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Aztreonam

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Overview

What is Aztreonam?

Aztreonam for Injection, USP contains the active ingredient aztreonam, a monobactam.  It was originally isolated from .  It is a synthetic bactericidal antibiotic.

The monobactams, having a unique monocyclic beta-lactam nucleus, are structurally different from other beta-lactam antibiotics (e.g., 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:

CHNOS                                   MW 435.44

Aztreonam for injection is a sterile, nonpyrogenic, sodium-free lyophilized, off-white to slightly yellow solid 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. 

Each 500 mg contains 500 mg aztreonam with approximately 390 mg arginine.

Each 1 gram vial contains 1 gram aztreonam with approximately 780 mg arginine.

Each 2 gram vial contains 2 grams aztreonam with approximately 1.56 grams arginine.



What does Aztreonam look like?



What are the available doses of Aztreonam?

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What should I talk to my health care provider before I take Aztreonam?

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How should I use Aztreonam?

To reduce the development of drug-resistant bacteria and maintain the effectiveness of aztreonam for injection, USP and other antibacterial drugs, aztreonam for injection 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.

Aztreonam for Injection is indicated for the treatment of the following infections caused by susceptible Gram-negative microorganisms:

Urinary Tract Infections

Lower Respiratory Tract Infections

Septicemia

Skin and Skin-Structure Infections

Intra-abdominal Infections

Gynecologic Infections

Aztreonam for injection 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.  Aztreonam for injection is effective against most of the commonly  encountered Gram-negative aerobic pathogens seen in general surgery.

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Aztreonam for injection 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.

                                                                                    

* Maximum recommended dose is 8 g per day.

Because of the serious nature of infections due to , 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 (e.g., intra-abdominal abscess), peritonitis or other severe systemic or life-threatening infections.

The duration of therapy depends on the severity of infection.  Generally, aztreonam for injection 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.


What interacts with Aztreonam?

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What are the warnings of Aztreonam?

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What are the precautions of Aztreonam?

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What are the side effects of Aztreonam?

Local reactions such as phlebitis/thrombophlebitis following intravenous administration, and discomfort/swelling at the injection site following intramuscular 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:

Hypersensitivity

Hematologic

Cardiovascular

Respiratory

Hepatobiliary

Nervous System

Musculoskeletal

Special Senses

nasal congestion, halitosis

Other

Body as a Whole

Pediatric Adverse Reactions

Of the 612 pediatric patients who were treated with aztreonam for injection 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%).  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 1,000/mm) 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 aztreonam for injection administered.

Adverse Laboratory Changes

Adverse laboratory changes without regard to drug relationship that were reported during clinical trials were:

Hepatic

Hematologic

Renal


What should I look out for while using Aztreonam?

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 aztreonam for injection, USP 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 ).

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 (e.g., 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 (e.g., maintenance of ventilation, pressor amines, antihistamines, corticosteroids).  Serious hypersensitivity reactions may require epinephrine and other emergency measures (see ).

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against may need to be discontinued.  Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of , 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.


What might happen if I take too much Aztreonam?

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


How should I store and handle Aztreonam?

StorageStore in a well-closed container at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [see USP Controlled Room Temperature].StorageStore in a well-closed container at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [see USP Controlled Room Temperature].Aztreonam for Injection, USP


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Clinical Information

Chemical Structure

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Clinical Pharmacology

Mechanism of Action

Aztreonam 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 Resistance

Resistance to aztreonam is primarily through hydrolysis by beta-lactamase, alteration of penicillin-binding proteins (PBPs), and decreased permeability.

Interaction with Other Antimicrobials

Aztreonam and aminoglycosides have been shown to be synergistic against most strains of , 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 and in clinical infections as described in the section.

Aerobic Gram-negative microorganisms:

The following data are available, but their clinical significance is unknown.  At least 90% of the following microorganisms exhibit an 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:

Aztreonam and aminoglycosides have been shown to be synergistic against most strains of , 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, e.g., and species.  Aztreonam has little effect on the anaerobic intestinal microflora in studies.  and its cytotoxin were not found in animal models following administration of aztreonam (see

When available, the clinical microbiology laboratory should provide the results of 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

Quantitative methods are used to determine antimicrobial 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 aztreonam powder.  The MIC values should be interpreted according to the criteria in Table 2.

Diffusion Techniques

Quantitative 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.  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. 

                                

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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.  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.

                                                                                                  

Non-Clinical Toxicology
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 aztreonam for injection, USP 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 ).

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 (e.g., 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 (e.g., maintenance of ventilation, pressor amines, antihistamines, corticosteroids).  Serious hypersensitivity reactions may require epinephrine and other emergency measures (see ).

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against may need to be discontinued.  Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of , 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.

Prescribing aztreonam for injection 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 (and ) and fungi.  Should superinfection occur during therapy, appropriate measures should be taken.

Local reactions such as phlebitis/thrombophlebitis following intravenous administration, and discomfort/swelling at the injection site following intramuscular 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:

Hypersensitivity

Hematologic

Cardiovascular

Respiratory

Hepatobiliary

Nervous System

Musculoskeletal

Special Senses

nasal congestion, halitosis

Other

Body as a Whole

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

Tips

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Interactions

Interactions

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