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Ceftazidime and Avibactam Sodium for Injection 2.5g
Composition:
Each vial contains:
- Ceftazidime (as Ceftazidime Sodium) 2g
- Avibactam (as Avibactam Sodium) 0.5g
Description:
Ceftazidime is a third-generation cephalosporin antibiotic with broad-spectrum activity against Gram-negative bacteria, including Pseudomonas aeruginosa. Avibactam is a non-β-lactam β-lactamase inhibitor that enhances the activity of ceftazidime by inhibiting bacterial resistance mechanisms (β-lactamases). This combination is particularly effective against carbapenem-resistant Enterobacterales (CRE) and multidrug-resistant (MDR) infections.
Indications:
Ceftazidime and Avibactam for Injection is indicated for the treatment of the following infections in adults and pediatric patients (≥3 months) caused by susceptible Gram-negative bacteria:
- Complicated intra-abdominal infections (cIAI) (in combination with metronidazole)
- Complicated urinary tract infections (cUTI), including pyelonephritis
- Hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP)
- Bacteremia associated with the above infections
Dosage & Administration:
- Adults and Adolescents (≥18 years):
- 2.5g (2g ceftazidime + 0.5g avibactam) every 8 hours via intravenous (IV) infusion over 2 hours
- Duration:
- cIAI and cUTI: 5-14 days
- HAP/VAP: 7-14 days
- Pediatric Patients (≥3 months - <18 years):
- 50 mg/kg (maximum 2.5g per dose) every 8 hours via IV infusion over 2 hours
- Patients with Renal Impairment:
- Dosage adjustment required based on creatinine clearance (CrCl ≤50 mL/min)
Administration:
- Intravenous (IV) Infusion:
- Reconstitute with sterile water for injection and further dilute in 0.9% sodium chloride or 5% dextrose
- Administer over 2 hours via IV infusion
Contraindications:
- Hypersensitivity to Ceftazidime, Avibactam, cephalosporins, or penicillins
Precautions:
- Perform a skin sensitivity test before administration in allergic patients
- Monitor renal function regularly, especially in critically ill patients
- Use with caution in patients with seizures or neurological disorders
Adverse Reactions:
- Gastrointestinal: Nausea, vomiting, diarrhea
- Allergic Reactions: Rash, pruritus, anaphylaxis (rare)
- Hematologic: Leukopenia, thrombocytopenia
- Hepatic: Elevated liver enzymes (ALT, AST)
- Neurological: Confusion, seizures (rare, mainly in renally impaired patients)
Drug Interactions:
- May enhance the nephrotoxicity of aminoglycosides
- May interact with probenecid, leading to reduced clearance of Avibactam
Storage Conditions:
- Store below 25°C, protect from light and moisture
- Reconstituted solution should be used within 12 hours at room temperature or 24 hours if refrigerated
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