Usage
Ceftazidime + Sulbactam is prescribed for severe bacterial infections, especially in hospitalized patients. It is a β-lactam/β-lactamase inhibitor combination antibiotic used to treat a wide range of infections, including complicated intra-abdominal infections, urinary tract infections, hospital-acquired and ventilator-associated pneumonia, septicemia, bone and joint infections, skin and skin structure infections, meningitis, and infections in immunocompromised patients. Ceftazidime, a third-generation cephalosporin antibiotic, disrupts bacterial cell wall synthesis, leading to cell death. Sulbactam, a β-lactamase inhibitor, protects ceftazidime from degradation by bacterial enzymes, broadening its spectrum of activity against resistant strains.
Alternate Names
While Ceftazidime + Sulbactam itself doesn’t have a widely recognized international nonproprietary name (INN), the individual components do: ceftazidime and sulbactam. Several brand names exist globally, including Zydotum.
How It Works
Pharmacodynamics: Ceftazidime exerts its bactericidal action by binding to penicillin-binding proteins (PBPs) essential for bacterial cell wall synthesis. This binding inhibits the cross-linking of peptidoglycans, crucial components of the cell wall, causing cell lysis and death. Sulbactam, a β-lactamase inhibitor, irreversibly binds to and inhibits β-lactamase enzymes produced by bacteria. These enzymes normally break down β-lactam antibiotics like ceftazidime, rendering them ineffective. By inhibiting β-lactamases, sulbactam protects ceftazidime, extending its activity against β-lactamase-producing, resistant bacteria.
Pharmacokinetics: Ceftazidime + Sulbactam is administered parenterally (IV or IM). Both components are eliminated primarily via renal excretion, with minimal hepatic metabolism. Dosage adjustments are necessary for patients with renal impairment. Both drugs achieve therapeutic concentrations in various tissues and fluids, including cerebrospinal fluid, making them effective against meningitis.
Elimination pathways: Ceftazidime and Sulbactam are both predominantly excreted via the kidneys, with some hepatic elimination.
Dosage
Standard Dosage
Adults:
The standard dose of Ceftazidime + Sulbactam is 1.5-3 grams every 8-12 hours via IV or IM injection or infusion, based on infection severity.
Children:
For children older than 2 months, the recommended dose is 30-100 mg/kg/day, divided into 2-3 doses. For neonates (0-2 months), the dosage is lower, usually 25-60 mg/kg/day divided into two doses. Higher doses (up to 150 mg/kg/day, max 6g/day) may be necessary for immunocompromised children, cystic fibrosis patients, or children with meningitis.
Special Cases:
- Elderly Patients: For patients over 80 years, a maximum daily dose of 3 g is recommended.
- Patients with Renal Impairment: Dosage adjustment is crucial in renal impairment. Dose reduction or increased dosing intervals may be necessary depending on creatinine clearance.
- Patients with Hepatic Dysfunction: Dosage adjustments are typically not necessary.
- Patients with Comorbid Conditions: Caution is advised in patients with gastrointestinal diseases, especially colitis.
Clinical Use Cases
- Intubation/Surgical Procedures/Mechanical Ventilation/ICU Use: Standard adult dosing applies, adjusted based on infection severity and renal function.
- Emergency Situations: Standard adult dosing applies.
Dosage Adjustments
Dose adjustments are necessary for patients with renal impairment, with the frequency and amount of the dose being determined by the degree of renal dysfunction.
Side Effects
Common Side Effects:
- Stomach pain
- Allergic reactions (rash, itching)
- Nausea
- Diarrhea
- Vomiting
- Pain, inflammation at injection site
- Phlebitis/thrombophlebitis (with IV administration)
- Eosinophilia
- Thrombocytosis
Rare but Serious Side Effects:
- Angioedema
- Seizures
- Encephalopathy
- Coma
- Neuromuscular excitability
- Myoclonia
- Clostridium difficile-associated diarrhea
- Jaundice
- Erythema multiforme
- Stevens-Johnson syndrome
Long-Term Effects:
- Overgrowth of non-susceptible organisms
Adverse Drug Reactions (ADR):
- Anaphylaxis
- Severe hypersensitivity reactions
Contraindications
- Hypersensitivity to ceftazidime, sulbactam, other cephalosporins, penicillins, or β-lactamase inhibitors.
- History of ceftazidime-associated cholestatic jaundice or hepatic dysfunction.
Drug Interactions
- Aminoglycosides (increased risk of nephrotoxicity)
- Probenecid (decreased renal clearance of ceftazidime)
- Furosemide
- Chloramphenicol
- Alcohol (interaction unknown, advise caution).
Pregnancy and Breastfeeding
Ceftazidime + Sulbactam is classified under Pregnancy Category B. It should be used during pregnancy only if clearly needed. Low concentrations are excreted in breast milk, so caution is needed when administering to nursing women.
Drug Profile Summary
- Mechanism of Action: Ceftazidime inhibits bacterial cell wall synthesis; sulbactam inhibits β-lactamases.
- Side Effects: Common: Nausea, vomiting, diarrhea, allergic reactions. Serious: Seizures, Clostridium difficile-associated diarrhea, hypersensitivity reactions.
- Contraindications: Hypersensitivity to components, history of ceftazidime-associated jaundice/hepatic dysfunction.
- Drug Interactions: Aminoglycosides, probenecid, loop diuretics.
- Pregnancy & Breastfeeding: Use with caution if clearly needed. Excreted in breast milk.
- Dosage: Adults: 1.5-3g IV/IM every 8-12 hours. Children: dose by weight; adjust for renal impairment.
- Monitoring Parameters: Renal function, signs of superinfection, liver function tests.
Popular Combinations
- Metronidazole (for intra-abdominal infections).
Precautions
- Evaluate renal function before and during therapy.
- Monitor for signs of superinfection (e.g., candidiasis, Clostridium difficile-associated diarrhea).
- Patients with a history of penicillin allergy should be cautiously evaluated before use.
- Avoid alcohol during therapy.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Ceftazidime + Sulbactam?
A: Adults: 1.5-3g IV/IM every 8-12 hours. Children: Weight based dosing (see above); adjust for renal impairment.
Q2: What are the common side effects?
A: Nausea, vomiting, diarrhea, allergic reactions, pain at the injection site.
Q3: Is Ceftazidime + Sulbactam safe in pregnancy?
A: Category B; use only if clearly needed.
Q4: How does Ceftazidime + Sulbactam work?
A: Ceftazidime inhibits cell wall synthesis; sulbactam inhibits bacterial β-lactamases.
Q5: What infections does it treat?
A: Wide range, including intra-abdominal, urinary tract, respiratory, skin, bone/joint, septicemia, and meningitis.
Q6: Are there any drug interactions?
A: Yes, with aminoglycosides, probenecid, loop diuretics, and possibly alcohol.
Q7: What precautions should be taken?
A: Monitor renal function, signs of superinfection, and be cautious in penicillin-allergic patients.
Q8: Should the dose be adjusted for renal impairment?
A: Yes, dosage adjustment is crucial in renal impairment.
Q9: Can it be used in children?
A: Yes, with weight-based dosing.
Q10: What should I do if a patient develops severe diarrhea?
A: Discontinue medication and evaluate for Clostridium difficile-associated diarrhea.
