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Aztreonam information from DrugsUpdate  

See Available Brands of Aztreonam in India

P - Caution when used during pregnancy.
L - Contraindicated in lactation
LI - Lab *

Aztreonam (trade name Azactam) is a synthetic monocyclic beta-lactam antibiotic (a monobactam) originally isolated from Chromobacterium violaceum. It was approved by the U.S. Food and Drug Administration (FDA) in 1986. It is resistant to some beta-lactamases, but is inactivated by extended-spectrum beta-lactamases.

Pharmacodynamics

Pharmacokinetics

Absorption
IV
C max is 54 mcg/mL (500 mg dose), 90 mcg/mL (1 g dose); and 204 mcg/mL (2 g dose) immediately after administration.
IM
T max is approximately 1 h; produces comparable serum concentrations to IV doses.
Distribution
Vd is approximately 12.6 L; approximately 56% protein bound. Widely distributed to fluids and tissues, including CSF (inflamed meninges) and breast milk; crosses placenta.
Elimination
The t ½ is approximately 1.7 h; serum clearance is 91 mL/min; renal clearance is 56 mL/min; 60% to 70% is recovered in the urine by 8 h; approximately 12% recovered in the feces.
Special Populations
Renal Function Impairment
Serum t ½ may be prolonged.
Hepatic Function Impairment
Serum t ½ may be prolonged.
Elderly
Serum t ½ may be prolonged.

Aztreonam Indications / Aztreonam Uses

Information Not Available

Aztreonam Adverse Reactions / Aztreonam Side Effects

IV: Phloebitis and thrombophloebitis. IM: Pain and swelling at inj site; diarrhoea, nausea, vomiting, altered taste; jaundice, hepatitis, high liver enzymes; long prothrombin time, partial thromboplastin time; rash, urticaria, eosinophilia.


Potentially Fatal:Thrombocytopenia, neutropenia; overgrowth of susceptible organisms; pseudomembranous colitis.

Precautions

Monitor
Review culture and sensitivity of organism as available.


Hypersensitivity
Reactions range from mild to life-threatening. Administer cautiously to penicillin- or cephalosporin-sensitive patients because of possible cross-reactivity.

Renal Function
Reduced dose required.

Superinfection
May result in overgrowth of nonsusceptible bacterial or fungal organisms.

Special Precautions

Hypersensitivity to other β-lactams; renal and hepatic impairment; pregnancy


Other Drug Interactions

Concurrent use with oral anticoagulants may increase prothrombin time

Other Interactions

Information Not Available

Dosage

Intramuscular
Gonorrhoea
Adult: 1 g as a single dose.
Renal impairment: Moderate-severe impairment: Same initial doses, adjust maintenance doses according to the patient's CrCl. Haemodialysis: A supplementary dose of 1/8 of the initial dose may be given after each session.
CrCl (ml/min) 


Dosage Recommendation
10-30Maintenance dose    Half of initial dose
<10Maintenance dose       One-quarter of initial dose

Intramuscular
Cystitis
Adult: 1 g as a single dose.
Renal impairment: Moderate-severe impairment: Same initial doses, adjust maintenance doses according to the patient's CrCl.


Haemodialysis: A supplementary dose of 1/8 of the initial dose may be given after each session.
CrCl (ml/min)                  Dosage Recommendation
10-30Maintenance dose    Half of initial dose
<10Maintenance dose       One-quarter of initial dose

Parenteral
Susceptible infections
Adult: 1-8 g daily in divided doses every 6-12 hour by slow IV inj over 3-5 minutes or as IV infusion over 20-60 minutes. Max: 8 g/day. Dose may be given via deep IM inj or IV inj over 3-5 minutes or IV infusion.
Child: and infants >1 wk: 30 mg/kg every 6 or 8 hours; ≥2 yr: 50 mg/kg every 6 or 8 hours for severe infections. Dose may be given via deep IM inj or slow IV inj or infusion. Doses >1 g should be given via IV route. Max (≥2 yr): 8 g/day.
Renal impairment: Moderate-severe impairment: Same initial doses, adjust maintenance doses according to the patient's CrCl. Haemodialysis: A supplementary dose of 1/8 of the initial dose may be given after each session.
CrCl (ml/min)              Dosage Recommendation
10-30                         Maintenance dose Half of initial dose.
<10                            Maintenance dose One-quarter of initial dose.


