AZACTAM IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for AZACTAM IN PLASTIC CONTAINER (AZACTAM IN PLASTIC CONTAINER).
Aztreonam binds to penicillin-binding proteins (PBPs) of susceptible bacteria, inhibiting bacterial cell wall synthesis. It is a monobactam with activity against aerobic gram-negative bacteria.
| Metabolism | Hepatic metabolism via hydrolysis of the beta-lactam ring; also undergoes renal elimination. Not extensively metabolized by CYP450 enzymes. |
| Excretion | Primarily renal (75-85% unchanged via glomerular filtration and tubular secretion); biliary/fecal <10%. |
| Half-life | 1.7-2.1 hours (normal renal function); prolonged to 4.2-6.0 hours in ESRD (CrCl <10 mL/min). |
| Protein binding | 50-60% (primarily albumin). |
| Volume of Distribution | 0.16-0.3 L/kg (primarily extracellular fluid; low tissue penetration). |
| Bioavailability | IM: 70-85%. |
| Onset of Action | IV: Immediate; IM: 30-60 minutes. |
| Duration of Action | 8-12 hours (dependent on renal function and MIC); requires dose adjustment in renal impairment. |
1-2 g IV/IM every 6-8 hours; maximum 8 g/day.
| Dosage form | INJECTABLE |
| Renal impairment | CrCl 30-60 mL/min: 1-2 g every 12 hours; CrCl 10-30 mL/min: 500 mg-1 g every 12 hours; CrCl <10 mL/min: 500 mg-1 g every 24 hours. |
| Liver impairment | No specific adjustment required; use standard dosing. |
| Pediatric use | Neonates (≤7 days): 30 mg/kg IV every 12 hours; Infants/children: 30-50 mg/kg IV/IM every 6-8 hours (max 6 g/day). |
| Geriatric use | Adjust based on renal function; no specific age-related adjustments. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for AZACTAM IN PLASTIC CONTAINER (AZACTAM IN PLASTIC CONTAINER).
| Breastfeeding | Aztreonam is excreted in human breast milk in low concentrations (M/P ratio not established). Considered compatible with breastfeeding; caution in infants with renal impairment or hypersensitivity. |
| Teratogenic Risk | Pregnancy Category B. No evidence of teratogenicity in animal studies. Insufficient human data; use only if clearly needed. First trimester: no known fetal risk. Second trimester: no known fetal risk. Third trimester: no known fetal risk. |
| Fetal Monitoring |
■ FDA Black Box Warning
None
| Serious Effects |
["Known hypersensitivity to aztreonam or any component of the formulation"]
| Precautions | ["Hypersensitivity reactions (including anaphylaxis) have been reported, especially in patients with a history of beta-lactam allergy","Clostridium difficile-associated diarrhea (CDAD) may occur","Renal impairment: dosage adjustment recommended","Seizures, especially in patients with renal impairment or CNS disorders","Lack of activity against gram-positive bacteria or anaerobes; use with appropriate agents for mixed infections"] |
| Food/Dietary | Avoid alcohol and products containing alcohol during treatment and for 48 hours after the last dose due to risk of disulfiram-like reaction. No other food interactions known. |
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| Monitor renal function, hepatic function, and complete blood count during prolonged therapy. No specific fetal monitoring required. |
| Fertility Effects | No evidence of impaired fertility in animal studies. No human data on fertility effects. |
| Clinical Pearls | Aztreonam is a monobactam antibiotic active against aerobic gram-negative bacilli, including Pseudomonas aeruginosa. It lacks activity against gram-positive and anaerobic organisms. Monitor renal function as dosage adjustment is required in creatinine clearance <30 mL/min. It is safe in penicillin-allergic patients due to minimal cross-reactivity. Administer as a 20-60 minute IV infusion. Incompatible with nafcillin, cephradine, and metronidazole. |
| Patient Advice | This medication is used to treat bacterial infections, not viral infections. · Take the full course as prescribed, even if you feel better. · Report any signs of allergic reaction such as rash, itching, or difficulty breathing. · May cause diarrhea; contact your doctor if it becomes severe or bloody. · Avoid alcohol during treatment and for 48 hours after to prevent disulfiram-like reaction. |