|Other Info:||Manufactured by:Bristol-Myers Squibb CompanyPrinceton, NJ 08543 USADistributed by:Elan Pharmaceuticals Inc.San Diego, CA 92121 USAMade in Italy© 2004 Elan Pharmaceuticals, Inc.1177334A2/6001715Revised January 2007|
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 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 (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.
Both animal and human data suggest that AZACTAM 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 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 two 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.