Parenteral
Skin and soft tissue infections
Adult: 1-8 g daily in divided doses every 6-12 hr by slow IV inj over 3-5 minutes or as IV infusion over 20-60 minutes. Max: 8 g/day. Dose may be given via deep IM inj or IV inj over 3-5 minutes or IV infusion.
Child: and infants >1 week: 30 mg/kg every 6 or 8 hour; ≥2 year: 50 mg/kg every 6 or 8 hr for severe infections. Dose may be given via deep IM inj or slow IV inj or infusion. Doses >1 g should be given via IV route. Max (≥2 year): 8 g/day.
Renal impairment: Moderate-severe impairment: Same initial doses, adjust maintenance doses according to the patient's CrCl. Haemodialysis: A supplementary dose of 1/8 of the initial dose may be given after each session.
CrCl (ml/min)         Dosage Recommendation
10-30                     Maintenance dose: Half of initial dose.
<10                      Maintenance dose: One-quarter of initial dose.


Parenteral
Pelvic infections
Adult: 1-8 g daily in divided doses every 6-12 hr by slow IV inj over 3-5 minutes or as IV infusion over 20-60 minutes. Max: 8 g/day. Dose may be given via deep IM inj or IV inj over 3-5 minutes or IV infusion.
Child: and infants >1 wk: 30 mg/kg every 6 or 8 hr; ≥2 yr: 50 mg/kg every 6 or 8 hr for severe infections. Dose may be given via deep IM inj or slow IV inj or infusion. Doses >1 g should be given via IV route. Max (≥2 yr): 8 g/day.
Renal impairment: Moderate-severe impairment: Same initial doses, adjust maintenance doses according to the patient's CrCl. Haemodialysis: A supplementary dose of 1/8 of the initial dose may be given after each session.
CrCl (ml/min)     Dosage Recommendation
10-30                Maintenance dose: Half of initial dose.
<10                  Maintenance dose: One-quarter of initial dose.


Parenteral
Intra-abdominal infections
Adult: 1-8 g daily in divided doses every 6-12 hr by slow IV inj over 3-5 minutes or as IV infusion over 20-60 minutes. Max: 8 g/day. Dose may be given via deep IM inj or IV inj over 3-5 minutes or IV infusion.
Child: and infants >1 wk: 30 mg/kg every 6 or 8 hr; ≥2 yr: 50 mg/kg every 6 or 8 hr for severe infections. Dose may be given via deep IM inj or slow IV inj or infusion. Doses >1 g should be given via IV route. Max (≥2 yr): 8 g/day.
Renal impairment: Moderate-severe impairment: Same initial doses, adjust maintenance doses according to the patient's CrCl. Haemodialysis: A supplementary dose of 1/8 of the initial dose may be given after each session.
CrCl (ml/min)  Dosage Recommendation
10-30            Maintenance dose: Half of initial dose.
<10               Maintenance dose: One-quarter of initial dose.


Parenteral
Lower respiratory tract infections
Adult: 1-8 g daily in divided doses every 6-12 hr by slow IV inj over 3-5 minutes or as IV infusion over 20-60 minutes. Max: 8 g/day. Dose may be given via deep IM inj or IV inj over 3-5 minutes or IV infusion.
Child: and infants >1 wk: 30 mg/kg every 6 or 8 hr; ≥2 yr: 50 mg/kg every 6 or 8 hr for severe infections. Dose may be given via deep IM inj or slow IV inj or infusion. Doses >1 g should be given via IV route. Max (≥2 yr): 8 g/day.
Renal impairment: Moderate-severe impairment: Same initial doses, adjust maintenance doses according to the patient's CrCl. Haemodialysis: A supplementary dose of 1/8 of the initial dose may be given after each session.
CrCl (ml/min)       Dosage Recommendation
10-30                  Maintenance dose: Half of initial dose.
<10                     Maintenance dose: One-quarter of initial dose.


Parenteral
Meningitis
Adult: 1-8 g daily in divided doses every 6-12 hr by slow IV inj over 3-5 minutes or as IV infusion over 20-60 minutes. Max: 8 g/day. Dose may be given via deep IM inj or IV inj over 3-5 minutes or IV infusion.
Child: and infants >1 wk: 30 mg/kg every 6 or 8 hour; ≥2 your: 50 mg/kg every 6 or 8 hr for severe infections. Dose may be given via deep IM inj or slow IV inj or infusion. Doses >1 g should be given via IV route. Max (≥2 yr): 8 g/day.
Renal impairment: Moderate-severe impairment: Same initial doses, adjust maintenance doses according to the patient's CrCl. Haemodialysis: A supplementary dose of 1/8 of the initial dose may be given after each session.
CrCl (ml/min)        Dosage Recommendation
10-30                   Maintenance dose: Half of initial dose.
<10                      Maintenance dose: One-quarter of initial dose.


