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. …

• 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 2: Aztreonam for Injection Dosage Guidelines for Adults* * Maximum recommended dose is 8 g per day
• 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 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. …

• The safety and effectiveness of intravenous aztreonam for injection have been established in the age groups 9 months to 16 years
• Use of aztreonam for injection in these age groups is supported by evidence from adequate and well-controlled studies of aztreonam for injection
• In adults with additional efficacy, safety, and pharmacokinetic data from noncomparative clinical studies
• In pediatric patients. …

Clinical studies of aztreonam for injection 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. …

• Patients should be counseled that antibacterial drugs including aztreonam for injection should only be used to treat bacterial infections
• They do not treat viral infections (e.g., the common cold)
• When aztreonam for injection 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. …

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 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 (e.g., penicillins, cephalosporins, and/or carbapenems). …

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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. …

Pregnancy 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 1,800 and 1,200 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. …

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

Storage Store in original packages at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]; avoid excessive heat. The container closure is not made with natural rubber latex. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.