary tract infections500 mg or 1 g8 or 12Moderately severe systemic infections1 g or 2 g8 or 12Severe systemic or life-threatening infections2 g6 or 8Because of the serious nature of infections due to Pseudomonas aeruginosa, dosage of 2 g every six or eight hours is recommended, at least upon initiation of therapy, in systemic infections caused by this organism.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.

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 and 30 mL/min/1.73 m2 after an initial loading dose of 1 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 valueIn patients with severe renal
failure (creatinine clearance less than 10 mL/min/1.73 m2),
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

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.

Dosage In Pediatric Patients

AZACTAM 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.)Table 5: Azactam Dosage Guidelines for Pediatric Patients*Type of InfectionDoseFrequency(hours)* Maximum recommended dose is 120 mg/kg/day.
Mild to moderate infections30 mg/kg8Moderate to severe infections30 mg/kg6 or 8

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.

Directions For Use Of Azactam (Aztreonam Injection) In Galaxy Plastic Container (Pl 2040).

AZACTAM is to be administered as an intermittent intravenous
infusion only.


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

Thawing Of Plastic Containers

Thaw frozen container at room temperature,
25°C (77°F) or in a refrigerator, 2°C to 8°C (36°F-46°F). After thawing is
complete, invert the container to assure a well-mixed solution. (DO
for minute leaks by squeezing container firmly. If leaks are detected, discard
solution as sterility may be impaired.The container
should be visually inspected. Thawed solutions should not be used unless clear;
solutions will be colorless to yellow. Components of the solution may precipitate
in the frozen state and will dissolve upon reaching room temperature with
little or no agitation. If after visual inspection the solution remains discolored,
cloudy, or if an insoluble precipitate is noted or if any seals or outlet
ports are not intact, the container should be discarded.DO
solution in GALAXY plastic container (PL 2040) remains chemically stable for
either 14 days under refrigeration (2°C-8°C/36°F-46°F) or for 48 hours
at room temperature (25°C/77°F). DO NOT REFREEZE THAWED ANTIBIOTICS.

Preparation For Intravenous Administration

  • Use aseptic technique.Suspend container(s) from eyelet support.Remove protector from outlet port at bottom of container.Attach administration set. Refer to complete directions accompanying
  • Set.Additives or other medication should not be added to AZACTAM
  • Or infused simultaneously
  • Through the same intravenous line. If the same intravenous line is used for
  • Sequential infusion of several different drugs, it should be flushed before
  • And after infusion of AZACTAM with an infusion solution compatible with AZACTAM (aztreonam injection)
  • In GALAXY plastic container (PL 2040)* and any other drug(s) administered
  • Via this common line.It is recommended that the intravenous
  • Administration apparatus be replaced at least once every 48 hours.CAUTION:
  • Do not use plastic containers in series connections. Such use could result
  • In an embolism due to residual air being drawn from the primary container
  • Before administration of the fluid from the secondary container is complete.

Intravenous Administration

  • Infusion of AZACTAM should be completed within a 20- to
  • 60-minute period. The plastic container is a single-dose unit; discard any
  • Unused portion remaining in the container.*The following
  • Infusion solutions are compatible with AZACTAM (aztreonam injection) in GALAXY
  • Plastic container (PL 2040): Sodium Chloride Injection,
  • USP, 0.9% Ringer’s Injection, USP Lactated Ringer’s Injection,
  • USP Dextrose Injection, USP, 5%
  • Or 10% Dextrose and Sodium Chloride
  • Injection, USP, 5%:0.9%, 5%:0.45%, or 5%:0.2% Sodium Lactate Injection, USP
  • (M/6 Sodium Lactate) Ionosol® B
  • And 5% Dextrose Isolyte® E Isolyte® E
  • With 5% Dextrose Isolyte® M
  • With 5% Dextrose Normosol®-R Normosol®-R
  • And 5% Dextrose Normosol®-M
  • And 5% Dextrose Mannitol Injection, USP, 5%
  • Or 10% Lactated Ringer’s and 5% Dextrose
  • Injection Plasma-Lyte M
  • And 5% Dextrose

How Supplied

AZACTAM® (aztreonam
injection) in GALAXY plastic container (PL 2040) is supplied as a frozen,
50 mL single-dose intravenous solution as follows:1 g aztreonam/50 mL container: Packages of 24NDC 0003-2230-112 g aztreonam/50 mL container: Packages of 24NDC 0003-2240-11Store at or below –20°C (–4°F) [see Directions for
Use of AZACTAM (aztreonam injection) in GALAXY
Plastic Container (PL 2040)].


  • Naber KG, Dette GA, Kees F, Knothe H, Grobecker H. Pharmacokinetics, in
  • Vitro activity, therapeutic efficacy, and clinical safety of aztreonam
  • Vs. cefotaxime in the treatment of complicated urinary tract infections. J
  • Antimicrob Chemother 1986;17:517-527.Creasey WA, Platt TB, Frantz M, Sugerman AA. Pharmacokinetics of
  • Aztreonam in elderly male volunteers. Br J Clin Pharmacol 1985;19:233-237.Meyers BR, Wilkinson P, Mendelson MH, et al. Pharmacokinetics
  • Of aztreonam in healthy elderly and young adult volunteers. J Clin
  • Pharmacol 1993;33:470-474.Sattler FR, Schramm M, Swabb EA. Safety of aztreonam and SQ 26,992
  • In elderly patients with renal insufficiency. Rev Infect Dis 1985;7
  • (suppl 4):S622-S627.Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard - Ninth Edition. CLSI document M07-A9, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2012.National Committee for Clinical Laboratory Standards. Methods
  • For Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically—Fifth
  • Edition. Approved Standard NCCLS Document M7-A5, Vol. 20, No. 2, NCCLS, Wayne,
  • PA, January 2000.Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Disk Diffusion Susceptibility Tests; Approved Standard – Eleventh Edition CLSI document M02-A11, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2012.Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing; Twenty-third Informational Supplement, CLSI document M100-S23. CLSI document M100-S23, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2013.Deger F, Douchamps J, Freschi E, et al. Aztreonam in the treatment of serious gram-negative infections in the elderly. Int J Clin Pharmacol Ther and Toxicol 1988;26:22-26.Knockaert DC, Dejaeger E, Nestor L, et al. Aztreonam-flucloxacillin double beta-lactam treatment as empirical therapy of serious infections in very elderly patients. Age and Aging 1981;20:135-139.Roelandts F. Clinical use of aztreonam in a psychogeriatric population. Acta Clin Belg 1992;47:251-255.Andrews R, Fasoli R, Scoggins WG, et al. Combined aztreonam and gentamicin therapy for pseudomonal lower respiratory tract infections. Clin Therap 1994;16:236-252.


AZACTAM and the Bristol-Myers Squibb logo
are registered trademarks of Bristol-Myers Squibb Company.All other trademarks are the property of their respective owners.AZACTAM® (aztreonam
injection) in GALAXY plastic container (PL 2040) ismanufactured
to Bristol-Myers Squibb specificationsby:Baxter Healthcare
CorporationDeerfield, IL 60015for:Bristol-Myers
Squibb CompanyPrinceton, NJ 08543 USA1266449A0Rev June 2013

* Please review the disclaimer below.

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