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AZTREONAM Clinical Studies (aztreonam for injection, USP)

CLINICAL STUDIES

A total of 612 pediatric patients aged 1 month to 12 years were enrolled in uncontrolled clinical trials of aztreonam in the treatment of serious Gram-negative infections, including urinary tract, lower respiratory tract, skin and skin-structure, and intra-abdominal infections.

Preparation of Parenteral Solutions

General

Upon the addition of the diluent to the container, contents should be shaken immediately and vigorously. Constituted solutions are not for multiple-dose use; should the entire volume in the container not be used for a single-dose, the unused solution must be discarded.

Depending upon the concentration of aztreonam and diluent used, constituted aztreonam for injection yields a colorless to light straw yellow solution which may develop a slight pink tint on standing (potency is not affected). Parenteral drug products should be inspected visually for particulate matter and discoloration whenever solution and container permit.

Admixtures with Other Antibiotics

Intravenous infusion solutions of aztreonam for injection not exceeding 2% w/v prepared with Sodium Chloride Injection, USP 0.9% or Dextrose Injection, USP 5%, to which clindamycin phosphate, gentamicin sulfate, tobramycin sulfate, or cefazolin sodium have been added at concentrations usually used clinically, are stable for up to 48 hours at room temperature or 7 days under refrigeration. Ampicillin sodium admixtures with aztreonam in Sodium Chloride Injection, USP 0.9% are stable for 24 hours at room temperature and 48 hours under refrigeration; stability in Dextrose Injection, USP 5% is 2 hours at room temperature and 8 hours under refrigeration.

Aztreonam-cloxacillin sodium and aztreonam-vancomycin hydrochloride admixtures are stable in Dianeal 137 (Peritoneal Dialysis Solution) with 4.25% Dextrose for up to 24 hours at room temperature.

Aztreonam is incompatible with nafcillin sodium, cephradine, and metronidazole.

Other admixtures are not recommended since compatibility data are not available.

Intravenous Solutions

For Bolus Injection

The contents of an aztreonam for injection vial should be constituted with 6 to 10 mL Sterile Water for Injection, USP.

For Infusion

If the contents of vial are to be transferred to an appropriate infusion solution, each gram of aztreonam should be initially constituted with at least 3 mL Sterile Water for Injection, USP. Further dilution may be obtained with one of the following intravenous infusion solutions:

 
Sodium Chloride Injection, USP, 0.9%
 
Ringer's Injection, USP
 
Lactated Ringer's Injection, USP
 
Dextrose Injection, USP, 5% or 10%
 
Dextrose and Sodium Chloride Injection, USP, 5%:0.9%, 5%:0.45%, or 5%:0.2%
 
Sodium Lactate Injection, USP (M/6 Sodium Lactate)
 
Ionosol® B and 5% Dextrose
 
Isolyte® M with 5% Dextrose
 
Normosol®-R
 
Normosol®-R and 5% Dextrose
 
Normosol®-M and 5% Dextrose
 
Mannitol Injection, USP, 5% or 10%
 
Lactated Ringer's and 5% Dextrose Injection

Intramuscular Solutions

The contents of an aztreonam for injection vial should be constituted with at least 3 mL of an appropriate diluent per gram aztreonam. The following diluents may be used:

 
Sterile Water for Injection, USP
 
Sterile Bacteriostatic Water for Injection, USP (with benzyl alcohol or with methyl- and propylparabens)
 
Sodium Chloride Injection, USP, 0.9%
 
Bacteriostatic Sodium Chloride Injection, USP (with benzyl alcohol)

Stability of Intravenous and Intramuscular Solutions

Aztreonam for Injection solutions for intravenous infusion at concentrations not exceeding 2% w/v must be used within 48 hours following constitution if kept at controlled room temperature (59°F to 86°F/15°C to 30°C) or within 7 days if refrigerated (36°F to 46°F/2°C to 8°C).

Aztreonam for Injection solutions at concentrations exceeding 2% w/v, except those prepared with Sterile Water for Injection, USP or Sodium Chloride Injection, USP, should be used promptly after preparation; the 2 excepted solutions must be used within 48 hours if stored at controlled room temperature or within 7 days if refrigerated.

Intravenous Administration

Bolus Injection

A bolus injection may be used to initiate therapy. The dose should be slowly injected directly into a vein, or the tubing of a suitable administration set, over a period of 3 to 5 minutes (see next paragraph regarding flushing of tubing).

Infusion

With any intermittent infusion of aztreonam and another drug with which it is not pharmaceutically compatible, the common delivery tube should be flushed before and after delivery of aztreonam with any appropriate infusion solution compatible with both drug solutions; the drugs should not be delivered simultaneously. Any aztreonam infusion should be completed within a 20- to 60-minute period. With use of a Y-type administration set, careful attention should be given to the calculated volume of aztreonam solution required so that the entire dose will be infused. A volume control administration set may be used to deliver an initial dilution of aztreonam for injection (see Preparation of Parenteral Solutions: Intravenous Solutions: For Infusion) into a compatible infusion solution during administration; in this case, the final dilution of aztreonam should provide a concentration not exceeding 2% w/v.

Intramuscular Administration

The dose should be given by deep injection into a large muscle mass (such as the upper outer quadrant of the gluteus maximus or lateral part of the thigh). Aztreonam is well tolerated and should not be admixed with any local anesthetic agent.

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