Aztreonam (Page 5 of 6)

Adverse Laboratory Changes

Adverse laboratory changes without regard to drug relationship that were reported during clinical trials were:

Hepatic —elevations of AST (SGOT), ALT (SGPT), and alkaline phosphatase; signs or symptoms of hepatobiliary dysfunction occurred in less than 1% of recipients (see above).

Hematologic —increases in prothrombin and partial thromboplastin times, positive Coombs’ test.

Renal —increases in serum creatinine.

OVERDOSAGE:

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

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 m 2 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 m 2), 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.

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 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.

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