Azactam®(aztreonam for injection, USP)

Product (generic name)AZACTAM® (aztreonam for injection, USP)
Indication

AZACTAM® (aztreonam for injection, USP) is indicated for the treatment of the following infections caused by gram-negative organisms:

  • Urinary tract infections, including pyelonephritis and cystitis
  • Lower respiratory tract infections, including pneumonia and bronchitis
  • Septicemia
  • Skin and skin-structure infections
  • Intra-abdominal infections, including peritonitis
  • Gynecologic infections, including endometritis and pelvic cystitis                                 
Therapeutic Focus AreaInfectious Diseases - Antibiotic, injectable
Product DescriptionAZACTAM® (aztreonam for injection, USP) is a monobactam indicated for the treatment of the infections caused by susceptible gram-negative microorganisms and principally used by surgeons, infectious disease specialists and internal medicine physicians to treat pneumonia, post-surgical infections and septicemia.
Dosage Strengths

IV/IM 500 mg, 1 g, 2 g

Single-dose 15 mL capacity vials (500 mg/vial; 1 g/vial; 2 g/vial)

Single-dose 100 mL capacity intravenous infusion bottles with bail bands (1 g/bottle; 2 g/bottle)

Also supplied as a frozen 50 mL single-dose intravenous solution (1 g/50 mL container; 2 g/50 mL container)

Mode of AdministrationInjectable IV/IM
Clinical EfficacyPlease see full Prescribing Information
Important Safety
Information
Aztreonam has a low incidence of the most common adverse reactions: local reactions (2.4%), diarrhea, nausea/vomiting, rash (less than 1.4%). AZACTAM® (aztreonam for injection, USP) is contraindicated in patients with known hypersensitivity to aztreonam or any other component in the formulation.

Clostridium difficile associated diarrhea (CDAD) occurs with use of nearly all antibacterial agents, including AZACTAM®, and severity ranges from mild diarrhea to fatal colitis. Antibacterial agent use alters the normal flora of the colon leading to overgrowth of C. difficile.  Consider CDAD in all patients presenting with diarrhea following antibiotic use. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.
About Gram-Negative Infections

Source: Elan website
For targeting gram-negative infections:
  • Intra-abdominal infections, including peritonitis caused by susceptible strains of E coli, Klebsiella species including K pneumoniae, Enterobacter species including Enterobacter cloacae, * P aeruginosa, Citrobacter freundii,* and Serratia species* including S marcescens*.
  • Lower respiratory tract infections, including pneumonia and bronchitis caused by susceptible strains of E coli, K pneumoniae, P aeruginosa, Haemophilus influenzae, Proteus mirabilis, Enterobacter species, and S marcescens*
  • Urinary tract infections (complicated and uncomplicated), including pyelonephritis and cystits (initial and recurrent) caused by susceptible strains of E coli, K pneumoniae, P mirabilis, P aeruginosa, E cloacae, Klebsiella oxytoca,* Citrobacter species, and S marcescens*
  • Skin and skin-structure infections, including those associated with postoperative wounds, ulcers, and burns caused by susceptible strains of E coli, P mirabilis, S marcescens, Enterobacter species, P aeruginosa, K pneumoniae, and Citrobacter species*
  • Septicemia, caused by susceptible strains of E coli, K pneumoniae, P aeruginosa, P mirabilis,* S marcescens,* and Enterobacter species
  • Gynecologic infections, including endometritis and pelvic cellulitis caused by susceptible strains of E coli, K pneumoniae,* Enterobacter species* including E cloacae,* and P mirabilis*                                 
*Efficacy for this organism in this organ system was studied in fewer than 10 infections.
Size of MarketThe global antibacterial drugs market was worth $25.2 billion in 2001 and is forecast to reach $27.6 billion in 2007. The injectable antibiotic market is estimated at $2.8 billion.
Publications

Aztreonam References

Boucher, BA. Role of aztreonam in the treatment of nosocomial pneumonia in the critically ill surgical patient. Am J Surg. 2000; 179(suppl 2A):455-505.

Fabian TC, Hess MM, Croce MA, Wilson RS, et al. Superiority of aztreonam/clindamycin compared with gentamicin/clindamycin in patients with penetrating abdominal trauma. Am J Surg 1994; 167(3):291-296.

Polk HC, Jr., Livingston DH, Fry DE, Malangoni MA, et al. Treatment of pneumonia in mechanically ventilated trauma patients. Results of a prospective trial. Arch Surg 1997; 132(10):1086-1092.

Sader HS, Huynh HK, Jones RN. Contemporary in vitro synergy rates for aztreonam combined with newer fluoroquinolones and beta-lactams tested against gram-negative bacilli. Diagnostic Microbiology & Infectious Disease 2003; 47(3):547-550.

Medical InquiriesMedical Information Services can be reached at:

Toll-Free Phone: 1-888-638-7605

An Elan Medical Information Services representative is available to answer medical information inquiries from 9:00 am–7:00 pm EST Monday through Friday.



Download Printer Friendly PDF:
» Click here

Last updated: 02/20/04