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AZTREONAM Dosage and Administration (aztreonam for injection, USP)

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 2: Aztreonam for Injection Dosage Guidelines for Adults*
Type of InfectionDoseFrequency
(hours)
*
Maximum recommended dose is 8 g per day.
Urinary tract infections500 mg or 1 g8 or 12
Moderately severe systemic infections1 g or 2 g8 or 12
Severe systemic or life-threatening infections2 g6 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 (eg, 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 m2 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) × (140−age)      
                           72 × serum creatinine (mg/dL)
    Females:   0.85 × above value

In patients with severe renal failure (creatinine clearance less than 10 mL/min/1.73 m2), 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 3: Aztreonam for Injection Dosage Guidelines for Pediatric Patients*
Type of InfectionDoseFrequency
(hours)
*
Maximum recommended dose is 120 mg/kg/day.
Mild to moderate infections30 mg/kg8
Moderate to severe infections30 mg/kg6 or 8
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