Parenteral
Septicaemia
Adult: 1-8 g daily in divided doses every 6-12 hr by slow IV inj over 3-5 minutes or as IV infusion over 20-60 minutes. Max: 8 g/day. Dose may be given via deep IM inj or IV inj over 3-5 minutes or IV infusion.
Child: and infants >1 wk: 30 mg/kg every 6 or 8 hour; ≥2 year: 50 mg/kg every 6 or 8 hour for severe infections. Dose may be given via deep IM inj or slow IV inj or infusion. Doses >1 g should be given via IV route. Max (≥2 year): 8 g/day.
Renal impairment: Moderate-severe impairment: Same initial doses, adjust maintenance doses according to the patient's CrCl. Haemodialysis: A supplementary dose of 1/8 of the initial dose may be given after each session.
CrCl (ml/min)         Dosage Recommendation
10-30                    Maintenance dose: Half of initial dose.
<10                       Maintenance dose: One-quarter of initial dose.


Parenteral
Bone and joint infections
Adult: 1-8 g daily in divided doses every 6-12 hr by slow IV inj over 3-5 minutes or as IV infusion over 20-60 minutes. Max: 8 g/day. Dose may be given via deep IM inj or IV inj over 3-5 minutes or IV infusion.
Child: and infants >1 wk: 30 mg/kg every 6 or 8 hr; ≥2 year: 50 mg/kg every 6 or 8 hr for severe infections. Dose may be given via deep IM inj or slow IV inj or infusion. Doses >1 g should be given via IV route. Max (≥2 year): 8 g/day.
Renal impairment: Moderate-severe impairment: Same initial doses, adjust maintenance doses according to the patient's CrCl. Haemodialysis: A supplementary dose of 1/8 of the initial dose may be given after each session.
CrCl (ml/min)         Dosage Recommendation
10-30                   Maintenance dose: Half of initial dose.
<10                     Maintenance dose: One-quarter of initial dose.


Parenteral
Gonorrhoea
Adult: 1-8 g daily in divided doses every 6-12 hr by slow IV inj over 3-5 minutes or as IV infusion over 20-60 minutes. Max: 8 g/day. Dose may be given via deep IM inj or IV inj over 3-5 minutes or IV infusion.
Child: and infants >1 week: 30 mg/kg every 6 or 8 hr; ≥2 year: 50 mg/kg every 6 or 8 hr for severe infections. Dose may be given via deep IM inj or slow IV inj or infusion. Doses >1 g should be given via IV route. Max (≥2 year): 8 g/day.
Renal impairment: Moderate-severe impairment: Same initial doses, adjust maintenance doses according to the patient's CrCl. Haemodialysis: A supplementary dose of 1/8 of the initial dose may be given after each session.
CrCl (ml/min)        Dosage Recommendation
10-30                  Maintenance dose: Half of initial dose.
<10                     Maintenance dose: One-quarter of initial dose.


Parenteral
Urinary tract infections
Adult: 0.5–1 g every 8–12 hour. Dose may be given via deep IM inj or IV inj over 3-5 minutes or IV infusion.

Incompatibility


Incompatible with cefradine, metronidazole, nafcillin and vancomycin.

Food(before/after)

Information Not Available

List of Contraindications

Aztreonam and Pregnancy

Caution when used during pregnancy.


Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).

Aztreonam and Lactation

Contraindicated in lactation

Aztreonam and Children

Information Not Available

Aztreonam and Geriatic

Information Not Available

Aztreonam and Other Contraindications

Hypersensitivity; lactation

Storage

Intramuscular
Once reconstituted, it should be used within 48 hr if stored at 15-30°C or 7 days if stored at 2-8°C.

Parenteral
Once reconstituted, it should be used within 48 hr if stored at 15-30°C or 7 days if stored at 2-8°C.

Lab interference

Intramuscular
Once reconstituted, it should be used within 48 hr if stored at 15-30°C or 7 days if stored at 2-8°C.

Parenteral
Once reconstituted, it should be used within 48 hr if stored at 15-30°C or 7 days if stored at 2-8°C.

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