Aztreonam

Name: Aztreonam

Aztreonam Overview

Aztreonam is a prescription medicine used to treat certain bacterial infections. Aztreonam is in a class of drugs called monobactam antibacterials. It interferes with the growth of bacterial cells and causes them to die.

This medication is available in an injectable form to be given directly into a vein (IV) or muscle (IM) by a healthcare professional.

Aztreonam also comes in inhalational form. It is inhaled through the mouth into the lungs using a machine called an Altera Nebulizer. It is usually given three times a day for 28 days.

Common side effects of aztreonam injectable include nausea, vomiting, and irritation or discomfort at injection site.

Common side effects of aztreonam inhalation include cough, wheezing, and sore throat.

Uses of Aztreonam

Injectable:

Aztreonam is a prescription medicine used to treat certain bacterial infections.

This medication may be prescribed for other uses. Ask your doctor or pharmacists for more information.

Inhalation:

Aztreonam is used to treat patients above the age of 7 with cystic fibrosis (CF) who have a lung infection caused by the bacteria Pseudomonas aeruginosa (P. aeruginosa).  

This medication may be prescribed for other uses. Ask your doctor or pharmacists for more information.

 

Aztreonam Drug Class

Aztreonam is part of the drug class:

  • Monobactams

Aztreonam Precautions

Injectable/Inhalational:

  • It is common to feel better early in the course of therapy, but you should take all of your medication as prescribed. 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 aztreonam or other antibacterial drugs in the future.
  • Diarrhea is a common problem caused by antibiotics. This should stop once the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, watery and bloody stools (with or without stomach cramps and fever) can occur even as late as 2 or more months after having taken the last dose of the antibiotic. If this occurs, contact your doctor as soon as possible.
  • Severe allergic reactions. Stop your treatment with aztreonam and call your doctor right away if you have any symptoms of an allergic reaction, including:
    • Rash or swelling of your face
    • Throat tightness
  • Trouble breathing right after treatment with aztreonam (bronchospasm). To decrease the chance of this happening, be sure to use your inhaled bronchodilator medicine before each treatment with aztreonam. 
  • Do not take aztreonam if you are allergic to it or to any of its inactive ingredients.
  • Tell your doctor if you are allergic to any other medications, especially antibiotics, before taking aztreonam. There might be a small risk taking aztreonam if you have had an allergic reaction to particularly an antibiotic in the past.
 

Inform MD

Before taking aztreonam, tell your doctor if you:

  • are allergic to any antibiotics
  • have liver or kidney problems
  • are pregnant or plan to become pregnant
  • are breastfeeding or plan to breastfeed. Talk to your doctor about the best way to breastfeed your baby if you take aztreonam.

Tell your doctor about all the medicine you take, including prescription and non-prescription medicines, vitamins and herbal supplements.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine

Aztreonam and Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category B. There are no well-done studies that have been done in humans with aztreonam. In animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

Aztreonam Dosage

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

Injectable:

The dose your doctor recommends may be based on the susceptibility of the bacteria, severity and site of infection, and the condition of the patient.

Inhalation:

The dose of aztreonam for both adults and children 7 years of age and older is one vial of aztreonam (75 mg of aztreonam), mixed with one ampule of saline (diluent) 3 times a day.

Description

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 (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:

 


C13H17N5O8S2                                   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.

Dosage and administration

Dosage in Adult Patients

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.



                                                                                     Table 4:  Aztreonam for Injection Dosage Guidelines for Adults*


 
Type of Infection
 

 
Dose
 

 
Frequency
 
(hours)


Urinary tract infections
 
500 mg or 1 g
 

 
8 or 12
 

Moderately severe systemic infections
 
1 g or 2 g
 

 
8 or 12
 

Severe systemic or life-threatening infections
 
2 g
 

 
6 or 8
 

* Maximum recommended dose is 8 g per day.



Because 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 (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.


Renal Impairment in Adult Patients

Prolonged serum levels of Aztreonam may occur in patients with transient or persistent renal insufficiency.  Therefore, the dosage of Aztreonam for injection 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.

                   Males: Clcr =       weight (kg) x (140 - age)

                                              72 x serum creatinine (mg/dL)

                   Females: 0.85 x above value

In 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 session.

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

Aztreonam for injection 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: Aztreonam for Injection Dosage Guidelines for Pediatric Patients* 


 
Type of Infection
 

 
Dose
 

 
Frequency
 
(hours)


 
Mild to moderate infections
 

 
30 mg/kg
 

 
8
 

 
Moderate to severe infections
 

 
30 mg/kg
 

 
6 or 8
 

*Maximum recommended dose is 120 mg/kg/day.


How supplied

Aztreonam for Injection, USP


 
Product
 
No.


 
NDC
 
No.


 
Strength
 


 
PRX400120 
 

 
63323-401-24 
 

 
1 g per vial 
 

 
20 mL single dose vial, supplied in packages of ten.
 

 
PRX400220
 

 
63323-402-24
 

 
2 g per vial
 

 
30 mL single dose vial, supplied in packages of ten.
 

Storage

Store in original packages at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]; avoid excessive heat.
This container closure is not made with natural rubber latex.

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